Proposed Rule: Air Programs: Ambient Air Quality Standards, National&#8212 8-Hour Ozone Standard Level Revised To Provide Increased Protection For Children and Other At-Risk Populations Hearings

Wednesday,
July 11, 2007
Part II
Environmental
Protection Agency
40 CFR Part 50
National Ambient Air Quality Standards
for Ozone; Proposed Rule
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37818 Federal Register / Vol. 72, No. 132 / Wednesday, July 11, 2007 / Proposed Rules
ENVIRONMENTAL PROTECTION EPA solicits comment on specifying a comment, EPA recommends that you
AGENCY cumulative, seasonal standard in terms include your name and other contact
of a 3-year average of the annual sums information in the body of your
40 CFR Part 50 of weighted hourly concentrations; on comment and with any disk or CD–ROM
[EPA–HQ–OAR–2005–0172; FRL–8331–5] the range of alternative 8-hour standard you submit. If EPA cannot read your
levels for which comment is being comment due to technical difficulties
RIN 2060–AN24 solicited for the primary standard, and cannot contact you for clarification,
including retaining the current EPA may not be able to consider your
National Ambient Air Quality secondary standard, which is identical comment. Electronic files should avoid
Standards for Ozone to the current primary standard; and on the use of special characters, any form
AGENCY: Environmental Protection an alternative approach to setting a of encryption, and be free of any defects
Agency (EPA). cumulative, seasonal secondary or viruses. For additional information
standard(s). about EPA’s public docket, visit the EPA
ACTION: Proposed rule.
DATES: Written comments on this Docket Center homepage at http://
SUMMARY: Based on its review of the air proposed rule must be received by www.epa.gov/epahome/dockets.htm.
quality criteria for ozone (O3) and October 9, 2007. Docket: All documents in the docket
related photochemical oxidants and are listed in the www.regulations.gov
ADDRESSES: Submit your comments,
national ambient air quality standards index. Although listed in the index,
identified by Docket ID No. EPA–HQ–
(NAAQS) for O3, EPA proposes to make some information is not publicly
OAR–2005–0172, by one of the
revisions to the primary and secondary available, e.g., CBI or other information
following methods:
NAAQS for O3 to provide requisite whose disclosure is restricted by statute.
• www.regulations.gov: Follow the
protection of public health and welfare, Certain other material, such as
on-line instructions for submitting
respectively, and to make corresponding copyrighted material, will be publicly
comments.
revisions in data handling conventions • E-mail: a-and-r-Docket@epa.gov. available only in hard copy. Publicly
for O3. • Fax: 202–566–1741. available docket materials are available
With regard to the primary standard • Mail: Docket No. EPA–HQ–OAR– either electronically in
for O3, EPA proposes to revise the level 2005–0172, Environmental Protection www.regulations.gov or in hard copy at
of the 8-hour standard to a level within Agency, Mail code 6102T, 1200 the Air and Radiation Docket and
the range of 0.070 to 0.075 parts per Pennsylvania Ave., NW., Washington, Information Center, EPA/DC, EPA West,
million (ppm), to provide increased DC 20460. Please include a total of two Room 3334, 1301 Constitution Ave.,
protection for children and other ‘‘at copies. NW., Washington, DC. The Public
risk’’ populations against an array of O3- • Hand Delivery: Docket No. EPA– Reading Room is open from 8:30 a.m. to
related adverse health effects that range HQ–OAR–2005–0172, Environmental 4:30 p.m., Monday through Friday,
from decreased lung function and Protection Agency, EPA West, Room excluding legal holidays. The telephone
increased respiratory symptoms to 3334, 1301 Constitution Ave., NW., number for the Public Reading Room is
serious indicators of respiratory Washington, DC. Such deliveries are (202) 566–1744 and the telephone
morbidity including emergency only accepted during the Docket’s number for the Air and Radiation
department visits and hospital normal hours of operation, and special Docket and Information Center is (202)
admissions for respiratory causes, and arrangements should be made for 566–1742.
possibly cardiovascular-related deliveries of boxed information. Public Hearings: The EPA intends to
morbidity as well as total nonaccidental Instructions: Direct your comments to hold public hearings around the end of
and cardiopulmonary mortality. The Docket ID No. EPA–HQ–OAR–2005– August to early September in several
EPA also proposes to specify the level 0172. The EPA’s policy is that all cities across the country, and will
of the primary standard to the nearest comments received will be included in announce in a separate Federal Register
thousandth ppm. The EPA solicits the public docket without change and notice the dates, times, and addresses of
comment on alternative levels down to may be made available online at the public hearings on this proposed
0.060 ppm and up to and including www.regulations.gov, including any rule.
retaining the current 8-hour standard of personal information provided, unless FOR FURTHER INFORMATION CONTACT: Dr.
0.08 ppm (effectively 0.084 ppm using the comment includes information David J. McKee, Health and
current data rounding conventions). claimed to be Confidential Business Environmental Impacts Division, Office
With regard to the secondary standard Information (CBI) or other information of Air Quality Planning and Standards,
for O3, EPA proposes to revise the whose disclosure is restricted by statute. U.S. Environmental Protection Agency,
current 8-hour standard with one of two Do not submit information that you Mail code C504–06, Research Triangle
options to provide increased protection consider to be CBI or otherwise Park, NC 27711; telephone: 919–541–
against O3-related adverse impacts on protected through www.regulations.gov 5288; fax: 919–541–0237; e-mail:
vegetation and forested ecosystems. One or e-mail. The www.regulations.gov Web mckee.dave@epa.gov.
option is to replace the current standard site is an ‘‘anonymous access’’ system,
SUPPLEMENTARY INFORMATION:
with a cumulative, seasonal standard which means EPA will not know your
expressed as an index of the annual sum identity or contact information unless General Information
of weighted hourly concentrations, you provide it in the body of your
cumulated over 12 hours per day (8 a.m. comment. If you send an e-mail What Should I Consider as I Prepare My
to 8:00 p.m.) during the consecutive 3- comment directly to EPA without going Comments for EPA?
month period within the O3 season with through www.regulations.gov, your e- 1. Submitting CBI. Do not submit this
the maximum index value, set at a level mail address will be automatically information to EPA through
within the range of 7 to 21 ppm-hours. captured and included as part of the www.regulations.gov or e-mail. Clearly
The other option is to make the comment that is placed in the public mark the part or all of the information
secondary standard identical to the docket and made available on the that you claim to be CBI. For CBI
proposed primary 8-hour standard. The Internet. If you submit an electronic information in a disk or CD ROM that
Federal Register / Vol. 72, No. 132 / Wednesday, July 11, 2007 / Proposed Rules 37819
you mail to EPA, mark the outside of the risk assessments and other related E. Conclusions on the Elements of the
disk or CD ROM as CBI and then technical documents are available at Secondary Standard
identify electronically within the disk or http://www.epa.gov/ttn/naaqs/ 1. Indicator
2. Cumulative, Seasonal Standard
CD ROM the specific information that is standards/ozone/s_o3_cr_td.html. EPA
3. 8-Hour Average Standard
claimed as CBI. In addition to one will be making available corrected F. Proposed Decision on the Secondary
complete version of the comment that versions of the final Staff Paper and Standard
includes information claimed as CBI, a human exposure and health risk V. Creation of Appendix P—Interpretation of
copy of the comment that does not assessment technical support the NAAQS for Ozone
contain the information claimed as CBI documents on these same EPA Web A. Data Completeness
must be submitted for inclusion in the sites on or around July 16, 2007. These B. Data Handling and Rounding O3
public docket. Information so marked and other related documents are also Conventions
will not be disclosed except in available for inspection and copying in VI. Ambient Monitoring Related to Proposed
Revised Standards
accordance with procedures set forth in the EPA docket identified above.
VII. Statutory and Executive Order Reviews
40 CFR part 2. References
2. Tips for Preparing Your Comments. Table of Contents
When submitting comments, remember The following topics are discussed in I. Background
to: this preamble:
A. Legislative Requirements
• Identify the rulemaking by docket I. Background
number and other identifying A. Legislative Requirements Two sections of the Clean Air Act
information (subject heading, Federal B. Related Control Requirements (CAA) govern the establishment and
Register date and page number). C. Review of Air Quality Criteria and revision of the NAAQS. Section 108 (42
• Follow directions—The Agency Standards for O3 U.S.C. 7408) directs the Administrator
II. Rationale for Proposed Decision on the to identify and list ‘‘air pollutants’’ that
may ask you to respond to specific Primary Standard
questions or organize comments by A. Health Effects Information
‘‘in his judgment, may reasonably be
referencing a Code of Federal 1. Mechanisms anticipated to endanger public health
Regulations (CFR) part or section 2. Nature of Effects and welfare’’ and whose ‘‘presence
number. 3. Interpretation and Integration of the * * * in the ambient air results from
• Explain why you agree or disagree, Health Evidence numerous or diverse mobile or
suggest alternatives, and substitute 4. O3-Related Impacts on Public Health stationary sources’’ and to issue air
language for your requested changes. B. Human Exposure and Health Risk quality criteria for those that are listed.
• Describe any assumptions and Assessments Air quality criteria are intended to
provide any technical information and/ 1. Exposure Analyses ‘‘accurately reflect the latest scientific
2. Quantitative Health Risk Assessment
or data that you used. knowledge useful in indicating the kind
C. Conclusions on the Adequacy of the
• If you estimate potential costs or Current Primary Standard and extent of identifiable effects on
burdens, explain how you arrived at 1. Background public health or welfare which may be
your estimate in sufficient detail to 2. Evidence- and Exposure/Risk-Based expected from the presence of [a]
allow for it to be reproduced. Considerations pollutant in ambient air * * *.’’
• Provide specific examples to 3. CASAC Views Section 109 (42 U.S.C. 7409) directs
illustrate your concerns, and suggest 4. Administrator’s Proposed Conclusions the Administrator to propose and
alternatives. Concerning Adequacy of Current promulgate ‘‘primary’’ and ‘‘secondary’’
• Explain your views as clearly as Standard NAAQS for pollutants listed under
possible, avoiding the use of profanity D. Conclusions on the Elements of the section 108. Section 109(b)(1) defines a
or personal threats. Primary Standard
1. Indicator
primary standard as one ‘‘the attainment
• Make sure to submit your and maintenance of which in the
2. Averaging Time
comments by the comment period 3. Form judgment of the Administrator, based on
deadline identified. 4. Level such criteria and allowing an adequate
Availability of Related Information E. Proposed Decision on the Primary margin of safety, are requisite to protect
Standard the public health.’’ 1 A secondary
A number of documents relevant to III. Communication of Public Health standard, as defined in section
this rulemaking are available on EPA Information 109(b)(2), must ‘‘specify a level of air
Web sites. The Air Quality Criteria for IV. Rationale for Proposed Decision on the quality the attainment and maintenance
Ozone and Related Photochemical Secondary Standard
A. Vegetation Effects Information
of which, in the judgment of the
Oxidants (Criteria Document) (two Administrator, based on such criteria, is
volumes, EPA/ and EPA/, date) is 1. Mechanisms Governing Plant Response
to Ozone requisite to protect the public welfare
available on EPA’s National Center for from any known or anticipated adverse
2. Nature of Effects
Environmental Assessment Web site. To 3. Adversity of Effects effects associated with the presence of
obtain this document, go to http:// B. Biologically Relevant Exposure Indices [the] pollutant in the ambient air.’’ 2
www.epa.gov/ncea, and click on C. Vegetation Exposure and Impact
‘‘Ozone.’’ The Staff Paper, human Assessment 1 The legislative history of section 109 indicates
exposure and health risk assessments, 1. Exposure Characterization that a primary standard is to be set at ‘‘the
vegetation exposure and impact 2. Assessment of Risks to Vegetation maximum permissible ambient air level * * *
assessment, and other related technical D. Conclusions on the Adequacy of the which will protect the health of any [sensitive]
Current Standard group of the population,’’ and that for this purpose
documents are available on EPA’s Office
1. Background ‘‘reference should be made to a representative

of Air Quality Planning and Standards sample of persons comprising the sensitive group
2. Evidence- and Exposure/Risk-Based
(OAQPS) Technology Transfer Network Considerations
rather than to a single person in such a group’’ [S.
(TTN) Web site. The Staff Paper is Rep. No. 91–1196, 91st Cong., 2d Sess. 10 (1970)].
3. CASAC Views 2 Welfare effects as defined in section 302(h) (42
available at http://www.epa.gov/ttn/ 4. Administrator’s Proposed Conclusions U.S.C. 7602(h)) include, but are not limited to,
naaqs/standards/ozone/ Concerning Adequacy of Current ‘‘effects on soils, water, crops, vegetation, man-
s_o3_cr_sp.html, and the exposure and Standard Continued
The requirement that primary costs of implementing the standards. Id. they give her considerable discretion when
standards include an adequate margin of at 471. As discussed by Justice Breyer in she does so.
safety was intended to address Whitman v. American Trucking This discretion would seem sufficient to
uncertainties associated with Associations, however, ‘‘this avoid the extreme results that some of the
inconclusive scientific and technical interpretation of § 109 does not require industry parties fear. After all, the EPA, in
information available at the time of the EPA to eliminate every health risk, setting standards that ‘‘protect the public
standard setting. It was also intended to however slight, at any economic cost, health’’ with ‘‘an adequate margin of safety,’’
provide a reasonable degree of however great, to the point of ‘‘hurtling’’ retains discretionary authority to avoid
protection against hazards that research industry over ‘‘the brink of ruin,’’ or regulating risks that it reasonably concludes
has not yet identified. Lead Industries even forcing ‘‘deindustrialization.’’ Id. are trivial in context. Nor need regulation
Association v. EPA, 647 F.2d 1130, 1154 at 494 (Breyer J., concurring in part and lead to deindustrialization. Preindustrial
(DC Cir 1980), cert. denied, 449 U.S. concurring in judgment) (citations society was not a very healthy society; hence
1042 (1980); American Petroleum omitted). Rather, as Justice Breyer a standard demanding the return of the Stone
Institute v. Costle, 665 F.2d 1176, 1186 explained: Age would not prove ‘‘requisite to protect the
(D.C. Cir. 1981), cert. denied, 455 U.S. public health.’’
The statute, by its express terms, does not Although I rely more heavily than does the
1034 (1982). Both kinds of uncertainties compel the elimination of all risk; and it
are components of the risk associated Court upon legislative history and alternative
grants the Administrator sufficient flexibility
with pollution at levels below those at to avoid setting ambient air quality standards sources of statutory flexibility, I reach the
which human health effects can be said ruinous to industry. same ultimate conclusion. Section 109 does
to occur with reasonable scientific Section 109(b)(1) directs the Administrator not delegate to the EPA authority to base the
certainty. Thus, in selecting primary to set standards that are ‘‘requisite to protect national ambient air quality standards, in
standards that include an adequate the public health’’ with ‘‘an adequate margin whole or in part, upon the economic costs of
margin of safety, the Administrator is of safety.’’ But these words do not describe compliance.
a world that is free of all risk—an impossible
seeking not only to prevent pollution and undesirable objective. (citation omitted). Id. at 494–496.
levels that have been demonstrated to be Nor are the words ‘‘requisite’’ and ‘‘public
harmful but also to prevent lower Section 109(d)(1) of the CAA requires
health’’ to be understood independent of
pollutant levels that may pose an context. We consider football equipment that ‘‘not later than December 31, 1980,
unacceptable risk of harm, even if the ‘‘safe’’ even if its use entails a level of risk and at 5-year intervals thereafter, the
risk is not precisely identified as to that would make drinking water ‘‘unsafe’’ for Administrator shall complete a
nature or degree. The CAA does not consumption. And what counts as thorough review of the criteria
require the Administrator to establish a ‘‘requisite’’ to protecting the public health published under section 108 and the
primary NAAQS at a zero-risk level or will similarly vary with background national ambient air quality standards
circumstances, such as the public’s ordinary * * * and shall make such revisions in
at background concentration levels, see tolerance of the particular health risk in the
Lead Industries Association v. EPA, 647 particular context at issue. The Administrator
such criteria and standards and
F.2d at 1156 n. 51, but rather at a level can consider such background circumstances promulgate such new standards as may
that reduces risk sufficiently so as to when ‘‘deciding what risks are acceptable in be appropriate * * *.’’ Section
protect public health with an adequate the world in which we live.’’ (citation 109(d)(2) requires that an independent
margin of safety. omitted). scientific review committee ‘‘shall
In addressing the requirement for an The statute also permits the Administrator complete a review of the criteria * * *
adequate margin of safety, EPA to take account of comparative health risks. and the national primary and secondary
considers such factors as the nature and That is to say, she may consider whether a ambient air quality standards * * * and
severity of the health effects involved, proposed rule promotes safety overall. A rule
likely to cause more harm to health than it
shall recommend to the Administrator
the size of the population(s) at risk, and any new * * * standards and revisions
prevents is not a rule that is ‘‘requisite to
the kind and degree of the uncertainties protect the public health.’’ For example, as of existing criteria and standards as may
that must be addressed. The selection of the Court of Appeals held and the parties do be appropriate * * *.’’ This
any particular approach to providing an not contest, the Administrator has the independent review function is
adequate margin of safety is a policy authority to determine to what extent performed by the Clean Air Scientific
choice left specifically to the possible health risks stemming from Advisory Committee (CASAC) of EPA’s
Administrator’s judgment. Lead reductions in tropospheric ozone (which, it Science Advisory Board.
Industries Association v. EPA, 647 F.2d is claimed, helps prevent cataracts and skin
at 1161–62; Whitman v. American cancer) should be taken into account in B. Related Control Requirements
Trucking Associations, 531 U.S. 457, setting the ambient air quality standard for
495 (2001) (Breyer, J., concurring in part ozone. (citation omitted). States have primary responsibility for
The statute ultimately specifies that the ensuring attainment and maintenance of
and concurring in judgment). standard set must be ‘‘requisite to protect the
In setting standards that are ambient air quality standards once EPA
public health’’ ‘‘in the judgment of the has established them. Under section 110
‘‘requisite’’ to protect public health and Administrator,’’ § 109(b)(1), 84 Stat. 1680
welfare, as provided in section 109(b), of the Act (42 U.S.C. 7410) and related
(emphasis added), a phrase that grants the
EPA’s task is to establish standards that Administrator considerable discretionary
provisions, States are to submit, for EPA
are neither more nor less stringent than standard-setting authority. approval, State implementation plans
necessary for these purposes. Whitman The statute’s words, then, authorize the (SIPs) that provide for the attainment
v. American Trucking Associations, 531 Administrator to consider the severity of a and maintenance of such standards
U.S. 457, 473. In establishing pollutant’s potential adverse health effects, through control programs directed to
‘‘requisite’’ primary and secondary the number of those likely to be affected, the emission sources. The majority of man-
distribution of the adverse effects, and the made NOX and VOC emissions that
standards, EPA may not consider the
uncertainties surrounding each estimate. contribute to O3 formation in the United
(citation omitted). They permit the States come from three types of sources:
made materials, animals, wildlife, weather,
visibility and climate, damage to and deterioration
Administrator to take account of comparative
health consequences. They allow her to take
mobile sources, industrial processes
of property, and hazards to transportation, as well
as effects on economic values and on personal account of context when determining the (which include consumer and
comfort and well-being.’’ acceptability of small risks to health. And commercial products), and the electric
power industry.3 Mobile sources and federal rules, or amendments to existing criteria are used for identifying the most
the electric power industry were rules, that will establish new effective application of conservation
responsible for 78 percent of annual nationwide VOC content limits for systems and activities.
NOX emissions in 2004. That same year, several categories of consumer and The EPA will work together with
99 percent of man-made VOC emissions commercial products, including aerosol USDA and with States to identify
came from industrial processes coatings, architectural and industrial appropriate measures to meet the
(including solvents) and mobile sources. maintenance coatings, and household primary and secondary standards,
Emissions from natural sources, such as and institutional commercial products. including site-specific conservation
trees, may also comprise a significant These rules will take effect in 2009, and systems and activities. Based on prior
portion of total VOC emissions in will yield significant new reductions in experience identifying conservation
certain regions of the country, especially nationwide VOC emissions—about measures and practices to meet the PM
during the O3 season, which are 200,000 tons per year. Additionally, in NAAQS requirements, the EPA will use
considered natural background O3 nonattainment areas, we anticipate a similar process to identify measures
emissions. reductions of an additional 25,000 tons that could meet the O3 requirements.
EPA has developed new emissions per year following completion of control The EPA anticipates that certain USDA-
standards for many types of stationary technique recommendations for 3 approved conservation systems and
sources and for nearly every class of additional consumer and commercial activities that reduce agricultural
mobile sources in the last decade to product categories. These emission emissions of NOX and VOC may be able
reduce O3 by decreasing emissions of reductions primarily result from solvent to satisfy the requirements for
NOX and VOC. These programs controls and typically occur where and applicable sources to implement
complement State and local efforts to when the solvent is used, such as during reasonably available control measures
improve O3 air quality and meet current manufacturing processes. for purposes of attaining the primary
national standards. Under the Federal The power industry is one of the and secondary O3 NAAQS.
Motor Vehicle Control Program largest emitters of NOX in the United
C. Review of Air Quality Criteria and
(FMVCP, see title II of the CAA, 42 States. Power industry emission sources
Standards for O3
U.S.C. 7521–7574), EPA has established include large electric generating units
new emissions standards for nearly and some large industrial boilers and Tropospheric (ground-level) O3 is
every type of automobile, truck, bus, turbines. The EPA’s landmark Clean Air formed from biogenic and
motorcycle, earth mover, and aircraft Interstate Rule (CAIR), issued on March anthropogenic precursor emissions.
engine, and for the fuels used to power 10, 2005, permanently caps power Naturally occurring O3 in the
these engines. EPA also established new industry emissions of NOX in the troposphere can result from biogenic
standards for the smaller engines used eastern United States. The first phase of organic precursors reacting with
in small watercraft, lawn and garden the cap begins in 2009, and a lower naturally occurring nitrogen oxides
equipment. Recently EPA proposed new second phase cap begins in 2015. By (NOX) and by stratospheric O3 intrusion
standards for locomotive and marine 2015, EPA projects that the CAIR and into the troposphere. Anthropogenic
diesel engines. Benefits from engine other programs in the Eastern U.S. will precursors of O3, specifically NOX and
standards increase modestly each year reduce power industry O3 season NOX volatile organic compounds (VOC),
as older, more-polluting vehicles and emissions in that region by about 50 originate from a wide variety of
engines are replaced with newer, percent and annual NOX emissions by stationary and mobile sources. Ambient
cleaner models. In time, these programs about 60 percent from 2003 levels. O3 concentrations produced by these
will yield substantial emission With respect to agricultural sources, emissions are directly affected by
reductions. Benefits from fuel programs the U.S. Department of Agriculture temperature, solar radiation, wind speed
generally begin as soon as a new fuel is (USDA) has approved conservation and other meteorological factors.
available. systems and activities that reduce The last review of the O3 NAAQS was
The reduction of VOC emissions from agricultural emissions of NOX and VOC. completed on July 18, 1997, based on
industrial processes has been achieved Current practices that may reduce the 1996 O3 CD (U.S. EPA, 1996a) and
either directly or indirectly through emissions of NOX and VOC include 1996 O3 Staff Paper (U.S. EPA, 1996b).
implementation of control technology engine replacement programs, diesel EPA revised the primary and secondary
standards, including maximum retrofit programs, manipulation of O3 standards on the basis of the then
achievable control technology, pesticide applications including timing latest scientific evidence linking
reasonably available control technology, of applications, and animal feeding exposures to ambient O3 to adverse
and best available control technology operations waste management health and welfare effects at levels
standards; or are anticipated due to techniques. The EPA recognizes that allowed by the 1-hour average standards
proposed or upcoming proposals based USDA has been working with the (62 FR 38856). The O3 standards were
on generally available control agricultural community to develop revised by replacing the existing
technology or best available controls conservation systems and activities to primary 1-hour average standard with
under provisions related to consumer control emissions of O3 precursors. an 8-hour average O3 standard set at a
and commercial products. These These conservation activities are level of 0.08 ppm, which is equivalent
standards have resulted in VOC voluntarily adopted through the use of to 0.084 ppm using the standard
emission reductions of almost a million incentives provided to the agricultural rounding conventions. The form of the
tons per year accumulated starting in producer. In cases where the States need primary standard was changed to the
1997 from a variety of sources including these measures to attain the standard, annual fourth-highest daily maximum 8-
the measures could be adopted. The hour average concentration, averaged
combustion sources, coating categories,

and chemical manufacturing. The EPA EPA will continue to work with USDA over three years. The secondary O3
is currently working to finalize new on these activities with efforts to standard was changed by making it
identify and/or improve the control identical in all respects to the revised
3 See EPA report, Evaluating Ozone Control efficiencies, prioritize the adoption of primary standard.
Programs in the Eastern United States: Focus on the these conservation systems and Following promulgation of the revised
NOX Budget Trading Program, 2004. activities, and ensure that appropriate O3 NAAQS, petitions for review were
filed addressing a broad range of issues. In response to the DC Circuit Court’s and 25, 2006. In an October 24, 2006
In May 1999, in response to those remand to consider the potential letter to the Administrator, CASAC
challenges, the U.S. Court of Appeals for indirect beneficial health effects of O3 in provided advice and recommendations
the District of Columbia Circuit held shielding the public from the effects of to the Agency concerning the second
that EPA’s approach to establishing the solar (UV) radiation, on November 14, draft Staff Paper (Henderson, 2006c). A
level of the standards in 1997, both for 2001, EPA proposed to leave the 1997 final Staff Paper (EPA, 2007) was
the O3 and for the particulate matter 8-hour NAAQS unchanged (66 FR released on January 31, 2007. Around
(PM) NAAQS promulgated on the same 57267). After considering public the time of the release of the final Staff
day, effected ‘‘an unconstitutional comment on the proposed decision, Paper in January 2007, EPA discovered
delegation of legislative authority.’’ EPA reaffirmed the 8-hour O3 NAAQS a small error in the exposure model that
American Trucking Associations v. set in 1997 (68 FR 614). Finally, on when corrected resulted in slight
EPA, 175 F.3d 1027 (DC Cir., 1999). April 30, 2004, EPA issued an 8-hour increases in the human exposure
Although the D.C. Circuit stated that implementation rule that, among other estimates. Since the exposure estimates
‘‘factors EPA uses in determining the things, provided that the 1-hour O3 are an input to the lung function portion
degree of public health concern NAAQS would no longer apply to areas of the health risk assessment, this
associated with different levels of O3 one year after the effective date of the correction also resulted in slight
and PM are reasonable,’’ it remanded designation of those areas for the 8-hour increases in the lung function risk
the rule to EPA, stating that when EPA NAAQS (69 FR 23966).4 For most areas, estimates as well. The exposure and risk
considers these factors for potential the date that the 1-hour NAAQS no estimates discussed in this notice reflect
non-threshold pollutants ‘‘what EPA longer applied was June 15, 2005. (See the corrected estimates, and thus are
lacks is any determinate criterion for 40 CFR 50.9 for details.) slightly different than the exposure and
drawing lines’’ to determine where the The EPA initiated this current review risk estimates cited in the January 31,
standards should be set. Id. at 1034. in September 2000 with a call for 2007 Staff Paper.5 In a March 26, 2007
Consistent with EPA’s long-standing information (65 FR 57810) for the letter (Henderson, 2007), CASAC offered
interpretation and DC Circuit precedent, development of a revised Air Quality additional advice to the Administrator
the court also reaffirmed prior rulings Criteria Document for O3 and Other with regard to recommendations and
holding that in setting the NAAQS, it is Photochemical Oxidants (henceforth the revisions to the primary and secondary
‘‘not permitted to consider the cost of ‘‘Criteria Document’’). A project work O3 NAAQS.
implementing those standards.’’ Id. at plan (U.S. EPA, 2002) for the The schedule for completion of this
1040–41. The DC Circuit further preparation of the Criteria Document review is governed by a consent decree
directed EPA to consider on remand the was released in November 2002 for resolving a lawsuit filed in March 2003
potential indirect beneficial health CASAC and public review. EPA held a by a group of plaintiffs representing
effects of O3 pollution in shielding the series of workshops in mid-2003 on national environmental and public
public from the effects of solar several draft chapters of the Criteria health organizations, alleging that EPA
ultraviolet (UV) radiation, as well as the Document to obtain broad input from had failed to complete the current
direct adverse health effects of O3 the relevant scientific communities. review within the period provided by
pollution. These workshops helped to inform the statute.6 The modified consent decree
preparation of the first draft Criteria that governs this review, entered by the
Both sides filed cross appeals on the Document (EPA, 2005a), which was court on December 16, 2004, provides
constitutional and cost issues to the released for CASAC and public review that EPA sign for publication notices of
United States Supreme Court, and the on January 31, 2005; a CASAC meeting proposed and final rulemaking
Court granted certiorari. On February was held on May 4–5, 2005 to review concerning its review of the O3 NAAQS
27, 2001, the U.S. Supreme Court issued the first draft Criteria Document. A no later than March 28, 2007 and
a unanimous decision upholding the second draft Criteria Document (EPA, December 19, 2007, respectively. This
EPA’s position on both the 2005b) was released for CASAC and consent decree was further modified in
constitutional and the cost issues. public review on August 31, 2005, and October 2006 to change these proposed
Whitman v. American Trucking was discussed along with a first draft and final rulemaking dates to no later
Associations, 531 U.S. at 464, 475–76. Staff Paper (EPA, 2005c) at a CASAC than May 30, 2007 and February 20,
On the constitutional issue, the Court meeting held on December 6–8, 2005. In 2008, respectively. These dates for
held that the statutory requirement that a February 16, 2006 letter to the signing the publication notices of
NAAQS be ‘‘requisite’’ to protect public Administrator, the CASAC offered final proposed and final rulemaking were
health with an adequate margin of safety comments on all chapters of the Criteria further extended to no later than June
sufficiently guided EPA’s discretion, Document (Henderson, 2006a), and the 20, 2007 and March 12, 2008,
affirming EPA’s approach of setting final Criteria Document (EPA, 2006a) respectively.
standards that are neither more nor less was released on March 21, 2006. In a This action presents the
stringent than necessary. The Supreme June 8, 2006 letter (Henderson, 2006b) Administrator’s proposed decisions on
Court remanded the case to the D.C. to the Administrator, the CASAC offered the review of the current primary and
Circuit for resolution of any remaining additional advice to the Agency secondary O3 standards. Throughout
issues that had not been addressed by concerning chapter 8 of the final Criteria this preamble a number of conclusions,
that Court’s earlier decisions. Id. at 475– Document (Integrative Synthesis) to findings, and determinations proposed
76. On March 26, 2002, the D.C. Circuit help inform the second draft Staff Paper. by the Administrator are noted. While
Court rejected all remaining challenges A second draft Staff Paper (EPA,
to the NAAQS, holding under 2006b) was released on July 17, 2006
5 EPA plans to make available corrected versions

traditional standard of review that EPA and reviewed by CASAC on August 24 of the final Staff Paper and the human exposure and
‘‘engaged in reasoned decision-making’’ health risk assessment technical support documents
in setting the 1997 O3 NAAQS. 4 On December 22, 2006, the D.C. Circuit vacated on or around July 16, 2007 on the EPA web site
the April 30, 2004 implementation rule. South listed in the Availability of Related Information
Whitman v. American Trucking Coast Air Quality Management District v. EPA, 472 section of this notice.
Associations, 283 F.3d 355 (DC Cir. F.3d 882. In March 2007, EPA requested the Court 6 American Lung Association v. Whitman (No.
2002). to reconsider its decision. 1:03CV00778, D.D.C. 2003).
they identify the reasoning that supports exposure to O3, or for which the Criteria grows and as other factors, such as
this proposal, they are not intended to Document judges associations with O3 biological plausibility and strength,
be final or conclusive in nature. The to be causal, likely causal, or for which consistency, and coherence of evidence,
EPA invites general, specific, and/or the evidence is highly suggestive that O3 increase. Conclusions regarding
technical comments on all issues contributes to the reported effects. This biological plausibility, consistency, and
involved with this proposal, including rationale also draws upon the results of coherence of evidence of O3-related
all such proposed judgments, quantitative exposure and risk health effects are drawn from the
conclusions, findings, and assessments, discussed below in section integration of epidemiological studies
determinations. II.B. Evidence- and exposure/risk-based with mechanistic information from
considerations that form the basis for controlled human exposure studies and
II. Rationale for Proposed Decision on
the Administrator’s proposed decisions animal toxicological studies. As
the Primary Standard
on the adequacy of the current standard discussed below, this type of
This section presents the rationale for and on the elements of the range of mechanistic linkage has been firmly
the Administrator’s proposed decision proposed alternative standards are established for several respiratory
to revise the existing 8-hour O3 primary discussed below in sections II.C and endpoints (e.g., lung function
standard by lowering the level of the II.D, respectively. decrements, lung inflammation) but
standard to within a range from 0.070 to Judgments made in the Criteria remains far more equivocal for
0.075 ppm, and to specify the standard Document and Staff Paper about the cardiovascular endpoints (e.g.,
to the nearest thousandth ppm (i.e., to extent to which relationships between cardiovascular-related hospital
the nearest parts per billion). As various health endpoints and short-term admissions). For epidemiological
discussed more fully below, this exposures to ambient O3 are likely studies, strength of association refers to
rationale is based on a thorough review, causal have been informed by several the magnitude of the association and its
in the Criteria Document, of the latest factors. As discussed below in section statistical strength, which includes
scientific information on human health II.A, these factors include the nature of assessment of both effects estimate size
effects associated with the presence of the evidence (i.e., controlled human and precision. In general, when
O3 in the ambient air. This rationale also exposure, epidemiological, and/or associations yield large relative risk
takes into account and is consistent toxicological studies) and the weight of estimates, it is less likely that the
with: (1) Staff assessments of the most evidence, which takes into account such association could be completely
policy-relevant information in the considerations as biological plausibility, accounted for by a potential confounder
Criteria Document and staff analyses of coherence of evidence, strength of or some other bias. Consistency refers to
air quality, human exposure, and health association, and consistency of the persistent finding of an association
risks, presented in the Staff Paper, upon evidence. between exposure and outcome in
which staff recommendations for In assessing the health effects data multiple studies of adequate power in
revisions to the primary O3 standard are base for O3, it is clear that human different persons, places, circumstances
based; (2) CASAC advice and studies provide the most directly and times. For example, the magnitude
recommendations, as reflected in applicable information for determining of effect estimates is relatively
discussions of drafts of the Criteria causality because they are not limited consistent across recent studies showing
Document and Staff Paper at public by the uncertainties of dosimetry association between short-term, but not
meetings, in separate written comments, differences and species sensitivity long-term, O3 exposure and mortality.
and in CASAC’s letters to the differences, which would need to be Based on the information discussed
Administrator; and (3) public comments addressed in extrapolating animal below in sections II.A.1–II.A.3,
received during the development of toxicology data to human health effects. judgments concerning the extent to
these documents, either in connection Controlled human exposure studies which relationships between various
with CASAC meetings or separately. provide data with the highest level of health endpoints and ambient O3
In developing this rationale, EPA has confidence since they provide human exposures are likely causal are
drawn upon an integrative synthesis of effects data under closely monitored summarized below in section II.A.3.c.
the entire body of evidence, published conditions and can provide exposure- These judgments reflect the nature of
through early 2006, on human health response relationships. Epidemiological the evidence and the overall weight of
effects associated with the presence of data provide evidence of associations the evidence, and are taken into
O3 in the ambient air. As discussed between ambient O3 levels and more consideration in the quantitative
below in section II.A, this body of serious acute and chronic health effects exposure and risk assessments,
evidence addresses a broad range of (e.g., hospital admissions and mortality) discussed below in Section II.B.
health endpoints associated with that cannot be assessed in controlled To put judgments about health effects
exposure to ambient levels of O3 (EPA, human exposure studies. For these that have been demonstrated to be
2006a, chapter 8), and includes over one studies the degree of uncertainty caused by exposure to O3, or for which
hundred epidemiologic studies introduced by confounding variables the Criteria Document judges
conducted in the U.S., Canada, and (e.g., other pollutants, temperature) and associations with O3 to be causal, likely
many countries around the world.7 In other factors affects the level of causal, or for which the evidence is
considering this evidence, EPA focuses confidence that the health effects being highly suggestive that O3 contributes to
on those health endpoints that have investigated are attributable to O3 the reported effects into a broader
been demonstrated to be caused by exposures, alone and in combination public health context, EPA has drawn
with other copollutants. upon the results of the quantitative
In using a weight of evidence exposure and risk assessments. These
7 In its assessment of the epidemiological
evidence judged to be most relevant to making approach to inform judgments about the assessments provide estimates of the
decisions on the level of the O3 primary standard, degree of confidence that various health likelihood that individuals in particular
EPA has placed greater weight on U.S. and effects are likely to be caused by population groups that are at risk for
Canadian epidemiologic studies, since studies
conducted in other countries may well reflect
exposure to O3, confidence increases as various O3-related physiological health
different demographic and air pollution the number of studies consistently effects would experience ‘‘exposures of
characteristics. reporting a particular health endpoint concern’’ and specific health endpoints
under varying air quality scenarios (e.g., children, and emergency department effects, as well as a characterization of
just meeting the current or alternative visits and hospital admissions in people the uncertainties and variability
standards), as well as characterizations with lung disease). Estimates of the inherent in such estimates. This
of the kind and degree of uncertainties number of people likely to experience assessment also provided insights into
inherent in such estimates. exposures of concern cannot be directly the distribution of risks and patterns of
In this review, the term ‘‘exposures of translated into quantitative estimates of risk reductions associated with meeting
concern’’ is defined as personal the number of people likely to alternative O3 standards.
exposures while at moderate or greater experience specific health effects, since As discussed below, a substantial
exertion to 8-hour average ambient O3 sufficient information to draw such amount of new research has been
levels at and above specific benchmark comparisons is not available—if such conducted since the last review of the
levels which represent exposure levels information were available, these health O3 NAAQS, with important new
at which O3-related health effects are outcomes would have been included in information coming from epidemiologic
known or can reasonably be inferred to the quantitative risk assessment. Due to studies as well as from controlled
occur in some individuals, as discussed individual variability in responsiveness, human exposure, toxicological, and
below in section II.B.1.8 EPA only a subset of individuals who have dosimetric studies. The newly available
emphasizes that although the analysis of exposures at and above a specific research studies evaluated in the
‘‘exposures of concern’’ was conducted benchmark level can be expected to Criteria Document and the exposure and
using three discrete benchmark levels experience such adverse health effects, risk assessments presented in the Staff
(i.e., 0.080, 0.070, and 0.060 ppm), the and susceptible subpopulations such as Paper have undergone intensive
concept is more appropriately viewed as those with asthma are expected to be scrutiny through multiple layers of peer
a continuum with greater confidence affected more by such exposures than review and many opportunities for
and less uncertainty about the existence healthy individuals. The amount of public review and comment. While
of health effects at the upper end and weight to place on the estimates of important uncertainties remain in the
less confidence and greater uncertainty exposures of concern at any of these qualitative and quantitative
as one considers increasingly lower O3 benchmark levels depends in part on characterizations of health effects
exposure levels. EPA recognizes that the weight of the scientific evidence attributable to exposure to ambient O3,
there is no sharp breakpoint within the concerning health effects associated the review of this information has been
continuum ranging from at and above with O3 exposures at and above that extensive and deliberate. In the
0.080 ppm down to 0.060 ppm. In benchmark level. It also depends on judgment of the Administrator, this
considering the concept of exposures of judgments about the importance from a intensive evaluation of the scientific
concern, it is important to balance public health perspective of the health evidence has provided an adequate
concerns about the potential for health effects that are known or can reasonably basis for regulatory decision making.
effects and their severity with the be inferred to occur as a result of This review also provides important
increasing uncertainty associated with exposures at and above the benchmark input to EPA’s research plan for
our understanding of the likelihood of level. Such public health policy improving our future understanding of
such effects at lower O3 levels. judgments are embodied in the NAAQS the effects of ambient O3 at lower levels,
Within the context of this continuum, especially in at-risk population groups.
standard setting criteria (i.e., standards
estimates of exposures of concern at
that, in the judgment of the A. Health Effects Information
discrete benchmark levels provide some
Administrator, are requisite to protect This section outlines key information
perspective on the public health
public health with an adequate margin contained in the Criteria Document
impacts of O3-related health effects that
of safety). (chapters 4–8) and in the Staff Paper
have been demonstrated in human
clinical and toxicological studies but As discussed below in section II.B.2, (chapter 3) on known or potential effects
cannot be evaluated in quantitative risk the quantitative health risk assessment on public health which may be expected
assessments, such as lung inflammation, conducted as part of this review from the presence of O3 in ambient air.
increased airway responsiveness, and includes estimates of risks of lung The information highlighted here
changes in host defenses. They also help function decrements in asthmatic and summarizes: (1) New information
in understanding the extent to which all school age children, respiratory available on potential mechanisms for
such impacts have the potential to be symptoms in asthmatic children, health effects associated with exposure
reduced by meeting the current and respiratory-related hospital admissions, to O3; (2) the nature of effects that have
alternative standards. These O3-related and non-accidental and been associated directly with exposure
physiological effects are plausibly cardiorespiratory-related mortality to O3 and indirectly with the presence
linked to the increased morbidity seen associated with recent ambient O3 of O3 in ambient air; (3) an integrative
in epidemiological studies (e.g., as levels, as well as risk reductions and interpretation of the evidence, focusing
indicated by increased medication use remaining risks associated with just on the biological plausibility and
in asthmatics, school absences in all meeting the current and various coherence of the evidence; and (4)
alternative O3 standards in a number of considerations in characterizing the
8 Exposures of concern were also considered in example urban areas. There were two public health impact of O3, including
the last review of the O3 NAAQS, and were judged parts to this risk assessment: one part the identification of ‘‘at risk’’
by EPA to be an important indicator of the public
health impacts of those O3-related effects for which
was based on combining information subpopulations.
information was too limited to develop quantitative from controlled human exposure studies The decision in the last review
estimates of risk but which had been observed in with modeled population exposure, and focused primarily on evidence from
humans at and above the benchmark level of 0.08 the other part was based on combining short-term (e.g., 1 to 3 hours) and
ppm for 6-to 8-hour exposures * * * including

increased nonspecific bronchial responsiveness (for information from community prolonged ( 6 to 8 hours) controlled-
example, aggravation of asthma), decreased epidemiological studies with either exposure studies reporting lung
pulmonary defense mechanisms (suggestive of monitored or adjusted ambient function decrements, respiratory
increased susceptibility to respiratory infection),
and indicators of pulmonary inflammation (related
concentrations levels. This assessment symptoms, and respiratory
to potential aggravation of chronic bronchitis or not only provided estimates of the inflammation in humans, as well as
long-term damage to the lungs). (62 FR 38868) potential magnitude of O3-related health epidemiology studies reporting excess
hospital admissions and emergency well as recent meta-analyses that have are well documented, and precursors to
department (ED) visits for respiratory evaluated potential sources of lung injury can become apparent within
causes. The Criteria Document prepared heterogeneity in O3-mortality 3 hours after exposure in humans.
for this review emphasizes a large associations. Repeated respiratory inflammation can
number of epidemiological studies lead to a chronic inflammatory state
1. Overview of Mechanisms
published since the last review with with altered lung structure and lung
these and additional health endpoints, Evidence on possible mechanisms by function and may lead to chronic
including the effects of acute (short-term which exposure to O3 may result in respiratory diseases such as fibrosis and
and prolonged) and chronic exposures acute and chronic health effects is emphysema (EPA, 2006a, section 8.6.2).
to O3 on lung function decrements and discussed in chapters 5 and 6 of the The severity of symptoms and
enhanced respiratory symptoms in Criteria Document.9 Evidence from magnitude of response to acute
asthmatic individuals, school absences, dosimetry, toxicology, and human exposures depend on inhaled dose, as
and premature mortality. It also exposure studies has contributed to an well as individual susceptibility to O3,
emphasizes important new information understanding of the mechanisms that as discussed below. At the same O3
from toxicology, dosimetry, and help to explain the biological dose, individuals who are more
controlled human exposure studies. plausibility and coherence of evidence susceptible to O3 will have a larger
Highlights of the evidence include: for O3-induced respiratory health effects response than those who are less
(1) Two new controlled human- reported in epidemiological studies. susceptible; among individuals with
exposure studies are now available that More detailed information about the similar susceptibility, those who receive
examine respiratory effects associated physiological mechanisms related to the a larger dose will have a larger response
with prolonged O3 exposures at levels respiratory effects of short- and long- to O3.
below 0.080 ppm, which was the lowest term exposure to O3 can be found in The inhaled dose is the product of O3
exposure level that had been examined section II.A.3.b.i and II.A.3.b.iii, concentration (C), minute ventilation or
in the last review. respectively. In the past, however, little ventilation rate, and duration of
(2) Numerous controlled human- information was available to help exposure (T), or (C x ventilation rate x
exposure studies have examined explain potential biological mechanisms T). A large body of data regarding the
indicators of O3-induced inflammatory which linked O3 exposure to premature interdependent effect of these
response in both the upper respiratory mortality or cardiovascular effects. As components of inhaled dose on
tract (URT) and lower respiratory tract discussed more fully in section pulmonary responses was assessed in
(LRT), while other studies have II.A.3.b.ii below, since the last review the 1986 and 1996 O3 Criteria
examined changes in host defense an emerging body of animal toxicology Documents. In an attempt to describe O3
capability following O3 exposure of and human clinical evidence is dose-response characteristics, acute
healthy young adults and increased beginning to suggest mechanisms that responses were modeled as a function of
airway responsiveness to allergens in may mediate acute O3 cardiovascular total inhaled O3 dose which was
subjects with allergic asthma and effects. While much is known about generally found to be a better predictor
allergic rhinitis exposed to O3. mechanisms that play a role in O3- of response than O3 concentration,
(3) Animal toxicology studies provide related respiratory effects, additional ventilation rate, or duration of exposure,
new information regarding mechanisms research is needed to more clearly alone, or as a combination of any two
of action, increased susceptibility to understand the role that O3 may have in of these factors (EPA 2006a, section 6.2).
respiratory infection, and the biological contributing to cardiovascular effects. Predicted O3-induced decrements in
plausibility of acute effects and chronic, With regard to the mechanisms lung function have been shown to be a
irreversible respiratory damage. related to short-term respiratory effects, function of exposure concentration,
(4) Numerous acute exposure scientific evidence discussed in the duration and exercise level for healthy,
epidemiological studies published Criteria Document (section 5.2) young adults (McDonnell et al., 1997). A
during the past decade offer added indicates that reactions of O3 with lipids meta-analysis of 21 studies (Mudway
evidence of ambient O3-related lung and antioxidants in the epithelial lining and Kelly, 2004) showed that markers of
function decrements and respiratory fluid and the epithelial cell membranes inflammation and increased cellular
symptoms in physically active healthy of the lung can be the initial step in permeability in healthy subjects are
subjects and asthmatic subjects, as well mediating deleterious health effects of associated with total O3 dose.
as evidence on new health endpoints, O3. This initial step activates a cascade The Criteria Document summarizes
such as the relationships between of events that lead to oxidative stress, information on potentially susceptible
ambient O3 concentrations and school injury, inflammation, airway epithelial and vulnerable groups in section 8.7. As
absenteeism and between ambient O3 damage and increased alveolar described there, the term susceptibility
and cardiac-related physiological permeability to vascular fluids. refers to innate (e.g., genetic or
endpoints. Inflammation can be accompanied by developmental) or acquired (e.g.,
(5) Several additional studies have increased airway responsiveness, which personal risk factors, age) factors that
been published over the last decade is an increased bronchoconstrictive make individuals more likely to
examining the temporal associations response to airway irritants and experience effects with exposure to
between O3 exposures and emergency allergens. Continued respiratory pollutants. A number of population
department visits for respiratory inflammation also can alter the ability to groups have been identified as
diseases and on respiratory-related respond to infectious agents, allergens potentially susceptible to health effects
hospital admissions. and toxins. Acute inflammatory as a result of O3 exposure, including
(6) A large number of newly available responses to O3 in some healthy people people with existing lung diseases,
epidemiological studies have examined including asthma, children and older

the effects of acute exposure to PM and 9 While most of the available evidence addresses adults, and people who have larger than
O3 on mortality, notably including large mechanisms for O3, O3 clearly serves as an indicator normal lung function responses that
for the total photochemical oxidant mixture found
multicity studies that provide much in the ambient air. Some effects may be caused by
may be due to genetic susceptibility. In
more robust and credible information one or more components in the overall pollutant addition, some population groups have
than was available in the last review, as mix, either separately or in combination with O3. been identified as having increased
vulnerability to O3-related effects due to morbidity effects observed in polymorphism (i.e., the occurrence
increased likelihood of exposure while epidemiological studies. together in the same population of more
at elevated ventilation rates, including Children with and without asthma than one allele or genetic marker at the
healthy children and adults who are were found to be particularly same locus with the least frequent allele
active outdoors, for example, outdoor susceptible to O3 effects on lung or marker occurring more frequently
workers, and joggers. Taken together, function and generally have greater lung than can be accounted for by mutation
the susceptible and vulnerable groups function responses than older people. alone) in observed differences in
are more commonly referred to as ‘‘at- The American Academy of Pediatrics antioxidant enzymes and genes
risk’’ groups 10, as discussed more fully (2004) notes that children and infants involved in inflammation to modulate
below in section II.A.4.b. are among the population groups most pulmonary function and inflammatory
susceptible to many air pollutants, responses to O3 exposure. These
Based on new evidence from animal, including O3. This is in part because
human clinical and epidemiological observations suggest a potential role for
their lungs are still developing. For these markers in the innate
studies the Criteria Document concludes example, eighty percent of alveoli are susceptibility to O3, however, the
that people with preexisting pulmonary formed after birth, and changes in lung validity of these markers and their
disease are likely to be among those at development continue through relevance in the context of prediction to
increased risk from O3 exposure. adolescence (Dietert et al., 2000). population studies needs additional
Altered physiological, morphological Moreover, children have high minute experimentation.
and biochemical states typical of ventilation rates and relatively high
respiratory diseases like asthma, COPD Clinical studies that provide
levels of physical activity which also
and chronic bronchitis may render information about mechanisms of the
increases their O3 dose (Plunkett et al.,
people sensitive to additional oxidative initial response to O3 (e.g., lung function
1992). Thus, children are at risk due to
burden induced by O3 exposure (EPA decrements, inflammation, and injury to
both their susceptibility and
2006a, section 8.7). Children and adults the lung) also inform the selection of
vulnerability.
with asthma are the group that has been Looking more broadly at age-related appropriate lag times to analyze in
studied most extensively. Evidence from differences in susceptibility, several epidemiological studies through
controlled human exposure studies mortality studies have investigated age- elucidation of the time course of these
indicates that asthmatics may exhibit related differences in O3 effects (EPA, responses (EPA 2006a, section 8.4.3).
larger lung function decrements in 2006a, section 7.6.7.2), primarily in the Based on the results of these studies, it
response to O3 exposure than healthy older adult population. Among the would be reasonable to expect that lung
controls. As discussed more fully in studies that observed positive function decrements could be detected
section II.A.4.b.ii below, asthmatics associations between O3 and mortality, epidemiologically within lags of 0 (same
present a differential response profile a comparison of all age or younger age day) or 1 to 2 days following O3
for cellular, molecular, and biochemical (65 years of age) O3-mortality effect exposure, given the rapid onset of lung
estimates to that of the elderly function changes and their persistence
parameters (CD, Figure 8–1) that are
population (>65 years) indicates that, in for 24 to 48 hours among more
altered in response to acute O3
general, the elderly population is more responsive human subjects in clinical
exposure. They can have larger
susceptible to O3 mortality effects. studies. Other responses take longer to
inflammatory responses, as manifested
There is supporting evidence of age- develop and can persist for longer
by larger increases in markers of
related differences in susceptibility to periods of time. For example, although
inflammation such as white bloods cells
O3 lung function effects. The Criteria asthmatic individuals may begin to
(e.g., PMNs) or inflammatory cytokines.
Document concludes that the elderly experience symptoms soon after O3
Asthmatics, and people with allergic
population (>65 years of age) appears to exposure, it may take anywhere from 1
rhinitis, are more likely to mount an
be at greater risk of O3-related mortality to 3 days after exposure for these
allergic-type response upon exposure to
and hospitalizations compared to all subjects to seek medical attention as a
O3, as manifested by increases in white result of increased airway
blood cells associated with allergy (i.e., ages or younger populations, and
children (<18 years of age) experience responsiveness or inflammation that
eosinophils) and related molecules, may persist for 2 to 3 days. This may be
which increase inflammation in the other potentially adverse respiratory
health outcomes with increased O3 reflected by epidemiologic observations
airways. The increased inflammatory of significantly increased risk for
and allergic responses also may be exposure (EPA, 2006a, section 7.6.7.2).
Controlled human exposure studies asthma-related emergency department
associated with the larger late-phase visits or hospital admissions with 1- to
have also indicated a high degree of
responses that asthmatics can interindividual variability in some of 3-day lags, or, perhaps, enhanced
experience, which can include the pulmonary physiological distributed lag risks (combined across 3
increased bronchoconstrictor responses parameters, such as lung function days) for such morbidity indicators.
to irritant substances or allergens and decrements. The variable effects in Analogously, one might project
additional inflammation. These more individuals have been found to be increased mortality within 0 to 3 day
serious responses in asthmatics and reproducible, in other words, a person lags as a possible consequence of O3-
others with lung disease provide who has a large lung function response induced increases in clotting agents
biological plausibility for the respiratory after exposure to O3 will likely have arising from the cascade of events,
about the same response if exposed starting with cell injury described
10 In previous Staff Papers and Federal Register
again to the same dose of O3 (EPA above, occurring within 12 to 24 hours
notices announcing proposed and final decisions on
2006a, p. 6–2). In human clinical of O3 exposure. The time course for
the O3 and other NAAQS, EPA has used the phrase

‘‘sensitive population groups’’ to include both studies, group mean responses are not many of these initial responses to O3 is
population groups that are at increased risk because representative of this segment of the highly variable. Moreover these
they are more susceptible and population groups population that has much larger than observations pertain only to the initial
that are at increased risk due to increased
vulnerability or exposure. In this notice, we use the
average responses to O3. Recent studies, response to O3. Consequent responses
phrase, ‘‘at risk’’ populations to include both types discussed in section II.A.4.iv below, can follow. For example, Jörres et al.,
of population groups. reported a role for genetic (1996) found that in subjects with
asthma and allergic rhinitis, a maximum i. Effects on the Respiratory System concentrations ≥ 0.080 ppm develop
percent fall in FEV1 of 27.9% and 7.8%, From Short-Term and Prolonged O3 significant, reversible, transient
respectively, occurred 3 days after O3 Exposures decrements in pulmonary function if
exposure when they were challenged Controlled human exposure studies minute ventilation or duration of
with the highest common dose of have shown that O3 induces a variety of exposure is increased sufficiently; (2)
allergen. health effects, including: lung function children experience similar lung
decrements, respiratory symptoms, function responses but report lesser
2. Nature of Effects symptoms from O3 exposure relative to
increased airway responsiveness,
respiratory inflammation and young adults; (3) O3-induced lung
The Criteria Document provides new function responses are decreased in the
evidence that notably enhances our permeability, increased susceptibility to
respiratory infection, and acute elderly relative to young adults; (4)
understanding of short-term and there is a large degree of intersubject
prolonged exposure effects, including morphological effects. Epidemiology
studies have reported associations variability in physiological and
effects on lung function, symptoms, and symptomatic responses to O3, but
between O3 exposures (i.e., 1-hour,
inflammatory effects reported in responses tend to be reproducible
8-hour and 24-hour) and a wide range
controlled exposure studies. These of respiratory-related health effects within a given individual over a period
studies support and extend the findings including: Pulmonary function of several months; (5) subjects exposed
of the previous Criteria Document. decrements; respiratory symptoms; repeatedly to O3 for several days show
There is also a significant body of new increased asthma medication use; an attenuation of response upon
epidemiological evidence of increased school absences; increased successive exposures, but this
associations between short-term and emergency department visits and attenuation is lost after about a week
prolonged exposure to O3 and effects hospital admissions. without exposure; and (6) acute O3
such as premature mortality, hospital exposure initiates an inflammatory
(a) Pulmonary Function Decrements, response which may persist for at least
admissions and emergency department
Respiratory Symptoms, and Asthma 18 to 24 hours post exposure.
visits for respiratory (e.g., asthma)
Medication Use The development of these respiratory
causes. Key epidemiological and
(i) Results From Controlled Human effects is time-dependent during both
controlled human exposure studies are
Exposure Studies exposure and recovery periods, with
summarized below and discussed in great overlap for development and
chapter 3 of the Staff Paper, which is A large number of studies published disappearance of the effects. In healthy
based on scientific evidence critically prior to 1996 that investigated short- human subjects exposed to typical
reviewed in chapters 5, 6, and 7 of the term O3 exposure health effects on the ambient O3 levels near 0.120 ppm, lung
Criteria Document, as well as the respiratory system from short-term O3 function responses largely resolve
Criteria Document’s integration of exposures were reviewed in the 1986 within 4 to 6 hours post-exposure, but
scientific evidence contained in chapter and 1996 Criteria Documents (EPA, cellular effects persist for about 24
8.11 Conclusions drawn about O3-related 1986, 1996). In the last review, 0.50 hours. In these healthy subjects, small
health effects are based upon the full ppm was the lowest O3 concentration at residual lung function effects are almost
body of evidence from controlled which statistically significant completely gone within 24 hours, while
human exposure, epidemiological and reductions in forced vital capacity (FVC) in hyperresponsive subjects, recovery
toxicological data contained in the and forced expiratory volume in 1 can take as much as 48 hours to return
Criteria Document. second (FEV1) were reported in to baseline. The majority of these
sedentary subjects. During exercise, responses are attenuated after repeated
a. Morbidity spirometric (lung function) and consecutive exposures, but such
symptomatic responses were observed attenuation to O3 is lost one week post-
This section summarizes scientific at much lower O3 exposures. When exposure.
information on the effects of inhalation minute ventilation was considerably Since 1996, there have been a number
of O3, including public health effects of increased by continuous exercise (CE) of studies published investigating lung
short-term, prolonged, and long-term during O3 exposures lasting 2 hour or function and symptomatic responses
exposures on respiratory morbidity and less at ≥ 0.12 ppm, healthy subjects that generally support the observations
cardiovascular system effects, as generally experienced decreases in previously drawn. Recent studies for
discussed in chapters 6, 7 and 8 of the FEV1, FVC, and other measures of lung acute exposures of 1 to 2 hours and 6
Criteria Document and chapter 3 of the function; increases in specific airway to 8 hours in duration are compiled in
Staff Paper. This section also resistance (sRaw), breathing frequency, the Staff Paper (Appendix 3C). As
summarizes the uncertainty about the and airway responsiveness; and summarized in more detail in the Staff
potential indirect effects on public symptoms such as cough, pain on deep Paper (section 3.3.1.1), among the more
health associated with changes due to inspiration, shortness of breath, throat important of the recent studies that
increases in UV–B radiation exposure, irritation, and wheezing. When examined changes in FEV1 in large
such as UV–B radiation-related skin exposures were increased to 4 to 8 hours numbers of subjects over a range of 1–
cancers, that may be associated with in duration, statistically significant lung 2 hours at exposure levels of 0.080 to
reductions in ambient levels of ground- function and symptom responses were 0.40 ppm were studies by McDonnell et
level O3, as discussed in chapter 10 of reported at O3 concentrations as low as al. (1997) and Ultman et al. (2004).
the Criteria Document and chapter 3 of 0.08 ppm and at lower minute These studies observed considerable
ventilation (i.e., moderate rather than intersubject variability in FEV1
the Staff Paper.

high level exercise) than the shorter decrements, which was consistent with
duration studies. findings in the 1996 Criteria Document.
The most important observations For prolonged exposures (4 to 8
11 Health effects discussions are also drawn from drawn from studies reviewed in the hours) in the range of 0.080 to 0.160
the more detailed information and tables presented 1996 Criteria Document were that: (1) ppm O3 using moderate intermittent
in the Criteria Document’s annexes. Young healthy adults exposed to O3 exercise and typically using square-
wave exposure patterns (i.e., a constant exposures) when the results were not ambient O3 concentrations, in
exposure level during time of exposure), corrected for the effects of exercise combination with other air pollutants,
several pre- and post-1996 studies alone in filtered air (EPA, 2007, Figure on lung function decrements and
(Folinsbee et al., 1988, 1994; Horstman 3–1B) and with 23 percent of subjects (7 respiratory symptoms have been
et al., 1990; Adams, 2002, 2003a, 2006) of 30) experiencing such effects when published over the last decade that
have reported statistically significant the results were corrected (EPA, 2007, p. support the major findings of the 1996
lung function responses and increased 3–6).14 Criteria Document that lung function
symptoms in healthy adults with These studies by Adams (2002, 2006) changes, as measured by decrements in
increasing duration of exposure, O3 are notable in that they are the only FEV1 or peak expiratory flow (PEF), and
concentration, and minute ventilation. available controlled exposure human respiratory symptoms in healthy adults
Studies that employed triangular studies that examine respiratory effects and asthmatic children are closely
exposure patterns (i.e., integrated associated with prolonged O3 exposures correlated to ambient O3 concentrations.
exposures that begin at a low level, rise at levels below 0.080 ppm, which was Pre-1996 field studies focused primarily
to a peak, and return to a low level the lowest exposure level that had been on children attending summer camps
during the exposure) (Hazucha et al., examined in the last review. The Adams and found O3-related impacts on
1992; Adams 2003a, 2006) suggest that (2006) study investigated a range of measures of lung function, but not
the triangular exposure pattern can exposure levels (0.000, 0.040, 0.060, and respiratory symptoms, in healthy
potentially lead to greater FEV1 0.080 ppm O3) using square-wave and children. The newer studies have
decrements and respiratory symptoms triangular exposure patterns. The study expanded to evaluate O3-related effects
than square-wave exposures (when the was designed to examine multiple on outdoor workers, athletes, the
overall O3 doses are equal). These comparisons of pulmonary function elderly, hikers, school children, and
results suggest that peak exposures, (FEV1) and respiratory symptom asthmatics. Collectively, these studies
reflective of the pattern of ambient O3 responses (total subjective symptoms confirm and extend clinical
concentrations in some locations, are (TSS) and pain on deep inspiration observations that prolonged (i.e., 6–8
important in terms of O3 toxicology. (PDI)) between these various exposure hour) exposure periods, combined with
McDonnell (1996) used data from a protocols at six different time points elevated levels of exertion or exercise,
series of studies to investigate the within the exposure periods. At the increase the dose of O3 to the lungs at
frequency distributions of FEV1 0.060 ppm exposure level, the author a given ambient exposure level and
decrements following 6.6 hour reported no statistically significant result in larger lung function effects.
exposures and found statistically differences for FEV1 decrements nor for The results of one large study of hikers
significant but relatively small group most respiratory symptoms responses; (Korrick et al., 1998), which reported
mean decreases in average FEV1 statistically significant responses were outcome measures stratified by several
responses (between 5 and 10 percent) at reported only for TSS for the triangular factors (e.g., gender, age, smoking status,
0.080 ppm O3.12 Notably, about 26 exposure pattern toward the end of the presence of asthma) within a population
percent of the 60 exposed subjects had exposure period, with the PDI responses capable of more than normal exertion,
lung function decrements >10 percent, being noted as following a closely provide useful insight. In this study,
including about 8 percent of the subjects similar pattern (Adams, 2006, p. 131– lung function was measured before and
that experienced large decrements (>20 132). EPA’s reanalysis of the data from after hiking, and individual O3
percent) (EPA, 2007, Figure 3–1A). the Adams (2006) study, comparing exposures were estimated by averaging
These results (which were not corrected FEV1 responses pre- and post-exposure hourly O3 concentrations from ambient
for exercise in filtered air responses) at the 0.060 ppm exposure level, found monitors located at the base and
demonstrate that while average small group mean differences from summit. The mean 8-hour average O3
responses may be relatively small at the responses to filtered air that were concentration was 0.040 ppm (8-hour
0.080 ppm exposure level, some statistically significant.15 Notably, these average concentration range of 0.021
individuals experience more severe studies report a small percentage of ppm to 0.074 ppm O3). Decreased lung
effects that may be clinically significant. subjects experiencing lung function function was associated with O3
Similar results at the 0.080 ppm decrement (≥ 10 percent) at the 0.060 exposure, with the greatest effect
exposure level (for 6.6 hours during ppm exposure level.16 estimates reported for the subgroup that
intermittent exercise) were seen in more
recent studies of 30 healthy young (ii) Results of Epidemiological and Field reported having asthma or wheezing,
adults by Adams (2002, 2006).13 In these Studies and for those who hiked for longer
studies, relatively small but statistically periods of time.
A relatively large number of field
significant lung function decrements studies investigating the effects of Asthma panel studies conducted both
and respiratory symptom responses in the U.S. and in other countries have
were found (for both square-wave and 14 These distributional results presented in the reported that decrements in PEF are
triangular exposure patterns), with 17 Criteria Document and Staff Paper for the Adams associated with routine O3 exposures
studies are based on study data that were not among asthmatic and healthy persons.
percent of the subjects (5 of 30) included in the publication but were obtained from
experiencing ≥ 10 percent FEV1 the author.
One large U.S. multicity study, the
decrements (comparing pre- and post- 15 Brown, J.S. (2007). EPA Office of Research and National Cooperative Inner City Asthma
Development memorandum to Ozone NAAQS Study or NCICAS, (Mortimer et al.,
12 This study and other studies (Folinsbee et al., Review Docket (OAR–2005–0172); Subject: The 2002) examined O3-related changes in
1988; Horstman et al., 1990; and McDonnell et al., effects of ozone on lung function at 0.06 ppm in PEF in 846 asthmatic children from 8
1991), conducted in EPA’s clinical research facility healthy adults, June 14, 2007.
urban areas and reported that the
in Chapel Hill, NC, measured ozone concentrations 16 Based on study data (Adams, 2006) provided by
to within +/¥5 percent or +/¥0.004 ppm at the the author, 7 percent of the subjects (2 of 30 incidence of ≥ 10 percent decrements in
0.080 ppm exposure level. subjects) experienced notable FEV1 decrements ≥ 10 morning PEF are associated with
13 These studies, conducted at a facility at the percent) with the square wave exposure pattern at increases in 8-hour average O3 for a 5-
University of California, in Davis, CA, reported O3 the 0.060 ppm exposure level (comparing pre- and
concentrations to be accurate within +/¥0.003 ppm post-exposures) when the results were corrected for
day cumulative lag, suggesting that O3
over the range of concentrations included in these the effects of exercise alone in filtered air (EPA, exposure may be associated with
studies. 2007, p. 3–6). clinically significant changes in PEF in
asthmatic children; however, no statistically significant in several cities, smaller, U.S. studies which showed
associations were reported with evening when the individual data are pooled only limited or a lack of evidence for
PEF. The mean 8-hour average O3 was from all eight cities, statistically symptom increases associated with O3
0.048 ppm across the 8 cities. Excluding significant effects were observed for the exposure, these studies had less
days when 8-hour average O3 was incidence of symptoms. The authors statistical power and/or were conducted
greater than 0.080 ppm (less than 5 also reported that the odds ratios in areas with relatively low 1-hour
percent of days), the associations with remained essentially the same and maximum average O3 levels, in the
morning PEF remained statistically statistically significant for the incidence range of 0.03 to 0.09 ppm. Even so, the
significant. Mortimer et al. (2002) of morning symptoms when days with evidence has continued to expand since
discussed potential biological 8-hour O3 concentrations above 0.080 1996 and now is considered to be much
mechanisms for delayed effects on ppm were excluded. These days stronger than in the previous review.
pulmonary function in asthma, which represented less than 5 percent of days The Criteria Document concludes that
included increased nonspecific airway in the study. the asthma panel studies, as a group,
responsiveness secondary to airway Gent and colleagues (2003) followed
and the NCICAS in particular, indicate
inflammation due to O3 exposure. Two 271 asthmatic children under age 12
a positive association between ambient
other panel studies (Romieu et al., 1996, and living in southern New England for
concentrations and respiratory
1997) carried out simultaneously in 6 months (April through September)
using a daily symptom diary. They symptoms and increased medication use
northern and southwestern Mexico City
found that mean 1-hour max O3 and 8- in asthmatics. The evidence has
with mildly asthmatic school children
hour max O3 concentrations were continued to expand since 1996 and
reported statistically significant O3-
related reductions in PEF, with 0.0586 ppm (SD 19.0) and 0.0513 ppm now is considered to be much stronger
variations in effect depending on lag (SD 15.5), respectively. The data were than in the previous review of the O3
time and time of day. Mean 1-hour analyzed for two separate groups of primary standard.
maximum O3 concentrations in these subjects, those who used maintenance School absenteeism is another
locations ranged from 0.190 ppm (SD asthma medications during the follow- potential surrogate for the health
80) in northern Mexico City to 0.196 up period and those who did not. The implications of O3 exposure in children.
ppm (SD 78) in southwestern Mexico need for regular medication was The association between school
City. While several studies report considered to be a proxy for more severe absenteeism and ambient O3
statistically significant associations asthma. Not taking any medication on a concentrations was assessed in two
between O3 exposure and reduced PEF regular basis and not needing to use a relatively large field studies. Chen et al.
in asthmatics, other studies did not, bronchodilator would suggest the (2000) examined total daily school
possibly due to low levels of O3 presence of very mild asthma. absenteeism in about 28,000 elementary
exposure. EPA concludes that these Statistically significant effects of 1-day school students in Nevada over a 2-year
studies collectively indicate that O3 may lag O3 were observed on a variety of period (after adjusting for PM10 and CO
be associated with short-term declines respiratory symptoms only in the concentrations) and found that ambient
in lung function in asthmatic medication user group. Both daily 1- O3 concentrations with a distributed lag
individuals and that the Mortimer et al. hour max and 8-hour max O3 of 14 days were statistically
(2002) study showed statistically concentrations were similarly related to significantly associated with an
significant effect at concentrations in symptoms such as chest tightness and increased rate of school absences.
the range below 0.080 ppm O3. shortness of breath. Effects of O3, but Gilliland et al. (2001) studied O3-related
Most of the panel studies which have not PM2.5, remained significant and absences among about 2,000 4th grade
investigated associations between O3 even increased in magnitude in two- students in 12 southern California
exposure and respiratory symptoms or pollutant models. Some of the communities and found statistically
increased use of asthma medication are associations were noted at 1-hour max
significant associations between 8-hour
focused on asthmatic children. Two O3 levels below 0.060 ppm. In contrast,
average O3 concentrations (with a
large U.S. studies (Mortimer et al., 2002; no effects were observed among
distributed lag out to 30 days) and all
Gent et al., 2003) have reported asthmatics not using maintenance
absence categories, and particularly for
associations between ambient O3 medication. In terms of person days of
respiratory causes. Neither PM10 nor
concentrations and daily symptoms/ follow-up, this is one of the larger
asthma medication use, even after studies currently available that address NO2 were associated with any
adjustment for copollutants. Results symptom outcomes in relation to O3, respiratory or nonrespiratory illness-
were more mixed, meaning that a and provides supportive evidence for related absences in single pollutant
greater proportion of studies were not effects of O3 independent of PM2.5. models. The Criteria Document
both positive and statistically Study limitations include the post-hoc concludes that these studies of school
significant, across smaller U.S. and nature of the population stratification by absences suggest that ambient O3
international studies that focused on medication use. Also, the study did not concentrations, accumulated over two to
these health endpoints. account for all of the important four weeks, may be associated with
The NCICAS reported morning meteorological factors that might school absenteeism, and particularly
symptoms in 846 asthmatic children influence these results, such as relative illness-related absences, but further
from 8 U.S. urban areas to be most humidity or dew point. replication is needed before firm
strongly associated with a cumulative 1- The multicity study by Mortimer et al. conclusions can be reached regarding
to 4-day lag of O3 concentrations (2002), which provides an asthmatic the effect of O3 on school absences. In
(Mortimer et al., 2002). The NCICAS population representative of the United addition, more research is needed to
used standard protocols that included States, and several single-city studies help shed light on the implications of
instructing caretakers of the subjects to indicate a robust association of O3 variation in the duration of the lag
record symptoms (including cough, concentrations with respiratory structures (i.e., 1 day, 5 days, 14 days,
chest tightness, and wheeze) in the daily symptoms and increased medication use and 30 days) found both across studies
diary by observing or asking the child. in asthmatics. While there are a number and within data sets by health endpoint
While these associations were not of well-conducted, albeit relatively and exposure metric.
(b) Increased Airway Responsiveness changes in FEV1 or respiratory Lung inflammation and increased
As discussed in more detail in the symptoms. Other studies of repeated permeability, which are distinct events
Criteria Document (section 6.8) and exposure to O3 suggest that changes in controlled by different mechanisms, are
Staff Paper (section 3.3.1.1.2), increased airway responsiveness tend to be two commonly observed effects of O3
airway responsiveness, also known as somewhat less affected by attenuation exposure observed in all of the species
airway hyperresponsiveness (AHR) or with consecutive exposures than studied. Increased cellular permeability
bronchial hyperreactivity, refers to a changes in FEV1 (EPA, 2006a, p. 6–31). is a disruption of the lung barrier that
condition in which the propensity for The Criteria Document (section 6.8) leads to leakage of serum proteins,
the airways to bronchoconstrict due to concludes that O3 exposure is linked influx of polymorphonuclear leukocytes
a variety of stimuli (e.g., exposure to with increased airway responsiveness. (neutrophils or PMNs), release of
cold air, allergens, or exercise) becomes Both human and animal studies indicate bioactive mediators, and movement of
augmented. This condition is typically that increased airway responsiveness is compounds from the airspaces into the
quantified by measuring the decrement not mechanistically associated with blood.
inflammation, and does not appear to be A number of controlled human
in pulmonary function after inhalation
strongly associated with initial exposure studies have analyzed
exposure to specific (e.g., antigen,
decrements in lung function or bronchoalveolar lavage (BAL) and nasal
allergen) or nonspecific (e.g.,
increases in symptoms. As a result of lavage (NL)17 fluids and cells for
methacholine, histamine)
increased airway responsiveness markers of inflammation and lung
bronchoconstrictor stimuli. Exposure to
induced by O3 exposure, human airways damage (EPA, 2006a, Annex AX6).
O3 causes an increase in airway
may be more susceptible to a variety of Increased lung inflammation is
responsiveness as indicated by a
stimuli, including antigens, chemicals, demonstrated by the presence of
reduction in the concentration of neutrophils found in BAL fluid in the
stimuli required to produce a given and particles. Because asthmatic
subjects typically have increased airway lungs, which has long been accepted as
reduction in FEV1 or airway obstruction. a hallmark of inflammation. It is
Increased airway responsiveness is an responsiveness at baseline, enhanced
apparent, however, that inflammation
important consequence of exposure to bronchial response to antigens in
within airway tissues may persist
O3 because its presence means that the asthmatics raises potential public health
beyond the point that inflammatory
airways are predisposed to narrowing concerns as they could lead to increased
cells are found in the BAL fluid. Soluble
on inhalation of various stimuli, such as morbidity (e.g., medication usage,
mediators of inflammation, such as
specific allergens, cold air or SO2. school absences, emergency room visits,
cytokines and arachidonic acid
Statistically significant and clinically hospital admissions) or to more
metabolites have been measured in the
relevant decreases in pulmonary persistent alterations in airway
BAL fluid of humans exposed to O3. In
function have been observed in early responsiveness (Criteria Document, p.
addition to their role in inflammation,
phase allergen response in subjects with 8–21). As such, increased airway
many of these compounds have
allergic rhinitis after consecutive (4-day) responsiveness after O3 exposure bronchoconstrictive properties and may
3-hour exposures to 0.125 ppm O3 (Holz represents a plausible link between O3 be involved in increased airway
et al., 2002). Similar increased airway exposure and increased hospital responsiveness following O3 exposure.
responsiveness in asthmatics to house admissions. An in vitro study of epithelial cells from
dust mite antigen 16 to 18 hours after (c) Respiratory Inflammation and nonatopic and atopic asthmatics
exposure to a single dose of O3 (0.160 Increased Permeability exposed to 0.010 to 0.100 ppm O3
ppm for 7.6 hours) was observed. These showed significantly increased
observations, based on O3 exposures to Based on evidence from the previous permeability compared to cells from
levels much higher than the current review, acute inflammatory responses in normal persons. This indicates a
standard level suggest that O3 exposure the lung have been observed subsequent potentially inherent susceptibility of
may be a clinically important factor that to 6.6 hour O3 exposures to the lowest cells from asthmatic individuals for O3-
can exacerbate the response to ambient tested level—0.080 ppm—in healthy induced permeability.
bronchoconstrictor substances in adults engaged in moderately high In the 1996 Criteria Document,
individuals with preexisting allergic exercise (section 6.9 of the Criteria assessment of controlled human
asthma or rhinitis. Further, O3 may have Document and section 3.3.1.3 of the exposure studies indicated that a single,
an immediate impact on the lung Staff Paper). Some of these prior studies acute (1 to 4 hours) O3 exposure
function of asthmatics as well as suggest that inflammatory responses (≥ 0.080 to 0.100 ppm) of subjects
contribute to effects that persist for may be detected in some individuals engaged in moderate to heavy exercise
longer periods. following O3 exposures in the absence could induce a number of cellular and
Kreit et al. (1989) found that O3 can of O3-induced pulmonary decrements in biochemical changes suggestive of
induce increased airway responsiveness those subjects. These studies also pulmonary inflammation and lung
in asthmatic subjects to O3, who demonstrate that short-term exposures permeability (EPA, 2006a, p. 8–22).
typically have increased airway to O3 also can cause increased These changes persisted for at least 18
responsiveness at baseline. A permeability in the lungs of humans and hours. Markers from BAL fluid
subsequent study (Jörres et al., 1996) experimental animals. Inflammatory following both 2-hour and 4-hour O3
suggested an increase in specific (i.e., responses and epithelial permeability exposures repeated up to 5 days
allergen-induced) airway reactivity in have been seen to be independent of indicate that there is ongoing cellular
subjects with allergic asthma, and to a spirometric responses. Not only are the damage irrespective of attenuation of
lesser extent in subjects with allergic newer lung inflammation and increased
rhinitis after short-term exposure to cellular permeability findings discussed 17 Graham and Koren (1990) compared
higher O3 levels; other studies reported in the Criteria Document (pp. 8–21 to 8– inflammatory mediators present in NL and BAL
similar results. According to one study 24) consistent with the previous review, fluids of humans exposed to 0.4 ppm O3 for 2 hours
and found similar increases in PMNs in both fluids,
(Folinsbee and Hazucha, 2000), changes but they provide better characterization suggesting a qualitative correlation between
in airway responsiveness after O3 of the physiological mechanisms by inflammatory changes in the lower airways (BAL)
exposure resolve more slowly than which O3 causes these effects. and upper respiratory tract (NL).
some cellular inflammatory responses of induction of oxidative stress is (e) Morphological Effects
the airways, pulmonary function, and implicated in injury and inflammation.
symptom scores (EPA, 2006a, p. 8–22). Alterations in the expression of The 1996 Criteria Document found
Acute airway inflammation was shown cytokines, chemokines, and adhesion that short-term O3 exposures cause
in Devlin et al. (1990) to occur among molecules, indicative of an ongoing similar alterations in lung morphology
adults exposed to 0.080 ppm O3 for 6.6 oxidative stress response, as well as in all laboratory animal species studied,
hours with exercise. McBride et al. injury repair and regeneration including primates. As discussed in the
(1994) reported that asthmatic subjects processes, have been reported in animal Staff Paper (section 3.3.1.1.5), cells in
were more sensitive than non- toxicology and human in vitro studies the centriacinar region (CAR) of the lung
asthmatics to upper airway evaluating biochemical mediators (the segment between the last
inflammation for O3 exposures that did implicated in injury and inflammation. conducting airway and the gas exchange
not affect pulmonary function (EPA, While antioxidants in ELF confer some region) have been recognized as a
2006a, p. 6–33). However, the public protection, O3 reactivity is not primary target of O3-induced damage
health significance of these changes is eliminated at environmentally relevant (epithelial cell necrosis and remodeling
not entirely clear. exposures (Criteria Document, p. 8–24). of respiratory bronchioles), possibly
The studies reporting inflammatory Further, antioxidant reactivity with O3 because epithelium in this region
responses and markers of lung injury is both species-specific and dose- receives the greatest dose of O3
have clearly demonstrated that there is dependent.
significant variation in response of delivered to the lower respiratory tract.
subjects exposed, especially to 6.6 hours (d) Increased Susceptibility to Following chronic O3 exposure,
O3 exposures at 0.080 and 0.100 ppm. Respiratory Infection structural changes have been observed
To provide some perspective on the As discussed in more detail in the in the CAR, the region typically affected
public health impact for these effects, Criteria Document (sections 5.2.2, 6.9.6, in most chronic airway diseases of the
the Staff Paper (section 3.3.1.1.3) notes and 8.4.2), short-term exposures to O3 human lung (EPA, 2006a, p. 8–24).
that one study (Devlin et al., 1991) have been shown to impair Ciliated cells in the nasal cavity and
showed that roughly 10 to 50 percent of physiological defense capabilities in airways, as well as Type I cells in the
the 18 young healthy adult subjects experimental animals by depressing gas-exchange region, are also identified
experienced notable increases (i.e., ≥ 2 alveolar macrophage (AM) functions as targets. While short-term O3
fold increase) in most of the and by altering the mucociliary
exposures can cause epithelial cell
inflammatory and cellular injury clearance of inhaled particles and
proliferation and fibrolitic changes in
indicators analyzed, associated with 6.6- microbes resulting in increased
susceptibility to respiratory infection. the CAR, these changes appear to be
hour exposures at 0.080 ppm. Similar,
Short-term O3 exposures also interfere transient with recovery time after
although in some cases higher, fractions
of the population of 10 healthy adults with the clearance process by exposure, depending on species and O3
tested saw > 2 fold increases associated accelerating clearance for low doses and dose. The potential impacts of repeated
with 6.6-hour exposures to 0.100 ppm. slowing clearance for high doses. short-term and chronic morphological
The authors of this study expressed the Animal toxicological studies have effects of O3 exposure are discussed
view that ‘‘susceptible subpopulations reported that acute O3 exposures below in the section on effects from
such as the very young, elderly, and suppress alveolar phagocytosis and long-term exposures. Long-term or
people with pulmonary impairment or immune system functions. Dysfunction prolonged exposure has been found to
disease may be even more affected’’ of host defenses and subsequent cause chronic lesions similar to early
(Devlin et al., 1991). increased susceptibility to bacterial lung lesions of respiratory bronchiolitis,
Since 1996, a substantial number of infection in laboratory animals has been which have the potential to progress to
human exposure studies have been induced by short-term exposures to O3 fibrotic lung disease (Criteria Document,
published which have provided levels as low as 0.080 ppm. p. 8–25).
important new information on lung A single controlled human exposure
study reviewed in the 1996 Criteria Recent studies continue to show that
inflammation and epithelial
permeability. Mudway and Kelly (2004) Document reported that exposure to short-term and sub-chronic exposures to
examined O3-induced inflammatory 0.080 to 0.100 ppm O3 for 6.6 hours O3 cause similar alterations in lung
responses and epithelial permeability (with moderate exercise) induced structure in a variety of experimental
with a meta-analysis of 21 controlled decrements in the ability of AMs to animal species. For example, a series of
human exposure studies and showed phagocytose microorganisms (EPA, new studies that used infant rhesus
that an influx in neutrophils and protein 2006a, p. 8–26). Integrating the recent monkeys and simulated seasonal
in healthy subjects is associated with animal study results with human ambient exposure (0.5 ppm 8 hours/day
total O3 dose (product of O3 exposure evidence available in the 1996 for 5 days, every 14 days for 11
concentration, exposure duration, and Criteria Document, the Criteria episodes) reported remodeling in the
minute ventilation) (EPA, 2006a, p. 6– Document concludes that available distal airways; abnormalities in tracheal
34). Results of the analysis suggest that evidence indicates that short-term O3 basement membrane; eosinophil
the time course for inflammatory exposures have the potential to impair accumulation in conducting airways;
responses (including recruitment of host defenses in humans, primarily by and decrements in airway innervation
neutrophils and other soluble interfering with AM function. Any (Criteria Document, p. 8–25). Based on
mediators) is not clearly established, but impairment in AM function may lead to evidence from animal toxicological
there is evidence that attenuation decreased clearance of microorganisms
studies, short-term and sub-chronic

profiles for many of these parameters or nonviable particles. Compromised exposures to O3 can cause
are different (EPA, 2006a, p. 8–22). AM functions in asthmatics may morphological changes in the
The Criteria Document (chapter 8) increase their susceptibility to other O3
respiratory systems, particularly in the
concludes that interaction of O3 with effects, the effects of particles, and
CAR, of a number of laboratory animal
lipid constituents of epithelial lining respiratory infections (EPA, 2006a, p. 8–
fluid (ELF) and cell membranes and the 26). species (EPA, 2006a, section 5.2.4).
(f) Emergency Department Visits/ 1992) were included in the quantitative because unscheduled hospital
Hospital Admissions for Respiratory risk assessment in the prior review and admissions occur in response to
Causes are included in the current assessment unanticipated disease exacerbations and
Increased summertime emergency along with estimates for respiratory- are more likely than scheduled
department visits and hospital related hospital admissions in admissions to be affected by variations
admissions for respiratory causes have Cleveland, Detroit, and Los Angeles in environmental factors, such as daily
based on more recent studies (Staff O3 levels. Results of a fairly large
been associated with ambient exposures
Paper, chapter 5). Significant number of these studies published
to O3. As discussed in section 3.3.1.1.6
uncertainties and the difficulty of during the past decade are summarized
of the Staff Paper, numerous studies
obtaining reliable baseline incidence in Criteria Document (chapter 7 Annex),
conducted in various locations in the
numbers resulted in emergency and results of U.S. and Canadian studies
U.S. and Canada consistently have
department visits not being used in the are shown in Figure 1 below (in section
shown a relationship between ambient
quantitative risk assessment in either II.A.3). As a group, these hospital
O3 levels and increased incidence of
the last or the current O3 NAAQS admissions studies tend to be larger
emergency department visits and
review. geographically and temporally than the
hospital admissions for respiratory In the past decade, a number of
causes, even after controlling for emergency department visit studies and
studies have examined the temporal
modifying factors, such as weather and pattern associations between O3 provide results that are generally more
copollutants. Such associations between exposures and emergency department consistent. The strongest associations of
elevated ambient O3 during summer visits for respiratory causes (EPA, respiratory hospital admissions with O3
months and increased hospital 2006a, section 7.3.2). These studies are concentrations were observed using
admissions have a plausible biological summarized in the Criteria Document short lag periods, in particular for a 0-
basis in the human and animal evidence (chapter 7 Annex) and some are shown day lag (same day exposure) and a 1-day
of functional, symptomatic, and in Figure 1 (in section II.A.3). lag (previous day exposure). Most
physiologic effects discussed above and Respiratory causes for emergency studies in the United States and Canada
in the increased susceptibility to department visits include asthma, indicated positive, statistically
respiratory infections observed in bronchitis, emphysema, pneumonia, significant associations between
laboratory animals. and other upper and lower respiratory ambient O3 concentrations and
In the last review of the O3 NAAQS, infections, such as influenza, but respiratory hospital admissions in the
the Criteria Document evaluated asthma visits typically dominate the warm season. However, not all studies
emergency department visits and daily incidence counts. Most studies found a statistically significant
hospital admissions as possible report positive associations. Among relationship with O3, possibly because
outcomes following exposure to O3 studies with adequate controls for of very low ambient O3 levels. Analyses
(EPA, 2006a, section 7.3). The evidence seasonal patterns, many reported at least for confounding using multipollutant
was limited for emergency department one significant positive association regression models suggest that
visits, but results of several studies involving O3. copollutants generally do not confound
generally indicated that short-term In reviewing evidence for associations the association between O3 and
exposures to O3 were associated with between emergency department visits respiratory hospitalizations. Ozone
respiratory emergency department for asthma and short-term O3 exposures, effect estimates were robust to PM
visits. The strongest and most consistent the Criteria Document notes that in adjustment in all-year and warm-season
evidence, at both lower levels (i.e., general, O3 effect estimates from only data.
below 0.120 ppm 1-hour max O3) and at summer only analyses tended to be
Overall, the Criteria Document
higher levels (above 0.120 ppm 1-hour positive and larger compared to results
concludes that positive and robust
max O3), was found in the group of from cool season or all year analyses
studies which investigated associations were found between
(Figure 7–8, EPA, 2006a, p. 7–68).
summertime18 daily hospital Several of the studies reported ambient O3 concentrations and various
admissions for respiratory causes in significant associations between O3 respiratory disease hospitalization
different eastern North American cities. concentrations and emergency outcomes, when focusing particularly
These studies consistently demonstrated department visits for respiratory causes, on results of warm-season analyses.
that ambient O3 levels were associated in particular asthma. However, Recent studies also generally indicate a
with increased hospital admissions and inconsistencies were observed which positive association between O3
accounted for about one to three excess were at least partially attributable to concentrations and emergency
respiratory hospital admissions per differences in model specifications and department visits for asthma during the
million persons with each 0.100 ppm analysis approach among various warm season (EPA, 2006a, p. 7–175).
increase in 1-hour max O3, after studies. For example, ambient O3 These positive and robust associations
adjustment for possible confounding concentrations, length of the study are supported by the human clinical,
effects of temperature and copollutants. period, and statistical methods used to animal toxicological, and
Overall, the 1996 Criteria Document control confounding by seasonal epidemiological evidence for lung
concluded that there was strong patterns and copollutants appear to function decrements, increased
evidence that ambient O3 exposures can affect the observed O3 effect on respiratory symptoms, airway
cause significant exacerbations of emergency department visits. Thus, the inflammation, and increased airway
preexisting respiratory disease in the Criteria Document has concluded that responsiveness. Taken together, the
stratified analyses by season generally overall evidence supports a causal
general public. Excess respiratory-

related hospital admissions associated supported a positive association relationship between acute ambient O3
with O3 exposures for the New York between O3 concentrations and exposures and increased respiratory
City area (based on Thurston et al., emergency department visits for asthma morbidity outcomes resulting in
in the warm season. increased emergency department visits
18 Discussion of the reasons for focusing on warm Hospital admissions studies focus and hospitalizations during the warm
season studies is found in the section 2.A.3.a below. specifically on unscheduled admissions season (EPA, 2006a, p. 8–77).
ii. Effects on the Respiratory System of function that were consistent with early second cohort of children are supportive
Long-Term O3 Exposures indicators of focal fibrogenesis in the of a weak association, the definitive 8-
The 1996 Criteria Document proximal alveolar region, without overt year follow-up analysis of the first
concluded that there was insufficient fibrosis. Because O3 at sufficient cohort (Gauderman et al., 2004a)
evidence from the limited number of concentrations is a strong respiratory provides little evidence that long-term
studies to determine whether long-term irritant and has been shown to cause exposure to ambient O3 at current levels
O3 exposures resulted in chronic health inflammation and restructuring of the is associated with significant deficits in
effects at ambient levels observed in the respiratory airways, it is plausible that the growth rate of lung function in
U.S. However, the aggregate evidence long-term O3 exposures might have a children. Avol et al. (2001) examined
suggested that O3 exposure, along with negative impact on baseline lung children who had moved away from
other environmental factors, could be function, particularly during childhood participating communities in southern
responsible for health effects in exposed when these exposures might have long- California to other states with improved
populations. Animal toxicological term risks. air quality. They found that a negative,
Several epidemiological studies but not statistically significant,
studies carried out in the 1980’s and
published since 1996 have examined association was observed between O3
1990’s demonstrated that long-term
the relationship between lung function and lung function parameters.
exposures can result in a variety of
development and long-term O3 Collectively, the results of these reports
morphological effects, including
exposure. The most extensive and from the children’s health cohorts
permanent changes in the small airways
robust study of respiratory effects in provide little evidence to support an
of the lungs, including remodeling of
relation to long-term air pollution impact of long-term O3 exposures on
the distal airways and CAR and
exposures among children in the U.S. is lung function development.
deposition of collagen, possibly Evidence for a significant relationship
representing fibrotic changes. These the Children’s Health Study carried out
between long-term O3 exposures and
changes result from the damage and in 12 communities of southern
decrements in maximally attained lung
repair processes that occur with California starting in 1993. One analysis
function was reported in a nationwide
repeated exposure. Fibrotic changes (Peters et al., 1999a) examined the
study of first year Yale students (Kinney
were also found to persist after months relationship between long-term O3
et al., 1998; Galizia and Kinney, 1999)
of exposure providing a potential exposures and self-reports of respiratory
(EPA, 2006a, p. 7–120). Males had much
pathophysiologic basis for changes in symptoms and asthma in a cross
larger effect estimates than females,
airway function observed in children in sectional analysis and found a limited which might reflect higher outdoor
some recent epidemiological studies. It relationship between outcomes of activity levels and correspondingly
appears that variable seasonal ambient current asthma, bronchitis, cough and higher O3 exposures during childhood.
patterns of exposure may be of greater wheeze and a 0.040 ppm increase in 1- A similar study of college freshmen at
concern than continuous daily hour max O3 (EPA, 2006a, p. 7–115). University of California at Berkeley also
exposures. Another analysis (Peters et al., 1999b) reported significant effects of long-term
Several studies published since 1996 examined the relationship between lung O3 exposures on lung function (Künzli
have investigated lung function changes function at baseline and levels of air et al., 1997; Tager et al., 1998). In a
over seasonal time periods (EPA, 2006a, pollution in the community. They comparison of students whose city of
section 7.5.3). The Criteria Document (p. reported evidence that annual mean O3 origin was either Los Angeles or San
7–114) summarizes these studies levels were associated with decreases in Francisco, long-term O3 exposures were
collectively indicate that seasonal O3 FVC, FEV1, PEF and forced expiratory associated with significant changes in
exposure is associated with smaller flow (FEF25–75) (the latter two being mid- and end-expiratory flow measures,
growth-related increases in lung statistically significant) among females which could be considered early
function in children than they would but not males. In a separate analysis indicators for pathologic changes that
have experienced living in areas with (Gauderman et al., 2000) of 4th, 7th, and might progress to COPD.
lower O3 levels and that there is some 10th grade students, a longitudinal There have been a few studies that
limited, as yet uncertain, evidence that analysis of lung function development investigated associations between long-
seasonal O3 also may affect lung over four years found no association term O3 exposures and the onset of new
function in young adults, although the with O3 exposure. The Children’s cases of asthma (EPA, 2006a, section
uncertainty about the role of Health Study enrolled a second cohort 7.5.6). The Adventist Health and Smog
copollutants makes it difficult to of more than 1500 fourth graders in (AHSMOG) study cohort of about 4,000
attribute the effects to O3 alone. 1996 (Gauderman et al., 2002). While was drawn from nonsmoking, non-
Lung capacity grows during the strongest associations with negative Hispanic white adult Seventh Day
childhood and adolescence as body size lung function growth were observed Adventists living in California (Greer et
increases, reaches a maximum during with acid vapors in this cohort, children al., 1993; McDonnell et al., 1999).
the twenties, and then begins to decline from communities with higher 4-year During the ten-year follow-up in 1987,
steadily and progressively with age. average O3 levels also experienced a statistically significant increased
Long-term exposure to air pollution has smaller increases in various lung relative risk of asthma development was
long been thought to contribute to function parameters. The strongest observed in males, compared to a
slower growth in lung capacity, relationship with O3 was with PEF. nonsignificant relative risk in females
diminished maximally attained Specifically, children from the least- (Greer et al., 1993). In the 15-year
capacity, and/or more rapid decline in polluted community had a small but follow-up in 1992, it was reported that
lung capacity with age (EPA, 2006a, statistically significant increase in PEF for males, there was a statistically
section 7.5.4). Toxicological findings as compared to those from the most- significant increased relative risk of
evaluated in the 1996 Criteria Document polluted communities. In two-pollutant developing asthma associated with 8-
demonstrated that repeated daily models, only 8-hour average O3 and NO2 hour average O3 exposures, but there
exposure of rats to an episodic profile of were significant joint predictors of FEV1 was no evidence of an association in
O3 caused small, but significant, and maximal midexpiratory flow females. Consistency of results in the
decrements in growth-related lung (MMEF). Although results from the two studies with different follow-up
times provides supportive evidence of and colleagues (Evans et al., 2003; secretions of vasoconstrictive
the potential for an association between Schelegle et al., 2003; Chen et al., 2003; substances and/or effects on neuronal
long-term O3 exposure and asthma Plopper and Fanucchi, 2000) reflexes that may result in increased
incidence in adult males; however, investigated infant rhesus monkeys arterial blood pressure and/or altered
representativeness of this cohort to the exposed to simulated, seasonal O3 and electrophysiologic control of heart rate
general U.S. population may be limited demonstrated: (1) Remodeling in the or rhythm. Some animal toxicology
(EPA, 2006a, p. 7–125). distal airways, (2) abnormalities in studies have shown O3-induced
In a similar study (McConnell et al., tracheal basement membrane; (3) decreases in heart rate, mean arterial
2002) of incident asthma among eosinophil accumulation in conducting pressure, and core temperature. One
children (ages 9 to 16 at enrollment), airways; and (4) decrements in airway controlled human exposure study that
annual surveys of 3,535 children innervation (EPA, 2006a, p. 5–45). evaluated effects of O3 exposure on
initially without asthma were used to These findings provide additional cardiovascular health outcomes found
identify new-onset asthma cases as part information regarding possible injury- no significant O3-induced differences in
of the Children’s Health Study. Six repair processes occurring with long- ECG or blood pressure in healthy or
high-O3 and six low-O3 communities term O3 exposures suggesting that these hypertensive subjects but did observe a
were identified where the children processes are only partially reversible significant O3-induced increase the
resided. There were 265 children who and may progress following cessation of alveolar-to-arterial PO2 gradient and
reported new-onset asthma during the O3 exposure. Further, these processes heart rate in both groups resulting in an
follow-up period. Although asthma risk may lead to nonreversible structural overall increase in myocardial work and
was no higher for all residents of the six damage to lung tissue; however, there is impairment in pulmonary gas exchange
high-O3 communities versus the six still too much uncertainty to (Gong et al., 1998). In another controlled
low-O3 communities, asthma risk was characterize the significance of these human exposure study, inhalation of a
3.3 times greater for children who findings to human exposure profiles and mixture of PM2.5 and O3 by healthy
played three or more sports as compared effect levels (EPA, 2006a, p. 8–25). subjects increased brachial artery
with children who played no sports In summary, in the past decade, vasoconstriction and reactivity (Brook et
within the high-O3 communities. This important new longitudinal studies al., 2002).
association was absent in the have examined the effect of chronic O3 The evidence from a few animal
communities with lower O3 exposure on respiratory health studies also includes potential direct
concentrations. No other pollutants outcomes. Limited evidence from recent effects such as O3-induced release from
were found to be associated with new- long-term morbidity studies have lung epithelial cells of platelet
onset asthma (EPA, 2006a, p. 7–125). suggested in some cases that chronic activating factor (PAF) that may
Playing sports may result in extended exposure to O3 may be associated with contribute to blood clot formation that
outdoor activity and exposure occurring seasonal declines in lung function or would have the potential to increase the
during periods when O3 levels are reduced lung function development, risk of serious cardiovascular outcomes
higher. It should be noted, however, that increases in inflammation, and (e.g., heart attack, stroke, mortality).
the results of the Children’s Health development of asthma in children and Also, interactions of O3 with surfactant
Study were based on a small number of adults. Seasonal decrements or smaller components in epithelial lining fluid of
new-onset asthma cases among children increases in lung function measures the lung may result in production of
who played three or more sports. Future have been reported in several studies; oxysterols and reactive oxygen species
replication of these findings in other however, the extent to which these that may exhibit PAF-like activity
cohorts would help determine whether changes are transient remains uncertain. contributing to clotting and also may
a causal interpretation is appropriate. While there is supportive evidence from exert cytotoxic effects on lung and heart
In animal toxicology studies, the animal studies involving effects from muscle cells.
progression of morphological effects chronic exposures, large uncertainties Epidemiologic panel and field studies
reported during and after a chronic still remain as to whether current that examined associations between O3
exposure in the range of 0.50 to 1.00 ambient levels and exposure patterns and various cardiac physiologic
ppm O3 is complex, with inflammation might cause these same effects in endpoints have yielded limited
peaking over the first few days of human populations. The Criteria evidence suggestive of a potential
exposure, then dropping, then Document concludes that association between acute O3 exposure
plateauing, and finally, largely epidemiological studies of new asthma and altered heart rate variability,
disappearing (EPA, 2006a, section development and longer-term lung ventricular arrhythmias, and incidence
5.2.4.4). By contrast, fibrotic changes in function declines remain inconclusive of heart attacks. A number of
the tissue increase very slowly over at present (EPA, 2006a, p. 7–134). epidemiological studies have also
months of exposure, and, after exposure reported associations between short-
ceases, the changes sometimes persist or iii. Effects on the Cardiovascular System term exposures and hospitalization for
increase. Epithelial hyperplasia peaks of O3 Exposure cardiovascular diseases. As shown in
soon after the inflammatory response At the time of the 1997 review, the Figure 7–13 of the Criteria Document,
but is usually maintained in both the possibility of O3-induced cardiovascular many of the studies reported negative or
nose and lungs with continuous effects was largely unrecognized. Since inconsistent associations. Some other
exposure; it also does not return to pre- then, a very limited body of evidence studies, especially those that examined
exposure levels after the end of from animal, controlled human the relationship when O3 exposures
exposure. Patterns of exposure in this exposure and epidemiologic studies has were higher, have found robust positive
same concentration range determine emerged that provides evidence for associations between O3 and
effects, with 18 months of daily some potential plausible mechanisms cardiovascular hospital admissions
exposure, causing less morphologic for how O3 exposures might exert (EPA, 2006a, p. 7–82). For example, one
damage than exposures on alternating cardiovascular system effects, however study reported a positive association
months. This is important as much needs to be done to substantiate between O3 and cardiovascular hospital
environmental O3 exposure is typically these potential mechanisms. Possible admissions in Toronto, Canada in a
seasonal. Long-term studies by Plopper mechanisms may involve O3-induced summer-only analysis (Burnett et al.,
1997b). The results were robust to analytic designs). Key findings are only from the warm season. The
adjustment for various PM indices, available from multi-city time-series reported effect estimate of
whereas the PM effects diminished studies that report associations between approximately 0.92 percent change in
when adjusting for gaseous pollutants. O3 and mortality. These studies include mortality per 0.040 ppm O3 (1-hour
Other studies stratified their analysis by analyses using data from 90 U.S. cities maximum) was similar to time-series
temperature, i.e., by warm days versus in the National Mortality, Morbidity and analysis results with adjustment for
cool days. Several analyses using warm Air Pollution (NMMAPS) study temperature (approximately 0.76
season days consistently produced (Dominici et al., 2003) and from 95 U.S. percent per 0.040 ppm O3), suggesting
positive associations. communities in an extension to the that associations between O3 and
The epidemiologic evidence for NMMAPS analyses (Bell et al., 2004). mortality were robust to the different
cardiovascular morbidity is much The original 90-city NMMAPS adjustment methods for temperature.
weaker than for respiratory morbidity, analysis, with data from 1987 to 1994, An initial publication from APHEA, a
with only one of several U.S./Canadian was primarily focused on investigating European multi-city study, reported
studies showing statistically significant effects of PM10 on mortality. A statistically significant associations
positive associations of cardiovascular significant association was reported between daily maximum O3
hospitalizations with warm-season O3 between mortality and 24-hour average concentrations and mortality in four
concentrations. Most of the available O3 concentrations in analyses using all cities in a full year analysis (Toulomi et
European and Australian studies, all of available data as well as in the warm al., 1997). An extended analysis was
which conducted all-year O3 analyses, season only analyses (Dominici et al., done using data from 23 cities
did not find an association between 2003). The estimate using all available throughout Europe (Gryparis et al.,
short-term O3 concentrations and data was about half that for the summer- 2004). In this report, a positive but not
cardiovascular hospitalizations. Overall, only data at a lag of 1-day. The extended statistically significant association was
the currently available evidence is NMMAPS analysis included data from found between mortality and 1-hour
inconclusive regarding an association 95 U.S. cities and included an daily maximum O3 in a full year
between cardiovascular hospital additional 6 years of data, from 1987– analysis. Gryparis et al. (2004) noted
admissions and ambient O3 exposure 2000 (Bell et al., 2004). Significant that there was a considerable seasonal
(EPA, 2006a, p. 7–83). associations were reported between O3 difference in the O3 effect on mortality;
In summary, based on the evidence and mortality in analyses using all thus, the small effect for the all-year
from animal toxicology, human available data. The effect estimate for data might be attributable to inadequate
controlled exposure, and epidemiologic increased mortality was approximately adjustment for confounding by
studies, from the Criteria Document 0.5 percent per 0.020 ppm change in 24- seasonality. Focusing on analyses using
concludes that this generally limited hour average O3 measured on the same summer measurements, the authors
body of evidence is suggestive that O3 day, and approximately 1.04 percent per report statistically significant
can directly and/or indirectly contribute 0.020 ppm change in 24-hour average O3 associations with total mortality,
to cardiovascular-related morbidity, but in a 7-day distributed lag model (EPA, cardiovascular mortality and with
that much needs to be done to more 2006a, p. 7–88). In analyses using only respiratory mortality (EPA, 2006a, p. 7–
fully integrate links between ambient O3 data from the warm season, the results 93, 7–99).
exposures and adverse cardiovascular were not significantly different from the Numerous single-city analyses have
full-year results. The authors also report also reported associations between
outcomes (EPA, 2006a, p. 8–77).
that O3-mortality associations were mortality and short-term O3 exposure,
b. Mortality robust to adjustment for PM (EPA, especially for those analyses using
i. Mortality and Short-Term O3 2006a, p. 7–100). Using a subset of the warm season data. As shown in Figure
Exposure NMMAPS data set, Huang et al. (2005) 7–21 of the Criteria Document, the
focused on associations between results of recent publications show a
The 1996 Criteria Document cardiopulmonary mortality and O3 pattern of positive, often statistically
concluded that an association between exposure (24-hour average) during the significant associations between short-
daily mortality and O3 concentration for summer season only. The authors report term O3 exposure and mortality during
areas with high O3 levels (e.g., Los an approximate 1.47 percent increase the warm season. In considering results
Angeles) was suggested. However, due per 0.020 ppm change in O3 from year-round analyses, there remains
to a very limited number of studies concentration measured on the same a pattern of positive results but the
available at that time, there was day and an approximate 2.52 percent findings are less consistent. In most
insufficient evidence to conclude that increase per 0.020 ppm change in O3 single-city analyses, effect estimates
the observed association was likely concentration using a 7-day distributed were not substantially changed with
causal. lag model. These findings suggest that adjustment for PM (EPA, 2006a, Figure
The current Criteria Document the effect of O3 on mortality is 7–22).
includes results from numerous immediate but also persists for several In addition, several meta-analyses
epidemiological analyses of the days. have been conducted on the
relationship between O3 and mortality. As discussed below in section relationship between O3 and mortality.
Additional single city analyses have II.A.3.a, confounding by weather, As described in section 7.4.4 of the
also been conducted since 1996, especially temperature, is complicated Criteria Document, these analyses
however, the most pivotal studies in by the fact that higher temperatures are reported fairly consistent and positive
EPA’s (and CASAC’s) finding of associated with the increased combined effect estimates ranging from
increased support for the relationship photochemical activities that are approximately 1.5 to 2.5 percent
between premature mortality and O3 is important for O3 formation. Using a increase in mortality for a standardized
in part related to differences in study case-crossover study design, Schwartz change in O3 (EPA, 2006a, Figure 7–20).
design—limiting analyses to warm (2005) assessed associations between Three recent meta-analyses evaluated
seasons, better control for copollutants, daily maximum concentrations and potential sources of heterogeneity in O3-
particularly PM, and use of multicity mortality, matching case and control mortality associations (Bell et al., 2005;
designs (both time series and meta- periods by temperature, and using data Ito et al., 2005; Levy et al., 2005). The
Criteria Document (p. 7–96) observes were higher than those for total reanalysis also includes additional
common findings across all three mortality. For cardiovascular mortality, evaluation of data from the initial ACS
analyses, in that all reported that effect the Criteria Document (Figure 7–25, p. cohort study report that had only
estimates were larger in warm season 7–106) suggests that effect estimates are reported results of associations between
analyses, reanalysis of results using consistently positive and more likely to mortality and long-term exposure to fine
default convergence criteria in be larger and statistically significant in particles and sulfates (Pope et al., 1995).
generalized additive models (GAM) did warm season analyses. The findings This reanalysis was discussed in the
not change the effect estimates, and regarding the effect size for respiratory Staff Paper (section 3.3.2.2) but not in
there was no strong evidence of mortality have been less consistent, the Criteria Document.
confounding by PM. Bell et al. (2005) possibly because of lower statistical In this reanalysis of data from the
and Ito et al. (2005) both provided power in this subcategory of mortality. previous Harvard Six City prospective
suggestive evidence of publication bias, The Criteria Document (p. 8–78) cohort study, the investigators
but O3-mortality associations remained concludes that these findings are highly replicated and validated the findings of
after accounting for that potential bias. suggestive that short-term O3 exposure the original studies, and the report
The Criteria Document concludes that directly or indirectly contribute to non- included additional quantitative results
the ‘‘positive O3 effects estimates, along accidental and cardiopulmonary-related beyond those available in the original
with the sensitivity analyses in these mortality, but additional research is report (Krewski et al., 2000). In the
three meta-analyses, provide evidence needed to more fully establish reanalysis of data from the Harvard Six
of a robust association between ambient underlying mechanisms by which such Cities study, the effect estimate for the
O3 and mortality’’ (EPA, 2006a, p. 7–97). effects occur.19 association between long-term O3
Most of the single-pollutant model concentrations and mortality was
estimates from single-city studies range ii. Mortality and Long-Term O3 negative and nearly statistically
from 0.5 to 5 percent excess deaths per Exposure significant (relative risk = 0.87, 95
standardized increments. Corresponding Little evidence was available in the percent CI: 0.76, 1.00).
summary estimates in large U.S. multi- last review on the potential for The ACS study is based on health
city studies ranged between 0.5 to 1 associations between mortality and data from a large prospective cohort of
percent with some studies noting long-term exposure to O3. In the approximately 500,000 adults and air
heterogeneity across cities and studies Harvard Six City prospective cohort quality data from about 150 U.S. cities.
(EPA, 2006a, p. 7–110). analysis, the authors report that The initial report (Pope et al., 1995)
Finally, from those studies that mortality was not associated with long- focused on associations with fine
included assessment of associations term exposure to O3 (Dockery et al., particles and sulfates, for which
with specific causes of death, it appears 1993). The authors note that the range significant associations had been
that effect estimates for associations of O3 concentrations across the six cities reported in the earlier Harvard Six
with cardiovascular mortality are larger was small, which may have limited the Cities study (Dockery et al., 1993). As
than those for total mortality. The meta- power of the study to detect associations part of the major reanalysis of these
analysis by Bell et al. (2005) observed a between mortality and O3 levels (EPA, data, results for associations with other
slightly larger effect estimate for 2006a, p. 7–127). air pollutants were also reported, and
cardiovascular mortality compared to As discussed in section 7.5.8 of the the authors report that no significant
mortality from all causes. The effect Criteria Document, in this review there associations were found between O3 and
estimate for respiratory mortality was are results available from three all-cause mortality. However, a
approximately one-half that of prospective cohort studies: the significant association was reported for
cardiovascular mortality in the meta- American Cancer Society (ACS) study cardiopulmonary mortality in the warm
analysis. However, other studies have (Pope et al., 2002), the Adventist Health season (Krewski et al., 2000). The ACS
observed larger effect estimates for and Smog (AHSMOG) study (Beeson et II study (Pope et al., 2002) reported
respiratory mortality compared to al., 1998; Abbey et al., 1999), and the results of associations with an extended
cardiovascular mortality. The apparent U.S. Veterans Cohort study (Lipfert et data base; the mortality records for the
inconsistency regarding the effect size of al., 2000, 2003). In addition, a major cohort had been updated to include 16
O3-related respiratory mortality may be reanalysis report includes evaluation of years of follow-up (compared with 8
due to reduced statistical power in this data from the Harvard Six City cohort years in the first report) and more recent
subcategory of mortality (EPA, 2006a, p. study (Krewski et al., 2000).20 This air quality data were included in the
7–108). analyses. Similar to the earlier
In summary, many single- and multi- 19 In commenting on the Criteria Document, the
reanalysis, a marginally significant
city studies observed positive CASAC Ozone Panel raised questions about the
implications of these time-series results in a policy
association was observed between long-
associations of ambient O3 context, emphasizing that ‘‘* * * while the time- term exposure to O3 and
concentrations with total nonaccidental series study design is a powerful tool to detect very cardiopulmonary mortality in the warm
and cardiopulmonary mortality. The small effects that could not be detected using other season. No other associations with
Criteria Document finds that the results designs, it is also a blunt tool’’ (Henderson, 2006b).
mortality were observed in both the full-
from U.S. multi-city time-series studies They note that ‘‘* * * not only is the interpretation
of these associations complicated by the fact that year and warm season analyses.
provide the strongest evidence to date the day-to-day variation in concentrations of these The Adventist Health and Smog
for O3 effects on acute mortality. Recent pollutants is, to a varying degree, determined by (AHSMOG) cohort includes about 6,000
meta-analyses also indicate positive risk meteorology, the pollutants are often part of a large
adults living in California. In two
estimates that are unlikely to be and highly correlated mix of pollutants, only a very
few of which are measured’’ (Henderson, 2006b). studies from this cohort, a significant
confounded by PM; however, future
Even with these uncertainties, the CASAC Ozone association has been reported between
work is needed to better understand the Panel, in its review of the Staff Paper, found ‘‘* * * long-term O3 exposure and increased
influence of model specifications on the premature total non-accidental and
risk of lung cancer mortality among
risk coefficient (EPA, 2006a, p. 7–175). cardiorespiratory mortality for inclusion in the
quantitative risk assessment to be appropriate.’’ males only (Beeson et al., 1998; Abbey
A meta-analysis that examined specific (Henderson, 2006b).
causes of mortality found that the 20 This reanalysis report and the original more detail in section 8.2.3 of the Air Quality
cardiovascular mortality risk estimates prospective cohort study findings are discussed in Criteria for Particulate Matter (EPA, 2004).
et al., 1999). No significant associations gas phase pollution. Of these, only information linking (a) Changes in
were reported between long-term O3 latitude and altitude can be defined patterns of ground-level O3
exposure and mortality from all causes with small uncertainty in any effort to concentrations likely to occur as a result
or cardiopulmonary causes. Due to the assess the changes in UV–B flux that of programs implemented to attain the
small numbers of lung cancer deaths (12 may be attributable to any changes in 1997 O3 NAAQS to (b) changes in
for males, 18 for females) and the tropospheric O3 as a result of any relevant exposures to UV–B radiation of
precision of the effect estimate (i.e., the revision to the O3 NAAQS. Such an concern to public health was too
wide confidence intervals), the Criteria assessment of UV–B related health uncertain at that time to warrant any
Document discussed concerns about the effects would also need to take into relaxation in the level of public health
plausibility of the reported association account human habits, such as outdoor protection previously determined to be
with lung cancer (EPA, 2006a, p. 7– activities (including age- and requisite to protect against the
130). occupation-related exposure patterns), demonstrated direct adverse respiratory
The U.S. Veterans Cohort study dress and skin care to adequately effects of exposure to O3 in the ambient
(Lipfert et al., 2000, 2003) of estimate UV–B exposure levels. air (68 FR 614). At that time, the more
approximately 50,000 middle-aged However, little is known about the recent information on protective effects
males diagnosed with hypertension, impact of these factors on individual of UV–B radiation was not available,
reported some positive associations exposure to UV–B. such that only adverse UV–B-related
between mortality and peak O3 Moreover, detailed information does effects could be considered. Taking into
exposures (95th percentile level for not exist regarding other factors that are consideration the more recent
several years of data). The study relevant to assessing changes in disease information available in this review, the
included numerous analyses using incidence, including: Type (e.g., peak or Criteria Document and Staff Paper
subsets of exposure and mortality cumulative) and time period (e.g., conclude that the effect of changes in
follow-up periods which spanned the childhood, lifetime, current) of ground-level O3 concentrations, likely to
years 1960 to 1996. In the results of exposures related to various adverse occur as a result of revising the O3
analyses using deaths and O3 exposure health outcomes (e.g., damage to the NAAQS, on UV-induced health
estimates concurrently across the study skin, including skin cancer; damage to outcomes, including whether these
period, there were positive, statistically the eye, such as cataracts; and immune changes would ultimately result in
significant associations between peak O3 system suppression); wavelength increased or decreased incidence of
and mortality (EPA, 2006a, p. 7–129). dependency of biological responses; and UV–B-related diseases, cannot yet be
Overall, the Criteria Document interindividual variability in UV–B critically assessed. EPA requests
concludes that consistent associations resistance to such health outcomes. comment on available studies or data
have not been reported between long- Beyond these well recognized adverse that would be relevant to conducting a
term O3 exposure and all-cause, health effects associated with various critical assessment with reasonable
cardiopulmonary or lung cancer wavelengths of UV radiation, the certainty of UV-induced health
mortality (EPA, 2006a, p. 7–130). Criteria Document (section 10.2.3.6) also outcomes and how evidence of UV-
c. Role of Ground-Level O3 in Solar discusses protective effects of UV–B induced health outcomes might inform
Radiation-Related Human Health Effects radiation. Recent reports indicate the the Agency’s review of the primary O3
necessity of UV–B in producing vitamin standard.
Beyond the direct health effects D, and that vitamin D deficiency can
attributable to inhalation exposure to O3 cause metabolic bone disease among 3. Interpretation and Integration of
in the ambient air discussed above, the children and adults, and may also Health Evidence
Criteria Document also assesses increase the risk of many common As discussed below, in assessing the
potential indirect effects related to the chronic diseases (e.g., type I diabetes new health evidence, the Criteria
presence of O3 in the ambient air by and rheumatoid arthritis) as well as the Document integrates findings from
considering the role of ground-level O3 risk of various types of cancers. Thus, experimental (e.g., toxicological,
in mediating human health effects that the Criteria Document concludes that dosimetric and controlled human
may be directly attributable to exposure any assessment that attempts to quantify exposure) and epidemiological studies,
to solar ultraviolet radiation (UV–B). the consequences of increased UV–B to make judgments about the extent to
The Criteria Document (chapter 10) exposure on humans due to reduced which causal inferences can be made
focuses this assessment on three key ground-level O3 must include about observed associations between
factors, including those factors that consideration of both negative and health endpoints and exposure to O3. In
govern (1) UV–B radiation flux at the positive effects. However, as with other evaluating the evidence from
earth’s surface, (2) human exposure to impacts of UV–B on human health, this epidemiological studies, the EPA
UV–B radiation, and (3) human health beneficial effect of UV–B radiation has focuses on well-recognized criteria,
effects due to UV–B radiation. In so not been studied in sufficient detail to including: The strength of reported
doing, the Criteria Document provides a allow for a credible health benefits or associations, including the magnitude
thorough analysis of the current risk assessment. In conclusion, the and precision of reported effect
understanding of the relationship effect of changes in surface-level O3 estimates and their statistical
between reducing ground-level O3 concentrations on UV-induced health significance; the robustness of reported
concentrations and the potential impact outcomes cannot yet be critically associations, or stability in the effect
these reductions might have on assessed within reasonable uncertainty estimates after considering factors such
increasing UV–B surface fluxes and (Criteria Document, p. 10–36). as alternative models and model
indirectly contributing to UV–B related The Agency last considered indirect specification, potential confounding by
health effects. effects of O3 in the ambient air in its co-pollutants, and issues related to the
There are many factors that influence 2003 final response to a remand of the consequences of exposure measurement
UV–B radiation penetration to the Agency’s 1997 decision to revise the O3 error; potential aggregation bias in
earth’s surface, including latitude, NAAQS. In so doing, based on the pooling data; and the consistency of the
altitude, cloud cover, surface albedo, available information in the last review, effects associations as observed by
PM concentration and composition, and the Administrator determined that the looking across results of multiple- and
single-city studies conducted by (2) In evaluating the robustness of results for associations between ambient
different investigators in different places associations, the Criteria Document O3 concentrations and personal
and times. Consideration is also given to (sections 7.1.3 and 8.4.4.3) and Staff exposures to O3. Collectively, these
evaluating concentration-response Paper (section 3.4.2) have primarily studies observed that the daily averaged
relationships observed in considered the impact of exposure error, personal O3 exposures tend to be well
epidemiological studies to inform potential confounding by copollutants, correlated with ambient O3
judgments about the potential for and alternative models and model concentrations despite the substantial
threshold levels for O3-related effects. specifications. variability that existed among the
Integrating more broadly across In time-series and panel studies, the personal measurements. These studies
epidemiological and experimental temporal (e.g., daily or hourly) changes provide supportive evidence that
evidence, the Criteria Document also in ambient O3 concentrations measured ambient O3 concentrations from central
focuses on the coherence and at centrally-located ambient monitoring monitors may serve as valid surrogate
plausibility of observed O3-related stations are generally used to represent measures for mean personal exposures
health effects to reach judgments about a community’s exposure to ambient O3. experienced by the population, which is
the extent to which causal inferences In prospective cohort or cross-sectional of most relevance for time-series
can be made about observed studies, air quality data averaged over a studies. A better understanding of the
associations between health endpoints period of months to years are used as relationship between ambient
and exposure to O3 in the ambient air. indicators of a community’s long-term concentrations and personal exposures,
exposure to ambient O3 and other as well as of the other factors that affect
a. Assessment of Evidence From pollutants. In both types of analyses,
Epidemiological Studies relationship will improve the
exposure error is an important interpretation of concentration-
Key elements of the evaluation of consideration, as actual exposures to population health response associations
epidemiological studies are briefly individuals in the population will vary observed.
summarized below. across the community.
(1) The strength of associations most Ozone concentrations measured at The Criteria Document (section
directly refers to the magnitude of the central ambient monitoring sites may 7.1.3.1) also discusses the potential
reported relative risk estimates. Taking explain, at least partially, the variance influence of exposure error on
a broader view, the Criteria Document in individual exposures to ambient O3; epidemiologic study results. Zeger et al.
draws upon the criteria summarized in however, this relationship is influenced (2000) outlined the components to
a recent report from the U.S. Surgeon by various factors related to building exposure measurement error, finding
General, which define strength of an ventilation practices and personal that ambient exposure can be assumed
association as ‘‘the magnitude of the behaviors. Further, the pattern of to be the product of the ambient
association and its statistical strength’’ exposure misclassification error and the concentration and an attenuation factor
which includes assessment of both influence of confounders may differ (i.e., building filter) and that panel
effect estimate size and precision, which across the outcomes of interest as well studies and time-series studies that use
is related to the statistical power of the as in susceptible populations. As ambient concentrations instead of
study (CDC, 2004). In general, when discussed in the Criteria Document personal exposure measurements will
associations are strong in terms of (section 3.9), only a limited number of estimate a health risk that is attenuated
yielding large relative risk estimates, it studies have examined the relationship by that factor. Navidi et al. (1999) used
is less likely that the association could between ambient O3 concentrations and data from a children’s cohort study to
be completely accounted for by a personal exposures to ambient O3. One compare effect estimates from a
potential confounder or some other of the strongest predictors of the simulated ‘‘true’’ exposure level to
source of bias, whereas with relationship between ambient results of analyses from O3 exposures
associations that yield small relative concentrations and personal exposures determined by several methods, finding
risk estimates it is especially important appears to be time spent outdoors. The that O3 exposures based on the use of
to consider potential confounding and strongest relationships were observed in ambient monitoring data overestimate
other factors in assessing causality. outdoor workers (Brauer and Brook, the individual’s O3 exposure and thus
Effect estimates between O3 and some of 1995, 1997; O’Neill et al., 2004). generally result in O3 effect estimates
the health outcomes are generally small Statistically significant correlations that are biased downward (EPA, 2006a,
in size and could thus be characterized between ambient concentrations and p. 7–8). Similarly, in a reanalysis of a
as weak. For example, effect estimates personal exposures were also observed study by Burnett et al. (1994) on the
for associations with mortality generally for children, who likely spend more acute respiratory effects of ambient air
range from 0.5 to 5 percent increases per time outdoors in the warm season (Linn pollution, Zidek et al. (1998) reported
0.040 ppm increase in 1-hour maximum et al., 1996; Xue et al., 2005). There is that accounting for measurement error,
O3 or equivalent, whereas associations some concern about the extent to which as well as making a few additional
for hospitalization range up to 50 ambient concentrations are changes to the analysis, resulted in
percent increases per standardized O3 representative of personal O3 exposures qualitatively similar conclusions, but
increment. However, the Criteria of another particularly susceptible the effects estimates were considerably
Document notes that there are large group of individuals, the debilitated larger in magnitude (EPA, 2006a, p. 7–
multicity studies that find small elderly, since those who suffer from 8). A simulation study by Sheppard et
associations between short-term O3 chronic cardiovascular or respiratory al. (2005) also considered attenuation of
exposure and mortality or morbidity conditions may tend to protect the risk based on personal behavior,
and have done so with great precision themselves more than healthy their microenvironment, and the
due to the statistical power of the individuals from environmental threats qualities of the pollutant in time-series
studies (EPA, 2006a, p. 8–40). That is, by reducing their exposure to both O3 studies. Of particular interest is their
the power of the studies allows the and its confounders, such as high finding that risk estimates were not
authors to reliably distinguish even temperature and PM. Studies by Sarnat further attenuated in time-series studies
weak relationships from the null et al. (2001, 2005) that included this even when the correlations between
hypothesis with statistical confidence. susceptible group reported mixed personal exposures and ambient
concentrations were weak. In addition emphasis is on controlling or adjusting study of asthmatic children (Mortimer et
to overestimation of exposure and the for potential confounders in estimating al., 2002), the O3 effect was attenuated,
resulting underestimation of effects, the the effects of one pollutant, while the but there was still a positive association;
use of ambient O3 concentrations may emphasis for effect modification is on in Gent et al. (2003), effects of O3, but
obscure the presence of thresholds in identifying and assessing the effects for not PM2.5, remained statistically
epidemiologic studies (EPA, 2006a, p. different modifiers. The Criteria significant and even increased in
7–9). Document (p. 7–148) observes that O3 is magnitude in two-pollutant models
As discussed in the Criteria Document generally not highly correlated with (EPA, 2006a, p. 7–53). Considering this
(section 3.9), using ambient other criteria pollutants (e.g., PM10, CO, body of studies, the Criteria Document
concentrations to determine exposure SO2 and NO2), but may be more highly concludes: ‘‘Multipollultant regression
generally overestimates true personal O3 correlated with secondary fine particles, analyses indicated that O3 risk
exposures by approximately 2- to 4-fold especially during the summer months, estimates, in general, were not sensitive
in available studies, resulting in and that the degree of correlation to the inclusion of copollutants,
attenuated risk estimates. The between O3 and other pollutants may including PM2.5 and sulfate. These
implication is that the effects being vary across seasons. For example, results suggest that the effects of O3 on
estimated occur at fairly low exposures positive associations are observed respiratory health outcomes appear to
and the potency of O3 is greater than between O3 and pollutants such as fine be robust and independent of the effects
these effects estimates indicate. As very particles during the warmer months, but of other copollutants (EPA, 2006a, p. 7–
few studies evaluating O3 health effects negative correlations may be observed 154).’’
with personal O3 exposure during the cooler months (EPA, 2006a, The Criteria Document observes that
measurements exist in the literature, p. 7–17). Thus, the Criteria Document another challenge of time-series
effect estimates determined from (section 7.6.4) pays particular attention epidemiological analysis is assessing the
ambient O3 concentrations must be to the results of season-specific analyses relationship between O3 and health
evaluated and used with caution to and studies that assess effects of PM in outcomes while avoiding bias due to
assess the health risks of O3. In the potential confounding of O3-health confounding by other time-varying
absence of available data on personal O3 relationships. The Criteria Document factors, particularly seasonal trends and
exposure, the use of routinely also discussed the limitations of weather variables (EPA, 2006a, p. 7–14).
monitored ambient O3 concentrations as commonly used multipollutant models These variables are of particular interest
a surrogate for personal exposures is not that include the difficulty in because O3 concentrations have a well-
generally expected to change the interpreting results where the characterized seasonal pattern and are
principal conclusions from O3 copollutants are highly colinear, or also highly correlated with changes in
epidemiologic studies. Therefore, where correlations between pollutants temperature, such that it can be difficult
population health risk estimates derived change by season (EPA, 2006a, p. 7– to distinguish whether effects are
using ambient O3 levels from currently 150). This is particularly the situation associated with O3 or with seasonal or
available observational studies, with where O3 and a copollutant, such as weather variables in statistical analyses.
appropriate caveats about personal The Criteria Document (section
sulfates, are formed under the same
exposure considerations, remain useful. 7.1.3.4) discusses statistical modeling
atmospheric condition; in such cases
The Criteria Document recommends approaches that have been used to
multipollutant models would produce
caution in the quantitative use of effect adjust for time-varying factors,
unstable and possibly misleading results
estimates calculated using ambient O3 highlighting a series of analyses that
(EPA, 2006a, p. 7–152).
concentrations as they may lead to were done in a Health Effects Institute-
underestimation of the potency of O3. For mortality, the results from funded reanalysis of numerous time-
However, the Staff Paper observes that numerous multi-city and single-city series studies. While the focus of these
the use of these risk estimates for studies indicate that O3-mortality reanalyses was on associations with PM,
comparing relative risk reductions associations do not appear to be a number of investigators also examined
between alternative ambient O3 substantially changed in multipollutant the sensitivity of O3 coefficients to the
standards considered in the risk models including PM10 or PM2.5 (EPA, extent of adjustment for temporal trends
assessment (discussed below in section 2006a, p. 7–101; Figure 7–22). Focusing and weather factors. In addition, several
II.B.2) is less likely to suffer from this on results of warm season analyses, recent studies, including U.S. multi-city
concern. effect estimates for O3-mortality studies (Bell et al., 2005; Huang et al.,
Confounding occurs when a health associations are fairly robust to 2005; Schwartz et al., 2005) and a meta-
effect that is caused by one risk factor adjustment for PM in multipollutant analysis study (Ito et al., 2005),
is attributed to another variable that is models (EPA, 2006a, p. 7–102; Figure 7– evaluated the effect of model
correlated with the causal risk factor; 23). The Criteria Document concludes specification on O3-mortality
epidemiological analyses attempt to that in the few multipollutant analyses associations. As discussed in the
adjust or control for potential conducted for these endpoints, Criteria Document (section 7.6.3.1),
confounders. Copollutants (e.g., PM, copollutants generally do not confound these studies generally report that
CO, SO2 and NO2) can meet the criteria the relationship between O3 and associations reported with O3 are not
for potential confounding in O3-health respiratory hospitalization (EPA, 2006a, substantially changed with alternative
associations if they are potential risk p. 7–79 to 7–80; Figure 7–12). modeling strategies for adjusting for
factors for the health effect under study Multipollutant models were not used as temporal trends and meteorologic
and are correlated with O3. Effect commonly in studies of relationships effects. In the meta-analysis by Ito et al.
modifiers include variables that may between respiratory symptoms or lung (2005), a separate multi-city analysis
influence the health response to the function with O3, but the Criteria was presented that found that
pollutant exposure (e.g., co-pollutants, Document reports that results of alternative adjustments for weather
individual susceptibility, smoking or available analyses indicate that such resulted in up to 2-fold difference in the
age). Both are important considerations associations generally were robust to O3 effect estimate. Significant
for evaluating effects in a mixture of adjustment for PM2.5 (EPA, 2006a, p. 7– confounding can occur when strong
pollutants, but for confounding, the 154). For example, in a large multi-city seasonal cycles are present, suggesting
that season-specific results are more (2004) found that the effect estimate for colleagues (1997a,b) plotted the
generally robust than year-round results an association between short-term O3 relationships between air pollutant
in such cases. A number of exposure and mortality was little concentrations and both respiratory and
epidemiological studies have conducted changed when days exceeding 0.060 cardiovascular hospitalization, and it
season-specific analyses, and have ppm (24-hour average) were excluded in appears in these results that the
generally reported stronger and more the analysis. Bell et al. (2006) found no associations with O3 are found in the
precise effect estimates for O3 difference in estimated effect even when concentration range above about 0.030
associations in the warm season than in all days with 24-hour O3 concentrations ppm (1-hour maximum; <0.025 ppm, 8-
analyses conducted in the cool seasons <0.020 ppm were excluded (EPA, 2006a, hour average). Vedal and colleagues
or over the full year. p. 8–43). Using data from 8 U.S. cities, (2003) reported a significant association
(3) Consistency refers to the persistent Mortimer and colleagues (2002) also between O3 and mortality in British
finding of an association between reported that associations between O3 Columbia where O3 concentrations were
exposure and outcome in multiple and both lung function and respiratory quite low (mean 1-hour maximum
studies of adequate power in different symptoms remained statistically concentration of 0.0273 ppm). The
persons, places, circumstances and significant and of the same or greater authors did not specifically test for
times (CDC, 2004). In considering magnitude in effect size when threshold levels, but the fact that the
results from multi-city studies and concentrations greater than 0.080 ppm association was found in an area with
single-city studies in different areas, the (8-hour average) were excluded (EPA, such low O3 concentrations suggests
Criteria Document (p. 8–41) observes 2006a, p. 7–46). Several single-city that any potential threshold level would
general consistency in effects of short- studies also report similar findings of be quite low in this data set.
term O3 exposure on mortality, associations that remain or are increased In summary, the Criteria Document
respiratory hospitalization and other in magnitude and statistical significance finds that, taken together, the available
respiratory health outcomes. The when data at the upper end of the evidence from clinical and
variations in effects that are observed concentration range are removed (EPA, epidemiological studies suggests that no
may be attributable to differences in 2006a, section 7.6.5). clear conclusion can now be reached
relative personal exposure to O3, as well Other time-series epidemiological with regard to possible threshold levels
as varying concentrations and studies have used statistical modeling for O3-related effects (EPA, 2006a, p. 8–
composition of copollutants present in approaches to evaluate whether 44). Thus, the available epidemiological
different regions. Thus, the Criteria thresholds exist in associations between evidence neither supports nor refutes
Document (p. 8–41) concludes that short-term O3 exposure and mortality. the existence of thresholds at the
‘‘consideration of consistency or As discussed in section 7.6.5 of the population level for effects such as
heterogeneity of effects is appropriately Criteria Document, one European multi- increased hospital admissions and
understood as an evaluation of the city study included evaluation of the premature mortality. There are
similarity or general concordance of shape of the concentration-response limitations in epidemiological studies
results, rather than an expectation of curve, and observed no deviation from that make discerning thresholds in
finding quantitative results with a very a linear function across the range of O3 populations difficult, including low
narrow range.’’ measurements from the study (Gryparis data density in the lower concentration
(4) The Staff Paper recognizes that it et al., 2004; EPA, 2006a, p. 7–154). ranges, the possible influence of
is likely that there are biological Several single-city studies also observed exposure measurement error, and
thresholds for different health effects in a monotonic increase in associations interindividual differences in
individuals or groups of individuals between O3 and morbidity that suggest susceptibility to O3-related effects in
with similar innate characteristics and that no population threshold exists populations. There is the possibility that
health status. For O3 exposure, (EPA, 2006a, p. 7–159). thresholds for individuals may exist in
individual thresholds would On the other hand, a study in Korea reported associations at fairly low levels
presumably vary substantially from used several different modeling within the range of air quality observed
person to person due to individual approaches and reported that a in the studies but not be detectable as
differences in genetic susceptibility, threshold model provided the best fit for population thresholds in
pre-existing disease conditions and the data. The results suggested a epidemiological analyses.
possibly individual risk factors such as potential threshold level of about 0.045
diet or exercise levels (and could even ppm (1-hour maximum concentration; b. Biological Plausibility and Coherence
vary from one time to another for a <0.035 ppm, 8-hour average) for an of Evidence
given person). Thus, it would be association between mortality and short- The body of epidemiological studies
difficult to detect a distinct threshold at term O3 exposure during the summer discussed in the Staff Paper emphasizes
the population level below which no months (Kim et al., 2004; EPA, 2006a, the role of O3 in association with a
individual would experience a given p. 8–43). The authors reported larger variety of adverse respiratory and
effect, especially if some members of a effect estimates for the association for cardiovascular effects. While
population are unusually sensitive even data above the potential threshold level, recognizing a variety of plausible
down to very low concentrations (EPA, suggesting that an O3-mortality mechanisms, there exists a general
2004, p. 9–43, 9–44). association might be underestimated in consensus suggesting that O3 could,
Some studies have tested associations the non-threshold model. A threshold either directly or through initiation,
between O3 and health outcomes after analysis recently reported by Bell et al. interfere with basic cellular oxidation
removal of days with higher O3 levels (2006) for 98 U.S. communities, processes responsible for inflammation,
from the data set; such analyses do not including the same 95 communities in reduced antioxidant capacity,
necessarily indicate the presence or Bell et al. (2004), indicated that if a atherosclerosis and other effects.
absence of a threshold, but provide population threshold existed for Reasoning that O3 influences cellular
some information on whether the mortality, it would likely fall below a chemistry through basic oxidative
relationship is found using only lower- 24-hour average O3 concentration of properties (as opposed to a unique
concentration data. For example, using 0.015 ppm (<0.025 ppm, 8-hour chemical interaction), other reactive
data from 95 U.S. cities, Bell et al. average). In addition, Burnett and oxidizing species (ROS) in the
atmosphere acting either independently controlled human exposure studies and few epidemiological studies have
or in combination with O3 may also animal toxicological studies to draw reported positive associations between
contribute to a number of adverse conclusions regarding the coherence of short-term O3 exposure and respiratory
respiratory and cardiovascular health evidence and biological plausibility of mortality, though the associations are
effects. Consequently, the role of O3 O3-related health effects to reach not generally statistically significant
should be considered more broadly as judgments about the causal nature of (EPA, 2006a, p. 7–108).
O3 behaves as a generator of numerous observed associations. As summarized Considering the evidence from
oxidative species in the atmosphere. below, coherence and biological epidemiological studies, the results
In considering the biological plausibility are discussed for each of the described above provide evidence for
plausibility of reported O3-related following types of O3-related effects: coherence in O3-related effects on the
effects, the Staff Paper (section 3.4.6) short-term effects on the respiratory respiratory system. Effect estimates from
considers this broader question of system, effects on the cardiovascular U.S. and Canadian studies are shown in
health effects of pollutant mixtures system, effects related to long-term O3 Figure 1, where it can be seen that
containing O3. The potential for O3- exposure, and short-term mortality- mostly positive associations have been
related enhancements of PM formation, related health endpoints. reported with respiratory effects ranging
particle uptake, and exacerbation of PM- from respiratory symptoms, such as
induced cardiovascular effects i. Coherence and Plausibility of Short-
Term Effects on the Respiratory System cough or wheeze, to hospitalization for
underscores the importance of various respiratory diseases, and there is
considering contributions of O3 Acute respiratory morbidity effects suggestive evidence for associations
interactions with other often co- that have been associated with short- with respiratory mortality. Many of the
occurring air pollutants to health effects term exposure to O3 include such health reported associations are statistically
due to O3-containing pollutant mixes. endpoints as decrements in lung significant, particularly in the warm
The Staff Paper summarizes some function, increased airway season. In Figure 1, the central effect
examples of important pollutant responsiveness, airway inflammation, estimate is indicated by a square for
mixture effects from studies that increased permeability related to each result, with the vertical bar
evaluate interactions of O3 with other epithelial injury, immune system representing the 95 percent confidence
co-occurring pollutants, as discussed in effects, emergency department visits for interval around the estimate. In the
chapters 4, 5, and 6 of the Criteria respiratory diseases, and hospitalization discussions that follow, an individual
Document. due to respiratory illness. study result is considered to be
All of the types of interactive effects Recent epidemiological studies have
statistically significant if the 95 percent
of O3 with other co-occurring gaseous supported evidence available in the
confidence interval does not include
and nongaseous viable and nonviable previous O3 NAAQS review on
zero.21 Positive effect estimates indicate
PM components of ambient air mixes associations between ambient O3
increases in the health outcome with O3
noted above argue that O3 acts not only exposure and decline in lung function
exposure. In considering these results as
alone but that O3 also is a surrogate for children. The Criteria Document (p.
a whole, it is important to consider not
indicator for air pollution mixes which 8–34) concludes that exposure to
only whether statistical significance at
may enhance the risk of adverse effects ambient O3 has a significant effect on
the 95 percent confidence level is
due to O3 acting in combination with lung function and is associated with
reported in individual studies but also
other pollutants. Viewed from this increased respiratory symptoms and
the general pattern of results, focusing
perspective, those epidemiologic medication use, particularly in
in particular on studies with greater
findings of morbidity and mortality asthmatics. Short-term exposure to O3
statistical power that report relatively
associations, with ambient O3 has also been associated with more
more precise results.
concentrations extending to quite low severe morbidity endpoints, such as
BILLING CODE 6560–50–P
levels in many cases, become more emergency department visits and
understandable and plausible. hospital admissions for respiratory 21 Results for studies of respiratory symptoms are
The Criteria Document integrates cases, including specific respiratory presented as odds ratios; an odds ratio of 1.0 is
epidemiological studies with illness (e.g., asthma) (EPA, 2006a, equivalent to no effect, and thus is presented as
mechanistic information from sections 7.3.2 and 7.3.3). In addition, a equivalent to the zero effect estimate line.
BILLING CODE 6560–50–C healthy humans exposed to O3 at enhancement of response resulting from
Considering also evidence from ambient concentrations include: previous O3 exposures. Lung function
toxicological, chamber, and field decreased inspiratory capacity; mild studies of several animal species acutely
studies, the Criteria Document (section bronchoconstriction; rapid, shallow exposed to relatively low O3 levels (0.25
8.6) discusses biological plausibility and breathing during exercise; subjective to 0.4 ppm) show responses similar to
coherence of evidence for acute O3- symptoms of tracheobronchial airway those observed in humans, including
induced respiratory health effects. irritation, including cough and pain on increased breathing frequency,
Inhalation of O3 for several hours while deep inspiration; decreases in measures decreased tidal volume, increased
subjects are physically active can elicit of lung function; and increased airway resistance, and decreased FVC.
both acute adverse pathophysiological resistance. The severity of symptoms Alterations in breathing pattern return
changes and subjective respiratory tract and magnitude of response depends on to normal within hours of exposure, and
symptoms (EPA, 2006a, section 8.4.2). inhaled dose, individual O3 sensitivity, attenuation in functional responses
Acute pulmonary responses observed in and the degree of attenuation or
EP11JY07.000</GPH>
following repeated O3 exposures is ii. Coherence and Plausibility of Effects important in persons with significant
similar to those observed in humans. on the Cardiovascular System preexisting cardiovascular impairment.
Physiological and biochemical There is very limited experimental As noted above in section II.A.2.b, a
alterations investigated in controlled evidence of animals and humans that limited number of new epidemiological
human exposure and animal toxicology has evaluated possible mechanisms or studies have reported associations
studies tend to support certain physiological pathways by which acute between short-term O3 exposure and
hypotheses of underlying pathological O3 exposures may induce
mechanisms which lead to the effects on the cardiovascular system.
cardiovascular system effects. Ozone Among these studies, three were
development of respiratory-related induces lung injury, inflammation, and
effects reported in epidemiology studies population-based and involved
impaired mucociliary clearance, with a relatively large cohorts; two of these
(e.g., increased hospitalization and host of associated biochemical changes
medication use). Some of these are: (a) studies evaluated associations between
all leading to increased lung epithelial O3 and heart rate variability (HRV) and
Decrements in lung function, (b)
permeability. As noted above in section the other study evaluated the
bronchoconstriction, (c) increased
II.A.2.b, the generation of lipid association between O3 levels and the
airway responsiveness, (d) airway
ozonation products and ROS in lung relative risk of myocardial infarction
inflammation, (e) epithelial injury, (f)
tissues can influence pulmonary (MI). Such studies may offer more
immune system activation, (g) host
hemodynamics, and ultimately the informative results based on their large
defense impairment, and (h) sensitivity
cardiovascular system. Other potential subject-pool and design. Results from
of individuals, which depends on at
mechanisms by which O3 exposure may these three studies were suggestive of an
least a person’s age, disease status,
be associated with cardiovascular association between O3 exposure and
genetic susceptibility, and the degree of
attenuation present due to prior disease outcomes have been described. the cardiovascular endpoints studied. In
exposures. The time sequence, Laboratory animals exposed to relatively other recent studies on the incidence of
magnitude, and overlap of these high O3 concentrations (≥0.5 ppm)
MI and some more subtle cardiovascular
complex events, both in terms of demonstrate tissue edema in the heart
health endpoints, such as changes in
development and recovery, illustrate the and lungs. Ozone-induced changes in
HRV or cardiac arrhythmia, some but
inherent difficulty of interpreting the heart rate, edema of heart tissue, and
not all studies reported associations
biological plausibility of O3-induced increased tissue and serum levels of
with short-term exposure to O3 (EPA,
cardiopulmonary health effects (EPA, ANF found with 8-hour 0.5 ppm O3
exposure in animal toxicology studies 2006a, section 7.2.7.1). From these
2006a, p. 8–48). studies, the Criteria Document
The interaction of O3 with airway (Vesely et al., 1994a, b, c) also raise the
possibility of potential cardiovascular concludes that the ‘‘current evidence is
epithelial cell membranes and ELF to rather limited but suggestive of a
form lipid ozonation products and ROS effects of acute ambient O3 exposures.
Animal toxicology studies have found potential effect on HRV, ventricular
is supported by numerous human, arrhythmias, and MI incidence’’ (EPA,
animal and in vitro studies. Ozonation both transient and persistent ventilatory
responses with and without progressive 2006a, p. 7–65).
products and ROS initiate a cascade of
events that lead to oxidative stress, decreases in heart rate (Arito et al., An increasing number of studies have
injury, inflammation, airway epithelial 1997). Observations of O3-induced evaluated the association between O3
damage and increased epithelial damage vasoconstriction in a controlled human exposure and cardiovascular hospital
and increased alveolar permeability to exposure study by Brook et al. (2002) admissions. As discussed in section
vascular fluids. Repeated respiratory suggests another possible mechanism 7.3.4 of the Criteria Document, many
inflammation can lead to a chronic for O3-related exacerbations of reported negative or inconsistent
inflammatory state with altered lung preexisting cardiovascular disease. One associations, whereas other studies,
structure and lung function and may controlled human study (Gong et al., especially those that examined the
lead to chronic respiratory diseases such 1998) evaluated potential cardiovascular relationship when O3 exposures were
as fibrosis and emphysema (EPA, 2006a, health effects of O3 exposure. The higher, have found positive and robust
section 8.6.2). Continued respiratory overall results did not indicate acute associations between O3 and
inflammation also can alter the ability to cardiovascular effects of O3 in either the cardiovascular hospital admissions. The
respond to infectious agents, allergens hypertensive or control subjects. The Criteria Document finds that the overall
and toxins. Acute inflammatory authors observed an increase in rate- evidence from these studies remains
responses to O3 are well documented, pressure product and heart rate, a inconclusive regarding the effect of O3
and lung injury can become apparent decrement for FEV1, and a >10 mm Hg on cardiovascular hospitalizations (EPA,
within 3 hours after exposure in increase in the alveolar/arterial pressure 2006a, p. 7–83).
humans. difference for O2 following O3 exposure.
Taken together, the Criteria Document Foster et al. (1993) demonstrated that The Criteria Document notes that the
concludes that the evidence from even in relatively young healthy adults, suggestive positive epidemiologic
experimental human and animal O3 exposure can cause ventilation to findings of O3 exposure on cardiac
toxicology studies indicates that acute shift away from the well-perfused basal autonomic control, including effects on
O3 exposure is causally associated with lung. This effect of O3 on ventilation HRV, ventricular arrhythmias and MI,
respiratory system effects, including O3- distribution may persist beyond 24- and reported associations between O3
induced pulmonary function hours post-exposure (Foster et al., exposure and cardiovascular
decrements, respiratory symptoms, lung 1997). These findings suggest that O3 hospitalizations generally in the warm
inflammation, and increased lung may exert cardiovascular effects season gain credibility and scientific
permeability, airway indirectly by impairing alveolar-arterial support from the results of experimental
hyperresponsiveness, increased uptake O2 transfer and potentially reducing O2 animal toxicology and human clinical
of nonviable and viable particles, and supply to the myocardium. Ozone studies, which are indicative of
consequent increased susceptibility to exposure may increase myocardial work plausible pathways by which O3 may
PM-related toxic effects and respiratory and impair pulmonary gas exchange to exert cardiovascular effects (EPA, 2006a,
infections (EPA, 2006a, p. 8–48). a degree that could perhaps be clinically section 8.6.1).
iii. Coherence and Plausibility of Effects epidemiologic studies (EPA, 2006a, found that individuals with the lowest
Related to Long-Term O3 Exposure p. 8–51). FEV1 values have the highest levels of
CRP, and those with the highest FEV1
Human chamber studies can not iv. Coherence and Plausibility of Short-
values have the lowest CRP levels
evaluate effects of long-term exposures Term Mortality-Related Health
(Manino et al., 2003; Sin and Man,
to O3; there is some evidence available Endpoints
2003). This complex series of
from toxicological studies. While early An extensive epidemiological physiological and biochemical reactions
animal toxicology studies of long-term literature on air pollution related following O3 exposure may tilt the
O3 exposures were conducted using mortality risk estimates from the U.S., biological homeostasis mechanisms
continuous exposures, more recent Canada, and Europe is discussed in the which could lead to adverse health
studies have focused on exposures Criteria Document (sections 7.4 and effects in people with compromised
which mimic diurnal and seasonal 8.6.3). These single- and multi-city cardiopulmonary systems.
patterns and more realistic O3 exposure mortality studies coupled with meta- Of much interest are several other
levels (EPA, 2006a, p. 8–50). Studies of analyses generally indicate associations types of newly available data that
monkeys that compared these two between acute O3 exposure and elevated support reasonable hypotheses that may
exposure scenarios found increased risk for all-cause mortality, even after help to explain the findings of O3-
airway pathology only with the latter adjustment for the influence of season related increases in cardiovascular
design. Persistent and irreversible and PM. Several single-city studies that mortality observed in some
effects reported in chronic animal specifically evaluated the relationship epidemiological studies. These include
toxicology studies suggest that between O3 exposure and the direct effect of O3 on increasing PAF
additional complementary human data cardiopulmonary mortality also in lung tissue that can then enter the
are needed from epidemiologic studies reported results suggestive of a positive general circulation and possibly
(EPA, 2006a, p. 8–50). association (EPA, 2006a, p. 8–51). These contribute to increased risk of blood clot
There is limited evidence from human mortality studies suggest a pattern of formation and the consequent increased
studies for long-term O3-induced effects effects for causality that have risk of MI, cerebrovascular events
on lung function. As discussed in biologically plausible explanations, but (stroke), or associated cardiovascular-
section 8.6.2 of the Criteria Document, our knowledge regarding potential related mortality. Ozone reactions with
previous epidemiological studies have underlying mechanisms is very limited cholesterol in lung surfactant to form
provided only inconclusive evidence for at this time and requires further epoxides and oxysterols that are
either mortality or morbidity effects of research. Most of the physiological and cytotoxic to lung and heart muscles and
long-term O3 exposure. The Criteria biochemical parameters investigated in that contribute to atherosclerotic plaque
Document observes that the human and animal studies suggest that formation in arterial walls represent
inconsistency in findings may be due to O3-induced biochemical effects are another potential pathway. Stimulation
a lack of precise exposure information, relatively transient and attenuate over of airway irritant receptors may lead to
the possibility of selection bias, and the time. The Criteria Document (p. 8–52) increases in tissue and serum levels of
hypothesizes a generic pathway of O3- ANF, changes in heart rate, and edema
difficulty of controlling for confounders
induced lung damage, potentially of heart tissue. A few new field and
(EPA, 2006a, p. 8–50). Several new
involving oxidative lung damage with panel studies of human adults have
longitudinal epidemiology studies have
subsequent inflammation and/or decline reported associations between ambient
evaluated associations between long-
in lung function leading to respiratory O3 concentrations and changes in
term O3 exposures and morbidity and
distress in some sensitive population cardiac autonomic control (e.g., HRV,
mortality and suggest that these long-
groups (e.g., asthmatics), or other ventricular arrhythmias, and MI). These
term exposures may be related to
plausible pathways noted below that represent plausible pathways that may
changes in lung function in children;
may lead to O3-related contributions to lead to O3-related contributions to
however, little evidence is available to
cardiovascular effects that ultimately cardiovascular effects that ultimately
support a relationship between chronic increase risk of mortality. increase the risk of mortality.
O3 exposure and mortality or lung The third National Health and In addition, O3-induced increases in
cancer incidence (EPA, 2006a, p. 8–50). Nutrition Examination Follow-up data lung permeability allow more ready
The Criteria Document (p. 8–51) analysis indicates that about 20 percent entry for inhaled PM into the blood
concludes that evidence from animal of the adult population has reduced stream, and O3 exposure may increase
toxicology studies strongly suggests that FEV1 values, suggesting impaired lung the risk of PM-related cardiovascular
chronic O3 exposure is capable of function in some portion of the effects. Furthermore, increased ambient
damaging the distal airways and population. Most of these individuals O3 levels contribute to ultrafine PM
proximal alveoli, resulting in lung tissue have COPD, asthma or fibrotic lung formation in the ambient air and indoor
remodeling leading to apparent disease (Manino et al., 2003), which are environments. Thus, the contributions
irreversible changes. Such structural associated with persistent low-grade of elevated ambient O3 concentrations to
changes and compromised pulmonary inflammation. Furthermore, patients ultrafine PM formation and human
function caused by persistent with COPD are at increased risk for exposure, along with the enhanced
inflammation may exacerbate the cardiovascular disease. Also, lung uptake of inhaled fine particles,
progression and development of chronic disease with underlying inflammation consequently may contribute to
lung disease. Together with the limited may be linked to low-grade systemic exacerbation of PM-induced
evidence available from epidemiological inflammation associated with cardiovascular effects in addition to
studies, these findings offer some atherosclerosis, independent of cigarette
those more directly induced by O3 (EPA,

insight into potential biological smoking (EPA, 2006a, p. 8–52). Lung 2006a, p. 8–53).
mechanisms for suggested associations function decrements in persons with
between long-term or seasonal cardiopulmonary disease have been c. Summary
exposures to O3 and reduced lung associated with inflammatory markers, Judgments concerning the extent to
function development in children such as C-reactive protein (CRP) in the which relationships between various
which have been observed in blood. At a population level it has been health endpoints and ambient O3
exposures are likely causal are informed public health impacts associated with airways may promote deeper
by the conclusions and discussion in exposure to ambient O3. penetration. However, most of the
the Criteria Document as discussed evidence on gender differences appears
a. Factors That Modify Responsiveness
above and summarized in section 3.7.5 to be equivocal, with one study
to Ozone
of the Staff Paper. These judgments (Hazucha et al., 2003) suggesting that
reflect the nature of the evidence and There are numerous factors that can physiological responses of young
overall weight of the evidence, and are modify individual responsiveness to O3. healthy males and females may be
taken into consideration in the These include: influence of physical comparable (EPA, 2006a, section 6.5.2).
quantitative risk assessment discussed activity; age; gender and hormonal A few studies have suggested that
below in section II.B.2. influences; racial, ethnic and ethnic minorities might be more
For example, there is a very high level socioeconomic status (SES) factors; responsive to O3 than Caucasian
of confidence that O3 induces lung environmental factors; and oxidant- population groups (EPA, 2006a, section
function decrements in healthy adults antioxidant balance. These factors are 6.5.3). This may be more the result of a
and children due in part to the dozens discussed in more detail in section 6.5 lack of adequate health care and
of controlled human exposure and of the Criteria Document. socioeconomic status (SES) than any
epidemiological studies consistently It is well established that physical differences in sensitivity to O3. The
showing such effects. The Criteria activity increases an individual’s limited data available, which have
Document (p. 8–74) states that these minute ventilation and will thus investigated the influence of race, ethnic
studies provide clear evidence of increase the dose of O3 inhaled (EPA, or other related factors on
causality for associations between short- 2006a, section 6.5.4). Increased physical responsiveness to O3, prevent drawing
term O3 exposures and statistically activity results in deeper penetration of any clear conclusions at this time.
significant declines in lung function in O3 into more distal regions of the lungs, Few human studies have examined
children, asthmatics and adults who which are more sensitive to acute O3 the potential influence of environmental
exercise outdoors. An increase in response and injury. This will result in factors such as the sensitivity of
respiratory symptoms (e.g., cough, greater lung function decrements for individuals who voluntarily smoke
shortness of breath) has been observed acute exposures of individuals during tobacco (i.e., smokers) and the effect of
in controlled human exposure studies of increased physical activity. Research high temperatures. New controlled
short-term O3 exposures, and significant has shown that respiratory effects are human exposure studies have confirmed
associations between ambient O3 observed at lower O3 concentrations if that smokers are less responsive to O3
exposures and a wide variety of the level of exertion is increased and/or than nonsmokers; however, time course
symptoms have been reported in duration of exposure and exertion are of development and recovery of these
epidemiology studies (EPA, 2006a, p. 8– extended. Predicted O3-induced effects, as well as reproducibility, was
75). Aggregate population time-series decrements in lung function have been not different from nonsmokers (EPA,
studies showing robust associations shown to be a function of exposure 2006a, section 6.5.5). Influence of
with respiratory hospital admissions concentration, duration and exercise ambient temperature on pulmonary
and emergency department visits are level for healthy, young adults effects induced by O3 has been studied
strongly supported by human clinical, (McDonnell et al., 1997). very little, but additive effects of heat
animal toxicologic, and epidemiologic Most of the studies investigating the and O3 exposure have been reported.
evidence for O3-related lung function influence of age have used lung function Antioxidants, which scavenge free
decrements, respiratory symptoms, decrements and symptoms as measures radicals and limit lipid peroxidation in
airway inflammation, and airway of response. For healthy adults, lung the ELF, are the first line of defense
hyperreactivity. The Criteria Document function and symptom responses to O3 against oxidative stress. Ozone exposure
(p. 8–77) concludes that, taken together, decline as age increases. The rate of leads to absorption of O3 in the ELF
the overall evidence supports the decline in O3 responsiveness appears with subsequent depletion of
inference of a causal relationship greater in those 18 to 35 years old antioxidant in the nasal ELF, but
between acute ambient O3 exposures compared to those 35 to 55 years old, concentration and antioxidant enzyme
and increased respiratory morbidity while there is very little change after age activity in ELF or plasma do not appear
outcomes resulting in increased 55. In one study (Seal et al., 1996) related to O3 responsiveness (EPA
emergency department visits and analyzing a large data set, a 5.4% 2006a, section 6.5.6). Controlled studies
hospitalizations during the warm decrement in FEV1 was estimated for 20 of dietary antioxidant supplements have
season. Further, recent epidemiologic year old individuals exposed to 0.12 shown some protective effects on lung
evidence has been characterized in the ppm O3, whereas similar exposure of 35 function decrements but not on
Criteria Document (p. 8–78) as highly year old individuals were estimated to symptoms and airway inflammatory
suggestive that O3 directly or indirectly have a 2.6% decrement. While healthy responses. Dietary antioxidant
contributes to non-accidental and children tend not to report respiratory supplements have provided some
cardiopulmonary-related mortality. symptoms when exposed to low levels protection to asthmatics by attenuating
of O3, for subjects 18 to 36 years old post-exposure airway
4. O3-Related Impacts on Public Health symptom responses induced by O3 tend hyperresponsiveness. Animal studies
The following discussion draws from to decrease with increasing age have also supported the protective
chapters 6 and 7 and section 8.7 of the (McDonnell et al., 1999). effects of ELF antioxidants.
Criteria Document and section 3.6 of the Limited evidence of gender
Staff Paper to characterize factors which differences in response to O3 exposure b. At-Risk Subgroups for O3-Related
modify responsiveness to O3, has suggested that females may be Effects
subpopulations potentially at risk for predisposed to a greater susceptibility to Several characteristics may increase
O3-related health effects, the adversity O3. Lower plasma and NL fluid levels of the extent to which a population group
of O3-related effects, and the size of the the most prevalent antioxidant, uric shows increased susceptibility or
at-risk subpopulations in the U.S. These acid, in females relative to males may be vulnerability. Information on potentially
considerations are all important a contributing factor. Consequently, susceptible and vulnerable groups is
elements in characterizing the potential reduced removal of O3 in the upper summarized in section 8.7 of the
Criteria Document. As described there, exposure in subjects performing as, if not more sensitive than, normal
the term susceptibility refers to innate continuous or intermittent exercise for subjects in manifesting O3-induced
(e.g., genetic or developmental) or variable periods of time. Significant O3- pulmonary function decrements. In one
acquired (e.g., personal risk factors, age) induced respiratory responses have key study (Horstman et al., 1995), the
factors that make individuals more been observed in clinical studies of FEV1 decrement observed in the
likely to experience effects with exercising individuals. The asthmatics was significantly larger than
exposure to pollutants. A number of epidemiologic studies discussed above in the healthy subjects (19% versus
population groups have been identified also indicate that prolonged exposure 10%, respectively). There was also a
as potentially susceptible to health periods, combined with elevated levels notable tendency for a greater O3-
effects as a result of O3 exposure, of exertion or exercise, may magnify O3 induced decrease in FEF25–75 in
including people with existing lung effects on lung function. Thus, outdoor asthmatics relative to the healthy
diseases, including asthma, children workers and others who participate in subjects (24% versus 15%,
and older adults, and people who have higher exertion activities outdoors respectively). A significant positive
larger than normal lung function during the time of day when high peak correlation in asthmatics was also
responses that may be due to genetic O3 concentrations occur appear to be reported between O3-induced
susceptibility. In addition, some particularly vulnerable to O3 effects on spirometric responses and baseline lung
population groups have been identified respiratory health. Although these function, i.e., responses increased with
as having increased vulnerability to O3- studies show a wide variability of severity of disease.
related effects due to increased response and sensitivity among subjects Asthmatics present a differential
likelihood of exposure while at elevated and the factors contributing to this response profile for cellular, molecular,
ventilation rates, including healthy variability continue to be incompletely and biochemical parameters (Criteria
children and adults who are active understood, the effect of increased Document, Figure 8–1) that are altered
outdoors, for example, outdoor workers, exertion is consistent. It should be noted in response to acute O3 exposure.
and joggers. Taken together, the that this wide variability of response Ozone-induced increases in neutrophils,
susceptible and vulnerable groups make and sensitivity among subjects may be IL–8 and protein were found to be
up ‘‘at-risk’’ groups.22 in part due to the wide range of other significantly higher in the BAL fluid
highly reactive photochemical oxidants from asthmatics compared to healthy
i. Active People subjects, suggesting mechanisms for the
coexisting with O3 in the ambient air.
A large group of individuals at risk increased sensitivity of asthmatics
from O3 exposure consists of outdoor ii. People With Lung Disease (Basha et al., 1994; McBride et al., 1994;
workers and children, adolescents, and People with preexisting pulmonary Scannell et al., 1996; Hiltermann et al.,
adults who engage in outdoor activities disease are likely to be among those at 1999; Holz et al., 1999; Bosson et al.,
involving exertion or exercise during increased risk from O3 exposure. 2003). Neutrophils, or PMNs, are the
summer daylight hours when ambient Altered physiological, morphological white blood cell most associated with
O3 concentrations tend to be higher. and biochemical states typical of inflammation. IL–8 is an inflammatory
This conclusion is based on a large respiratory diseases like asthma, COPD cytokine with a number of biological
number of controlled-human exposure and chronic bronchitis may render effects, primarily on neutrophils. The
studies and several epidemiologic field/ people sensitive to additional oxidative major role of this cytokine is to attract
panel studies which have been burden induced by O3 exposure. At the and activate neutrophils. Protein in the
conducted with healthy children and time of the last review, it was concluded airways is leaked from the circulatory
adults and those with preexisting that this group was at greater risk system, and is a marker for increased
respiratory diseases (EPA 2006a, because the impact of O3-induced cellular permeability.
sections 6.2, 6.3, 7.2, and 8.4.4). The responses on already-compromised Bronchial constriction following
controlled human exposure studies respiratory systems would noticeably provocation with O3 and/or allergens
show a clear O3 exposure-response impair an individual’s ability to engage presents a two-phase response. The
relationship with increasing spirometric in normal activity or would be more early response is mediated by release of
and symptomatic response as exercise likely to result in increased self- histamine and leukotrienes that leads to
level increases. Furthermore, O3- medication or medical treatment. At contraction of smooth muscle cells in
induced response increases as time of that time there was little evidence that the bronchi, narrowing the lumen and
exposure increases. Studies of outdoor people with pre-existing disease were decreasing the airflow. In people with
workers and others who participate in more responsive than healthy allergic airway disease, including
outdoor activities indicate that extended individuals in terms of the magnitude of people with rhinitis and asthma, these
exposures to O3 at elevated exertion pulmonary function decrements or mediators also cause accumulation of
levels can produce marked effects on symptomatic responses. The new results eosinophils in the airways (Bascom et
lung function, as discussed above in from controlled exposure and al., 1990; Jorres et al., 1996; Peden et al.,
section IIA.2 (Brauer et al., 1996; Höppe epidemiologic studies continue to 1995 and 1997; Frampton et al., 1997a;
et al., 1995; Korrick et al., 1998; indicate that individuals with Michelson et al., 1999; Hiltermann et
McConnell et al., 2002). preexisting pulmonary disease are a al., 1999; Holz et al., 2002; Vagaggini et
These field studies with subjects at sensitive subpopulation for O3 health al., 2002). In asthma, the eosinophil,
elevated exertion levels support the effects. which increases inflammation and
extensive evidence derived from Several clinical studies reviewed in allergic responses, is the cell most
controlled human exposure studies. The the 1996 Criteria Document on atopic frequently associated with exacerbations
majority of human chamber studies and asthmatic subjects had suggested of the disease. A study by Bosson et al.
have examined the effects of O3 but not clearly demonstrated enhanced (2003) evaluated the difference in O3-
responsiveness to acute O3 exposure induced bronchial epithelial cytokine
22 In the Staff Paper and documents from previous
compared to healthy subjects. The expression between healthy and
O3 NAAQS reviews, ‘‘at-risk’’ groups have also been majority of the newer studies reviewed asthmatic subjects. After O3 exposure
called ‘‘sensitive’’ groups, to mean both groups with
greater inherent susceptibility and those more likely in Chapter 6 of the Criteria Document the epithelial expression of IL–5 and
to be exposed. indicate that asthmatics are as sensitive GM-CSF increased significantly in
asthmatics, compared to healthy was determined 3 hours after exposure. evidence indicates that human clinical
subjects. Asthma is associated with Th2- Statistically significant decreases in and epidemiological panel studies of
related airway response (allergic FEV1 occurred in subjects with allergic lung function decrements and
response), and IL–5 is an important rhinitis (13.8%) and allergic asthma respiratory symptoms that evaluate only
Th2-related cytokine. The O3-induced (10.6%), and in healthy controls (7.3%). healthy, non-asthmatic subjects likely
increase in IL–5, and also in GM-CSF, Methacholine responsiveness was underestimate the effects of O3 exposure
which affects the growth, activation and statistically increased in asthmatics, but on asthmatics and other susceptible
survival of eosinophils, may indicate an not in subjects with allergic rhinitis or populations. The effects of O3 on lung
effect on the Th2-related airway healthy controls. Airway responsiveness function, inflammation, and increased
response and on airway eosinophils. to an individual’s historical allergen airway responsiveness demonstrated in
The authors reported that the O3- (either grass and birch pollen, house subjects with asthma and other allergic
induced Th2-related cytokine responses dust mite, or animal dander) was airway diseases, provide plausible
that were found within the asthmatic significantly increased after O3 exposure mechanisms underlying the more
group may indicate a worsening of their when compared to FA exposure. In serious respiratory morbidity effects,
asthmatic airway inflammation and thus subjects with asthma and allergic such as emergency department visits
suggest a plausible link to rhinitis, a maximum percent fall in and hospital admissions, and
epidemiological data indicating O3- FEV1 of 27.9% and 7.8%, respectively, respiratory mortality effects.
associated increases in bronchial occurred 3 days after O3 exposure when A number of epidemiological studies
reactivity and hospital admissions. they were challenged with of the highest have been conducted using asthmatic
The accumulation of eosinophils in common dose of allergen. The authors study populations. The majority of
the airways of asthmatics is followed by concluded that subjects with asthma or epidemiological panel studies that
production of mucus and a late-phase allergic rhinitis, without asthma, could evaluated respiratory symptoms and
bronchial constriction and reduced be at risk if a high O3 exposure is medication use related to O3 exposures
airflow. In a study of 16 intermittent followed by a high dose of allergen. focused on children. These studies
asthmatics, Hiltermann et al. (1999) Holz et al. (2002) reported an early suggest that O3 exposure may be
found that there was a significant phase lung function response in subjects associated with increased respiratory
inverse correlation between the O3- with rhinitis after a consecutive 4-day
symptoms and medication use in
induced change in the percentage of exposure to 0.125 ppm O3 that resulted
children with asthma. Other reported
eosinophils in induced sputum and the in a clinically relevant (>20%) decrease
change in PC20, the concentration of effects include respiratory symptoms,
in FEV1. Ozone-induced exacerbation of
methacholine causing a 20% decrease in lung function decrements, and
airway responsiveness persists longer
FEV1. Characteristic O3-induced emergency department visits, as
and attenuates more slowly than O3-
inflammatory airway neutrophilia at one discussed in the Criteria Document
induced lung function decrements and
time was considered a leading (section 7.6.7.1). Strong evidence from a
respiratory symptom responses and can
mechanism of airway large multi-city study (Mortimer et al.,
have important clinical implications for
hyperresponsiveness. However, 2002), along with support from several
asthmatics.
Hiltermann et al. (1999) determined that A small number of in vitro studies single-city studies suggest that O3
the O3-induced change in percentage corroborate the differences in the exposure may be associated with
neutrophils in sputum was not responses of asthmatic and healthy increased respiratory symptoms and
significantly related to the change in subject generally found in controlled medication use in children with asthma.
PC20. These results are consistent with human exposure studies. In vitro With regard to ambient O3 levels and
the results of Zhang et al. (1995), which studies (Schierhorn et al., 1999) of nasal increased hospital admissions and
found neutrophilia in a murine model to mucosal biopsies from atopic and emergency department visits for asthma
be only coincidentally associated with nonatopic subjects exposed to 0.1 ppm and other respiratory causes, strong and
airway hyperresponsiveness, i.e., there O3 found significant differences in consistent evidence establishes a
was no cause and effect relationship. release of IL–4, IL–6, IL–8, and TNF-a. correlation between O3 exposure and
(Criteria Document, AX 6–26). Another study by Schierhorn et al. increased exacerbations of preexisting
Hiltermann et al. (1999) concluded that (2002) found significant differences in respiratory disease for 1-hour maximum
the results point to the role of the O3-induced release of the O3 concentrations <0.12 ppm. As
eosinophils in O3-induced airway neuropeptides neurokinin A and discussed in the Criteria Document,
hyperresponsiveness. Increases in O3- substance P for allergic patients in section 7.3, several hospital admission
induced nonspecific airway comparison to nonallergic controls, and emergency department visit studies
responsiveness incidence and duration suggesting increased activation of in the U.S., Canada, and Europe have
could have important clinical sensory nerves by O3 in the allergic reported positive associations between
implications for asthmatics. tissues. Another study by Bayram et al. increase in O3 and increased risk of
Two studies (Jörres et al., 1996; Holz (2002) using in vitro culture of emergency department visits and
et al., 2002) observed increased airway bronchial epithelial cells recovered from hospital admissions for asthma and
responsiveness to O3 exposure with atopic and nonatopic asthmatics also other respiratory diseases, especially
bronchial allergen challenge in subjects found significant increases in epithelial during the warm season. Finally, from
with preexisting allergic airway disease. permeability in response to O3 epidemiological studies that included
Jörres et al. (1996) found that O3 causes exposure. assessment of associations with specific
an increased response to bronchial The new data on airway causes of death, some studies have
allergen challenge in subjects with responsiveness, inflammation, and observed larger effects estimates for
allergic rhinitis and mild allergic various molecular markers of respiratory mortality and others have
asthma. The subjects were exposed to inflammation and bronchoconstriction observed larger effects estimates for
0.25 ppm O3 for 3 hours with IE. Airway indicate that people with asthma and cardiovascular mortality. The apparent
responsiveness to methacholine was allergic rhinitis (with or without inconsistency regarding the effect size of
determined 1 hour before and after asthma) comprise susceptible groups for O3-related respiratory mortality may be
exposure; responsiveness to allergen O3-induced adverse effects. This body of due to reduced statistical power in this
subcategory of mortality (EPA, 2006a, p. compromised (EPA, 2006a, section Older adults are also often classified as
7–108). 6.10). being particularly susceptible to air
Newly available reports from pollution. The basis for increased O3
controlled human exposure studies (see iii. Children and Older Adults
sensitivity among the elderly is not
chapter 6 in the Criteria Document) Supporting evidence exists for known, but one hypothesis is that it
utilized subjects with preexisting heterogeneity in the effects of O3 by age. may be related to changes in the
cardiopulmonary diseases such as As discussed in section 6.5.1 of the respiratory tract lining fluid antioxidant
COPD, asthma, allergic rhinitis, and Criteria Document, children, defense network (Kelly et al., 2003).
hypertension. The data generated from adolescents, and young adults (<18 yrs (EPA 2006a, p. 8–60) Older adults have
these studies that evaluated changes in of age) appear, on average, to have lower baseline lung function than
spirometry did not find clear differences nearly equivalent spirometric responses younger people, and are also more likely
between filtered air and O3 exposure in to O3, but have greater responses than to have preexisting lung and heart
COPD subjects. However, the new data middle-aged and older adults when disease. Increased susceptibility of older
on airway responsiveness, exposed to comparable O3 doses. adults to O3 health effects is most
inflammation, and various molecular Symptomatic responses to O3 exposure, clearly indicated in the newer mortality
markers of inflammation and however, do not appear to occur in studies. Among the studies that
bronchoconstriction indicate that healthy children, but are observed in observed positive associations between
people with atopic asthma and allergic asthmatic children, particularly those O3 and mortality, a comparison of all
rhinitis comprise susceptible groups for who use maintenance medications. For age or younger age (≤65 years of age) O3-
O3-induced adverse health effects. adults (>17 yrs of age) symptoms mortality effect estimates to that of the
Although controlled human exposure gradually decrease with increasing age. elderly population (>65 years) indicates
studies have not found evidence of In contrast to young adults, the that, in general, the elderly population
larger spirometric changes in people diminished symptomatic responses in is more susceptible to O3 mortality
with COPD relative to healthy subjects, children and the diminished effects. The meta-analysis by Bell et al.
this may be due to the fact that most symptomatic and spirometric responses (2005) found a larger mortality effect
people with COPD are older adults who in older adults increases the likelihood estimate for the elderly than for all ages.
would not be expected to have such that these groups continue outdoor In the large U.S. 95 communities study
changes based on their age. However, in activities leading to greater O3 exposure (Bell et al., 2004), mortality effect
section 8.7.1, the Criteria Document and dose. estimates were slightly higher for those
notes that new epidemiological As described in the section 7.6.7.2 of aged 65 to 74 years, compared to
evidence indicates that people with the Criteria Document, many individuals less than 65 years and 75
COPD may be more likely to experience epidemiological field studies focused on years or greater. The absolute effect of
other effects, including emergency room the effect of O3 on the respiratory health O3 on premature mortality may be
visits, hospital admissions, or premature of school children. In general, children substantially greater in the elderly
mortality. For example, results from an experienced decrements in pulmonary population because of higher rates of
analysis of five European cities function parameters, including PEF, preexisting respiratory and cardiac
indicated strong and consistent O3 FEV1, and FVC. Increases in respiratory diseases. The Criteria Document
effects on unscheduled respiratory symptoms and asthma medication use concludes that the elderly population
hospital admissions, including COPD were also observed in asthmatic (>65 years of age) appear to be at greater
(Anderson et al., 1997). Also, an children. In one German study, children risk of O3-related mortality and
analysis of a 9-year data set for the with and without asthma were found to hospitalizations compared to all ages or
whole population of the Netherlands be particularly susceptible to O3 effects younger populations (EPA, 2006a, p. 7–
provided risk estimates for more on lung function. Approximately 20% 177).
specific causes of mortality, including of the children, both with and without The Criteria Document notes that,
COPD (Hoek et al., 2000, 2001; asthma, experienced a greater than 10% collectively, there is supporting
reanalysis, Hoek, 2003); a positive, but change in FEV1, compared to only 5% evidence of age-related differences in
nonsignificant, excess risk of COPD- of the elderly population and athletes susceptibility to O3 lung function
related mortality was found to be (Höppe et al., 2003). effects. The elderly population (>65
associated with short-term O3 The American Academy of Pediatrics years of age) appear to be at increased
concentrations. Moreover, as indicated (2004) notes that children and infants risk of O3-related mortality and
by Gong et al. (1998), the effects of O3 are among the population groups most hospitalizations, and children (<18
exposure on alveolar-arterial oxygen susceptible to many air pollutants, years of age) experience other
gradients may be more pronounced in including O3. This is in part because potentially adverse respiratory health
patients with preexisting obstructive their lungs are still developing. For outcomes with increased O3 exposure
lung diseases. Relative to healthy example, eighty percent of alveoli are (EPA, 2006a, section 7.6.7.2).
elderly subjects, COPD patients have formed after birth, and changes in lung
reduced gas exchange and low SaO2. development continue through iv. People With Increased
Any inflammatory or edematous adolescence (Dietert et al., 2000). Responsiveness to Ozone
responses due to O3 delivered to the Children are also likely to spend more New animal toxicology studies using
well-ventilated regions of the COPD time outdoors than adults, which results various strains of mice and rats have
lung could further inhibit gas exchange in increased exposure to air pollutants identified O3-sensitive and resistant
and reduce oxygen saturation. In (Wiley et al., 1991a,b). Moreover, strains and illustrated the importance of
addition, O3-induced vasoconstriction children have high minute ventilation genetic background in determining O3
could also acutely induce pulmonary rates and high levels of physical activity susceptibility (EPA, 2006a, section
hypertension. Inducing pulmonary which also increases their dose 8.7.4). Controlled human exposure
vasoconstriction and hypertension in (Plunkett et al., 1992). studies have also indicated a high
these patients would perhaps worsen Several mortality studies have degree of variability in some of the
their condition, especially if their right investigated age-related differences in pulmonary physiological parameters.
ventricular function was already O3 effects (EPA, 2006a, section 7.6.7.2). The variable effects in individuals have
been found to be reproducible, in other concludes that current cardiovascular evidence from animal toxicology
words, a person who has a large lung effects evidence from some field studies studies, which could be extrapolated to
function response after exposure to O3 is rather limited but supportive of a humans only with a significant degree
will likely have about the same response potential effect of short-term O3 of uncertainty, for the last two
if exposed again to the same dose of O3. exposure and HRV, cardiac arrhythmia, categories.
In human clinical studies, group mean and MI incidence (EPA, 2006a, p. 7–65). For ethical reasons, clear causal
responses are not representative of this In the Criteria Document’s evaluation of evidence from controlled human
segment of the population that has studies of hospital admissions for exposure studies still covers only effects
much larger than average responses to cardiovascular disease (EPA 2006a, in the first category. However, for this
O3. Recent studies of asthmatics by section 7.3.4), it is concluded that review there are results from
David et al. (2003) and Romieu et al. evidence from this growing group of epidemiological studies, upon which to
(2004) reported a role for genetic studies is generally inconclusive base judgments about adversity, for
polymorphism in observed differences regarding an association with O3 in effects in all of the categories.
in antioxidant enzymes and genes studies conducted during the warm Statistically significant and robust
involved in inflammation to modulate season (EPA 2006a, p. 7–83). This body associations have been reported in
pulmonary function and inflammatory of evidence suggests that people with epidemiology studies falling into the
responses to O3 exposure.23 heart disease may be at increased risk second and third categories. These more
Biochemical and molecular from short-term exposures to O3; serious effects include respiratory
parameters extensively evaluated in however, more evidence is needed to events (e.g., triggering asthma attacks)
these experiments were used to identify conclude that people with heart disease that may require medication (e.g.,
specific loci on chromosomes and, in are a susceptible population. asthma), but not necessarily
some cases, to relate the differential Other groups that might have hospitalization, as well as respiratory
expression of specific genes to enhanced sensitivity to O3, but for hospital admissions and emergency
biochemical and physiological which there is currently very little department visits for respiratory causes.
differences observed among these evidence, include groups based on race, Less conclusive, but still positive
species. Utilizing O3-sensitive and O3- gender and SES, and those with associations have been reported for
resistant species, it has been possible to nutritional deficiencies, which presents school absences and cardiovascular
identify the involvement of increased factors which modify responsiveness to hospital admissions. Human health
airway reactivity and inflammation O3. effects for which associations have been
processes in O3 susceptibility. However, suggested through evidence from
c. Adversity of Effects
most of these studies were carried out epidemiological and animal toxicology
using relatively high doses of O3, In making judgments as to when studies, but have not been conclusively
making the relevance of these studies various O3-related effects become demonstrated still fall primarily into the
questionable in human health effects regarded as adverse to the health of last two categories. In the last review of
assessment. The genes and genetic loci individuals, the Administrator has the O3 standard, evidence for these more
identified in these studies may serve as looked to guidelines published by the serious effects came from studies of
useful biomarkers and, ultimately, can American Thoracic Society (ATS) and effects in laboratory animals. Evidence
likely be integrated with the advice of CASAC. While recognizing from animal studies evaluated in this
epidemiological studies. that perceptions of ‘‘medical Criteria Document strongly suggests that
significance’’ and ‘‘normal activity’’ may O3 is capable of damaging the distal
v. Other Population Groups differ among physicians, lung airways and proximal alveoli, resulting
There is limited, new evidence physiologists and experimental subjects, in lung tissue remodeling leading to
supporting associations between short- the ATS (1985) 24 defined adverse apparently irreversible changes. Recent
term O3 exposures and a range of effects respiratory health effects as ‘‘medically advancements of dosimetry modeling
on the cardiovascular system. Some but significant physiologic changes also provide a better basis for
not all, epidemiological studies have generally evidenced by one or more of extrapolation from animals to humans.
reported associations between short- the following: (1) Interference with the Information from epidemiological
term O3 exposures and the incidence of normal activity of the affected person or studies provides supporting, but limited
MI and more subtle cardiovascular persons, (2) episodic respiratory illness, evidence of irreversible respiratory
health endpoints, such as changes in (3) incapacitating illness, (4) permanent effects in humans than was available in
HRV and cardiac arrhythmia. Others respiratory injury, and/or (5) progressive the prior review. Moreover, the findings
have reported associations with respiratory dysfunction.’’ During the from single-city and multi-city time-
hospitalization or emergency 1997 review, it was concluded that there series epidemiology studies and meta-
department visits for cardiovascular was evidence of causal associations analyses of these epidemiology studies
diseases, although the results across the from controlled human exposure studies are highly suggestive of an association
studies are not consistent. Studies also for effects in the first of these five ATS- between short-term O3 exposure and
report associations between short-term defined categories, evidence of mortality particularly in the warm
O3 exposure and mortality from statistically significant associations from season.
cardiovascular or cardiopulmonary epidemiological studies for effects in the While O3 has been associated with
causes. The Criteria Document second and third categories, and effects that are clearly adverse,
application of these guidelines, in
23 Similar to animal toxicology studies referred 24 In 2000, the American Thoracic Society (ATS)
particular to the least serious category of
above, a polymorphism in a specific published an official statement on ‘‘What effects related to ambient O3 exposures,
proinflammatory cytokine gene has been implicated Constitutes an Adverse Health Effect of Air
in O3-induced lung function changes in healthy, Pollution?’’ (ATS, 2000), which updated its earlier involves judgments about which
mild asthmatics and individuals with rhinitis. guidance (ATS, 1985). Overall, the new guidance medical experts on the CASAC panel
These observations suggest a potential role for these does not fundamentally change the approach and public commenters have expressed
markers in the innate susceptibility to O3, however, previously taken to define adversity, nor does it
the validity of these markers and their relevance in suggest a need at this time to change the structure
diverse views in the past. To help frame
the context of prediction to population studies or content of the tables describing gradation of such judgments, EPA staff have defined
needs additional experimentation. severity and adversity of effects described below. specific ranges of functional responses
(e.g., decrements in FEV1 and airway (Henderson, 2006c) that a focus on the d. Size of At-Risk Subpopulations
responsiveness) and symptomatic lower end of the range of moderate Although O3-related health risk
responses (e.g., cough, chest pain, levels of functional responses (e.g., FEV1 estimates may appear to be small, their
wheeze), together with judgments as to decrements ≥10%) is most appropriate significance from an overall public
the potential impact on individuals for estimating potentially adverse lung health perspective is determined by the
experiencing varying degrees of severity function decrements in active healthy large numbers of individuals in the
of these responses, that have been used people. subpopulations potentially at-risk for
in previous NAAQS reviews. These In judging the extent to which these O3-related health effects discussed
ranges of pulmonary responses and their above. For example, a population of
impacts represent effects that should be
associated potential impacts are concern includes people with
regarded as adverse to the health status
summarized in Tables 3–2 and 3–3 of respiratory disease, including
of individuals, an additional factor that
the Staff Paper. approximately 11 percent of U.S. adults
has been considered in previous
For active healthy people, moderate NAAQS reviews is whether such effects and 13 percent of children who have
levels of functional responses (e.g., FEV1 are experienced repeatedly during the been diagnosed with asthma and 6
decrements of ≥10% but <20%, lasting course of a year or only on a single percent of adults with chronic
up to 24 hours) and/or moderate occasion. While some experts would obstructive pulmonary disease (chronic
symptomatic responses (e.g., frequent judge single occurrences of moderate bronchitis and/or emphysema) in 2002
spontaneous cough, marked discomfort responses to be a ‘‘nuisance,’’ especially and 2003 (Table 8–4 in the Criteria
on exercise or deep breath, lasting up to Document, section 8.7.5.2). More
for healthy individuals, a more general
24 hours) would likely interfere with broadly, individuals with preexisting
consensus view of the adversity of such
normal activity for relatively few cardiopulmonary disease may constitute
moderate responses emerges as the
responsive individuals. On the other an additional population of concern,
frequency of occurrence increases.
hand, EPA staff determined that large with potentially tens of millions of
functional responses (e.g., FEV1 The new guidance builds upon and people included in each disease
decrements ≥20%, lasting longer than expands the 1985 definition of adversity category. In addition, subpopulations
24 hours) and/or severe symptomatic in several ways. There is an increased based on age group also comprise
responses (e.g., persistent focus on quality of life measures as substantial segments of the population
uncontrollable cough, severe discomfort indicators of adversity. There is also a that may be potentially at risk for O3-
on exercise or deep breath, lasting more specific consideration of related health impacts. Based on U.S.
longer than 24 hours) would likely population risk. Exposure to air census data from 2003, about 26 percent
interfere with normal activities for many pollution that increases the risk of an of the U.S. population are under 18
responsive individuals. EPA staff adverse effect to the entire population is years of age and 12 percent are 65 years
determined that these would be adverse, even though it may not of age or older. Hence, large proportions
considered adverse under ATS increase the risk of any individual to an of the U.S. population are included in
guidelines. In the context of standard unacceptable level. For example, a age groups include those most likely to
setting, CASAC indicated that a focus population of asthmatics could have a have increased susceptibility to the
on the mid to upper end of the range of distribution of lung function such that health effects of O3 and or those with
moderate levels of functional responses no individual has a level associated the highest ambient O3 exposures.
(e.g., FEV1 decrements ≥15% but <20%) with significant impairment. Exposure The Criteria Document (section
is appropriate for estimating potentially to air pollution could shift the 8.7.5.2) notes that the health statistics
adverse lung function decrements in distribution to lower levels that still do data illustrate what is known as the
active healthy people. However, for not bring any individual to a level that ‘‘pyramid’’ of effects. At the top of the
people with lung disease, even is associated with clinically relevant pyramid, there are approximately 2.5
moderate functional (e.g., FEV1 effects. However, this would be millions deaths from all causes per year
decrements ≥10% but <20%, lasting up considered to be adverse because in the U.S. population, with about
to 24 hours) or symptomatic responses individuals within the population 100,000 deaths from chronic lower
(e.g., frequent spontaneous cough, would have diminished reserve respiratory diseases. For respiratory
marked discomfort on exercise or with function, and therefore would be at health diseases, there are nearly 4
deep breath, wheeze accompanied by increased risk if affected by another million hospital discharges per year, 14
shortness of breath, lasting up to 24 agent. million emergency department visits,
hours) would likely interfere with 112 million ambulatory care visits, and
normal activity for many individuals, Of the various effects of O3 exposure an estimated 700 million restricted
and would likely result in more frequent that have been studied, many would activity days per year due to respiratory
use of medication. For people with lung meet the ATS definition of adversity. conditions from all causes per year.
disease, large functional responses (e.g., Such effects include, for example, any Applying small risk estimates for the
FEV1 decrements ≥20%, lasting longer detectible level of permanent lung O3-related contribution to such health
than 24 hours) and/or severe function loss attributable to air effects with relatively large baseline
symptomatic responses (e.g., persistent pollution, including both reductions in levels of health outcomes can result in
uncontrollable cough, severe discomfort lung growth or acceleration of the age- quite large public health impacts related
on exercise or deep breath, persistent related decline of lung function; to ambient O3 exposure. Thus, even a
wheeze accompanied by shortness of exacerbations of disease in individuals small percentage reduction in O3 health
breath, lasting longer than 24 hours) with chronic cardiopulmonary diseases; impacts on cardiopulmonary diseases
would likely interfere with normal reversible loss of lung function in would reflect a large number of avoided
activity for most individuals and would combination with the presence of cases. In considering this information
increase the likelihood that these symptoms; as well as more serious together with the concentration-
individuals would seek medical effects such as those requiring medical response relationships that have been
treatment. In the context of standard care including hospitalization and, observed between exposure to O3 and
setting, the CASAC indicated obviously, mortality. various health endpoints, the Criteria
Document (section 8.7.5.2) concludes whether, or how areas might meet the Exposure estimates were developed
that exposure to ambient O3 likely has specified standards.25 using a probabilistic exposure model
a significant impact on public health in As noted in section I.C above, around that is designed to explicitly model the
the U.S. the time of the release of the final Staff numerous sources of variability that
Paper in January 2007, EPA discovered affect people’s exposures. As discussed
B. Human Exposure and Health Risk
Assessments a small error in the exposure model that below, the model estimates population
when corrected resulted in slight exposures by simulating human activity
To put judgments about health effects increases in the simulated exposures. patterns, air conditioning prevalence,
that are adverse for individuals into a Since the exposure estimates are an air exchange rates, and other factors.
broader public health context, EPA has input to the lung function portion of the The modeled exposure estimates were
developed and applied models to health risk assessment, this correction developed for three recent years of
estimate human exposures and health also resulted in slight increases in the ambient O3 concentrations (2002, 2003,
risks. This broader context includes lung function risk estimates as well. The and 2004), as well as for O3
consideration of the size of particular exposure and risk estimates discussed concentrations adjusted to simulate
population groups at risk for various in this notice reflect the corrected conditions associated with just meeting
effects, the likelihood that exposures of estimates, and thus are slightly different the current NAAQS and various
concern will occur for individuals in than the exposure and risk estimates alternative 8-hour standards based on
such groups under varying air quality cited in the January 31, 2007 Staff the three year period 2002–2004.28 This
scenarios, estimates of the number of Paper.26 exposure assessment is more fully
people likely to experience O3-related described and presented in the Staff
effects, the variability in estimated 1. Exposure Analyses
Paper and in a technical support
exposures and risks, and the kind and a. Overview document, Ozone Population Exposure
degree of uncertainties inherent in Analysis for Selected Urban Areas (US
assessing the exposures and risks The EPA conducted exposure
analyses using a simulation model to EPA, 2006b; hereafter Exposure
involved. Analysis TSD). The scope and
As discussed below there are a estimate O3 exposures for the general
population, school age children (ages 5– methodology for this exposure
number of important uncertainties that
18), and school age children with assessment were developed over the last
affect the exposure and health risk
asthma living in 12 U.S. metropolitan few years with considerable input from
estimates. It is also important to note
areas representing different regions of the CASAC Ozone Panel and the
that there have been significant
the country where the current 8-hour O3 public.29
improvements in both the exposure and
health risk model. CASAC expressed the standard is not met. The emphasis on The goals of the O3 exposure
view that the exposure analysis children reflects the finding of the last assessment were: (1) To provide
represents a state-of-the-art modeling O3 NAAQS review that children are an estimates of the size of at-risk
approach and that the health risk important at-risk group. The 12 modeled populations exposed to various levels
assessment was ‘‘well done, balanced areas combined represent a significant associated with recent O3
and reasonably communicated’’ fraction of the U.S. urban population, 89 concentrations, and with just meeting
(Henderson, 2006c). While recognizing million people, including 18 million the current O3 NAAQS and alternative
and considering the kind and degree of school age children of whom O3 standards, in specific urban areas; (2)
uncertainties in both the exposure and approximately 2.6 million have asthma. to provide distributions of exposure
health risk estimates, the Staff Paper The selection of urban areas to include estimates over the entire range of
judged that the quality of the estimates in the exposure analysis took into ambient O3 concentrations as an
is such that they are suitable to be used consideration the location of O3 important input to the lung function
as an input to the Administrator’s epidemiological studies, the availability risk assessment summarized below in
decisions on the O3 primary standard of ambient O3 data, and the desire to section II.B.2; (3) to develop a better
(Staff Paper, p. 6–20—6–21). represent a range of geographic areas, understanding of the influence of
In modeling exposures and health population demographics, and O3 various inputs and assumptions on the
risks associated with just meeting the climatology. These selection criteria are exposure estimates; and (4) to gain
current and alternative O3 standards, discussed further in chapter 5 of the insight into the distribution of
EPA has simulated air quality to Staff Paper. The geographic extent of exposures and patterns of exposure
represent conditions just meeting these each modeled area consists of the
standards based on O3 air quality census tracts in the combined statistical Philadelphia-Camden-Vineland, PA–NJ–DE–MD;
patterns in several recent years and on area (CSA) as defined by OMB (OMB, Sacramento-Arden-Arcade-Truckee, CA–NV; St.
Louis-St. Charles-Farmington, MO–IL; Washington-
how the shape of the O3 air quality 2005).27 Baltimore-N. Virginia, DC–MD–VA–WV.
distribution has changed over time 28 All 12 of the CSAs modeled did not meet the
based on historical trends in monitored 25 Modeling that projects whether and how areas
current O3 NAAQS for the three year period
O3 air quality data. As described in the might attain alternative standards in a future year examined.
is presented in the Regulatory Impact Analysis 29 The general approach used in the current
Staff Paper (section 4.5.8) and discussed being prepared in connection with this rulemaking. exposure assessment was described in the draft
below, recent O3 air quality 26 EPA plans to make available corrected versions
Health Assessment Plan (EPA, 2005a) that was
distributions have been statistically of the final Staff Paper, and human exposure and released to the CASAC and general public in April
adjusted to simulate just meeting the health risk assessment technical support documents 2005 and was the subject of a consultation with the
current and selected alternative on or around July 16, 2007 on the EPA web site CASAC O3 Panel on May 5, 2005. In October 2005,
listed in the Availability of Related Information OAQPS released the first draft of the Staff Paper
standards. These simulations do not
section of this notice. containing a chapter discussing the exposure

reflect any consideration of specific 27 The 12 CSAs modeled are: Atlanta-Sandy analyses and first draft of the Exposure Analyses
control programs or strategies designed Springs-Gainesville, GA–AL; Boston-Worcester- TSD for CASAC consultation and public review on
to achieve the reductions in emissions Manchester, MA–NH; Chicago-Naperville-Michigan December 8, 2005. In July 2006, OAQPS released
City, IL–IN–WI; Cleveland-Akron-Elyria, OH; the second draft of the Staff Paper and second draft
required to meet the specified Detroit-Warren-Flint, MI; Houston-Baytown- of the Exposure Analyses TSD for CASAC review
standards. Further, these simulations do Huntsville, TX; Los Angeles-Long Beach-Riverside, and public comment which was held by the CASAC
not represent predictions of when, CA; New York-Newark-Bridgeport, NY–NJ–CT–PA; O3 Panel on August 24–25, 2006.
reductions associated with meeting Inhalation exposure models are useful (2007). The uncertainty of model
alternative O3 standards. in realistically estimating personal structure was judged to be of lesser
EPA recognizes that there are many exposures to O3 based on activity- importance than the uncertainties of the
sources of variability and uncertainty specific breathing rates, particularly model inputs and parameters. Model
inherent in the inputs to this assessment when recognizing that large scale structure refers to the algorithms in
and that there is uncertainty in the population exposure measurement APEX designed to simulate the
resulting O3 exposure estimates. With studies have not been conducted that processes that result in people’s
respect to variability, the exposure are representative of the overall exposures, for example, the way that
modeling approach accounts for population or at-risk subpopulations. APEX models exposures to individuals
variability in ambient O3 levels, The model EPA used to simulate O3 when they are near roads. The
demographic characteristics, population exposure is the Air uncertainties in the model input data
physiological attributes, activity Pollutants Exposure Model (APEX), the (e.g., measurement error, ambient
patterns, and factors affecting human inhalation exposure model concentrations, air exchange rates, and
microenvironmental (e.g., indoor) within the Total Risk Integrated activity pattern data) have been assessed
concentrations. In EPA’s judgment, the Methodology (TRIM) framework (EPA, individually, and their impact on the
most important uncertainties affecting 2006c,d). APEX is conceptually based uncertainty in the modeled exposure
the exposure estimates are related to the on the probabilistic NAAQS exposure estimates was assessed in a unified
modeling of human activity patterns model for O3 (pNEM/O3) used in the last quantitative analysis with results
over an O3 season, the modeling of O3 NAAQS review. Since that time, the expressed in the form of estimated
variations in ambient concentrations model has been restructured, improved, confidence ranges around the estimated
near roadways, and the modeling of air and expanded to reflect conceptual measures of exposure. This uncertainty
exchange rates that affect the amount of advances in the science of exposure analysis was conducted for one urban
O3 that penetrates indoors. Another modeling and newer input data area (Boston) using the observed 2002
important uncertainty that affects the available for the model. Key O3 concentrations and 2002
estimation of how many exposures are improvements to algorithms include concentrations adjusted to simulate just
associated with moderate or greater replacement of the cohort approach meeting the current standard, with the
exertion, is the characterization of with a probabilistic sampling approach expectation that the results would be
energy expenditure for children engaged focused on individuals, accounting for similar for other cities and years. One
in various activities. As discussed in fatigue and oxygen debt after exercise in significant source of uncertainty, due to
more detail in the Staff Paper (section the calculation of breathing rates, and a limitations in the database used to
4.3.4.7), the uncertainty in energy new approach for construction of model peoples’ daily activities, was not
expenditure values carries over to the longitudinal activity patterns for included in the unified analysis, and
uncertainty of the modeled breathing simulated persons. Major improvements was assessed through separate
rates, which are important since they to data input to the model include sensitivity analyses. This analysis
are used to classify exposures occurring updated air exchange rates, more recent indicates that the uncertainty of the
at moderate or greater exertion which census and commuting data, and a exposure results is relatively small. For
are the relevant exposures since O3- greatly expanded daily time-activities example, 95 percent uncertainty
related effects observed in clinical database. intervals were calculated for the APEX
studies only are observed when APEX is a probabilistic model
estimates of the percent of children or
individuals are engaged in some form of designed to explicitly model the
asthmatic children with exposures
exercise. The uncertainties in the numerous sources of variability that
above 0.060, 0.070, or 0.080 ppm under
exposure model inputs and the affect people’s exposures. APEX
simulates the movement of individuals moderate exertion, for two air quality
estimated exposures have been assessed
through time and space and estimates scenarios (current 2002 and 2002
using quantitative uncertainty and
their exposures to O3 in indoor, outdoor, adjusted to simulate just meeting the
sensitivity analyses. Details are
and in-vehicle microenvironments. The current standard) in Boston (Tables 26
discussed in the Staff Paper (section 4.6)
exposure model takes into account the and 27 in Langstaff, 2007). The 95
and in a technical memorandum
most significant factors contributing to percent uncertainty intervals for this set
describing the exposure modeling
total human O3 exposure, including the of 12 exposure estimates indicate the
uncertainty analysis (Langstaff, 2007).
temporal and spatial distribution of possibility of underpredictions of the
b. Scope and Key Components people and O3 concentrations exposure estimates ranging from 3 to 25
Population exposures to O3 are throughout an urban area, the variation percent of the modeled estimates, and
primarily driven by ambient outdoor of O3 levels within each overpredictions ranging from 4 to 11
concentrations, which vary by time of microenvironment, and the effects of percent of the estimates. For example,
day, location, and peoples’ activities. exertion on breathing rate in exposed APEX estimates the percent of asthmatic
Outdoor O3 concentration estimates individuals. A more detailed children with exposures above 0.070
used in the exposure assessment are description of APEX and its application ppm under moderate exertion to be 24
provided by measurements and is presented in chapter 4 of the Staff percent, for Boston 2002 O3
statistical adjustments to the measured Paper and associated technical concentrations adjusted to simulate just
concentrations. The current exposure documents (EPA, 2006b, c, d). meeting the current standard. The 95
analysis allows comparisons of Several methods have been used to percent uncertainty interval for this
population exposures to O3 within each evaluate the APEX model and to estimate is 23–30 percent, or ¥4 to +25
urban area, associated with current O3 characterize the uncertainty of the percent of the estimate. These
levels and with O3 levels just meeting model estimates. These include uncertainty intervals do not include the
several potential alternative air quality conducting model evaluation, uncertainty engendered by limitations
standards or scenarios. Human sensitivity analyses, and a detailed of the activity database, which is in the
exposure, regardless of the pollutant, uncertainty analysis for one urban area. range of one to ten percent.
depends on where individuals are These are discussed fully in the Staff The exposure periods modeled here
located and what they are doing. Paper (section 4.6) and in Langstaff are the O3 seasons in 2002, 2003, and
2004. The O3 season in each area in the measurement of ambient the extent to which such impacts might
includes the period of the year where concentrations, where the precision be reduced by meeting the current and
elevated O3 levels tend to be observed would extend to three instead of two alternative standards. This is especially
and for which routine hourly O3 decimal places (in ppm). true when there are exposure levels at
monitoring data are available. Typically The current standard and all which we know or can reasonably infer
this period spans from March or April alternative standards were modeled that specific O3-related health effects are
through September or October, or in using a quadratic rollback approach to occurring. We refer to exposures at and
some areas, spanning the entire year. adjust the hourly concentrations above these benchmark concentrations
Three years were modeled to reflect the observed in 2002–2004 to yield a design as ‘‘exposures of concern.’’
substantial year-to-year variability that value 31 corresponding to the standard EPA emphasizes that, although the
occurs in O3 levels and related being analyzed. The quadratic rollback analysis of ‘‘exposures of concern’’ was
meteorological conditions, and because technique reduces higher concentrations conducted using three discrete
the standard is specified in terms of a more than lower concentrations near benchmark levels (i.e., 0.080, 0.070, and
three-year period. The year-to-year ambient background levels.32 This 0.060 ppm), the concept is more
variability observed in O3 levels is due procedure was considered in a appropriately viewed as a continuum
to a combination of different weather sensitivity analysis in the last review of with greater confidence and less
patterns and the variation in emissions the O3 standard and has been shown to uncertainty about the existence of
of O3 precursors. Nationally, 2002 was be more realistic than a linear, health effects at the upper end and less
a relatively high year with respect to the proportional rollback method, where all confidence and greater uncertainty as
4th highest daily maximum 8-hour O3 of the ambient concentrations are one considers increasingly lower O3
levels observed in urban areas across the reduced by the same factor. exposure levels. EPA recognizes that
U.S. (EPA, 2007, Figure 2–16), with the there is no sharp breakpoint within the
c. Exposure Estimates and Key continuum ranging from at and above
mean of the distribution of O3 levels for
Observations 0.080 ppm down to 0.060 ppm. In
the urban monitors being in the upper
third among the years 1990 through The exposure assessment, which considering the concept of exposures of
2006. In contrast, on a national basis, provides estimates of the number of concern, it is important to balance
2004 is the lowest year on record people exposed to different levels of concerns about the potential for health
through 2006 for this same air quality ambient O3 while at specified exertion effects and their severity with the
statistic, and 8-hour daily maximum O3 levels 33 serve two purposes. First, the increasing uncertainty associated with
levels observed in most, but not all of entire range of modeled personal our understanding of the likelihood of
the 12 urban areas included in the exposures to ambient O3 is an essential such effects at lower O3 levels.
exposure and risk analyses were input to the portion of the health risk Within the context of this continuum,
assessment based on exposure-response estimates of exposures of concern at
relatively low compared to other recent
functions from controlled human discrete benchmark levels provide some
years. The 4th highest daily maximum
exposure studies, discussed in the next perspective on the public health
8-hour O3 levels observed in 2003 in the
section. Second, estimates of personal impacts of O3-related health effects that
12 urban areas and nationally generally
exposures to ambient O3 concentrations have been demonstrated in human
were between those observed in 2002
at and above specific benchmark levels clinical and toxicological studies but
and 2004.
provide some perspective on the public cannot be evaluated in quantitative risk
Regulatory scenarios examined
health impacts of health effects that we assessments, such as lung inflammation,
include the current 0.08 ppm, average of
cannot currently evaluate in increased airway responsiveness, and
the 4th daily maximum 8-hour averages
quantitative risk assessments that may changes in host defenses. They also help
over a three year period standard; in understanding the extent to which
standards with the same form but with occur at current air quality levels, and
such impacts have the potential to be
alternative levels of 0.080, 0.074, 0.070, reduced by meeting the current and
31 A design value is a statistic that describes the
and 0.064 ppm; standards specified as alternative standards. In the selection of
air quality status of a given area relative to the level
the average of the 3rd highest daily of the NAAQS. Design values are often based on specific benchmark concentrations for
maximum 8-hour averages over a three multiple years of data, consistent with specification this analysis, we first considered the
year period with alternative levels of of the NAAQS in Part 50 of the CFR. For the current
exposure level of 0.080 ppm, at which
0.084 and 0.074 ppm; and a standard O3 NAAQS, the 3-year average of the annual 4th-
highest daily maximum 8-hour average there is a substantial amount of clinical
specified as the average of the 5th concentrations, based on the monitor within (or evidence demonstrating a range of O3-
highest daily maximum 8-hour averages downwind of) an urban area yielding the highest 3- related health effects including lung
over a three year period with a level of year average, is the design value. inflammation and airway
0.074 ppm.30 The current standard uses 32 The quadratic rollback approach and
responsiveness in healthy individuals.
a rounding convention that allows areas evaluation of this approach are described by
Johnson (1997), Duff et al. (1998) and Rizzo (2005, Thus, as in the last review, this level
to have an average of the 4th daily 2006). was selected as a benchmark level for
maximum 8-hour averages as high as 33 As discussed above in Section II.A., O health
3 this assessment of exposures of concern.
0.084 ppm and still meet the standard. responses observed in human clinical studies are Evidence newly available in this review
All alternative standards analyzed were associated with exposures while engaged in
moderate or greater exertion and, therefore, these is the basis for identifying additional,
intended to reflect improved precision are the exposure measures of interest. The level of lower benchmark levels of 0.070 and
exertion of individuals engaged in particular 0.060 ppm for this assessment.
30 The current O standard is 0.08 ppm, but the activities is measured by an equivalent ventilation
3 More specifically, as discussed above
current rounding convention specifies that the rate (EVR), ventilation normalized by body surface
in section II.A.2, evidence available
average of the 4th daily maximum 8-hour average area (BSA, in m2), which is calculated as VE/BSA,
concentrations over a three-year period must be at where VE is the ventilation rate (liters/minute). from controlled human exposure and
0.084 ppm or lower to be in attainment of the Moderate and greater exertion levels were defined epidemiology studies indicates that
standard. When EPA staff selected alternative as EVR > 13 liters/min-m2 (Whitfield et al., 1996) people with asthma have larger and
standards to analyze, it was presumed that the same to correspond to the exertion levels measured in
type of rounding convention would be used, and most subjects studied in the controlled human
more serious effects than healthy
thus alternative standards of 0.084, 0.074, 0.064 exposure studies that reported health effects individuals, including lung function,
ppm were chosen. associated with 6.6 hour O3 exposures. respiratory symptoms, increased airway
responsiveness, and pulmonary levels in controlled human exposure of the number and percent of school age
inflammation, which has been shown to studies. EPA has not included these children and asthmatic school age
be a more sensitive marker than lung effects in the quantitative risk children exposed, with daily 8-hour
function responses. Further, a assessment due to a lack of adequate maximum exposures at or above each O3
substantial new body of evidence from information on the exposure-response benchmark level of exposures of
epidemiology studies shows relationships. concern, while at intermittent moderate
associations with serious respiratory The 1997 O3 NAAQS review or greater exertion and based on O3
morbidity and cardiopulmonary estimated exposures associated with 1- concentrations observed in 2002 and
mortality effects at O3 levels that extend hour heavy exertion, 1-hour moderate 2004. Table 1 summarizes estimates for
below 0.080 ppm. Additional, but very exertion, and 8-hour moderate exertion 2002 and 2004, because these years
limited new evidence from controlled for children, outdoor workers, and the reflect years that bracket relatively
human exposure studies shows lung general population. EPA’s analysis in higher and lower O3 levels, with year
function decrements and respiratory the 1997 Staff Paper showed that 2003 generally containing O3 levels in
symptoms in healthy subjects at an O3 exposure estimates based on the 8-hour between when considering the 12 urban
exposure level of 0.060 ppm. The moderate exertion scenario for children areas modeled. This table also reports
selected benchmark level of 0.070 ppm yielded the largest number of children the percent change in the number of
reflects the new information that experiencing exposures at or above persons exposed when a given
asthmatics have larger and more serious exposures of concern. Consequently, alternative standard is compared with
effects than healthy people and EPA has chosen to focus on the 8-hour the current standard.
therefore controlled human exposure moderate and greater exertion exposures Key observations important in
studies done with healthy subjects may in all and asthmatic school age children comparing exposure estimates
underestimate effects in this group, as in the current exposure assessment. associated with just meeting the current
well as the substantial body of While outdoor workers and other adults NAAQS and alternative standards under
epidemiological evidence of who engage in moderate or greater consideration include:
associations with O3 levels below 0.080 exertion for prolonged durations while (1) As shown in Table 6–1 of the Staff
ppm. The selected benchmark level of outdoors during the day in areas Paper, the patterns of exposure in terms
0.060 ppm additionally reflects the very experiencing elevated O3 concentrations of percentages of the population
limited new evidence from controlled also are at risk for experiencing exceeding a given exposure level are
human exposure studies that show lung exposures associated with O3-related very similar for the general population
function decrements and respiratory health effects, EPA did not focus on and for asthmatic and all school age (5–
symptoms in some healthy subjects at quantitative estimates for these 18) children, although children are
the 0.060 ppm exposure level, populations due to the lack of about twice as likely to be exposed,
recognizing that asthmatics are likely to information about the number of based on the percent of the population
have more serious responses and that individuals who regularly work or exposed, at any given level.
lung function is not likely to be as exercise outdoors. Thus, the exposure (2) As shown in Table 1 below, the
sensitive a marker for O3 effects as is estimates presented here and in the Staff number and percentage of asthmatic and
lung inflammation. Paper are most useful for making all school-age children aggregated across
The estimates of exposures of concern relative comparisons across alternative the 12 urban areas estimated to
were reported in terms of both ‘‘people air quality scenarios and do not experience 1 or more exposures of
exposed’’ (the number and percent of represent the total exposures in all concern decline from simulations of just
people who experience a given level of children or other groups within the meeting the current standard to
O3 concentrations, or higher, at least one general population associated with the simulations of alternative 8-hour
time during the O3 season in a given air quality scenarios. standards by varying amounts
year) and ‘‘occurrences of exposure’’ Population exposures to O3 were depending on the benchmark level, the
(the number of times a given level of estimated in 12 urban areas for 2002, population subgroup considered, and
pollution is experienced by the 2003, and 2004 air quality, and also the year chosen. For example, the
population of interest, expressed in using O3 concentrations adjusted to just estimated percentage of school age
terms of person-days of occurrences). meet the current and several alternative children experiencing one or more
Estimating exposures of concern is standards. The estimates of 8-hour exposures ≥ 0.070 ppm, while engaged
important because it provides some exposures of concern at and above in moderate or greater exertion, during
indication of the potential public health benchmark levels of 0.080, 0.070, and an O3 season is about 18 percent of this
impacts of a range of O3-related health 0.060 ppm aggregated across all 12 areas population when the current standard is
outcomes, such as lung inflammation, are shown in Table 1 for air quality met using the 2002 simulation; this is
increased airway responsiveness, and scenarios just meeting the current and reduced to about 12, 4, 1, and 0.2
changes in host defenses. These four alternative 8-hour average percent of children upon meeting
particular health effects have been standards.34 Table 1 provides estimates alternative standards of 0.080, 0.074,
demonstrated in controlled human 0.070, and 0.064 ppm, respectively (all
34 The full range of quantitative exposure
exposure studies of healthy individuals specified in terms of the 4th highest
estimates associated with just meeting the current
to occur at levels as low as 0.080 ppm and alternative O3 standards are presented in daily maximum 8-hour average), using
O3, but have not been evaluated at lower chapter 4 and Appendix 4A of the Staff Paper. the 2002 simulation.
TABLE 1.—NUMBER AND PERCENT OF ALL AND ASTHMATIC SCHOOL AGE CHILDREN IN 12 URBAN AREAS ESTIMATED TO
EXPERIENCE 8-HOUR OZONE EXPOSURES ABOVE 0.080, 0.070, AND 0.060 PPM WHILE AT MODERATE OR GREATER
EXERTION, ONE OR MORE TIMES PER SEASON AND THE NUMBER OF OCCURRENCES ASSOCIATED WITH JUST MEET-
ING ALTERNATIVE 8-HOUR STANDARDS BASED ON ADJUSTING 2002 AND 2004 AIR QUALITY DATA1, 2
All children, ages 5–18 aggregate for 12 urban areas, Asthmatic children, ages 5–18 Aggregate for 12
Benchmark 8-Hour air number of children exposed (% of all) [%reduction urban areas, number of children exposed (% of
levels of expo- quality stand- from current standard] group) [% reduction from current standard]
sures of con- ards3 (ppm)
cern (ppm) 2002 2004 2002 2004
0.080 ............. 0.084 700,000 (4%) ................... 30,000 (0%) ..................... 110,000 (4%) ................... 0 (0%)
0.080 290,000 (2%) [70%] ........ 10,000 (0%) [67%] .......... 50,000 (2%) [54%] .......... 0 (0%)
0.074 60,000 (0%) [91%] .......... 0 (0%) [100%] ................. 10,000 (0%) [91%] .......... 0 (0%)
0.070 10,000 (0%) [98%] .......... 0 (0%) [100%] ................. 0 (0%) [100%] ................. 0 (0%)
0.064 0 (0%) [100%] ................. 0 (0%) [100%] ................. 0 (0%) [100%] ................. 0 (0%)
0.070 ............. 0.084 3,340,000 (18%) .............. 260,000 (1%) ................... 520,000 (20%) ................. 40,000 (1%)
0.080 2,160,000 (12%) [35%] ... 100,000 (1%) [62%] ........ 330,000 (13%) [36%] ...... 10,000 (0%) [75%]
0.074 770,000 (4%) [77%] ........ 20,000 (0%) [92%] .......... 120,000 (5%) [77%] ........ 0 (0%) [100%]
0.070 270,000 (1%) [92%] ........ 0 (0%) [100%] ................. 50,000 (2%) [90%] .......... 0 (0%) [100%]
0.064 30,000 (0.2%) [99%] ....... 0 (0%) [100%] ................. 10,000 (0.2%) [98% ] ...... 0 (0%) [100%]
0.060 ............. 0.084 7,970,000 (44%) .............. 1,800,000 (10%) .............. 1,210,000 (47%) .............. 270,000 (11%)
0.080 6,730,000 (37%) [16%] ... 1,050,000 (6%) [42%] ..... 1,020,000 (40%) [16%] ... 150,000 (6%) [44%]
0.074 4,550,000 (25%) [43%] ... 350,000 (2%) [80%] ........ 700,000 (27%) [42%] ...... 50,000 (2%) [81%]
0.070 3,000,000 (16%) [62%] ... 110,000 (1%) [94%] ........ 460,000 (18%) [62%] ...... 10,000 (1%) [96%]
0.064 950,000 (5%) [88%] ........ 10,000 (0%) [99%] .......... 150,000 (6%) [88%] ........ 0 (0%) [100%]
1 Moderate or greater exertion is defined as having an 8-hour average equivalent ventilation rate ≥ 13 l-min/m2.
2 Estimates are the aggregate results based on 12 combined statistical areas (Atlanta, Boston, Chicago, Cleveland, Detroit, Houston, Los An-
geles, New York, Philadelphia, Sacramento, St. Louis, and Washington, DC). Estimates are for the ozone season which is all year in Houston,
Los Angeles and Sacramento and March or April to September or October for the remaining urban areas.
3 All standards summarized here have the same form as the current 8-hour standard which is specified as the 3-year average of the annual 4th
highest daily maximum 8-hour average concentrations must be at or below the concentration level specified. As described in the Staff Paper
(section 4.5.8), recent O3 air quality distributions have been statistically adjusted to simulate just meeting the current and selected alternative
standards. These simulations do not represent predictions of when, whether, or how areas might meet the specified standards.
(3) Substantial year-to-year variability (5) Of particular note, as discussed and outdoor workers experiencing lung
in exposure estimates is observed over above in section II.A. of this notice, high function and respiratory symptoms
the three-year modeling period. For inter-individual variability in associated with O3 exposures for 9
example, the estimated number of responsiveness means that only a subset urban areas.36 The risk assessment for
school age children experiencing one or of individuals in these groups who are the last review also included risk
more exposures ≥0.070 ppm during an exposed at and above a given estimates for excess respiratory-related
O3 season when the current standard is benchmark level would actually be hospital admissions related to O3
met in the 12 urban areas included in expected to experience such adverse concentrations for New York City. In the
the analysis is 3.3, 1.0, or 0.3 million for health effects. last review, the risk estimates played a
the 2002, 2003, and 2004 simulations, (6) In considering these observations, significant role in both the staff
respectively. it is important to take into account the recommendations and in the proposed
variability, uncertainties, and and final decisions to revise the O3
(4) There is substantial variability standards. The health risk assessment
limitations associated with this
observed across the 12 urban areas in conducted for the current review builds
assessment, including the degree of
the percent of the population subgroups uncertainty associated with a number of upon the methodology and lessons
estimated to experience exposures of model inputs and uncertainty in the learned from the prior review.
concern. For example, when 2002 O3 model itself, as discussed above.
concentrations are simulated to just a. Overview
meet the current standard, the aggregate 2. Quantitative Health Risk Assessment The updated health risk assessment
12 urban area estimate is 18 percent of This section discusses the approach conducted as part of this review
all school age children are estimated to used to develop quantitative health risk includes estimates of (1) Risks of lung
experience O3 exposures (≥0.070 ppm estimates associated with exposures to function decrements in all and
(Table 1 below), while the range of O3 building upon a more limited risk asthmatic school age children,
exposure estimates in the 12 urban areas assessment that was conducted during respiratory symptoms in asthmatic
considered separately for all children the last review.35 As part of the last children, respiratory-related hospital
range from 1 to 38 percent (EPA, 2007, review, EPA conducted a health risk admissions, and non-accidental and
Exhibit 2, p. 4–48). There was also assessment that produced risk estimates cardiorespiratory-related mortality
variability in exposure estimates among for the number and percent of children associated with recent ambient O3
the modeled areas when using the 2004 levels; (2) risk reductions and remaining
air quality simulation for the same 35 The methodology, scope, and results from the
scenario; however it was reduced and risk assessment conducted in the last review are 36 The 9 urban study areas included in the
described in Chapter 6 of the 1996 Staff Paper (EPA, exposure and risk analyses conducted during the
ranged from 0 to 7 percent in the 12 1996) and in several technical reports (Whitfield et last review were: Chicago, Denver, Houston, Los
urban areas (EPA, 2007, Exhibit 8, p. 4– al., 1996; Whitfield, 1997) and publication Angeles, Miami, New York City, Philadephia, St.
60). (Whitfield et al., 1998). Louis, and Washington, DC.
risks associated with just meeting the meeting the current and several (EPA, 2007, p. 6–20). With respect to
current 8-hour O3 NAAQS; and (3) risk alternative 8-hour standards. uncertainties about estimated
reductions and remaining risks The risk assessment covers a variety background concentrations, as
associated with just meeting various of health effects for which there is discussed below and in the Staff Paper
alternative 8-hour O3 NAAQS in a adequate information to develop (EPA 2007b, section 5.4.3), alternative
number of example urban areas. This quantitative risk estimates. However, as assumptions about background levels
risk assessment is more fully described noted by CASAC (Henderson, 2007) and have a variable impact depending on the
and presented in the Staff Paper (EPA, in the Staff Paper, there are a number of location, standard, and health endpoint
2007, chapter 5) and in a technical health endpoints (e.g., increased lung analyzed.
support document (TSD), Ozone Health inflammation, increased airway With respect to the lung function part
Risk Assessment for Selected Urban responsiveness, impaired host defenses, of the health risk assessment, key
Areas (Abt Associates, 2006, hereafter increased medication usage for uncertainties include uncertainties in
referred to as ‘‘Risk Assessment TSD’’). asthmatics, increased emergency the exposure estimates, discussed
The scope and methodology for this risk department visits for respiratory causes, above, and uncertainties associated with
assessment were developed over the last and increased school absences) for the shape of the exposure-response
few years with considerable input from which there currently is insufficient relationship, especially at levels below
the CASAC O3 Panel and the public.37 information to develop quantitative risk 0.08 ppm, 8-hour average, where only
The information contained in these estimates, but which are important to very limited data are available down to
documents included specific criteria for consider in assessing the overall public 0.04 ppm and there is an absence of data
the selection of health endpoints, health impacts associated with below 0.04 ppm (EPA, 2007, pp. 6–20—
studies, and locations to include in the exposures to O3. These additional health 6–21). Concerning the part of the risk
assessment. In a peer review letter sent endpoints are discussed above in assessment based on effects reported in
by CASAC to the Administrator section II.A.2 and are also taken into epidemiological studies, important
documenting its advice in October 2006 account in considering the level of uncertainties include uncertainties (1)
(Henderson, 2006c), the CASAC O3 exposures of concern in populations Surrounding estimates of the O3
Panel concluded that the risk particularly at risk, discussed above in coefficients for concentration-response
assessment was ‘‘well done, balanced, this notice. relationships used in the assessment, (2)
and reasonably communicated’’ and that There are two parts to the health risk involving the shape of the
the selection of health endpoints for assessment: one based on combining concentration-response relationship and
inclusion in the quantitative risk information from controlled human whether or not a population threshold
assessment was appropriate. exposure studies with modeled or non-linear relationship exists within
The goals of the risk assessment are: population exposure and the other the range of concentrations examined in
(1) To provide estimates of the potential based on combining information from the studies, (3) related to the extent to
magnitude of several morbidity effects community epidemiological studies which concentration-response
and mortality associated with current O3 with either monitored or adjusted relationships derived from studies in a
levels, and with meeting the current and ambient concentrations levels. Both given location and time when O3 levels
alternative 8-hour O3 standards in parts of the risk assessment were were higher or behavior and /or housing
specific urban areas; (2) to develop a implemented within a new probabilistic conditions were different provide
better understanding of the influence of version of TRIM.Risk, the component of accurate representations of the
various inputs and assumptions on the EPA’s Total Risk Integrated relationships for the same locations
risk estimates; and (3) to gain insights Methodology (TRIM) model framework with lower air quality distributions and/
into the distribution of risks and that estimates human health risks. or different behavior and/or housing
patterns of risk reductions associated EPA recognizes that there are many conditions, and (4) concerning the
with meeting alternative O3 standards. sources of uncertainty and variability in possible role of co-pollutants which also
The health risk assessment is intended the inputs to this assessment and that may have varied between the time of the
to be dependent on and reflect the there is significant variability and studies and the current assessment
overall weight and nature of the health uncertainty in the resulting O3 risk period. An important additional
effects evidence discussed above in estimates. As discussed in chapters 2, 5, uncertainty for the mortality risk
section II.A and in more detail in the and 6 of the Staff Paper, there is estimates is the extent to which the
Criteria Document and Staff Paper. significant year-to-year and city-to-city associations reported between O3 and
While not independent of the overall variability related to the air quality data non-accidental and cardiorespiratory
evaluation of the health effects that affects both the controlled human mortality actually reflect causal
evidence, the quantitative health risk exposure studies-based and relationships.
assessment provides additional insights epidemiological studies-based parts of As discussed below, some of these
regarding the relative public health the risk assessment. There are also uncertainties have been addressed
implications associated with just uncertainties associated with the air quantitatively in the form of estimated
quality adjustment procedure used to confidence ranges around central risk
37 The general approach used in the current risk simulate just meeting the current and estimates; others are addressed through
assessment was described in the draft Health selected alternative standards In the separate sensitivity analyses (e.g., the
Assessment Plan (EPA, 2005a) that was released to
the CASAC and general public in April 2005 and
prior review, different statistical influence of alternative estimates for
was the subject of a consultation with the CASAC approaches using alternative functional policy-relevant background levels) or
O3 Panel on May 5, 2005. In October 2005, OAQPS forms (i.e., quadratic, proportional, are characterized qualitatively. For both
released the first draft of the Staff Paper containing Weibull) were used to reflect how O3 air parts of the health risk assessment,
a chapter discussing the risk assessment and first

draft of the Risk Assessment TSD for CASAC quality concentrations have historically statistical uncertainty due to sampling
consultation and public review on December 8, changed. Based on sensitivity analyses error has been characterized and is
2005. In July 2006, OAQPS released the second conducted in the prior review, the expressed in terms of 95 percent
draft of the Staff Paper and second draft of the Risk choice of alternative air quality credible intervals. EPA recognizes that
Assessment TSD for CASAC review and public
comment which was held by the CASAC O3 Panel adjustment procedures had only a these credible intervals do not reflect all
on August 24–25, 2006. modest impact on the risk estimates of the uncertainties noted above.
b. Scope and Key Components to estimate risks for a single O3 season estimating these levels as an input to the
The current health risk assessment is or single warm O3 season, depending on health risk assessment.40
based on the information evaluated in the health effect, based on a simulation In the first part of the current risk
the final Criteria Document. The risk that adjusted each of these individual assessment, lung function decrement, as
assessment includes several categories years so that the three year period measured by FEV1, is the only health
of health effects and estimates risks would just meet the specified standard. response that is based on data from
associated with just meeting the current Consistent with the risk assessment controlled human exposure studies. As
and alternative 8-hour O3 NAAQS and discussed above, there is clear evidence
approach used in the last review, the
with several individual recent years of of a causal relationship between lung
risk estimates developed for both recent
air quality (i.e., 2002, 2003, and 2004). function decrements and O3 exposures
air quality levels and just meeting the
The risk assessment considers the same for school age children engaged in
current and selected alternative 8-hour
alternative air quality scenarios that moderate exertion based on numerous
standards represent risks associated
were examined in the human exposure controlled human exposure and summer
with O3 levels attributable to
analyses described above. Risk estimates camp field studies conducted by various
anthropogenic sources and activities
were developed for up to 12 urban areas investigators. Risk estimates have been
(i.e., risk associated with concentrations
selected to illustrate the public health developed for O3-related lung function
above ‘‘policy-relevant background’’).
impacts associated with these air quality decrements (measured as changes in
Policy-relevant background O3
scenarios.38 As discussed above in FEV1) for all school age children (ages
concentrations used in the O3 risk 5 to 18) and a subset of this group,
section II.B.1, the selection of urban assessment were defined in chapter 2 of
areas was largely determined by asthmatic school age children (ages 5 to
the Staff Paper (EPA, 2007, pp. 2–48— 18), whose average exertion over an 8-
identifying areas in the U.S. which 2–55) as the O3 concentrations that
represented a range of geographic areas, hour period was moderate or greater.
would be observed in the U.S. in the The exposure period and exertion level
population demographics, and absence of anthropogenic emissions of
climatology; with an emphasis on areas were chosen to generally match the
precursors (e.g., VOC, NOX, and CO) in exposure period and exertion level used
that do not meet the current 8-hour O3
the U.S., Canada, and Mexico. The in the controlled human exposure
NAAQS and which included the largest
results of a global tropospheric O3 studies that were the basis for the
areas with O3 nonattainment problems.
model (GEOS–CHEM) have been used to exposure-response relationships. A
The selection criteria also included
estimate monthly background daily combined data set including individual
whether or not there were acceptable
diurnal profiles for each of the 12 urban level data from the Folinsbee et al.
epidemiological studies available that
reported concentration-response areas for each month of the O3 season (1988), Horstman et al. (1990), and
relationships for the health endpoints using meteorology for the year 2001. McDonnell et al. (1991) studies, used in
selected for inclusion in the assessment. Based on the results of the GEOS–CHEM the previous risk assessment, and more
The short-term exposure related model, the Criteria Document indicates recent data from Adams (2002, 2003,
health endpoints selected for inclusion that background O3 concentrations are 2006) have been used to estimate
in the quantitative risk assessment generally predicted to be in the range of probabilistic exposure-response
include those for which the final 0.015 to 0.035 ppm in the afternoon, relationships for 8-hour exposures
Criteria Document and or Staff Paper and they are generally lower under under different definitions of lung
concluded that the evidence as a whole conditions conducive to man-made O3 function response (i.e., ≥10, 15, and 20
supports the general conclusion that O3, episodes.39 percent decrements in FEV1). As
acting alone and/or in combination with This approach of estimating risks in discussed in the Staff Paper (EPA, 2007,
other components in the ambient air excess of background is judged to be p. 5–27), while these specific controlled
pollution mix, is either clearly causal or more relevant to policy decisions human exposure studies only included
is judged to be likely causal. Some regarding ambient air quality standards healthy adults aged 18–35, findings
health effects met this criterion of likely than risk estimates that include effects from other controlled human exposure
causality, but were not included in the potentially attributable to studies and summer camp field studies
risk assessment for other reasons, such uncontrollable background O3 involving school age children in at least
as insufficient exposure-response data concentrations. Sensitivity analyses six different locations in the
or lack of baseline incidence data. examining the impact of alternative northeastern United States, Canada, and
As discussed in the section above estimates for background on lung Southern California indicated changes
describing the exposure analysis, in function and mortality risk estimates in lung function in healthy children
order to estimate the health risks have been developed and are included similar to those observed in healthy
associated with just meeting the current in the Staff Paper and Risk Assessment adults exposed to O3 under controlled
and alternative 8-hour O3 NAAQS, it is TSD and key observations are discussed chamber conditions.
necessary to estimate the distribution of below. Further, CASAC noted the Consistent with advice from CASAC
hourly O3 concentrations that would difficulties and complexities associated (Henderson, 2006c), EPA has considered
occur under any given standard. Since with available approaches to estimating both linear and logistic functional forms
compliance is based on a 3-year average, policy-relevant background in estimating the probabilistic exposure-
the amount of control has been applied concentrations (Henderson, 2007). response relationships for lung function
to each year of data (i.e., 2002 to 2004) Recognizing these complexities, EPA responses. A Bayesian Markov Chain
requests comments on the new Monte Carlo approach, described in
38 The 12 urban areas are the same urban areas
approach used in this review for more detail in the Risk Assessment TSD,
evaluated in the exposure analysis discussed in the has been used that incorporates both
prior section. However, for most of the health
endpoints based on findings from epidemiological 39 EPA notes that the estimated level of policy- model uncertainty and uncertainty due
studies, the geographic areas and populations relevant background O3 used in the prior risk
examined in the health risk assessment were assessment was a single concentration of 0.04 ppm, 40 Recognizing the importance of this issue, EPA
limited to those counties included in the original which was the midpoint of the range of levels for intends to conduct additional sensitivity analyses
epidemiological studies that served as the basis for policy-relevant background that was provided in related to policy-relevant background and its
the concentration-response relationships. the 1996 Criteria Document. implications for the risk assessment.
to sample size in the combined data set are quantitatively characterized and and that these other constituents may be
that served as the basis for the presented as 95 percentile credible responsible in whole or part for the
assessment. EPA has chosen a model intervals, there are additional observed effects.
reflecting a 90 percent weighting on a uncertainties and caveats associated Risk estimates for each health
logistic form and a 10 percent weighting with the lung function risk estimates. endpoint category were only developed
on a linear form as the base case for the These include uncertainties about the for areas that were the same or close to
current risk assessment. The basis for shape of the exposure-response the location where at least one
this choice is that the logistic form relationship, particularly at levels below concentration-response function for the
provides a very good fit to the combined 0.080 ppm, and about policy-relevant health endpoint had been estimated.43
data set, but a linear model cannot be background levels, for which sensitivity Thus, for respiratory symptoms in
entirely ruled out since there are only analyses have been conducted. moderate to severe asthmatic children
very limited data (i.e., 30 subjects) at the Additional important caveats and only the Boston urban area was
two lowest exposure levels (i.e., 0.040 uncertainties concerning the lung included and four urban areas were
and 0.060 ppm). EPA has conducted a function portion of the health risk included for respiratory-related hospital
sensitivity analysis which examines the assessment include: (1) The admissions. Nonaccidental mortality
impact on the lung function risk uncertainties and limitations associated risk estimates were developed for 12
estimates of two alternative choices, an with the exposure estimates discussed urban areas and 8 urban areas were
80 percent logistic/20 percent linear above and (2) the inability to account for included for cardiorespiratory mortality.
split and a 50 percent logistic/50 some factors which are known to affect The concentration-response
percent linear split. the exposure-response relationships relationships used in the assessment are
As noted above, risk estimates have (e.g., assigning healthy and asthmatic based on findings from human
been developed for three measures of children the same responses as observed epidemiological studies that have relied
lung function response (i.e., ≥10, 15, and in healthy adult subjects and not on fixed-site ambient monitors as a
20 percent decrements in FEV1). adjusting response rates to reflect the surrogate for actual ambient O3
However, the Staff Paper and risk increase and attenuation of responses exposures. In order to estimate the
estimates summarized below focus on that have been observed in studies of incidence of a particular health effect
FEV1 decrements ≥15 percent for all lung function responses upon repeated associated with recent air quality in a
school age children and ≥10 percent for exposures). A more complete discussion specific county or set of counties
asthmatic school age children, of assumptions and uncertainties is attributable to ambient O3 exposures in
consistent with the advice from CASAC contained in chapter 5 of the Staff Paper excess of background, as well as the
(Henderson, 2006c) that these levels of and in the Risk Assessment TSD (Abt change in incidence corresponding to a
response represent indicators of adverse Associates, 2006). given change in O3 levels resulting from
health effects in these populations. The just meeting the current or alternative 8-
The second part of the risk assessment
Risk Assessment TSD and Staff Paper hour O3 standards, three elements are
is based on health effects observed in
present the broader range of risk required for this part of the risk
epidemiological studies. Based on a
estimates including all three measures assessment. These elements are: (1) Air
review of the evidence evaluated in the
of lung function response. quality information (including recent air
Criteria Document and Staff Paper, as
Developing risk estimates for lung quality data for O3 from ambient
well as the criteria discussed in chapter
function decrements involved monitors for the selected location,
5 of the Staff Paper, the following
combining probabilistic exposure- estimates of background O3
categories of health endpoints
response relationships based on the concentrations appropriate for that
associated with short-term exposures to
combined data set from several location, and a method for adjusting the
ambient O3 concentrations were
controlled human exposure studies with recent data to reflect patterns of air
included in the risk assessment:
population exposure distributions for all quality estimated to occur when the area
respiratory symptoms in moderate to
and asthmatic school age children just meets a given O3 standard); (2)
severe asthmatic children, hospital
associated with recent air quality and relative risk-based concentration-
admissions for respiratory causes, and
air quality simulated to just meet the response functions that provide an
non-accidental and cardiorespiratory
current and alternative 8-hour O3 estimate of the relationship between the
mortality. As discussed above, there is
NAAQS based on the results from the health endpoints of interest and ambient
strong evidence of a causal relationship
exposure analysis described in the O3 concentration; and (3) annual or
for the respiratory morbidity endpoints
previous section. The risk estimates seasonal baseline health effects
included in the current risk assessment.
have been developed for 12 large urban incidence rates and population data,
With respect to nonaccidental and
areas for the O3 season.41 These 12 which are needed to provide an estimate
cardiorespiratory mortality, the Criteria
urban areas include approximately 18.3 of the seasonal baseline incidence of
Document concludes that there is strong
million school age children, of which health effects in an area before any
evidence which is highly suggestive of
2.6 million are asthmatic school age changes in O3 air quality.
a causal relationship between
children.42 A key component in the portion of the
nonaccidental and cardiorespiratory-
In addition to uncertainties arising risk assessment based on
related mortality and O3 exposures
from sample size considerations, which epidemiological studies is the set of
during the warm O3 season. As concentration-response functions which
discussed in the Staff Paper (chapter 5), provide estimates of the relationships
41 As discussed above in section II.B.1, the urban
EPA also recognizes that for some of the
areas were defined using the consolidated statistical
effects observed in epidemiological
areas definition and the total population residing in 43 The geographic boundaries for the urban areas
the 12 urban areas was approximately 88.5 million studies, such as increased respiratory- included in this portion of the risk assessment were
people. related hospital admissions and generally matched to the geographic boundaries
42 For 9 of the 12 urban areas, the O season is used in the epidemiological studies that served as
3 nonaccidental and cardiorespiratory
defined as a period running from March or April the basis for the concentration-response functions.
to September or October. In 3 of the urban areas
mortality, O3 may be serving as an In most cases, the urban areas were defined as
(Houston, Los Angeles, and Sacramento), the O3 indicator for reactive oxidant species in either a single county or a few counties for this
season is defined as the entire year. the overall photochemical oxidant mix portion of the risk assessment.
between each health endpoint of different urban areas, by including risk variability in these key inputs across all
interest and changes in ambient O3 estimates based on studies using U.S. locations has not been fully
concentrations. Studies often report different time periods and models, characterized, variability across the
more than one estimated concentration- where available, and/or are discussed selected locations is imbedded in the
response function for the same location throughout section 5.3 of the Staff analysis by using, to the extent possible,
and health endpoint. Sometimes models Paper. Because O3 effects observed in inputs specific to each urban area.
include different sets of co-pollutants the epidemiological studies have been
and/or different lag periods between the more clearly and consistently shown for c. Risk Estimates and Key Observations
ambient concentrations and reported warm season analyses, all analyses for
this portion of the risk assessment were The Staff Paper (chapter 5) and Risk
health responses. For some health
carried out for the same time period, Assessment TSD present risk estimates
endpoints, there are studies that
estimated multi-city and single-city O3 April through September. associated with just meeting the current
concentration-response functions. While The Criteria Document finds that no and several alternative 8-hour
the Risk Assessment TSD and chapter 5 definitive conclusion can be reached standards, as well as three recent years
of the Staff Paper present a more with regard to the existence of of air quality as represented by 2002,
comprehensive set of risk estimates, population thresholds in 2003, and 2004 monitoring data. As
EPA has focused on estimates based on epidemiological studies (Criteria discussed in the exposure analysis
multi-city studies where available. The Document, pp. 8–44). EPA recognizes, section above, there is considerable city-
advantages of relying more heavily on however, the possibility that thresholds to-city and year-to-year variability in the
concentration-response functions based for individuals may exist for reported O3 levels during this period, which
on multi-city studies include: (1) More associations at fairly low levels within results in significant variability in both
precise effect estimates due to larger the range of air quality observed in the portions of the health risk assessment.
data sets, reducing the uncertainty studies, but not be detectable as
population thresholds in In the 1997 risk assessment, risks for
around the estimated coefficient; (2) lung function decrements associated
greater consistency in data handling and epidemiological analyses. Based on the
Criteria Document’s conclusions, EPA with 1-hour heavy exertion, 1-hour
model specification that can eliminate moderate exertion, and 8-hour moderate
city-to-city variation due to study judged and CASAC concurred, that
there is insufficient evidence to support exertion exposures were estimated.
design; and (3) less likelihood of
use of potential population threshold Since the 8-hour moderate exertion
publication bias or exclusion of
levels in the quantitative risk exposure scenario for children clearly
reporting of negative or nonsignificant
findings. Where studies reported assessment. However, EPA recognizes resulted in the greatest health risks in
different effect estimates for varying lag that there is increasing uncertainty terms of lung function decrements, EPA
periods, consistent with the Criteria about the concentration-response has chosen to include only the 8-hour
Document, single day lag periods of 0 to relationship at lower concentrations moderate exertion exposures in the
1 days were used for associations with which is not captured by the current risk assessment for this health
respiratory hospital admissions and characterization of the statistical endpoint. Thus, the risk estimates
mortality. For mortality associated with uncertainty due to sampling error. presented here and in the Staff Paper are
exposure to O3 which may result over a Therefore, the risk estimates for most useful for making relative
several day period after exposure, respiratory symptoms in moderate to comparisons across alternative air
severe asthmatic children, respiratory- quality scenarios and do not represent
distributed lag models, which take into
related hospital admissions, and the total risks for lung function
account the contribution to mortality
premature mortality associated with decrements in children or other groups
effects over several days, were used
exposure to O3 must be considered in
where available. within the general population
light of uncertainties about whether or
One of the most important elements associated with any of the air quality
not these O3-related effects occur in
affecting uncertainties in the these populations at very low O3 scenarios. Thus, some outdoor workers
epidemiological-based portion of the concentrations. and adults engaged in moderate exertion
risk assessment is the concentration- With respect to variability within this over multi-hour periods (e.g., 6–8-hour
response relationships used in the portion of the risk assessment, there is exposures) also would be expected to
assessment. The uncertainty resulting variability among concentration- experience similar lung function
from the statistical uncertainty response functions describing the decrements. However, the percentage of
associated with the estimate of the O3 relation between O3 and both each of these other subpopulations
coefficient in the concentration- respiratory-related hospital admissions expected to experience these effects is
response function was characterized and nonaccidental and cardiorespiratory expected to be smaller than all school
either by confidence intervals or by mortality across urban areas. This age children who tend to spend more
Bayesian credible intervals around the variability is likely due to differences in hours outdoors while active based on
corresponding point estimates of risk. population (e.g., age distribution), the exposure analyses conducted during
Confidence and credible intervals population activities that affect the prior review.
express the range within which the true exposure to O3 (e.g., use of air Table 2 presents a summary of the
risk is likely to fall if the only conditioning), levels and composition of
uncertainty surrounding the O3 risk estimates for lung function
co-pollutants, baseline incidence rates,
coefficient involved sampling error. decrements for the current standard and
and/or other factors that vary across
Other uncertainties, such as differences urban areas. The current risk assessment several alternative 8-hour standard
in study location, time period (i.e., the incorporates some of the variability in levels with the same form as the current
years in which the study was key inputs to the analysis by using 8-hour standard. The estimates are for
conducted), and model uncertainties are location-specific inputs (e.g., location- the aggregate number and percent of all
not represented by the confidence or specific concentration-response school age children across 12 urban
credible intervals presented, but were functions, baseline incidence rates, and areas and the aggregate number and
addressed by presenting estimates for air quality data). Although spatial percent of asthmatic school age children
across 5 urban areas 44 who are remaining risk associated with a (3.2 percent of school age children)
estimated to have at least 1 moderate or relatively high year (i.e., based on would experience 1 or more moderate
greater lung function response (defined adjusting 2002 O3 air quality data) and lung function decrements for the 12
as FEV1 ≥15 percent in all children and relatively low year (based on adjusting urban areas associated with O3 levels
≥10 percent in asthmatic children) 2004 O3 air quality data) as well as the just meeting the current standard based
associated with 8-hour exposures to O3 year-to-year variability in the risk on 2002 air quality data compared to
while engaged in moderate or greater reduction estimated to occur associated 230,000 (1.2 percent of children)
exertion on average over the 8-hour with various alternative standards associated with just meeting the current
period. The lung function risk estimates relative to just meeting the current standard based on 2004 air quality data.
summarized in Table 2 illustrate the standard. For example, it is estimated
year-to-year variability in both that about 610,000 school age children
TABLE 2.—NUMBER AND PERCENT OF ALL AND ASTHMATIC SCHOOL AGE CHILDREN IN SEVERAL URBAN AREAS ESTI-
MATED TO EXPERIENCE MODERATE OR GREATER LUNG FUNCTION RESPONSES 1 OR MORE TIMES PER SEASON AS-
SOCIATED WITH 8-HOUR OZONE EXPOSURES ASSOCIATED WITH JUST MEETING ALTERNATIVE 8-HOUR STANDARDS
BASED ON ADJUSTING 2002 AND 2004 AIR QUALITY DATA 1, 2
All children, ages 5–18, FEV1 ≥15 percent, aggregate Asthmatic children, ages 5–18, FEV1 ≥10 percent, ag-
for 12 urban areas, number of children affected (% of gregate for 5 urban areas, number of children affected
8-Hour air quality stand- all) [% reduction from current standard] (% of group) [% reduction from current standard]
ards 3
2002 2004 2002 2004]
0.084 ppm (Current stand- 610,000 (3.3%) ................. 230,000 (1.2%) ................. 130,000 (7.8%) ................. 70,000 (4.2%).
ard).
0.080 ppm ......................... 490,000 (2.7%) [20% re- 180,000 (1.0%) [22% re- NA 4 ................................... NA.
duction]. duction].
0.074 ppm ......................... 340,000 (1.9%) [44% re- 130,000 (0.7%) [43% re- 90,000 (5.0%) [31 % re- 40,000 (2.7%) [43% reduc-
duction]. duction]. duction]. tion].
0.070 ppm ......................... 260,000 (1.5%) [57% re- 100,000 (0.5%) [57% re- NA ..................................... NA.
duction]. duction].
0.064 ppm ......................... 180,000 (1.0%) [70% re- 70,000 (0.4%) [70% reduc- 50,000 (3.0%) [62% reduc- 20,000 (1.5%) [71% reduc-
duction]. tion]. tion]. tion].
1 Associated with exposures while engaged in moderate or greater exertion which is defined as having an 8-hour average equivalent ventilation
rate ≥13 l-min/m 2.
2 Estimates are the aggregate central tendency results based on either 12 urban areas (Atlanta, Boston, Chicago, Cleveland, Detroit, Houston,
Los Angeles, New York, Philadelphia, Sacramento, St. Louis, and Washington, DC) or 5 urban areas (Atlanta, Chicago, Houston, Los Angeles,
New York). Estimates are for the O3 season which is all year in Houston, Los Angeles and Sacramento and March or April to September or Oc-
tober for the remaining urban areas.
3 All standards summarized here have the same form as the current 8-hour standard which is specified as the 3-year average of the annual 4th
highest daily maximum 8-hour average concentrations must be at or below the stated concentration level. As described in the Staff Paper (sec-
tion 4.5.8), recent O3 air quality distributions have been statistically adjusted to simulate just meeting the current and selected alternative stand-
ards. These simulations do not represent predictions of when, whether, or how areas might meet the specified standards
4 NA (not available) indicates that EPA did not develop risk estimates for these scenarios for the asthmatic school age children population.
As discussed in the Staff Paper, a child is similar. EPA recognizes that the three years analyzed, and for
child may experience multiple some children in the population might additional alternative standards are
occurrences of a lung function response have only 1 or 2 occurrences while presented in chapter 5 of the Staff Paper
during the O3 season. For example, others may have 6 or more occurrences and in the Risk Assessment TSD.
upon meeting the current 8-hour per O3 season. Risk estimates based on For just meeting the current 8-hour
standard, the median estimates are that adjusting 2003 air quality to simulate standard, the median estimates across
about 610,000 children would just meeting the current and alternative the 5 urban areas for asthmatic school
experience a moderate or greater lung 8-hour standards are intermediate to the age children range from 3.4 to 10.9
function response 1 or more times for estimates presented in Table 2 above in percent based on the 2002 simulation
the aggregate of the 12 urban areas over this notice and are presented in the Staff and from 3.2 to 6.9 percent based on the
a single O3 season (based on the 2002 Paper (chapter 5) and Risk Assessment 2004 simulation.
simulation), and that there would be TSD. Key observations important in
almost 3.2 million total occurrences. For just meeting the current 8-hour comparing estimated lung function risks
Thus, on average it is estimated that standard, Table 5–8 in the Staff Paper associated with attainment of the
there would be about 5 occurrences per shows that median estimates across the current NAAQS and alternative
O3 season per responding child for air 12 urban areas for all school age standards under consideration include:
quality just meeting the current 8-hour children experiencing 1 or more (1) As discussed above, there is
standard across the 12 urban areas. moderate lung function decrements significant year to year variability in the
While the estimated number of ranges from 0.9 to 5.4 percent based on range of median estimates of the number
occurrences per O3 season is lower the 2002 simulation and from 0.8 to 2.2 of school age children (ages 5–18)
when based on the 2004 simulation than percent based on the 2004 simulation. estimated to experience at least one
for the 2002 simulation, the estimated Risk estimates for each urban area FEV1 decrement ≥15 percent due to 8-
number of occurrences per responding included in the assessment, for each of hour O3 exposures across the 12 urban
44 Due to time constraints, lung function risk developed for only 5 of the 12 urban areas, and the geographic regions. The 5 areas were: Atlanta,
estimates for asthmatic school age children were areas were selected to represent different Chicago, Houston, Los Angeles, and New York City.
areas analyzed, and similarly across the percent (2002 simulation) and 5.5 > age 64 in Cleveland and Detroit, vs. all
5 urban areas analyzed for asthmatic percent (2004 simulation) of total ages in New York City), making
school age children (ages 5–18) incidence of chest tightness upon comparison of the risk estimates across
estimated to experience at least one meeting a 0.064 ppm, 4th-highest daily the areas very difficult.
FEV1 decrement ≥10 percent, when the maximum 8-hour average standard. (3) Based on the median estimates for
current and alternative 8-hour standards Similar patterns of effects and incidence for nonaccidental mortality
are just met. reductions in effects are observed for (based on the Bell et al. (2004) 95 cities
(2) For asthmatic school age children, each of the respiratory symptoms concentration-response function),
the median estimates of occurrences of examined. meeting the most stringent standard
FEV1 decrements ≥10% range from (2) The Staff Paper and Risk (0.064 ppm) is estimated to reduce
52,000 to nearly 510,000 responses Assessment TSD present unscheduled mortality by 40 percent of what it would
associated with just meeting the current hospital admission risk estimates for be associated with just meeting the
standard (based on the 2002 simulation) respiratory illness and asthma in New current standard (based on the 2002
and range from 61,000 to about 240,000 York City associated with short-term simulation). The patterns for
occurrences (based on the 2004 exposures to O3 concentrations in cardiorespiratory mortality are similar.
simulation). These risk estimates would excess of background levels from April The aggregate O3-related
be reduced to a range of 14,000 to about through September for several recent cardiorespiratory mortality upon just
275,000 occurrences (2002 simulation) years (2002, 2003, and 2004) and upon meeting the most stringent standard
and to about 18,000 to nearly 125,000 just meeting the current and alternative shown is estimated to be about 42
occurrences (2004 simulation) upon just 8-hour standards based on simulating percent of what it would be upon just
meeting the most stringent alternative 8- O3 levels using 2002–2004 O3 air quality meeting the current standard, using
hour standard (0.064 ppm, 4th highest). data. For total respiratory illness, EPA simulated O3 concentrations that just
The average number of occurrences per estimates about 6.4 cases per 100,000 meet the current and alternative 8-hour
asthmatic child in an O3 season ranged relevant population (2002 simulation) standards based on the 2002 simulation.
from about 6 to 11 associated with just and about 4.6 cases per 100,000 relevant Using the 2004 simulation, the
meeting the current standard (2002 population (2004 simulation), which corresponding reductions show a
simulation). The average number of represents 1.5 percent (2002 simulation) similar pattern but are somewhat
occurrences per asthmatic child ranged and 1.0 percent (2004 simulation) of greater.
from 4 to 12 upon meeting the most total incidence or about 510 cases (2002 (4) Much of the contribution to the
stringent alternative examined (0.064 simulation) and about 370 cases (2004 risk estimates for non-accidental and
ppm, 4th-highest) based on the 2002 simulation) upon just meeting the cardiorespiratory mortality upon just
simulation. The number of occurrences current 8-hour standard. For asthma- meeting the current 8-hour standard is
per asthmatic child is similar for the related hospital admissions, which are a associated with 24-hour O3
scenarios based on the 2004 simulation. subset of total respiratory illness concentrations between background and
As discussed above, several admissions, the estimates are about 5.5 0.040 ppm. Based on examining
epidemiological studies have reported cases per 100,000 relevant population relationships between 24-hour
increased respiratory morbidity (2002 simulation) and about 3.9 cases concentrations averaged across the
outcomes (e.g., respiratory symptoms in per 100,000 relevant population (2004 monitors within an urban area and 8-
moderate to severe asthmatic children, simulation), which represents about 3.3 hour daily maximum concentrations, 8-
respiratory-related hospital admissions) percent (2002 simulation) and 2.4 hour daily maximum levels at the
and increased nonaccidental and percent (2004 simulation) of total highest monitor in an urban area
cardiorespiratory mortality associated incidence or about 440 cases (2002) and associated with these averaged 24-hour
with exposure to ambient O3 about 310 cases (2004) for this same air levels are generally about twice as high
concentrations. The results and key quality scenario. as the 24-hour levels. Thus, most O3-
observations from this portion of the For increasingly more stringent related nonaccidental mortality is
risk assessment are presented below: alternative 8-hour standards, there is a estimated to occur when O3
(1) Estimates for increased respiratory gradual reduction in respiratory illness concentrations are between background
symptoms (i.e., chest tightness, cases per 100,000 relevant population and when the highest monitor in the
shortness of breath, and wheeze) in from 6.4 cases per 100,000 upon just urban area is at or below 0.080 ppm, 8-
moderate/severe asthmatic children meeting the current 8-hour standard to hour average concentration.
(ages 0–12) were developed for the 4.6 cases per 100,000 under the most The discussion below highlights
Boston urban area only. The median stringent 8-hour standard (i.e., 0.064 additional observations and insights
estimated number of days involving ppm, average 4th-highest daily from the O3 risk assessment, together
chest tightness (using the concentration- maximum) analyzed based on the 2002 with important uncertainties and
response relationship with only O3 in simulation. Similarly, based on the 2004 limitations.
the model) is about 6,100 (based on the simulation there is a gradual reduction (1) As discussed in the Staff Paper
2002 simulation) and about 4,500 (based from 4.6 cases per 100,000 relevant (section 5.4.5) EPA has greater
on the 2004 simulation) upon meeting population upon just meeting the confidence in relative comparisons in
the current 8-hour standard and this is current 8-hour standard to 3.0 cases per risk estimates between alternative
reduced to about 4,600 days (2002 100,000 under the 0.064 ppm, average standards than in the absolute
simulation) and 3,100 days (2004 4th-highest daily maximum standard. magnitude of risk estimates associated
simulation) upon meeting the most Additional respiratory-related with any particular standard.
stringent alternative examined (0.064 hospital admission estimates for three (2) Significant year-to-year variability
ppm, 4th-highest daily maximum 8- other locations are provided in the Risk in O3 concentrations combined with the
hour average). This corresponds to 11 Assessment TSD. EPA notes that the use of a 3-year design value to
percent (2002 simulation) and 8 percent concentration-response functions for determine the amount of air quality
(2004 simulation) of total incidence of each of these locations examined adjustment to be applied to each year
chest tightness upon meeting the different outcomes in different age analyzed, results in significant year-to-
current 8-hour standard and to about 8 groups (e.g., > age 30 in Los Angeles, year variability in the annual health risk
estimates upon just meeting the current available. The Administrator has taken important uncertainties associated with
and potential alternative 8-hour into account both evidence-based and the estimated exposures and risks; and
standards. quantitative exposure- and risk-based (3) the extent to which the O3-related
(3) There is noticeable city-to-city considerations in developing health effects indicated by the evidence
variability in estimated O3-related conclusions on the adequacy of the and the exposure and risk assessments
incidence of morbidity and mortality current primary O3 standard. Evidence- are considered important from a public
across the 12 urban areas analyzed for based considerations include the health perspective, taking into account
both recent years of air quality and for assessment of evidence from controlled the nature and severity of the health
air quality adjusted to simulate just human exposure, animal toxicological, effects, the size of the at-risk
meeting the current and selected field, and epidemiological studies for a populations, and the kind and degree of
potential alternative standards. This variety of health endpoints. For those the uncertainties associated with these
variability is likely due to differences in endpoints based on epidemiological considerations.
air quality distributions, differences in studies, greater weight has been placed The current primary O3 standard is an
exposure related to many factors on associations with health endpoints 8-hour standard, which was set at a
including varying activity patterns and that are causal or likely causal based on level of 0.08 ppm,46 with a form of the
air exchange rates, differences in an integrative synthesis of the entire annual fourth-highest daily maximum 8-
baseline incidence rates, and differences body of evidence, including not only all hour average concentration, averaged
in susceptible populations and age available epidemiological evidence but over three years. This standard was
distributions across the 12 urban areas. also evidence from animal toxicological chosen to provide protection to the
(4) With respect to the uncertainties and controlled human exposure studies. public, especially children and other at-
about estimated policy-relevant Less weight has been placed on risk populations, against a wide range of
background concentrations, as evidence of associations that were O3-induced health effects. As an
discussed in the Staff Paper (section judged to be only suggestive of possible introduction to this discussion of the
5.4.3), alternative assumptions about causal relationships. Consideration of adequacy of the current O3 standard, it
background levels had a variable impact quantitative exposure- and risk-based is useful to summarize the key factors
depending on the health effect information draws from the results of that formed the basis of the decision in
considered and the location and the exposure and risk assessments the last review to revise the averaging
standard analyzed in terms of the described above. More specifically, time, level, and form of the then current
absolute magnitude and relative changes estimates of the magnitude of O3-related 1-hour standard.
in the risk estimates. There was exposures and risks associated with In the last review, the key factor in
relatively little impact on either recent air quality levels, as well as the deciding to revise the averaging time of
absolute magnitude or relative changes exposure and risk reductions likely to the primary standard was evidence from
in lung function risk estimates due to be associated with just meeting the controlled human exposure studies of
alternative assumptions about current 8-hour primary O3 NAAQS, healthy young adult subjects exposed
background levels. With respect to O3- have been considered. for 1 to 8 hours to O3. The best
related non-accidental mortality, while In this review, a series of general documented health endpoints in these
notable differences (i.e., greater than 50 questions frames the approach to studies were decrements in indices of
percent)45 were observed for reaching a decision on the adequacy of lung function, such as forced expiratory
nonaccidental mortality in some areas, the current standard, such as the volume in 1 second (FEV1), and
particularly for more stringent following: (1) To what extent does respiratory symptoms, such as cough
standards, the overall pattern of newly available information reinforce or and chest pain on deep inspiration. For
estimated reductions, expressed in call into question evidence of short-term exposures of 1 to 3 hours,
terms of percentage reduction relative to associations of O3 exposures with effects group mean FEV1 decrements were
the current standard, was significantly identified in the last review?; (2) to what statistically significant for O3
less impacted. extent has evidence of new effects and/ concentrations only at and above 0.12
or at-risk populations become available ppm, and only when subjects engaged
C. Conclusions on the Adequacy of the since the last review?; (3) to what extent in very heavy exertion. By contrast,
Current Primary Standard have important uncertainties identified evidence available in the prior review
1. Background in the last review been reduced and showed that prolonged exposures of 6 to
have new uncertainties emerged?; (4) to 8 hours produced statistically
The initial issue to be addressed in
what extent does newly available significant group mean FEV1
the current review of the primary O3
information reinforce or call into decrements at the lowest O3
standard is whether, in view of the
question any of the basic elements of the concentrations evaluated in those
advances in scientific knowledge and
current standards? studies, 0.080 ppm, even when
additional information, the existing
The question of whether the available experimental subjects were engaged in
standard should be revised. In
evidence supports consideration of a more realistic intermittent moderate
evaluating whether it is appropriate to
standard that is more protective than the exertion levels. The health significance
retain or revise the current standard, the current standard includes consideration of this newer evidence led to the
Administrator builds upon the last of: (1) Whether there is evidence that conclusion in the 1997 final decision
review and reflects the broader body of associations, especially likely causal that the 8-hour averaging time is more
evidence and information now associations, extend to ambient O3 directly associated with health effects of
45 For example, assuming lower background
concentration levels that are as low as concern at lower O3 concentrations than
or lower than had previously been is the 1-hour averaging time.
levels resulted in increased estimates of non-

accidental mortality incidence per 100,000 that observed, and the important
were often 50 to 100 percent greater than the base uncertainties associated with that 46 If the standard were to be specified to the
case estimates; assuming higher background levels evidence; (2) the extent to which nearest thousandth ppm, the current 0.08 ppm 8-
resulted in decreased estimates of non-accidental hour standard would be equivalent to a standard set
mortality incidence per 100,000 that were less than
exposures of concern and health risks at 0.084 ppm, reflecting the data rounding
the base case estimates by 50 percent or more in are estimated to occur in areas upon conventions that are part of the definition of the
many of the areas. meeting the current standard and the current 8-hour standard.
Based on the available evidence of O3- to estimated ‘‘background’’ levels epidemiological studies to inform
related health effects, the following associated with nonanthropogenic judgments about a NAAQS for an
factors were of particular importance in sources of O3; and (9) CASAC’s advice individual pollutant, such as O3, within
the last review in informing the and recommendations. Additional a mix of highly correlated pollutants,
selection of the level and form of a new factors considered in selecting the form such as the mix of oxidants produced in
8-hour standard: (1) Quantitative of the standard included balancing the photochemical reactions in the
estimates of O3-related risks to active public health implications of the atmosphere, the Staff Paper notes that
children, who were judged to be an at- estimated number of times in an O3 there are limitations especially at
risk subgroup of concern, in terms of season that the standard level might be ambient O3 concentrations below levels
transient and reversible respiratory exceeded in an area that is in attainment at which O3-related effects have been
effects judged to be adverse, including with the standard with the year-to-year observed in controlled human exposure
moderate to large decreases in lung stability of the air quality statistic, studies. The Staff Paper (section 3.4.5)
function and moderate to severe pain on which can be particularly affected by also recognizes that the available
deep inspiration, and the uncertainty years with unusual meteorology. A more epidemiological evidence neither
and variability in such estimates; (2) stable air quality statistic serves to avoid supports nor refutes the existence of
consideration of both the estimated disruptions to ongoing control programs thresholds at the population level for
percentages, total numbers of children, that could result from moving into and effects such as increased hospital
and number of times they were likely to out of attainment, thereby interrupting admissions and premature mortality.
experience such effects; (3) the public health protection afforded by There are limitations in epidemiological
epidemiological evidence of such control programs. studies that make discerning thresholds
associations between ambient O3 and In reaching a final decision in the last in populations difficult, including low
increased respiratory hospital review, the Administrator was mindful data density in the lower concentration
admissions, and quantitative estimates that O3 exhibits a continuum of effects, ranges, the possible influence of
of percentages and total numbers of such that there is no discernible exposure measurement error, and
asthma-related admissions in one threshold above which public health variability in susceptibility to O3-related
example urban area that were judged to protection requires that no exposures be effects in populations.
be indicative of a pyramid of much allowed or below which all risks to
While noting these limitations in the
larger effects, including respiratory- public health can be avoided. The final
interpretation of the findings from the
related hospital admissions, emergency decision reflected a recognition that
important uncertainties remained, for epidemiological studies, the Staff Paper
department visits, doctor visits, and
example with regard to interpreting the (section 3.4.5) concludes that if a
asthma attacks and related increased
role of other pollutants co-occurring population threshold level does exist, it
medication use; (4) quantitative
with O3 in observed associations, would likely be well below the level of
estimates of the number of ‘‘exposures
the current O3 standard and possibly
of concern47’’ (defined as exposures ≥ understanding biological mechanisms of
O3-related health effects, and estimating within the range of background levels.
0.080 ppm for 6 to 8 hour) that active
human exposures and quantitative risks As discussed above in section II.A.3.a,
children are likely to experience, and
the uncertainty and variability in such to at-risk populations for these health this conclusion is supported by several
estimates; (5) the judgment that such effects. epidemiological studies that have
exposures are an important indicator of explored the question of potential
2. Evidence- and Exposure/Risk-Based thresholds directly, either using a
public health impacts of O3-related Considerations in the Staff Paper
effects for which information is too statistical curve-fitting approach to
limited to develop quantitative risk The Staff Paper (section 6.3.1) evaluate whether linear or non-linear
estimates, including increased considers the evidence presented in the models fit the data better using sub-sets
nonspecific bronchial responsiveness Criteria Document as discussed above in of the data, where days over or under a
(e.g., related to aggravation of asthma), section II.A as a basis for evaluating the specific cutpoint (e.g., 0.080 ppm or
decreased pulmonary defense adequacy of the current O3 standard, even lower O3 levels) were excluded
mechanisms (suggestive of increased recognizing that important uncertainties and then evaluating the association for
susceptibility to respiratory infection), remain. The extensive body of human statistical significance. In addition to
and indicators of pulmonary clinical, toxicological, and direct consideration of the
inflammation (related to potential epidemiological evidence serves as the epidemiological studies, findings from
aggravation of chronic bronchitis or basis for the judgments about O3-related controlled human exposure studies
long-term damage to the lungs); (6) the health effects discussed above, discussed above in section II.A.2.a.i(a)(i)
broader public health perspective of the including judgments about causal indicate that prolonged exposures
number of people living in areas that relationships with a range of respiratory produced statistically significant group
would breathe cleaner air as a result of morbidity effects, including lung mean FEV1 decrements and symptoms
the revised standard; (7) consideration function decrements, increased in healthy adult subjects at levels down
of the relative seriousness of various respiratory symptoms, airway to at least 0.060 ppm, with a small
health effects and the relative degree of inflammation, increased airway percentage of subjects experiencing
certainty in both the likelihood that responsiveness, and respiratory-related notable effects (e.g., >10 percent FEV1
people will experience various health hospitalizations and emergency decrement, pain on deep inspiration).
effects and their medical significance; department visits in the warm season, Controlled human exposure studies
(8) the relationship of a standard level and about the evidence being highly evaluated in the last review also found
suggestive that O3 directly or indirectly significant responses in indicators of
47 In the last review, ‘‘exposures of concern’’ contributes to non-accidental and lung inflammation and cell injury at
referred to exposures at and above 0.08 ppm, 8-hour cardiopulmonary-related mortality. 0.080 ppm in healthy adult subjects.
average, at which a range of health effects have been These judgments take into account The effects in these controlled human
observed in controlled human studies, but for
which data were too limited to allow for
important uncertainties that remain in exposure studies were observed in
quantitative risk assessment. (62 FR 38860, July 18, interpreting this evidence. For example, healthy young adult subjects, and it is
1997). with regard to the utility of time-series likely that more serious responses, and
responses at lower levels, would occur standard that would be less protective significant associations. The Staff Paper
in people with asthma and other than the current standard. (section 6.3.1.1) judges that such studies
respiratory diseases. These are directly relevant to considering the
a. Evidence-Based Considerations
physiological effects have been linked to adequacy of the current standard,
aggravation of asthma and increased In looking more specifically at the particularly in light of reported
susceptibility to respiratory infection, controlled human exposure and responses to O3 at levels below the
potentially leading to increased epidemiological evidence (which is current standard found in controlled
medication use, increased school and summarized in chapter 3 and Appendix human exposure studies.
work absences, increased visits to 3B of the Staff Paper), the Staff Paper
first notes that controlled human i. Lung Function, Respiratory
doctors’ offices and emergency Symptoms, and Other Respiratory
exposure studies provide the clearest
departments, and increased hospital Effects
and most compelling evidence for an
admissions. The observations provide
array of human health effects that are Health effects for which the Criteria
additional support for the conclusion in
directly attributable to acute exposures Document continues to find clear
the Staff Paper that the associations to O3 per se. Evidence from such human evidence of causal associations with
observed in the epidemiological studies, studies, together with animal short-term O3 exposures include lung
particularly for respiratory-related toxicological studies, help to provide function decrements, respiratory
effects and potentially for biological plausibility for health effects symptoms, pulmonary inflammation,
cardiovascular effects, extend down to observed in epidemiological studies. In and increased airway responsiveness. In
O3 levels well below the current considering the available evidence, the the last review, these O3-induced effects
standard (i.e., 0.084 ppm) (EPA, 2007, p. Staff Paper focuses on studies that were demonstrated with statistical
6–7). examined health effects that have been significance down to the lowest level
As discussed above in section II.A demonstrated to be caused by exposure tested in controlled human exposure
and in the Staff Paper (section 3.7), the to O3, or for which the Criteria studies at that time (i.e., 0.080 ppm). As
newly available information reinforces Document judges associations with O3 discussed in chapter 3 of the Staff
the judgments about the likelihood of to be causal or likely causal, or for Paper, and in section II.A.2.a.i.(a)(i)
causal relationships between O3 which the evidence is highly suggestive above, two new studies are notable in
exposure and respiratory effects that O3 contributes to the reported that they are the only controlled human
observed in the last review and effects. In considering the exposure studies that examined
broadens the evidence of O3-related epidemiological evidence as a basis for respiratory effects, including lung
associations to include additional reaching conclusions about the function decrements and respiratory
respiratory-related endpoints, newly adequacy of the current standard, the symptoms, in healthy adults at lower
identified cardiovascular-related health Staff Paper focuses on studies reporting exposure levels than had previously
endpoints, and mortality. Newly effects in the warm season, for which been examined. EPA’s reanalysis of the
available evidence also has shown that the effect estimates are more data from the most recent study shows
people with asthma are likely to consistently positive and statistically small group mean decrements in lung
experience more serious effects than significant than those from all-year function responses to be statistically
people who do not have asthma (section studies. The Staff Paper (section 6.3.1.1) significant at the 0.060 ppm exposure
considers the extent to which such level, while the author’s analysis did
II.A.4.b.ii above). The Staff Paper also
studies provide evidence of associations not yield statistically significant lung
concludes that substantial progress has
that extend down to ambient O3 function responses but did yield some
been made since the last review in
concentrations below the level of the statistically significant respiratory
advancing the understanding of
current standard, which would thereby symptom responses toward the end of
potential mechanisms by which ambient
call into question the adequacy of the the exposure period. Notably, these
O3, alone and in combination with other current standard. In so doing, the Staff studies report a small percentage of
pollutants, is causally linked to a range Paper notes, as discussed above, that if subjects experiencing lung function
of respiratory-related health endpoints, a population threshold level does exist decrements (≥ 10 percent) at the 0.060
and may be causally linked to a range for an effect observed in such studies, it ppm exposure level. These studies
of cardiovascular-related health would likely be at a level well below the provide very limited evidence of O3-
endpoints. Thus, the Staff Paper (section level of the current standard. The Staff related lung function decrements and
6.3.6) finds strong support in the Paper (section 6.3.1.1) also attempts to respiratory symptoms at this lower
evidence developed since the last characterize whether the area in which exposure level.
review, for consideration of an O3 a study was conducted likely would or The Staff Paper (section 3.3.1.1.1)
standard that is at least as protective as would not have met the current notes that evidence from controlled
the current standard and finds no standard during the time of the study, human exposures studies indicates that
support for consideration of an O3 although it recognizes that the people with moderate-to-severe asthma
standard that is less protective than the confidence that would appropriately be have somewhat larger decreases in lung
current standard. This conclusion is placed on the associations observed in function in response to O3 relative to
consistent with the advice and any given study, or on the extent to healthy individuals and that lung
recommendations of CASAC and with which the association would likely function responses in people with
the views expressed by all interested extend down to relatively low O3 asthma appear to be affected by baseline
parties who provided comments on concentrations, is not dependent on this lung function (i.e., magnitude of
drafts of the Staff Paper. While CASAC distinction. Further, the Staff Paper responses increases with increasing
and some commenters supported considered studies that examined disease severity). As discussed in the
revising the current standard to provide subsets of data that include only days Criteria Document (p.8–80), this newer
increased public health protection and with ambient O3 concentrations below information expands our understanding
other commenters supported retaining the level of the current O3 standard, or of the physiological basis for increased
the current standard, no one who below even lower O3 concentrations, sensitivity in people with asthma and
provided comments supported a and continue to report statistically other airway diseases, recognizing that
people with asthma present a different and international studies, have reported Since the last review, new
response profile for cellular, molecular, robust associations between ambient O3 epidemiological studies have evaluated
and biochemical responses than people concentrations and measures of lung the association between short-term
who do not have asthma. New evidence function and daily symptoms (e.g., chest exposures to O3 and unscheduled
indicates that some people with asthma tightness, wheeze, shortness of breath) hospital admissions for respiratory
have increased occurrence and duration in children with moderate to severe causes. Large multi-city studies, as well
of nonspecific airway responsiveness, asthma and between O3 and increased as many studies from individual cities,
which is an increased asthma medication use. Overall, the have reported positive and often
bronchoconstrictive response to airway multi-city NCICAS (2002), Gent et al. statistically significant O3 associations
irritants. Controlled human exposure (2003), and several other single-city with total respiratory hospitalizations as
studies also indicate that some people studies indicate a robust positive well as asthma- and COPD-related
with allergic asthma and rhinitis have association between ambient O3 hospitalizations, especially in studies
increased airway responsiveness to concentrations and increased analyzing the O3 effect during the
allergens following O3 exposure. respiratory symptoms and increased summer or warm season. Analyses using
Exposures to O3 exacerbated lung medication use in asthmatics. multipollutant regression models
function decrements in people with pre- In considering the large number of generally indicate that copollutants do
existing allergic airway disease, with single-city epidemiological studies not confound the association between
and without asthma. Ozone-induced reporting lung function or respiratory O3 and respiratory hospitalizations and
exacerbation of airway responsiveness symptoms in healthy or asthmatic that the O3 effect estimates were robust
persists longer and attenuates more populations (Staff Paper, Appendix 3B), to PM adjustment in all-year and warm-
slowly than O3-induced lung function the Staff Paper (p.6–11) notes that most season only data. The Criteria Document
decrements and respiratory symptom such studies that reported positive and (p.8–77) concludes that the evidence
responses and can have important often statistically significant supports a causal relationship between
clinical implications for asthmatics. associations in the warm season were acute O3 exposures and increased
The Staff Paper (p.6–10) also conducted in areas that likely would not respiratory-related hospitalizations
concludes that newly available human have met the current standard. In during the warm season.
exposure studies suggest that some considering the large multi-city NCICAS In looking specifically at U.S. and
people with asthma also have increased (Mortimer et al., 2002), the Staff Paper Canadian respiratory hospitalization
inflammatory responses, relative to non- notes that the 98th percentile 8-hour studies that reported positive and often
asthmatic subjects, and that this daily maximum O3 concentrations at the statistically significant associations (and
inflammation may take longer to monitor reporting the highest O3 that either did not use GAM or were
resolve. The new data on airway concentrations in each of the study reanalyzed to address GAM-related
responsiveness, inflammation, and areas ranged from 0.084 ppm to >0.10 problems), the Staff Paper (p.6–12) notes
various molecular markers of ppm. However, the authors indicate that that many such studies were conducted
inflammation and bronchoconstriction less than 5 percent of the days in the in areas that likely would not have met
indicate that people with asthma and eight urban areas had 8-hour daily O3 the current O3 standard, with many
allergic rhinitis (with or without concentrations exceeding 0.080 ppm. providing only all-year effect estimates,
asthma) comprise susceptible groups for Moreover, the authors observed that and with some reporting a statistically
O3-induced adverse effects. This body of when days with 8-hour average O3 significant association in the warm
evidence qualitatively informs the Staff levels greater than 0.080 ppm were season. Of the studies that provide some
Paper’s (pp.6–10 to 6–11) evaluation of excluded, similar effect estimates were indication that O3-related respiratory
the adequacy of the current O3 standard seen compared to estimates which hospitalizations may be occurring in
in that it indicates that human clinical included all of the days. There are also areas that likely would have met the
and epidemiological panel studies of a few other studies in which the current standard, the Staff Paper notes
lung function decrements and relevant air quality statistics provide that some are all-year studies, whereas
respiratory symptoms that evaluate only some indication that lung function and others reported statistically significant
healthy, non-asthmatic subjects likely respiratory symptom effects may be warm-season associations.
underestimate the effects of O3 exposure occurring in areas that likely would Emergency department visits for
on asthmatics and other susceptible have met the current standard (EPA, respiratory causes have been the focus
populations. 2007, p.6–12). of a number of new studies that have
The Staff Paper (p.6–11) notes that in examined visits related to asthma,
addition to the experimental evidence of ii. Respiratory Hospital Admissions and COPD, bronchitis, pneumonia, and
lung function decrements, respiratory Emergency Department Visits other upper and lower respiratory
symptoms, and other respiratory effects At the time of the last review, many infections, such as influenza, with
in healthy and asthmatic populations time-series studies indicated positive asthma visits typically dominating the
discussed above, epidemiological associations between ambient O3 and daily incidence counts. Among studies
studies have reported associations of increased respiratory hospital with adequate controls for seasonal
lung function decrements and admissions and emergency room visits, patterns, many reported at least one
respiratory symptoms in several providing strong evidence for a significant positive association
locations (Appendix 3B; also Figure 3– relationship between O3 exposure and involving O3. However, inconsistencies
4 for respiratory symptoms). As increased exacerbations of preexisting were observed which were at least
discussed in the Staff Paper (section lung disease at O3 levels below the level partially attributable to differences in
3.3.1.1.1) and above, two large U.S. of the then current 1-hour standard model specifications and analysis
panel studies which together followed (EPA 2007, section 3.3.1.1.6). Analyses approach among various studies. In
over 1000 asthmatic children on a daily of data from studies conducted in the general, O3 effect estimates from
basis (Mortimer et al., 2002, the northeastern U.S. indicated that O3 air summer-only analyses tended to be
National Cooperative Inner-City Asthma pollution was consistently and strongly positive and larger compared to results
Study, or NCICAS; and Gent et al., associated with summertime respiratory from cool season or all-year analyses.
2003), as well as several smaller U.S. hospital admissions. Almost all of the studies that reported
statistically significant effect estimates indicated that any threshold, if it exists, establish underlying mechanisms by
were conducted in areas that likely would likely occur at very low which such effects occur.
would not have met the current concentrations, far below the level of
b. Exposure- and Risk-Based
standard. The Criteria Document the current O3 NAAQS and nearing
Considerations
(section 7.3.2) concluded that analyses background levels.
stratified by season generally supported New data are also available from As discussed above in section II.B, the
a positive association between O3 several single-city studies conducted Staff Paper also estimated quantitative
concentrations and emergency world-wide, as well as from several exposures and health risks associated
department visits for asthma in the meta-analyses that have combined with recent air quality levels and with
warm season. These studies provide information from multiple studies. air quality that meets the current
evidence of effects in areas that likely Three recent meta-analyses evaluated standard to help inform judgments
would not have met the current potential sources of heterogeneity in O3- about whether or not the current
standard and evidence of associations mortality associations. All three standard provides adequate protection
that likely extend down to relatively analyses reported common findings, of public health. In so doing, it
low ambient O3 concentrations. including effect estimates that were presented the important uncertainties
statistically significant and larger in and limitations associated with the
iii. Mortality warm season analyses. Reanalysis of exposure and risk assessments
The 1996 Criteria Document results using default GAM criteria did (discussed above in section II.B and
concluded that an association between not change the effect estimates, and more fully in chapters 4 and 5 of the
daily mortality and O3 concentrations there was no strong evidence of Staff Paper).
for areas with high O3 levels (e.g., Los confounding by PM. The Criteria The Staff Paper (and the CASAC) also
Angeles) was suggested. However, due Document (p.7–175) finds that the recognized that the exposure and risk
to a very limited number of studies majority of these studies suggest that analyses could not provide a full picture
available at that time, there was there is an elevated risk of total of the O3 exposures and O3-related
insufficient evidence to conclude that nonaccidental mortality associated with health risks posed nationally. The Staff
the observed association was likely acute exposure to O3, especially in the Paper did not have sufficient
causal, and thus the possibility that O3 summer or warm season when O3 levels information to evaluate all relevant at-
exposure may be associated with are typically high, with somewhat larger risk groups (e.g., outdoor workers) or all
mortality was not relied upon in the effect estimate sizes for associations O3-related health outcomes (e.g.,
1997 decision on the O3 primary with cardiovascular mortality. increased medication use, school
standard. Overall, the Criteria Document (p.8– absences, and emergency department
Since the last review, as described 78) finds that the results from U.S. visits that are part of the broader
above, the body of evidence with regard multi-city time-series studies, along pyramid of effects discussed above in
to O3-related health effects has been with the meta-analyses, provide section II.A.4.d), and the scope of the
expanded by animal, human clinical, relatively strong evidence for Staff Paper analyses was generally
and epidemiological studies and now associations between short-term O3 limited to estimating exposures and
includes biologically plausible exposure and all-cause mortality even risks in 12 urban areas across the U.S.,
mechanisms by which O3 may affect the after adjustment for the influence of and to only five or just one area for
cardiovascular system. In addition, season and PM. The results of these some health effects included in the risk
there is stronger information linking O3 analyses indicate that copollutants assessment. Thus, national-scale public
to serious morbidity outcomes, such as generally do not appear to substantially health impacts of ambient O3 exposures
hospitalization, that are associated with confound the association between O3 are clearly much larger than the
increased mortality. Thus, there is now and mortality. In addition, several quantitative estimates of O3-related
a coherent body of evidence that single-city studies observed positive incidences of adverse health effects and
describes a range of health outcomes associations of ambient O3 the numbers of children likely to
from lung function decrements to concentrations with total nonaccidental experience exposures of concern
hospitalization and premature mortality. and cardiopulmonary mortality. associated with recent air quality or air
Newly available large multi-city Finally, from those studies that quality that just meets the current or
studies (Bell et al., 2004; Huang et included assessment of associations alternative standards. On the other
al.,2005; and Schwartz 2005) designed with specific causes of death, it appears hand, inter-individual variability in
specifically to examine the effect of O3 that effect estimates for associations responsiveness means that only a subset
and other pollutants on mortality have with cardiovascular mortality are larger of individuals in each group estimated
provided much more robust and than those for total mortality; effect to experience exposures exceeding a
credible information. Together these estimates for respiratory mortality are given benchmark exposure of concern
studies have reported significant less consistent in size, possibly due to level would actually be expected to
associations between O3 and mortality reduced statistical power in this experience such adverse health effects.
that were robust to adjustment for PM subcategory of mortality. For As described above in section II.B, the
and different adjustment methods for cardiovascular mortality, the Criteria Staff Paper estimated exposures and
temperature and suggest that the effect Document (p.7–106) suggests that effect risks for the three most recent years
of O3 on mortality is immediate but also estimates are consistently positive and (2002–2004) for which data were
persists for several days. One recent more likely to be larger and statistically available at the time of the analyses.
multi-city study (Bell et al., 2006) significant in warm season analyses. Within this 3-year period, 2002 was a
examined the shape of the The Criteria Document (p.8–78) year with relatively higher O3 levels in
concentration-response function for the concludes that these findings are highly most, but not all, areas and simulation
O3-mortality relationship in 98 U.S. suggestive that short-term O3 exposure of just meeting the current standard
urban communities for the period 1987 directly or indirectly contributes to based on 2002 air quality data provides
to 2000 specifically to evaluate whether nonaccidental and cardiopulmonary- a generally more upper-end estimate of
a ‘‘safe’’ threshold level exists. Results related mortality, but additional exposures and risks, while 2004 was a
from various analytic methods all research is needed to more fully year with relatively lower O3 levels in
most, but not all, areas and simulation observed, ranging to over an order of exposures of concern at or above the
of just meeting the current standard magnitude at the current standard level, 0.060 ppm benchmark level using the
using 2004 air quality data provides a in estimates of the number of children 2002 simulation. The exposure
generally more lower-end estimate of and, as shown in Table 6–1a and b of estimates for this benchmark level range
exposures and risks. the Staff Paper, the number of up to nearly 70 percent of all or
occurrences of exposures of concern at asthmatic school age children in the
i. Exposure Assessment Results
both of these benchmark levels. The single city with the least degree of
As discussed above in section II.B.1, Staff Paper states that it is appropriate protection associated with just meeting
the Staff Paper estimates personal to consider not just the average the current standard using the 2002
exposures to ambient O3 levels at and estimates across all years, but also to simulation. The Staff Paper indicates an
above specific benchmark levels to consider public health impacts in year aggregate estimate of about 10 percent of
provide some perspective on the public with relatively higher O3 levels. The asthmatic or all school age children
health impacts of health effects that Staff Paper also notes that there is would experience exposures at or above
cannot currently be evaluated in substantial city-to-city variability in the 0.06 ppm benchmark level
quantitative risk assessments but that these estimates, and notes that it is associated with just meeting the current
may occur at current air quality levels, appropriate to consider not just the standard using the 2004 simulation.
and the extent to which such impacts aggregate estimates across all cities, but
might be reduced by meeting the current ii. Risk Assessment Results
also to consider the public health
and alternative standards. As described impacts in cities that receive relatively As described in more detail in section
in greater detail in section II.B.1.c less protection upon meeting the current II.B.2 above and in chapters 5 and 6 of
above, the Staff Paper refers to standard. the Staff Paper, risk estimates have been
exposures at and above these As discussed in the Staff Paper (EPA, developed for several important health
benchmark levels as ‘‘exposures of 2007b, see section 6.3.1.2), about 50 endpoints, including: (1) Lung function
concern.’’ The Staff Paper notes that percent of asthmatic or all school age decrements (i.e., ≥15 percent and ≥20
exposures of concern, and the health children, representing nearly 1.3 million percent reductions in FEV1) in all
outcomes they represent, likely occur asthmatic children and about 8.5 school age children for 12 urban areas;
across a range of O3 exposure levels, million school age children in the 12 (2) lung function decrements (i.e., ≥10
such that there is no one exposure level urban areas examined, are estimated to percent and ≥20 percent reductions in
that addresses all relevant public health experience exposures of concern at or FEV1) in asthmatic school age children
concerns. Therefore, with the above the 0.070 ppm benchmark level for 5 urban areas (a subset of the 12
concurrence of the CASAC, the Staff (i.e., these individuals are estimated to urban areas); (3) respiratory symptoms
Paper estimated exposures of concern experience 8-hour O3 exposures at or (i.e., chest tightness, shortness of breath,
not only at 0.080 ppm O3, a level at above 0.070 ppm while engaged in wheeze) in moderate to severe asthmatic
which there are demonstrated effects, moderate or greater exertion 1 or more children for the Boston area; (4)
but also at 0.070 and 0.060 ppm O3. The times during the O3 season) associated respiratory-related hospital admissions
Staff Paper recognized that there will be with 2002 O3 air quality levels. In for 3 urban areas; and (5) nonaccidental
varying degrees of concern about contrast, about 17 percent of asthmatic and cardiorespiratory mortality for 12
exposures at each of these levels, based and all school age children are urban areas for three recent years (2002
in part on the population subgroups estimated to experience exposures of to 2004) and for just meeting the current
experiencing them. Given that there is concern at or above the 0.070 ppm standard using a 2002 simulation and a
clear evidence of inflammation, benchmark level associated with 2004 2004 simulation.
increased airway responsiveness, and O3 air quality levels. Just meeting the With regard to estimates of moderate
changes in host defenses in healthy current standard results in an aggregate lung function decrements, as shown in
people exposed to 0.080 ppm O3 and estimate of about 20 percent of Tables 6–2 of the Staff Paper, meeting
reason to infer that such effects will asthmatic or 18 percent or all school age the current standard substantially
continue at lower exposure levels, but children likely to experience exposures reduces the estimated number of school
with increasing uncertainty about the of concern at or above the 0.070 ppm age children experiencing one or more
extent to which such effects occur at benchmark level using the 2002 occurrences of FEV1 decrements ≥15
lower O3 concentrations, the Staff Paper, simulation. The exposure estimates for percent for the 12 urban areas, going
and the discussion below, focuses on this benchmark level range up to about from about 1.3 million children (7
exposures of concern at or above 40 percent of asthmatic or all school age percent of children) under 2002 air
benchmark levels of 0.070 and 0.060 children in the single city with the least quality to about 610,000 (3 percent of
ppm O3 for purposes of evaluating the degree of protection from this standard. children) based on the 2002 simulation,
adequacy of the current standard. Just meeting the current standard based and from about 620,000 children (3
The exposure estimates presented in on the 2004 simulation, results in an percent of children) to about 230,000 (1
the Staff Paper are for the number and aggregate estimate of about 1 percent of percent of children) using the 2004
percent of all school age children and asthmatic or all school age children simulation. In asthmatic children, the
asthmatic school age children exposed, experiencing exposures at the 0.07 ppm estimated number of children
and the number of person-days benchmark level. experiencing one or more occurrences of
(occurrences) of exposures, with daily 8- At the benchmark level of 0.060 ppm, FEV1 decrements ≥10 percent for the 5
hour maximum exposures at or above about 70 percent of all or asthmatic urban areas goes from about 250,000
several benchmark levels while at school age children are estimated to children (16 percent of asthmatic
intermittent moderate or greater experience exposures of concern at this children) under 2002 air quality to
exertion. As shown in the Table 1 in benchmark level for the aggregate of the about 130,000 (8 percent of asthmatic
this notice, the percent of population 12 urban areas associated with 2002 O3 children) using the 2002 simulation,
exposed at any given level is very levels. Just meeting the current standard and from about 160,000 (10 percent of
similar for all and asthmatic school age would result in an aggregate estimate of asthmatic children) to about 70,000 (4
children. Substantial year-to-year about 45 percent of asthmatic or all percent of asthmatic children) using the
variability in exposure estimates is school age children likely to experience 2004 simulation. Thus, even when the
current standard is met, about 4 to 8 concern from a public health information to estimate risks but which
percent of asthmatic school age children perspective. are important to consider in assessing
are estimated to experience one or more With regard to other O3-related health the adequacy of the current standard.
occurrences of moderate lung function effects, as shown in Tables 6–4 through The same is true for more serious, but
decrements, resulting in about 1 million 6–6 of the Staff Paper, the estimated less frequent effects. The Staff Paper
occurrences (using the 2002 simulation) risks of respiratory symptom days in estimated hospital admissions, but there
and nearly 700,000 occurrence (using moderate to severe asthmatic children, was not sufficient information to
the 2004 simulation) in just 5 urban respiratory-related hospital admissions, estimate emergency department visits in
areas. Moreover, the estimated number and non-accidental and a quantitative risk assessment.
of occurrences of moderate or greater cardiorespiratory mortality, Consideration of such unquantified
lung function decrements per child is respectively, are not reduced to as great risks in the Staff Paper reinforces the
on average approximately 6 to 7 in all an extent by meeting the current Staff Paper conclusion that
children and 8 to 10 in asthmatic standard as are lung function consideration should be given to
decrements. For example, just meeting
children in an O3 season, even when the revising the standard so as to provide
the current standard reduces the
current standard is met, depending on increased public health protection,
estimated average incidence of chest
the year used to simulate meeting the especially for at-risk groups such as
tightness in moderate to severe
current standard. In the 1997 review of asthmatic children living in the Boston people with asthma or other lung
the O3 standard a general consensus urban area by 11 to 15%, based on 2002 diseases, as well as children and older
view of the adversity of such moderate and 2004 simulations, respectively, adults, particularly those active
responses emerged as the frequency of resulting in an estimated incidence of outdoors, and outdoor workers.
occurrences increases, with the about 23,000 to 31,000 per 100,000
judgment that repeated occurrences of c. Summary
children attributable to O3 exposure
moderate responses, even in otherwise (Table 6–4). Just meeting the current Based on the available information
healthy individuals, may be considered standard is estimated to reduce the and taking into account the views of
adverse since they may well set the incidence of respiratory-related hospital CASAC and public comments, the Staff
stage for more serious illness. admissions in the New York City urban Paper initially notes that all parties
With regard to estimates of large lung area by about 16 to 18%, based on 2002 commenting on the NAAQS review
function decrements, the Staff Paper and 2004 simulations, respectively, agree that the standard should be at
notes that FEV1 decrements >20 percent resulting in an estimated incidence per least as protective as the current
would likely interfere with normal 100,000 population of 4.6 to 6.4, standard, as no party suggested it
activities in many healthy individuals, respectively (Table 6–5). Across the 12 should be revised to provide less
therefore single occurrences would be urban areas, the estimates of non- protection. The Staff Paper concludes
considered to be adverse. In people with accidental mortality incidence per that the overall body of evidence clearly
asthma, large lung function responses 100,000 relevant population range from calls into question the adequacy of the
would likely interfere with normal 0.4 to 2.6 (for 2002) and 0.5 to 1.5 (for current standard in protecting at-risk
activities for most individuals and 2004) (Table 6–6). Meeting the current groups, notably including asthmatic
would also increase the likelihood that standard results in a reduction of the children and other people with lung
these individuals would use additional estimated incidence per 100,000 disease, as well as all children and older
medication or seek medical treatment. population to a range of 0.3 to 2.4 based
adults, especially those active outdoors,
Not only would single occurrences be on the 2002 simulation and a range of
and outdoor workers,48 against an array
considered to be adverse to asthmatic 0.3 to 1.2 based on the 2004 simulation.
of adverse health effects that range from
individuals under the ATS definition, Estimates for cardiorespiratory mortality
show similar patterns. decreased lung function to serious
but they also would be cause for indicators of respiratory morbidity
In considering the estimates of the
medical concern. While the current proportion of population affected and including emergency department visits
standard reduces the occurrences of the number of occurrences of the health and hospital admissions for respiratory
large lung function decrements in all effects that are included in the risk causes, nonaccidental mortality, and
children and asthmatic children from assessment, the Staff Paper notes that possibly cardiovascular effects. The
about 60 to 70%, in a year with these limited estimates are indicative of available information provides strong
relatively higher O3 levels (2002), there a much broader array of O3-related support for consideration of an O3
are estimated to be about 500,000 health endpoints that are part of a standard that would provide increased
occurrences in all school children ‘‘pyramid of effects’’ that include health protection for these at-risk
across the entire 12 urban areas, and various indicators of morbidity that groups. The Staff Paper also concludes
about 40,000 occurrences in asthmatic could not be included in the risk that risks projected to remain upon
children across just 5 urban areas. As assessment (e.g., school absences, meeting the current standard, based on
noted above, it is clear that even when increased medication use, emergency the exposure and risk estimates
the current standard is met over a three- department visits) and which primarily discussed above and in more detail in
year period, O3 levels in each year can affect members of at-risk groups. While the Staff Paper, are indicative of risks to
vary considerably, as evidenced by the Staff Paper had sufficient at-risk groups that can be judged to be
relatively large differences between risk information to estimate and consider the important from a public health
estimates based on 2002 to 2004 air number of symptom days in children perspective, which reinforces the Staff
quality. The Staff Paper expressed the with moderate to severe asthma, it
Paper conclusion that consideration

view that it was appropriate to consider recognized that there are many other should be given to revising the level of
this yearly variation in O3 levels effects that may be associated with the standard so as to provide increased
allowed by the current standard in symptom days, such as increased
judging the extent to which impacts on medication use, school and work 48 In defining at-risk groups this way we are
members of at-risk groups in a year with absences, or visits to doctors’ offices, for including both groups with greater inherent
relatively higher O3 levels remains of which there was not sufficient sensitivity and those more likely to be exposed.
public health protection (EPA, 2007, exposure levels well below the current O3 pollution, including significant new
section 6.3.6). standard. ‘‘The CASAC considers each evidence concerning effects at O3
of these findings to be an important concentrations below the level of the
3. CASAC Views
indicator of adverse health effects’’ current standard, the Administrator
In its letter to the Administrator, the (Henderson, 2006c). proposes that the current standard does
CASAC O3 Panel, with full endorsement The CASAC Panel expressed the view not protect public health with an
of the chartered CASAC, unanimously that more emphasis should be placed on adequate margin of safety and should be
concluded that there is ‘‘no scientific the subjects in controlled human revised to provide additional public
justification for retaining’’ the current exposure studies with FEV1 decrements health protection. In considering
primary O3 standard, and the current greater than 10 percent, which can be whether the primary standard should be
standard ‘‘needs to be substantially clinically significant, rather than on the revised, the Administrator has carefully
reduced to protect human health, relatively small average decrements. considered the conclusions contained in
particularly in sensitive The Panel also emphasized significant the Criteria Document, the rationale and
subpopulations’’ (Henderson, 2006c, pp. O3-related inflammatory responses and recommendations contained in the Staff
1–2). In its rationale for this conclusion, markers of injury to the epithelial lining Paper, the advice and recommendations
the CASAC Panel concluded that ‘‘new of the lung that are independent of from the CASAC, and public comments
evidence supports and build-upon key, spirometric responses. Further, the to date. The Administrator notes that
health-related conclusions drawn in the Panel expressed the view that the Staff evidence of a range of respiratory-
1997 Ozone NAAQS review’’ (id., p. 3). Paper did not place enough emphasis on related morbidity effects seen in the last
The Panel points to studies discussed in serious morbidity (e.g., hospital review has been considerably
chapter 3 and Appendix 3B of the Staff admissions) and mortality observed in strengthened, both through toxicological
Paper in noting that several new single- epidemiology studies. On the basis of and controlled human exposure studies
city studies and large multi-city studies the large amount of recent data as well as through many new panel and
have provided more evidence for evaluating adverse health effects at epidemiological studies.
adverse health effects at concentrations levels at and below the current O3 In addition, new evidence from
lower than the current standard, and standard, it was the unanimous opinion controlled human exposure and
that these epidemiological studies are of the CASAC Panel that the current epidemiological studies identifies
backed-up by evidence from controlled primary O3 standard is not adequate to people with asthma as an important
human exposure studies. The Panel protect human health, that the relevant susceptible population for which
specifically noted evidence from the scientific data do not support estimates of respiratory effects in the
recent Adams (2006) study that reported consideration of retaining the current general population likely underestimate
statistically significant decrements in standard, and that the current standard the magnitude or importance of these
the lung function of healthy, moderately needs to be substantially reduced to be effects. New evidence about
exercising adults at a 0.080 ppm protective of human health, particularly mechanisms of toxicity more completely
exposure level, and importantly, also in sensitive subpopulations (Henderson, explains the biological plausibility of
reported adverse lung function effects in 2006c, pp. 4–5). O3-induced respiratory effects and is
some healthy individuals at 0.060 ppm. Further, the CASAC letter noted that beginning to suggest mechanisms that
The Panel concluded that these results ‘‘there is no longer significant scientific may link O3 exposure to cardiovascular
indicate that the current standard ‘‘is uncertainty regarding the CASAC’s effects. Further, there is now relatively
not sufficiently health-protective with conclusion that the current 8-hour strong evidence for associations
an adequate margin of safety,’’ noting primary NAAQS must be lowered’’ between O3 and total nonaccidental and
that that while similar studies in (Henderson, 2006c, p. 5). The Panel cardiopulmonary mortality, even after
sensitive groups such as asthmatics noted that a ‘‘large body of data clearly adjustment for the influence of season
have yet to be conducted, ‘‘people with demonstrates adverse human health and PM. Relative to the information that
asthma, and particularly children, have effects at the current level’’ of the was available to inform the Agency’s
been found to be more sensitive and to standard, such that ‘‘[R]etaining this 1997 decision to set the current
experience larger decrements in lung standard would continue to put large standard, the newly available evidence
function in response to O3 exposures numbers of individuals at risk for increases the Administrator’s
than would healthy volunteers respiratory effects and/or significant confidence that respiratory morbidity
(Mortimer et al., 2002)’’ (Henderson, impact on quality of life including effects such as lung function decrements
2006c, p. 4). asthma exacerbations, emergency room and respiratory symptoms are causally
The CASAC Panel also highlighted a visits, hospital admissions and related to O3 exposures, that indicators
number of O3-related adverse health mortality’’ (Henderson, 2006c). The of respiratory morbidity such as
effects, that are associated with Panel also noted that ‘‘scientific emergency department visits and
exposure to ambient O3, below the level uncertainty does exist with regard to the hospital admissions are causally related
of the current standard, based on a lower level of O3 exposure that would to O3 exposures, and that the evidence
broad range of epidemiological studies be fully protective of human health,’’ is highly suggestive that O3 exposures
(Henderson, 2006c). These adverse concluding that ‘‘it is possible that there during the O3 season contribute to
health effects include increases in is no threshold for an O3-induced premature mortality.
school absenteeism, respiratory hospital impact on human health and that some The Administrator judges that there is
emergency department visits among adverse events may occur at policy- important new evidence demonstrating
asthmatics and patients with other relevant background’’ (Henderson, that exposures to O3 at levels below the
respiratory diseases, hospitalizations for level of the current standard are
2006c, p.5).
respiratory illnesses, symptoms associated with a broad array of adverse
associated with adverse health effects 4. Administrator’s Proposed health effects, especially in at-risk
(including chest tightness and Conclusions Concerning Adequacy of populations. These at-risk populations
medication usage), and premature Current Standard include people with asthma or other
mortality (nonaccidental, Based on the large body of evidence lung diseases who are likely to
cardiorespiratory deaths) reported at concerning the public health impacts of experience more serious effects from
exposure to O3. As discussed in section to provide some perspective on the potentially more serious health effects
II.A.4 above, these groups also include extent to which at-risk groups would in at-risk groups such as people with
children and older adults with likely experience ‘‘exposures of asthma. This judgment is based on the
increased susceptibility, as well as those concern’’ 49 and on the potential strong evidence of effects in healthy
who are likely to be vulnerable as a magnitude of the risk of experiencing people at the 0.080 ppm exposure level
result of spending a lot of time outdoors various adverse health effects when and the new evidence that people with
engaged in physical activity, especially recent air quality data (from 2002 to asthma are likely to experience larger
active children and outdoor workers. 2004) are used to simulate meeting the and more serious effects than healthy
Examples of this important new current standard and alternative people at the same level of exposure. In
evidence include demonstration of O3- standards in a number of urban areas in the Administrator’s view, this evidence
induced lung function effects and the U.S.50 In considering the exposure does not support a focus on exposures
respiratory symptoms in some healthy assessment results, the Administrator is at and above the benchmark level of
individuals down to the previously relying on analyses that define 0.080 ppm O3, as it would not
observed exposure level of 0.080 ppm, exposures of concern by three adequately account for the increased
as well as very limited new evidence at benchmark exposure levels: 0.080, risk of harm from exposure for members
exposure levels well below the level of 0.070, and 0.060 ppm. Estimates of of at-risk groups, especially people with
the current standard. In addition, there exposures of concern in at-risk groups at asthma. The Administrator also judges
is now epidemiological evidence of and above these benchmark levels, that the evidence of demonstrated
statistically significant O3-related using O3 air quality data in 2002 and effects is too limited to support a
associations with lung function and 2004, provide some indication of the primary focus on exposures down to the
respiratory symptom effects, respiratory- potential magnitude of the incidence of lowest benchmark level considered of
related emergency department visits and health outcomes that cannot currently 0.060 ppm. The Administrator
hospital admissions, and increased be evaluated in a quantitative risk particularly notes that although the
mortality, in areas that likely would assessment, such as increased airway analysis of ‘‘exposures of concern’’ was
have met the current standard. There are responsiveness, increased pulmonary conducted to estimate exposures at and
also many epidemiological studies done inflammation, including increased above three discrete benchmark levels
in areas that likely would not have met cellular permeability, and decreased (0.080, 0.070, and 0.060 ppm), the
the current standard but which pulmonary defense mechanisms. These concept is appropriately viewed as a
nonetheless report statistically physiological effects have been continuum. As discussed at the outset
significant associations that generally demonstrated to occur in healthy people in section II.A above, the Administrator
extend down to ambient O3 at O3 exposures as low as 0.080 ppm, strives to balance concern about the
concentrations that are below the level the lowest level tested. They are potential for health effects and their
of the current standard. Further, there associated with aggravation of asthma, severity with the increasing uncertainty
are a few studies that have examined increased medication use, increased associated with our understanding of
subsets of data that include only days school and work absences, increased the likelihood of such effects at lower
with ambient O3 concentrations below susceptibility to respiratory infection, O3 exposure levels.
the level of the current standard, or increased visits to doctors’ offices and
below even much lower O3 emergency departments, increased The Administrator observes that
concentrations, and continue to report admissions to hospitals, and possibly to based on the aggregate exposure
statistically significant associations with cardiovascular system effects and estimates for the 2002 simulation
respiratory morbidity outcomes and chronic effects such as chronic summarized above in Table 1 (section
mortality. The Administrator recognizes bronchitis or long-term damage to the II.B.1) and in the Staff Paper (EPA,
that the evidence from controlled lungs that can lead to reduced quality of 2007b, Table 6–7) for the 12 U.S. urban
human exposure studies, together with life. areas included in the exposure analysis,
animal toxicological studies, provides In considering these various upon just meeting the current standard
considerable support for the biological benchmark levels for exposures of up to about 20 percent of asthmatic or
plausibility of the respiratory morbidity concern, the Administrator has focused all school age children are likely to
associations observed in the primarily on estimated exposures at and experience one or more exposures of
epidemiological studies and for above the 0.070 ppm benchmark level as concern at and above the 0.070 ppm
concluding that the associations extend an important surrogate measure for benchmark level; the 2004 simulation
below the level of the current standard. yielded an estimate of about 1 percent
Based on the strength of the currently 49 As discussed in section II.B.1.c above, of such children. The Administrator
available evidence of adverse health ‘‘exposures of concern’’ are estimates of personal notes from this comparison that there is
exposures while at moderate or greater exertion to substantial year-to-year variability,
effects, and on the extent to which the 8-hour average ambient O3 levels at and above
evidence indicates that such effects specific benchmark levels which represent ranging up to an order of magnitude or
result from exposures to ambient O3 exposure levels at which O3-related health effects more in estimates of the number of
concentrations below the level of the are known or can with varying degrees of certainty people and the number of occurrences
be inferred to occur in some individuals. Estimates of exposures of concern at and above
current standard, the Administrator of exposures of concern provide some perspective
judges that the current standard does on the public health impacts of health effects that this benchmark level. Moreover, within
not protect public health with an may occur in some individuals at recent air quality any given year, the exposure assessment
adequate margin of safety and that the levels but cannot be evaluated in quantitative risk indicates that there is substantial city-
assessments, and the extent to which such impacts to-city variability in the estimates of the
standard should be revised to provide might be reduced by meeting the current and
such protection, especially for at-risk children exposed or the number of
alternative standards.
groups, against a broad array of adverse 50 As described in the Staff Paper (section 4.5.8) occurrences of exposure at and above
health effects. and discussed above, recent O3 air quality this benchmark level. For example, city-
In reaching this judgment, the distributions have been statistically adjusted to specific estimates of the percent of
simulate just meeting the current and selected
Administrator has also considered the alternative standards. These simulations do not
asthmatic or all school age children
results of both the exposure and risk represent predictions of when, whether, or how likely to experience exposures at and
assessments conducted for this review, areas might meet the specified standards. above the benchmark level of 0.070 ppm
ranges from about 1 percent up to about Large lung function decrements (i.e., admissions. For nonaccidental
40 percent across the 12 urban areas ≥20 percent FEV1 decrement) would mortality, just meeting the current
upon just meeting the current standard likely interfere with normal activities in standard based on the 2002 simulation
based on the 2002 simulation; the 2004 many healthy individuals, therefore results in an estimated incidence of
simulation yielded estimates that range single occurrences would be considered from 0.3 to 2.4 per 100,000 population;
from about 0 up to about 7 percent. The to be adverse. In people with asthma, the 2004 simulation resulted in an
Administrator judges it is important to large lung function responses (i.e., ≥ 20 estimated incidence of from 0.3 to 1.2
recognize the substantial year-to-year percent FEV1 decrement), would likely per 100,000 population. Estimates for
and city-to-city variability in interfere with normal activities for most cardiorespiratory mortality show similar
considering these estimates. individuals and would also increase the patterns. (Abt Associates, 2007, Table 4–
With regard to the results of the risk likelihood that these individuals would 26).
assessment, as discussed above, the use additional medication or seek The Administrator recognizes that in
Administrator recognizes that a medical treatment. Not only would considering the estimates of the
simulation of just meeting the current single occurrences be considered to be proportion of population affected and
standard in the cities included in the adverse to asthmatic individuals under the number of occurrences of those
assessment indicate that the estimated the ATS definition, but they also would specific health effects that are included
risk is lower for all of the health be cause for medical concern for some in the risk assessment, these limited
endpoints evaluated. In considering the individuals. Upon just meeting the estimates based on 2002 and 2004
adequacy of the current standard, the current standard based on the 2002 simulations are indicative of a much
Administrator has focused on the risks simulation, close to 1 percent of broader array of O3-related health
estimated to remain upon just meeting asthmatic and all school age children endpoints that are part of a ‘‘pyramid of
the current standard. Based on the are estimated to experience one or more effects’’ (discussed above in section
aggregate risk estimates summarized occurrences of large lung function II.A.4.d) that include various indicators
above in Table 2 (section II.B.2 of this decrements in the aggregate across 5 and of morbidity that could not be included
notice), the Administrator observes that 12 urban areas, respectively, with close in the risk assessment (e.g., school
upon just meeting the current standard to 2 percent of both asthmatic and all absences, increased medication use,
based on the 2002 simulation, school age children estimated to emergency department visits) and
approximately 8 percent of asthmatic experience such effects in the city that which primarily affect members of at-
school age children across 5 urban areas receives relatively less protection from risk groups. Moreover, the
(ranging up to about 11 percent in the this standard. These estimates translate Administrator notes that the CASAC
city that receives relatively less into approximately 500,000 occurrences Panel supported a qualitative
protection) and approximately 3 percent of large lung function decrements in all consideration of the much broader array
of all school age children across 12 children across 12 urban areas, and of O3-related health endpoints, and
urban areas (ranging up to over 5 about 40,000 occurrences in asthmatic specifically referred to respiratory
percent in the city that receives children across just 5 urban areas upon emergency department visits in
relatively less protection) would still be just meeting the current standard based asthmatics and people with other lung
estimated to experience moderate or on the 2002 simulation; the 2004 diseases, increased medication use, and
greater lung function decrements one or simulation yielded estimates that increased respiratory symptoms
more times within an O3 season. The translate into approximately 160,000 reported at exposure levels well below
Administrator recognizes that, as with and 10,000 such occurrences in all the current standard.
the estimates of exposures of concern, children and asthmatic children, The Administrator believes the
there is substantial year-to-year and respectively. exposure and risk estimates discussed
city-to-city variability in these risk Upon just meeting the current in the Staff Paper and summarized
estimates. standard based on the 2002 simulation, above are important from a public
In addition to the percentage of the estimate of the O3-related risk of health perspective and are indicative of
asthmatic or all children estimated to respiratory symptom days in moderate potential exposures and risks to at-risk
experience 1 or more occurrences of an to severe asthmatic children in the groups. In reaching this proposed
effect, the Administrator recognizes that Boston area is about 8,000 symptom judgment, the Administrator considered
some individuals are estimated to have days; the 2004 simulation yielded an the following factors: (1) The estimates
multiple occurrences. For example, estimate of about 6,000 such symptoms of numbers of persons exposed at and
across all the cities in the assessment, days. These estimates translate into as above the 0.070 ppm benchmark level;
approximately 6 to 7 occurrences of many as one symptom day in 6, and one (2) the risk estimates of the proportion
moderate or greater lung function symptom day in 8, respectively, that are of the population and number of
decrements per child are estimated to attributable to O3 exposure during the occurrences of various health effects in
occur in all children and approximately O3 season of the total number of areas upon just meeting the current
8 to 10 occurrences are estimated to symptom days associated with all standard; (3) the year-to-year and city-
occur in asthmatic children in an O3 causes of respiratory symptoms in to-city variability in both the exposure
season, even upon just meeting the asthmatic children during those years. and risk estimates; (4) the uncertainties
current standard. In the last review, a The estimated O3-related risk of in these estimates; and (5) recognition
general consensus view of the adversity respiratory-related hospital admissions that there is a broader array of O3-
of such responses emerged as the upon just meeting the current standard related adverse health outcomes for
frequency of occurrences increases, with based on the 2002 simulation is greater which risk estimates could not be
the judgment that repeated occurrences than 500 hospital admissions in the quantified (that are part of a broader
of moderate responses, even in New York City area alone, or about 1.5 ‘‘pyramid of effects’’) and that the scope
otherwise healthy individuals, may be percent of the total incidence of of the assessment was limited to just a
considered adverse since they may well respiratory-related admissions sample of urban areas and to some but
set the stage for more serious illness. associated with all causes; the 2004 not all at-risk populations, leading to an
The Administrator continues to support simulation yielded an estimate of incomplete estimation of public health
this view. approximately 400 such hospital impacts associated with O3 exposures
across the country. The Administrator reductions in population exposures to 8-hour) exposures below the level of the
also notes that it was the unanimous O3 can generally be expected to lead to then current 1-hour NAAQS.
conclusion of the CASAC Panel that reductions in population exposures to (3) Results of the quantitative risk
there is no scientific justification for other photochemical oxidants. analyses showed that reductions in risks
retaining the current primary O3 The Staff Paper notes that while the from both short-term and prolonged
standard, that the current standard is new body of time-series epidemiological exposures could be achieved through a
not sufficiently health-protective with evidence cannot resolve questions about primary standard with an averaging
an adequate margin of safety, and that the relative contribution of other period of either 1 or 8 hours. Thus
the standard needs to be substantially photochemical oxidant species to the establishing both a 1-hour and an 8-hour
reduced to protect human health, range of morbidity and mortality effects standard would not be necessary to
particularly in at-risk subpopulations. associated with O3 in these types of reduce risks associated with the full
Based on all of these considerations, studies, control of ambient O3 levels is range of observed health effects.
the Administrator proposes that the generally understood to provide the best (4) The 8-hour averaging time is more
current O3 standard is not requisite to means of controlling photochemical directly associated with health effects of
protect public health with an adequate oxidants in general, and thus of concern at lower O3 concentrations than
margin of safety because it does not protecting against effects that may be the 1-hour averaging time. It was thus
provide sufficient protection and that associated with individual species and/ the consensus of CASAC ‘‘that an 8-
revision would result in increased or the broader mix of photochemical hour standard was more appropriate for
public health protection, especially for oxidants, independent of effects a human health-based standard than a 1-
members of at-risk groups. specifically related to O3. hour standard.’’ (Wolff, 1995)
In its letter to the Administrator, the (5) An 8-hour averaging results in a
D. Conclusions on the Elements of the significantly more uniformly protective
CASAC O3 Panel noted that O3 is ‘‘the
Primary Standard national standard than the then current
key indicator of the extent of oxidative
1. Indicator chemistry and serves to integrate 1-hour standard.
(6) An 8-hour averaging time
In the last review EPA focused on a multiple pollutants.’’ CASAC also stated
effectively limits both 1- and 8-hour
standard for O3 as the most appropriate that ‘‘although O3 itself has direct effects
exposures of concern.
surrogate for ambient photochemical on human health and ecosystems, it can In looking at the new information that
oxidants. In this review, while the also be considered as an indicator of the is discussed in section 7.6.2 of the
complex atmospheric chemistry in mixture of photochemical oxidants and current Criteria Document, the Staff
which O3 plays a key role has been of the oxidizing potency of the Paper noted that epidemiological
highlighted, no alternative to O3 has atmosphere’’ (Henderson, 2006c, p. 9). studies have used various averaging
been advanced as being a more Based on the available information, periods for O3 concentrations, most
appropriate surrogate for ambient and consistent with the views of EPA commonly 1-hour, 8-hour and 24-hour
photochemical oxidants. staff and the CASAC, the Administrator averages. As described more specifically
The Staff Paper (section 2.2.2) notes proposes to continue to use O3 as the in sections 3.3 and 3.4 of the Staff
that it is generally recognized that indicator for a standard that is intended Paper, in general the results presented
control of ambient O3 levels provides to address effects associated with from U.S. and Canadian studies show
the best means of controlling exposure to O3, alone or in combination no consistent difference for various
photochemical oxidants. Among the with related photochemical oxidants. In averaging times in different studies.
photochemical oxidants, the acute so doing, the Administrator recognizes Because the 8-hour averaging time
exposure chamber, panel, and field that measures leading to reductions in continues to be more directly associated
epidemiological human health database population exposures to O3 will also with health effects of concern from
provides specific evidence for O3 at reduce exposures to other controlled human exposure studies at
levels commonly reported in the photochemical oxidants. lower concentrations than do shorter
ambient air, in part because few other 2. Averaging Time averaging periods, the Staff Paper did
photochemical oxidants are routinely not evaluate alternative averaging times
measured. However, recent a. Short-Term and Prolonged (1 to 8 in this review and did not conduct
investigations on copollutant Hours) exposure or risk assessments for
interactions have used simulated urban The current 8-hour averaging time for standards with averaging times other
photochemical oxidant mixes. These the primary O3 NAAQS was set in 1997. than 8 hours.
investigations suggest the need for At that time, the decision to revise the The Staff Paper discusses an analysis
similar studies to help in understanding averaging time of the primary standard of a recent three-year period of air
the biological basis for effects observed from 1 to 8 hours was supported by the quality data (2002 to 2004) which was
in epidemiological studies that are following key observations and conducted to determine whether the
associated with air pollutant mixtures, conclusions: comparative 1- and 8-hour air quality
where O3 is used as the surrogate for the (1) The 1-hour averaging time of the patterns that were observed in the last
mix of photochemical oxidants. Meeting previous NAAQS was originally review continue to be observed based on
the O3 standard can be expected to selected primarily on the basis of health more recent air quality data. This
provide some degree of protection effects associated with short-term (i.e., updated air quality analysis (McCluney,
against potential health effects that may 1- to 3-hour) exposures. 2007) is very consistent with the
be independently associated with other (2) Substantial health effects analysis done in the last review in that
photochemical oxidants but which are information was available for the 1997 it indicates that only two urban areas of
not discernable from currently available review that demonstrated associations the U.S. have such ‘‘peaky’’ air quality
studies indexed by O3 alone. Since the between a wide range of health effects patterns such that the ratio of 1-hour to
precursor emissions that lead to the (e.g., moderate to large lung function 8-hour design values is greater than 1.5.
formation of O3 generally also lead to decrements, moderate to severe This suggests that, based on recent air
the formation of other photochemical symptoms and pulmonary quality data, it is reasonable to again
oxidants, measures leading to inflammation) and prolonged (i.e., 6- to conclude that an 8-hour average
standard at or below the current level Taking into consideration the Therefore, the Administrator proposes
would generally be expected to provide currently available evidence on long- to retain the 8-hour averaging time and
protection equal to or greater than the term O3 exposures, discussed above in is not proposing a separate 1-hour
previous 1-hour standard of 0.12 ppm in section II.A.2.a.ii, the Staff Paper standard. The Administrator also
almost all urban areas. Thus, the Staff concludes that a health-based standard concludes that a standard with a long-
Paper again concluded that setting a with a longer-term averaging time than term averaging time is not warranted at
standard with an 8-hour averaging time 8 hours is not warranted at this time. this time.
can effectively limit both 1- and 8-hour The Staff Paper notes that, while
3. Form
exposures of concern and is appropriate potentially more serious health effects
to provide adequate and more uniform have been identified as being associated In 1997, the primary O3 NAAQS was
protection of public health from both with longer-term exposure studies of changed from a ‘‘1-expected-
short-term and prolonged exposures to laboratory animals and in epidemiology exceedance’’ form per year over three
O3 in the ambient air. studies, there remains substantial years 51 to a concentration-based
uncertainty regarding how these data statistic, specifically the 3-year average
In its letter to the Administrator, the
could be used quantitatively to develop of the annual fourth-highest daily
CASAC O3 Panel supported the
a basis for setting a long-term health maximum 8-hour concentrations. The
continued use of an 8-hour averaging
standard. Because long-term air quality principal advantage of the
time for the primary O3 standard
patterns would be improved in areas concentration-based form is that it is
(Henderson, 2006c, p. 2), as did many
coming into attainment with an 8-hour more directly related to the ambient O3
commenters. Some other commenters
standard, the potential risk of health concentrations that are associated with
expressed the view that consideration
effects associated with long-term the health effects. With a concentration-
should be given to setting or reinstating
exposures would be reduced in any area based form, days on which higher O3
a 1-hour standard, in addition to
meeting an 8-hour standard. Thus, the concentrations occur would weigh
maintaining the use of an 8-hour
Staff Paper did not recommend proportionally more than days with
averaging time, to protect people in lower concentrations, since the actual
those parts of the country with consideration of a long-term, health-
based standard at this time. concentrations are used in determining
relatively more ‘‘peaky’’ exposure whether the standard is attained. That
In its final letter to the Administrator,
profiles. These commenters point out is, given that there is a continuum of
the CASAC O3 Panel offered no views
that when controlled exposure studies effects associated with exposures to
on the long-term exposure evidence, nor
using triangular exposure patterns (with varying levels of O3, the extent to which
did it suggest that consideration of a
relatively higher 1-hour peaks) have public health is affected by exposure to
primary O3 standard with a long-term
been compared to constant exposure ambient O3 is related to the actual
averaging time was appropriate. In fact,
patterns with the same aggregate O3 magnitude of the O3 concentration, not
the CASAC O3 Panel agreed with the
dose (in terms of concentration x time), just whether the concentration is above
choice of an 8-hour averaging time for
‘‘peaky’’ exposure patterns are seen to the primary O3 NAAQS suggested by a specified level.
lead to higher risks. The California Air Agency staff (Henderson, 2007). During the 1997 review, consideration
Resources Board made particular note of Similarly, no commenters expressed was given to a range of alternative
this point, expressing the view that a 1- support for considering such a long- forms, including the second-, third-,
hour standard would more closely term standard. fourth- and fifth-highest daily maximum
represent actual exposures, in that many 8-hour concentrations in an O3 season,
people spend only 1 to 2 hours a day c. Administrator’s Conclusions on recognizing that the public health risks
outdoors, and that it would be better Averaging Time associated with exposure to a pollutant
matched to O3 concentration profiles In considering the information without a clear, discernable threshold
along the coasts where O3 levels are discussed above, CASAC views and can be appropriately addressed through
typically high for shorter averaging public comments, the Administrator a standard that allows for multiple
periods than 8 hours. concludes that a standard with an 8- exceedances to provide increased
b. Long-term hour averaging time can effectively limit stability, but that also significantly
both 1- and 8-hour exposures of concern limits the number of days on which the
During the last review, there was a and that an 8-hour averaging time is level may be exceeded and the
large animal toxicological database for appropriate to provide adequate and magnitude of such exceedances.
consideration that provided clear more uniform protection of public Consideration was given to setting a
evidence of associations between long- health from both short-term (1- to 3- standard with a form that would
term (e.g., from several months to years) hour) and prolonged (6- to 8-hour) provide a margin of safety against
exposures and lung tissue damage, with exposures to O3 in the ambient air. This possible, but uncertain chronic effects,
additional evidence of reduced lung conclusion is based on the observations and would also provide greater stability
elasticity and accelerated loss of lung summarized above, particularly: (1) The to ongoing control programs. The
function. However, there was no fact that the 8-hour averaging time is fourth-highest daily maximum was
corresponding evidence for humans, more directly associated with health selected because it was decided that the
and the state of the science had not effects of concern at lower O3 differences in the degree of protection
progressed sufficiently to allow concentrations than are averaging times against potential chronic effects
quantitative extrapolation of the animal of shorter duration and (2) results from afforded by the alternatives within the
study findings to humans. For these quantitative risk analyses showing that range were not well enough understood
reasons, consideration of a separate attaining an 8-hour standard reduces the to use any such differences as a basis for
long-term primary O3 standard was not risk of experiencing health effects

judged to be appropriate at that time, associated with both 8-hour and shorter 51 The 1-expected-exceedance form essentially
recognizing that the 8-hour standard duration exposures. Furthermore, the requires that the fourth-highest air quality value in
3 years, based on adjustments for missing data, be
would act to limit long-term exposures Administrator observes that the CASAC less than or equal to the level of the standard for
as well as short-term and prolonged O3 Panel agreed with the choice of the standard to be met at an air quality monitoring
exposures. averaging time (Henderson, 2007). site.
choosing the most restrictive forms. On and associated control programs. level. In most cities, there are generally
the other hand, the relatively large Providing more stability is one of the only small differences in the estimated
percentage of sites that would reasons that EPA moved to a reductions in risks associated with the
experience O3 peaks well above 0.080 concentration-based form in 1997. third- to fifth-highest forms at a level of
ppm and the number of days on which The Staff Paper considered two 0.074 ppm simulated using 2002 and
the level of the standard may be concentration-based forms of the 2004 O3 monitoring data.
exceeded, even when attaining a fifth- standard: the nth-highest maximum The Staff Paper noted that there is not
highest 0.080 ppm concentration-based concentration and a percentile-based a clear health-based threshold for
standard, argued against choosing that form. A percentile-based statistic is selecting a particular nth-highest daily
form. useful for comparing datasets of varying maximum form of the standard from
As an initial matter, the Staff Paper length because it samples approximately among the ones analyzed. It also noted
considered whether it is appropriate to the same place in the distribution of air that the changes in the form considered
continue to specify the level of the O3 quality values, whether the dataset is in the analyses result in only small
standard to the nearest hundredth (two several months or several years long. differences in the estimated reductions
decimal places) ppm, or whether the However, a percentile-based form would in risks in most cities, although in some
precision with which ambient O3 allow more days with higher air quality cities larger differences are estimated.
concentrations are measured supports values in locations with longer O3 The Staff Paper concluded that a range
specifying the standard level to the seasons relative to places with shorter of concentration-based forms from the
thousandth ppm (i.e., to the part per O3 seasons. An nth-highest maximum third- to the fifth-highest daily
billion (ppb)). The Staff Paper discusses concentration form would more maximum 8-hour average concentration
an analysis conducted by EPA staff to effectively ensure that people who live is appropriate for consideration in
determine the impact of ambient O3 in areas with different length O3 seasons setting the standard. Given that there is
measurement error on calculated 8-hour receive the same degree of public health a continuum of effects associated with
average O3 design value concentrations, protection. For this reason, the exposure exposures to varying levels of O3, the
which are compared to the level of the and risk analyses were based on a form extent to which public health is affected
standard to determine whether the specified in terms of an nth-highest by exposure to ambient O3 is related to
standard is attained (Cox and Camalier, concentration, with n ranging from 3 the actual magnitude of the O3
2006). The results of this analysis to 5. concentration, not just whether the
suggest that instrument measurement The results of some of these analyses concentration is above a specified level.
error, or possible instrument bias, are shown in the Staff Paper (Figures 6– The principal advantage of a
contribute very little to the uncertainty 1 through 6–4) and specifically concentration-based form is that it is
in design values. More specifically, discussed in chapter 6. These figures more directly related to the ambient O3
measurement imprecision was illustrate the estimated percent change concentrations that are associated with
determined to contribute less than 1 ppb in risk estimates for the incidence of health effects. Robust, concentration-
to design value uncertainty, and a moderate or greater decrements in lung based forms, in the range of the third-
simulation study indicated that function (≥15 percent FEV1) in all to fifth-highest daily maximum 8-hour
randomly occurring instrument bias school age children and moderate or average concentration, including the
could contribute approximately 1 ppb. greater lung function decrements (≥10 current 4th-highest daily maximum
EPA staff interpreted this analysis as percent FEV1) in asthmatic school age form, minimize the inherent lack of
being supportive of specifying the level children, associated with going from year-to-year stability of exceedance-
of the standard to the nearest meeting the current standard to meeting based forms and provide insulation
thousandth ppm. If the current standard alternative standards with alternative from the impacts of extreme
were to be specified to this degree of forms based on the 2002 and 2004 meteorological events. Such instability
precision, the current standard would simulations. Figures 6–5 and 6–6 can have the effect of reducing public
effectively be at a level of 0.084 ppm, illustrate the estimated percent of health protection by disrupting ongoing
reflecting the data rounding conventions change in the estimated incidence of implementation plans and associated
that are part of the definition of the non-accidental mortality, associated control programs.
current 0.080 ppm 8-hour standard. with going from meeting the current With regard to the precision of the
This information was provided to the standard to meeting alternative standard, in their letter to the
CASAC O3 Panel and made available to standards, based on the 2002 and 2004 Administrator, the CASAC concluded
the public. simulations. These results are generally that current monitoring technology
In evaluating alternative forms for the representative of the patterns found in ‘‘allows accurate measurement of O3
primary standard in conjunction with all of the analyses. The estimated concentrations with a precision of parts
specific standard levels, the Staff Paper reductions in risk associated with per billion’’ (Henderson, 2006c). The
considered the adequacy of the public different forms of the standard, ranging CASAC recommended that the
health protection provided by the from third- to fourth-highest daily specification of the level of the O3
combination of the level and form to be maximum concentrations at 0.084 ppm, standard should reflect this degree of
the foremost consideration. In addition, and from third- to fifth-highest daily precision (Henderson, 2006c). Some
the Staff Paper recognized that it is maximum concentrations at 0.074 ppm, public comments supported specifying
important to have a form of the standard are generally less than the estimated the standard in terms of parts per
that is stable and insulated from the reductions associated with the different billion, or to three decimal places if
impacts of extreme meteorological levels that were analyzed. As seen in specified in terms of parts per million.52
events that are conducive to O3 these figures, there is much city-to-city Other public commenters stated that the
formation. Such instability can have the variability, particularly in the percent
effect of reducing public health changes associated with going from a 52 The Staff Paper notes that the 8-hour O
3
protection, because frequent shifting in fourth-highest to third-highest form at standard adopted by the State of California in 2006
is specified to the nearest thousandth part per
and out of attainment due to the current level of 0.084 ppm, and with million (at a level of 0.070 ppm) (http://
meteorological conditions can disrupt estimated reductions associated with www.arb.ca.gov/research/aaqs/ozone-rs/ozone-
an area’s ongoing implementation plans the fifth-highest form at a 0.074 ppm rs.htm).
basis for changing the current rounding fifth-highest daily maximum 8-hour In considering the available
procedures is not supported by a average concentrations. controlled human exposure studies, as
complete analysis of the O3 compliance discussed above in section
4. Level
monitoring procedures, including II.A.2.a.i(a)(i), two new studies are
consideration of uncertainty related to a. Evidence and Exposure/Risk Based notable in that they are the only
humidity effects and interferences from Considerations in the Staff Paper controlled human exposure studies that
aromatic compounds in the monitoring The approach used in the Staff Paper examined respiratory effects, including
of O3 levels. as a basis for staff recommendations on lung function decrements and
With regard to the form of the standard levels builds upon and respiratory symptoms, in healthy adults
standard, in their letter to the broadens the general approach used by at lower exposure levels than had
Administrator, CASAC recommended EPA in the last review. This approach previously been examined. EPA’s
that ‘‘a range of concentration-based reflects the more extensive and stronger reanalysis of the data from the most
forms from the third-to the fifth-highest body of evidence now available on a recent study shows small group mean
daily maximum 8-hour average broader range of health effects decrements in lung function responses
concentration’’ be considered to be statistically significant at the 0.060
associated with exposure to O3,
(Henderson, 2006c, p. 5). Some public ppm exposure level, while the author’s
including: (1) Additional respiratory-
commenters that expressed the view analysis did not yield statistically
related endpoints; (2) new information
that the current primary O3 standard is significant lung function responses (but
about the mechanisms underlying
not adequate also submitted comments did yield some statistically significant
respiratory morbidity effects supporting
that supported a more health-protective respiratory symptom responses toward
a judgment that the link between O3
form of the standard than the current the end of the exposure period).
exposure and these effects is causal; (3)
form (e.g., a second-or third-highest Notably, these studies report a small
newly identified cardiovascular-related
daily maximum form). Commenters who percentage of subjects experiencing lung
health endpoints from animal
expressed the view that the current function decrements (> 10 percent) at
standard is adequate did not provide toxicology, and controlled human
the 0.060 ppm exposure level. These
any views on alternative forms that exposures studies that are highly
studies provide very limited evidence of
would be appropriate for consideration suggestive that O3 can directly or
O3-related lung function decrements
should the Administrator consider indirectly contribute to cardiovascular
and respiratory symptoms at this lower
revisions to the standard. morbidity, and (4) new U.S. multi-city
exposure level.
The Administrator proposes that the time series studies, single city studies, In considering controlled human
level of the standard be specified to the and several meta-analyses of these exposure studies of pulmonary
nearest thousandth ppm, based on the studies that provide relatively strong inflammation, airway responsiveness,
staff’s analysis and conclusions evidence for associations between short- and impaired host defense capabilities,
discussed in the Staff Paper that current term O3 exposures and all-cause the Staff Paper notes that these studies
monitoring technology allows accurate (nonaccidental) mortality, at levels provide evidence of a lowest-observed-
measurement of O3 to support below the current primary standard: as effects level for such effects in healthy
specifying the 8-hour standard to this well as (5) evidence of increased adults at prolonged moderate exertion of
degree of precision, and on CASAC’s susceptibility in people with asthma 0.080 ppm. As discussed above, these
recommendation with respect to this and other lung diseases. In evaluating physiological effects have been linked to
aspect of the standard. The evidence-based and exposure/risk-based aggravation of asthma and increased
Administrator invites comment on this considerations, the Staff Paper susceptibility to respiratory infection,
proposal to specify the standard to the considered: (1) The ranges of levels of potentially leading to increased
thousandth ppm. alternative standards that are supported medication use, increased school and
The Administrator recognizes that by the evidence, and the uncertainties work absences, increased visits to
there is not a clear health-based and limitations in that evidence and (2) doctors’ offices and emergency
threshold for selecting a particular nth- the extent to which specific levels of departments, and increased hospital
highest daily maximum form of the alternative standards reduce the admissions. Further, pulmonary
standard from among the ones analyzed estimated exposures of concern and inflammation is related to increased
in the Staff Paper, and that the current risks attributable to O3 and other cellular permeability in the lung, which
form of the standard provides a stable photochemical oxidants, and the may be a mechanism by which O3
target for implementing programs to uncertainties associated with the exposure can lead to cardiovascular
improve air quality. The Administrator estimated exposure and risk reductions. system effects, and to potential chronic
also agrees that the adequacy of the In taking into account evidence-based effects such as chronic bronchitis or
public health protection provided by the considerations, the Staff Paper long-term damage to the lungs that can
combination of the level and form is a evaluated available evidence from lead to reduced quality of life. These are
foremost consideration. Based on this, controlled human exposure studies and all indicators of adverse O3-related
the Administrator proposes to retain the epidemiological studies, as well as the morbidity effects, which are consistent
form of the current standard, 4th-highest uncertainties and limitations in that with and lend plausibility to the adverse
daily maximum 8-hour average evidence. In particular, it focused on the morbidity effects and mortality effects
concentration, recognizing that the extent to which controlled human observed in epidemiological studies.
public health protection that would be exposure studies provide evidence of In considering epidemiological
provided by the standard is based on lowest-observed-effects levels and the studies, the Staff Paper first recognizes
combining this form with the level extent to which epidemiological studies that the available evidence neither
discussed below. Mindful of the provide evidence of associations that supports nor refutes the existence of
recommendation of the O3 CASAC extend down to the lower levels of O3 effect thresholds at the population level
Panel and the view expressed by concentrations observed in the studies for morbidity and mortality effects and
commenters, the Administrator also or some indication of potential effect that if a population threshold level does
invites comment on two alternative thresholds in terms of 8-hour average O3 exist, it would likely be well below the
forms of the standard, the third- and the concentrations. level of the current O3 standard and
possibly within the range of background Being mindful of the uncertainties models, the possible role of copollutants
levels. As discussed above (and more and limitations inherent in interpreting in interpreting reported associations
fully in the Staff Paper in chapter 3 and the available evidence, the Staff Paper with O3, and inferences of a likely
the Criteria Document in chapter 7), a states the view that the range of causal relationship between O3
number of studies reported some alternative O3 standards for exposure and nonaccidental mortality
suggestive evidence of possible consideration should take into account (for risk estimates based on
thresholds for morbidity and mortality information on lowest-observed-effects epidemiological studies).
outcomes in terms of 24-hour, 8-hour, levels in controlled human exposure Beyond these uncertainties, the Staff
and 1-hour averaging times. These studies as well as indications of possible Paper also recognized important
results, taken together, provide some effects thresholds reported in some limitations to the exposure and risk
indication of possible 8-hour average epidemiological studies and questions analyses. For example, the Staff Paper
threshold levels from below about 0.025 of biological plausibility in attributing did not have sufficient information to
to 0.035 ppm up to approximately 0.050 associations observed down to evaluate all relevant at-risk groups (e.g.,
ppm. Other studies, however, observe background levels to O3 exposures outdoor workers) or all O3-related health
linear concentration-response functions alone. Based on the evidence and these outcomes (e.g., increased medication
suggesting no effect threshold. The Staff considerations, it concluded that the use, school absences, emergency
Paper concludes that the statistically upper end of the range of consideration department visits), and the scope of the
significant associations between should be somewhat below 0.080 ppm, Staff Paper analyses was generally
ambient O3 concentrations and lung the lowest-observed-effects level for limited to estimating exposures and
function decrements, respiratory effects such as pulmonary risks in 12 urban areas across the U.S.,
symptoms, indicators of respiratory inflammation, increased airway and to only five or just one area for
morbidity including increased responsiveness and impaired host- some risk analyses. The Staff Paper
emergency department visits and defense capabilities in healthy adults notes that it is clear that national-scale
hospitals admissions, and possibly while at prolonged moderate exertion. public health impacts of ambient O3
mortality reported in a large number of The Staff Paper also concludes that the exposures are much larger than the
studies likely extend down to ambient lower end to the range of alternative O3 quantitative estimates of O3-related
O3 concentrations that are well below standards appropriate for consideration incidences of adverse health effects and
the level of the current standard (EPA, should be the lowest-observed-effects the numbers of children likely to
2007, p. 6–60). Toward the lower end of level for potentially adverse lung experience exposures of concern
the range of O3 concentrations observed function decrements and respiratory associated with meeting the current or
in such studies, ranging down to symptoms in some healthy adults, 0.060 alternative standards. On the other
background levels, however, the Staff ppm. hand, due to individual variability in
paper states that there is increasing In addition to the evidence-based responsiveness, only a subset of
uncertainty as to whether the observed considerations informing staff individuals who are estimated to
associations remain plausibly related to recommendations on alternative levels, experience exposures of concern at and
exposures to ambient O3, rather than to the Staff Paper also evaluated above a specific benchmark level can be
the broader mix of air pollutants present quantitative exposures and health risks expected to experience certain adverse
in the ambient atmosphere. estimated to occur upon meeting the health effects, although susceptible
The Staff Paper also considered current and alternative standards.54 In subpopulations such as those with
so doing, it presented the important asthma are expected to be affected more
studies that did subset analyses that
uncertainties and limitations associated by such exposures than healthy
include only days with ambient O3
with these exposure and risk individuals. In taking these limitations
concentrations below the level of the
assessments. For example, the Staff into account, the Staff Paper reflected
current standard, or below even lower
Paper noted important uncertainties CASAC’s advice not to rely solely on the
O3 concentrations, and continue to
affecting the exposure estimates are results of the exposure and risk
report statistically significant
related to modeling human activity assessments in considering alternative
associations. Notably, as discussed
patterns over an O3 season (especially standards, but also to place significant
above, Bell et al. (2006) conducted a
repetitive exposures), modeling ambient weight on the body of evidence of O3-
subset analysis that continued to show
concentrations near roadways and related health effects in drawing
statistically significant associations even modeling building air exchange rates conclusions about an appropriate range
when only days with a maximum 8- which impact estimates of indoor O3 of levels for consideration.
hour average O3 concentration below a concentrations. With regard to the risk The Staff Paper focused on alternative
value of approximately 0.061 ppm were assessment, important uncertainties standards with the same form as the
included.53 Also of note is the large include, for example, those related to current O3 standard (i.e. the 0.074/4,
multi-city NCICAS (Mortimer et al., exposure estimates for children engaged 0.070/4 and 0.064/4 scenarios).55
2002) that reported statistically in moderate or greater exertion, as well Having concluded in the Staff Paper that
significant associations between as those related to estimation of it was appropriate to consider a range of
ambient O3 concentrations and lung concentration-response functions, standard levels from somewhat below
function decrements even when days specification of concentration-response 0.080 ppm down to as low as 0.060
with 8-hour average O3 levels greater ppm, the Staff Paper looked to results of
than 0.080 ppm were excluded (which 54 As described in the Staff Paper (section 4.5.8) the analyses of exposure and risk for the
consisted of less than 5 percent of the and discussed above, recent O3 air quality 0.074/4 scenario to represent the public
days in the eight urban areas in the distributions have been statistically adjusted to
health impacts of selecting a standard in
study). simulate just meeting the current and selected

alternative standards. These simulations do not
55 The abbreviated notation used to identify the
represent predictions of when, whether, or how
53 Bellet al. (2006) referred to this level as being areas might meet the specified standards. Modeling current and alternative standards in this section and
approximately equivalent to 120 µg/m3, daily 8- that projects whether and how areas might attain in the risk assessment section of the Staff Paper is
hour maximum, the World Health Organization alternative standards in a future year is presented in terms of ppm and the nth highest daily
guideline and European Commission target value in the Regulatory Impact Analysis being prepared maximum 8-hour average. For example, the current
for O3. in connection with this rulemaking. standard is identified as ‘‘0.084/4.’’
the upper part of the range, the results simulation, exposures of concern at this and hospital admissions, as well as non-
of analyses of the 0.070/4 scenario to level are estimated to be substantially accidental mortality.
represent the impacts in the middle part lower. A standard set at this level is A standard set at lower part of the
of the range, and the results of the estimated to reduce the number of all staff-recommended range (e.g., the
analyses of the 0.064/4 scenario to and asthmatic school age children 0.064/4 scenario), would result in an
represent the lower part of the range. estimated to experience one or more aggregate estimate of less than 0.5
As discussed in section II.B.1 of this moderate lung function decrements by percent of all and asthmatic school age
notice, the exposure estimates presented about 30 to 50 percent relative to the children likely to experience exposures
in the Staff Paper are for the number current standard, with city-to-city of concern at the 0.070 ppm benchmark
and percent of all children and differences accounting for most of the level using the 2002 simulation and
asthmatic children exposed, and the variability in estimates. A standard set only about 1 percent of all and
number of person-days (occurrences) of at this level is estimated to reduce non- asthmatic school age children in the city
exposures, with daily 8-hour maximum accidental mortality by about 10 to 40 with the least degree of protection from
exposures at or above several percent, with most of the variability this standard. At the benchmark level of
benchmark levels while at intermittent occurring across the 12 city estimates. 0.060 ppm, in aggregate using the 2002
moderate or greater exertion. For Using the 2002 simulation, a standard simulation about 5 percent of all and
reasons discussed above in section set at this level (the 0.074/4 scenario) is asthmatic school age children are
II.C.2, the Staff Paper focused on estimated to reduce the incidence of estimated to experience exposures of
exposures of concern at the 0.070 and symptom days in children with concern; this number ranges up to 15
0.060 ppm benchmark levels for the moderate to severe asthma in the Boston percent of all and asthmatic school age
purpose of evaluating alternative area by about 1,000 days, a 15 percent children in the city with the least degree
standard levels. As shown in the Table reduction relative to the current of protection from this standard. A
1 in this notice, the percent of standard. With this reduction, it is standard set at this level is estimated to
population exposed at any given level is estimated that about 1 respiratory reduce the number of all and asthmatic
very similar for all and asthmatic school symptom day in 8 during the O3 season school age children estimated to
age children. Substantial year-to-year would be attributable to O3 exposure. experience one or more moderate lung
variability in exposure estimates is Estimated incidence of respiratory- function decrements by about 40 to 75
observed, ranging to over an order of related hospital admissions was reduced percent over the current standard, and
magnitude at the higher alternative by 14 to 17 percent by a standard set at non-accidental mortality by about 25 to
standard levels, in estimates of the 75 percent, with most of the variability
this level relative to the current
number of children and the number of occurring across the 12 city estimates.
standard, in the year with relatively
occurrences of exposures of concern at A standard set at the 0.064/4 scenario
high and relatively low O3 air quality is estimated, based on the 2002
both of these benchmark levels. The
levels respectively. simulation, to reduce the incidence of
Staff Paper also notes that there is
substantial city-to-city variability in The Staff Paper notes that a standard symptom days in children with
these estimates, and notes that it is set at the middle part of the staff- moderate to severe asthma in the Boston
appropriate to consider not just the recommended range, as indicated by the area by about 1,900 days, about a 25 to
aggregate estimates across all cities, but estimates for the 0.070/4 scenario, 30 percent reduction over the current
also to consider the public health would reduce the exposures of concern standard. But even with this reduction,
impacts in cities that receive relatively at the 0.070 ppm level substantially over it is estimated that 1 respiratory
less protection from the alternative the current standard, resulting in an symptom day in 10 during the O3 season
standards. aggregate estimate of about 1.5 to nearly is attributable to O3 exposure. Estimated
As discussed in the Staff Paper, a 2 percent of all or asthmatic school age incidence of respiratory-related hospital
standard set at the upper part of the children likely to experience exposures admissions would be reduced by 30 to
range recommended by EPA staff (e.g., of concern even using the 2002 35 percent over the current standard, a
the 0.074/4 scenario) would result in an simulation, and leaving approximately 5 reduction of 125 to 150 hospital
aggregate estimate of about 4 percent of percent or less of children likely to admissions in the New York City area
all or asthmatic school age children experience exposures of concern in the alone, using the 2002 and 2004
likely to experience exposures of city with the least degree of protection. simulations, respectively.
concern at the ≥0.070 ppm benchmark Using the 2004 simulation, it essentially
eliminates exposures of concern at this b. CASAC Views
level based on the 2002 simulation, a
year with relatively high O3 levels, level. It reduces exposures of concern at As stated in its letter to the
while the estimates range up to 12 the 0.060 ppm benchmark level less so, Administrator, ‘‘the CASAC
percent of all or asthmatic school age leaving larger percentages of all school unanimously recommends that the
children in the single city with the least age children unprotected using the 2002 current primary ozone NAAQS be
degree of protection from this standard. simulation (about 15 percent in revised and that the level that should be
Using the 2004 simulation, a year with aggregate) or in the city with the least considered for the revised standard be
relatively low O3 levels, exposures of protection from this standard (about 33 from 0.060 to 0.070 ppm’’ (Henderson,
concern at this level are essentially percent). However, using the 2004 2006c, p. 5). This recommendation
eliminated. At the benchmark level of simulation, it is estimated to reduce follows from its more general
≥0.060 ppm, in aggregate using the 2002 exposures of concern at this benchmark recommendation, discussed above, that
simulation about 22 percent of all or level to approximately 5 percent or less the current standard of 0.084 ppm needs
asthmatic school age children are of children even in the city with the to be substantially reduced to be
estimated to experience exposures of least degree of protection. It provides protective of human health, particularly
concern; this estimate ranges up to considerable additional protection for in at-risk subpopulations. The CASAC
about 46 percent of all or asthmatic members of at-risk groups, over the Panel noted that beneficial reductions in
school age children in the single city current O3 standard, against respiratory some adverse health effects were
with the least degree of protection from morbidity effects such as lung function estimated to occur upon meeting the
this standard. Using the 2004 decrements, respiratory symptom days lowest standard level (0.064 ppm)
considered in the risk assessment standards within the range of the the clinical studies, and that the large
(Henderson, 2006c, p. 4). The lower end alternative levels and forms identified bulk of this evidence derives from
of this range reflects CASAC’s views above in lieu of the standards he is studies of exposures at levels of 0.080
that ‘‘[W]hile data exist that adverse proposing today. and above. At those levels, there is
health effects may occur at levels lower The Administrator’s consideration of consistent evidence of lung function
than 0.060 ppm, these data are less alternative levels of the primary O3 decrements and respiratory symptoms
certain and achievable gains in standard builds on his proposal, in healthy young adults, as well as
protecting human health can be discussed above, that the overall body of evidence of inflammation and other
accomplished through lowering the evidence indicates that the current 8- medically significant airway responses.
ozone NAAQS to a level between 0.060 hour O3 standard is not requisite to Moreover there is no evidence that the
and 0.070 ppm.’’ (id.). In a subsequent protect public health with an adequate 0.080 ppm level is a threshold for these
letter to the Administrator, the CASAC margin of safety because it does not effects. Although the Administrator
reiterated that the Panel members ‘‘were provide sufficient protection and that takes note of the very limited new
unanimous in recommending that the revision would result in increased evidence of lung function decrements
level of the current primary ozone public health protection, especially for and respiratory symptoms in some
standard should be lowered from 0.08 members of at-risk groups, notably healthy individuals at the 0.060 ppm
ppm to no greater than 0.070 ppm’’ including asthmatic children and other exposure level, he judges this evidence
(Henderson, 2007, p. 2). Further, the people with lung disease, as well as all too limited to support a primary focus
CASAC Panel expressed the view that children and older adults, especially at this level. The Administrator also
the Criteria Document and Staff Paper, those active outdoors, and outdoor notes that clinical studies, supported by
together with the information in its workers, against an array of adverse epidemiological studies, provide
earlier letter, provide ‘‘overwhelming health effects. These effects range from important new evidence that people
scientific evidence for this health outcomes that could be with asthma are likely to experience
recommendation,’’ and emphasized the quantified in the risk assessment, larger and more serious effects than
Clean Air Act requirement that the including decreased lung function, healthy people from exposure to O3.
primary standard must be set to protect respiratory symptoms, serious There are also epidemiological studies
the public health with an adequate indicators of respiratory morbidity such that provide evidence of statistically
margin of safety (id.). as hospital admissions for respiratory significant associations between short-
causes, and nonaccidental mortality, to term O3 exposures and more serious
c. Administrator’s Proposed health outcomes that could not be
Conclusions on Level health effects such as emergency
directly estimated, including pulmonary department visits and hospital
For the reasons discussed below, and inflammation, increased medication admissions, and premature mortality, in
taking into account information and use, emergency department visits, and areas that likely would have met the
assessments presented in the Criteria possibly cardiovascular-related current standard. There are also many
Document and Staff Paper, the advice morbidity effects. In reaching a epidemiological studies done in areas
and recommendations of CASAC, and proposed decision about the level of the that likely would not have met the
the public comments to date, the O3 primary standard, the Administrator current standard but which nonetheless
Administrator proposes to revise the has considered: the evidence-based report statistically significant
existing 8-hour primary O3 standard. considerations from the Criteria
Specifically, the Administrator proposes associations that generally extend down
Document and the Staff Paper; the
to revise (1) The level of the primary O3 to ambient O3 concentrations that are
results of the exposure and risk
standard to within a range from 0.070 to below the level of the current standard.
assessments discussed above and in the
0.075 ppm and (2) the degree of Further, there are a few studies that
Staff Paper, giving weight to the
precision to which the level of the have examined subsets of data that
exposure and risk assessments as judged
standard is specified to the thousandth include only days with ambient O3
appropriate; CASAC advice and
ppm. concentrations below the level of the
recommendations, as reflected in
However, in recognition of alternative current standard, or below even much
discussions of drafts of the Criteria
views of the science, the exposure and lower O3 concentrations, and continue
Document and Staff Paper at public
risk assessments and the uncertainties to report statistically significant
meetings, in separate written comments,
inherent in these assessments, and the and in CASAC’s letters to the associations with respiratory morbidity
appropriate policy responses based on Administrator; EPA staff outcomes and mortality. In considering
the currently available information, the recommendations; and public this evidence, the Administrator notes
Administrator also solicits comments on comments received during the that the extent to which these studies
whether to proceed instead with: (1) development of these documents, either provide evidence of causal relationships
Alternative levels of the 8-hour primary in connection with CASAC meetings or with exposures to O3 alone down to the
O3 standard, within ranges of below separately. In considering what 8-hour lowest levels observed remains
0.070 ppm down to 0.060 ppm and standard is requisite to protect public uncertain. To further inform the
above 0.075 ppm up to and including health with an adequate margin of interpretation of this evidence, EPA
retaining the current standard; (2) safety, the Administrator is mindful that seeks comment on the degree to which
alternative forms of the standard, this choice requires judgment based on associations observed in
including the 3-year average of the an interpretation of the evidence and epidemiological studies reflect causal
annual third- and fifth-highest daily other information that neither overstates relationships between important health
maximum 8-hour average O3 nor understates the strength and endpoints and exposure to O3 alone at
concentrations; and (3) retaining the limitations of the evidence and ambient O3 levels below the current
degree of precision of the current information nor the appropriate standard.
standard (to the nearest hundredth inferences to be drawn. Therefore, the Administrator judges
ppm). Based on the comments received The Administrator notes that the most that revising the current standard to
and the accompanying rationales, the certain evidence of adverse health protect public health with an adequate
Administrator may adopt other effects from exposure to O3 comes from margin of safety is warranted, and
would reduce risk to public health, from epidemiological studies. The associated with our understanding of
based on: (1) The strong body of clinical epidemiological studies do not identify the likelihood of such effects at lower
evidence in healthy people at exposure any bright-line threshold level for O3 exposure levels. In focusing on this
levels of 0.080 and above of lung effects. At the same time, the benchmark, the Administrator notes that
function decrements, respiratory epidemiological studies are not upon just meeting a standard within the
symptoms, pulmonary inflammation, themselves direct evidence of a causal range of 0.070 to 0.075 ppm based on
and other medically significant airway link between exposure to O3 and the the 2002 simulation, the number of
responses, as well as some indication of occurrence of the effects. The school age children likely to experience
lung function decrements and Administrator considers these studies in exposures at and above this benchmark
respiratory symptoms at lower levels; the context of all the other available level in aggregate (for the 12 cities in the
(2) the substantial body of clinical and evidence in evaluating the degree of assessment), is estimated to be
epidemiological evidence indicating certainty that O3-related adverse health approximately 2 to 4 percent of all and
that people with asthma are likely to effects would occur at various ambient asthmatic children, and generally less
experience larger and more serious levels below 0.080 ppm, including the than 10 percent of children even in
effects than healthy people; and (3) the strong human clinical studies and the cities that receive the least degree of
body of epidemiological evidence toxicological studies that demonstrate protection from such a standard in a
indicating associations are observed for the biological plausibility and recent year with relatively high O3
a wide range of serious health effects, mechanisms for the effects of O3 on levels. A standard within the 0.070 to
including respiratory emergency airway inflammation and increased 0.075 ppm range would thus
department visits and hospital airway responsiveness at exposure substantially reduce exposures of
admissions, and premature mortality, at levels of 0.080 ppm and above. concern by about 90 to 80 percent,
and below 0.080 ppm. The Based on consideration of the entire respectively, from those estimated to
Administrator also judges that the body of evidence and information occur upon just meeting the current
estimates of exposures of concern and available at this time, as well as the standard. While placing less weight on
risks remaining upon just meeting the recommendations of CASAC, the the results of the risk assessment, in
current standard or a standard at the Administrator proposes that a standard light of the important uncertainties
0.080 ppm level provide additional within the range of 0.070 to 0.075 ppm inherent in the assessment, the
support for this view. For the same would be requisite to protect public Administrator notes that the results
reasons, and the reasons discussed health with an adequate margin of indicate that a standard set within this
above in section II.C on the adequacy of safety. A standard level within this range would likely reduce risks to at-
the current standard, the Administrator range would reduce the risk of a variety risk groups from the O3-related health
judges that the standard should be set of health effects associated with effects considered in the risk
below 0.080 ppm, a level at which the exposure to O3, including the assessment, and by inference across the
evidence provides a high degree of respiratory symptoms and lung function much broader array of O3-related health
certainty about the adverse effects of O3 effects demonstrated in the clinical effects that can only be considered
exposure even in healthy people. studies, and the emergency department qualitatively, relative to the level of
The Administrator next considered visits, hospital admissions and mortality protection afforded by the current
what standard level below 0.080 ppm effects indicated in the epidemiological standard. This lends support to the
would be requisite to protect public studies. All of these effects are proposed range.
health with an adequate margin of indicative of a much broader array of
safety, that is sufficient but not more O3-related health endpoints, such as The Administrator judges that a
than necessary to achieve that result, school absences and increased standard set within the range of 0.070 to
recognizing that such a standard would medication use, that are plausibly 0.075 ppm would provide a degree of
result in increased public health linked to these observed effects. reduction in risk that is important from
protection. The assessment of a standard The Administrator considered the a public health perspective, and that a
level calls for consideration of both the degree of improvements in public health standard within this range would be
degree of additional protection that that potentially could be achieved by a requisite to protect public health,
alternative levels of the standard might standard of 0.070 to 0.075 ppm, giving including the health of at-risk groups,
be expected to provide as well as the weight to the exposure and risk with an adequate margin of safety.
certainty that any specific level will in assessments as he judged appropriate, as EPA’s evaluation of the body of
fact provide such protection. In the discussed below. In considering the scientific evidence and quantitative
circumstances present in this review, results of the exposure assessment, as estimates of exposures and risks
there is no evidence-based bright line discussed above (section II.C.4), the indicates that substantial reductions in
that indicates a single appropriate level; Administrator has primarily focused on public health risks would occur
instead there is a combination of exposures at and above the 0.070 ppm throughout this range. Because there is
scientific evidence and other benchmark level as an important no bright line clearly directing the
information that needs to be considered surrogate measure for potentially more choice of level within this reasonable
holistically in making this public health serious health effects for at-risk groups, range, the choice of what is appropriate,
policy judgment, and selecting a including people with asthma. In so considering the strengths and
standard level from a range of doing, the Administrator particularly limitations of the evidence, and the
reasonable values. notes that although the analysis of appropriate inferences to be drawn from
The Administrator notes that at ‘‘exposures of concern’’ was conducted the evidence and the exposure and risk
exposure levels below 0.080 ppm there to estimate exposures at and above three assessments, is a public health policy
is only a very limited amount of discrete benchmark levels, the concept judgment. To further inform this
evidence from clinical studies is appropriately viewed as a continuum. judgment, EPA seeks comment on the
indicating effects in some healthy As discussed above, the Administrator extent to which the epidemiological and
individuals at levels as low as 0.060 strives to balance concern about the clinical evidence provides guidance as
ppm. The great majority of the evidence potential for health effects and their to the level of a standard that would be
concerning effects below 0.080 ppm is severity with the increasing uncertainty requisite to protect public health with
an adequate margin of safety, especially between O3 exposures and the 0.060 ppm, these data are less certain
for at-risk groups. occurrence of the health effects and that achievable gains in protecting
In considering the available examined, such that the assessment human health can be accomplished
information, the Administrator also continues to indicate reductions in O3- through lowering the O3 NAAQS to a
judges that a standard level below 0.070 related risks upon meeting a lower level between 0.060 and 0.070 ppm. In
ppm would not be appropriate. In standard level. As discussed above, addition to the views of CASAC
reaching this judgment, the however, the Administrator recognizes described above, the Agency received
Administrator notes that there is only that evidence of a causal relationship the public comments described below.
quite limited evidence from clinical between adverse health effects and O3 One group of commenters submitted
studies at exposure levels below 0.080 exposures becomes increasingly comments that supported revising the
ppm O3. Moreover, the Administrator uncertain at lower levels of exposure. level of the primary O3 standard from
recognizes that in the body of Given all of the information available to 0.070 ppm down to or even below 0.060
epidemiological evidence, many studies him at this time, the Administrator ppm, consistent with or below the range
report positive and statistically judges that the increasing uncertainty of recommended by CASAC. In
significant associations, while others the existence and magnitude of considering the available evidence as a
report positive results that are not additional public health protection that basis for their views, these commenters
statistically significant, and a few do not standards below 0.070 ppm might generally noted that the controlled
report any positive O3-related provide suggests that such lower human exposure studies, showing
associations. In addition, the standard levels would likely be below statistically significant declines in lung
Administrator judges that evidence of a what is necessary to protect public function, and increases in respiratory
causal relationship between adverse health with an adequate margin of symptoms, airway inflammation and
health outcomes and O3 exposures safety. airway responsiveness at a 0.080 ppm
becomes increasingly uncertain at lower In addition, the Administrator judges exposure level, were conducted with
levels of exposure. that a standard level higher than 0.075 healthy adults, not members of at-risk
The Administrator also has ppm would also not be appropriate. groups including people with asthma
considered the results of the exposure This judgment takes into consideration and active children generally. Further,
assessments in reaching his judgment the information discussed above in recognizing the substantial variability in
that a standard level below 0.070 ppm section II.B, and is based on the strong response between subjects, some of
would not be appropriate. The body of clinical evidence in healthy these commenters felt that the number
Administrator notes that in considering people at exposure levels of 0.080 ppm of subjects included in these studies
the results from the exposure and above, the substantial body of was too small to ascertain the full range
assessment, a standard set at the 0.070 clinical and epidemiological evidence of responses, especially for at-risk
ppm level, with the same form as the indicating that people with asthma are groups. Such considerations in part
current standard, is estimated to provide likely to experience larger and more were the basis for these commenters’
substantial reductions in exposures of serious effects than healthy people, the view that an O3 standard set at 0.080
concern (i.e., approximately 90 to 92 body of epidemiological evidence ppm is not protective of public health
percent reductions in the numbers of indicating that associations are observed and has no margin of safety for at-risk
school age children and 94 percent for a wide range of more serious health groups. In addition, some of these
reduction in the total number of effects at levels below 0.080 ppm, and commenters also noted that the World
occurrences) for both all and asthmatic the estimates of exposure and risk Health Organization’s guidelines for O3
school age children relative to just remaining upon just meeting a standard air quality are in the range of 0.061 to
meeting the current standard based on set at 0.080 ppm. The much greater 0.051 ppm.
a simulation of a recent year with certainty of the existence and magnitude In considering the results of the
relatively high O3 levels (2002). Thus, a of additional public health protection human exposure and health risk
0.070 ppm standard would be expected that such levels would forego provides assessment, this group of commenters
to provide protection from the the basis for judging that levels above generally expressed the view that these
exposures of concern that the 0.075 ppm would be higher than what assessments substantially underestimate
Administrator has primarily focused on is requisite to protect public health, the public health impacts of exposure to
for over 98 percent of all and asthmatic including the health of at-risk groups, O3. For example, several commenters
school age children even in a year with with an adequate margin of safety. noted that the assessments are done for
relatively high O3 levels, increasing to For the reasons discussed above, the a limited number of cities, they do not
over 99.9 percent of children in a year Administrator proposes to revise the address risks to important at-risk
with relatively low O3 levels (2004). level of the primary O3 standard to subpopulations (e.g., outdoor workers,
In considering the results of the within the range of 0.070 to 0.075 ppm. active people who spend their summers
health risk assessment, as discussed in Having reached this decision based on outdoors, children up to 5 years of age),
section II.B above, the Administrator the approach to interpreting the and they do not include many health
notes that there are important evidence described above, the effects that are important from a public
uncertainties and assumptions inherent Administrator recognizes that other health perspective (e.g., school
in the risk assessment and that this approaches to selecting a standard level absences, restricted activity days).
assessment is most appropriately used have been presented to the Agency. As Further, some of these commenters
to simulate trends and patterns that can described above, the CASAC has stated expressed the view that the primary O3
be expected as well as providing in two letters to the Administrator standard should be set to protect the
informed but still imprecise estimates of (Henderson, 2006c; Henderson, 2007) its most exposed and most vulnerable
the potential magnitude of risks. The unanimous recommendation that the groups, and the fact that some children
Administrator particularly notes that as current primary O3 NAAQS be revised are frequently indoors, and thus at
lower standard levels are modeled, to within the range from 0.060 to 0.070 lower risk, should not weigh against
including a standard set at a level below ppm. The CASAC Panel noted that setting a standard to protect those
0.070 ppm, the risk assessment while data exist that adverse health children who are active outdoors. To the
continues to assume a causal link effects may occur at levels lower than extent the exposure and risk estimates
are considered, some of these example, some commenters asserted relevant background O3 levels
commenters felt that primary that the results of time-series studies including: (1) Stratospheric O3
consideration should be given to the should not be used at all in quantitative contributions to the mid- and upper
estimates based on 2002 air quality, for risk assessments, that risk estimates troposphere, which are relatively long-
which most areas had relatively higher from single city time-series studies lived (1 to 2 months), and are
O3 levels than in 2004, so as to ensure should not be used since they are highly transported downward to the surface
public health protection even in years heterogeneous and influenced by over time; (2) potential trends in
with relatively worse O3 air quality publication bias, and that risk estimates stratospheric O3 levels due to changes in
levels. Some commenters also felt that from multi-city studies should not be stratospheric circulation or to reduction
the exposure analysis should focus on a used in estimating risk for individual of O3 depleting chemicals; (3) O3 levels
benchmark concentration for exposures cities. This group of commenters also due to lightning strikes in estimating
of concern at the 0.060 ppm level, the generally expressed the view that the policy-relevant background
lower end of the range of alternative assessments generally overestimate the concentrations; and (4) potential
standards advocated by the CASAC public health impacts of exposure to O3. uncertainty with regard to policy-
Panel. Noting that the risk assessment used a relevant background O3 levels having to
In sharp contrast to the views nonlinear exposure-response function to do with increases in O3 precursors
discussed above, other public estimate decreased lung function risks, elsewhere in the world. EPA asks for
commenters supported retaining the some commenters expressed the view comments on these issues and on how
current standard. In considering the that a nonlinear approach should also they may relate to the estimation and
available evidence as a basis for their be used to assess other acute morbidity consideration of policy-relevant
views, these commenters challenged a effects and mortality. This view was in background levels in setting the O3
number of aspects of the interpretation part based on judgments that it is not standards.
of the evidence presented in the Criteria possible to determine if thresholds exist Several Governors, State Legislators,
Document. For example, some of these using time-series analyses and that the and other local officials have expressed
commenters asserted that EPA generally lack of association of O3 to mortality in concerns related to a more stringent
overestimates the magnitude and the winter season is highly supportive standard. These officials recognize that
consistency of the results of short-term of the likelihood of the existence of an State and local governments have
exposure epidemiological studies (e.g., effect threshold. With regard to the risk important roles in developing and
for respiratory symptoms, school assessment based on controlled human implementing policy that improve air
absences, hospital admissions, exposure studies of lung function quality while at the same time achieving
mortality), mistakenly links statistical decrements, some commenters economic and quality of life objectives.
significance and consistency with expressed the view that the assessment In addition, these officials note that
strength of associations, and should not rely on what they States are just beginning to implement
underestimates the uncertainties in characterized as ‘‘outlier’’ information current air quality standards and raise
interpreting the results of such studies. to define exposure-response concern with moving forward on
Further, these commenters generally relationships, with reference to the data revised standards without first realizing
express the view that there is significant in the Adams (2006) study at the 0.060 the results from the last revision.
uncertainty related to the reliability of As a related concern, a number of
and 0.040 ppm exposure levels, but
estimates from time-series studies, in areas—including some of the cities
rather should focus on group central
that ambient monitors do not provide involved in the risk assessment—will
tendency response levels. Further, some
reliable estimates of personal exposures, have difficulty in complying with the
commenters expressed the view that the
such that the small reported morbidity current 8-hour standard within the next
air quality rollback algorithm used decade. As a result, the full public
and mortality risks are unlikely to be
introduces significant uncertainty, health gains in these areas from a more
attributable to people’s exposures to O3.
especially when applied to areas stringent 8-hour standard are unlikely to
Rather, these commenters variously
requiring very large reductions in air be realized for a number of years. In
attribute the reported risks to the
quality to meet the alternative standards light of the fact that these public health
inability of time series studies to
examined, and may result in gains may not fully materialize within
account for key model specification
overestimates in benefits from emission the attainment date structure set forth in
factors such as smoothing for time-
varying parameters, meteorological reductions. Some commenters noted the Clean Air Act, some commenters
factors, and removal of O3 by building that potential beneficial effects of O3 in question whether the Agency can or
ventilation systems, and confounding by shielding from UV–B radiation are not should consider these projected gains as
co-pollutants. In particular, these quantified in the assessment, and that a health based criterion for its
commenters generally asserted that the assessment should discuss the decisionmaking. EPA requests comment
reported associations between short- evidence for both adverse and beneficial on this view.
term O3 exposure and mortality are not effects with the same objectivity. The Administrator is mindful that the
causal, in that the reported relative risks Finally, some of these commenters country has important goals related to
are too small to provide a basis for asserted that since estimates of the increased production and use of
inferring causality and the associations exposures of concern (which they renewable energy, and that these new
are most likely due to confounding, defined as the benchmark concentration energy sources can have important
inappropriately specified statistical of 0.080 ppm) and lung function public health, environmental and other
models, or publication bias. decrements are substantially below the benefits, such as national security
In considering the results of the estimates available when the current O3 benefits. In some contexts and
human exposure and health risk standard was set in 1997, retaining the situations, however, the use of
assessment, this group of commenters current standard is the most appropriate renewable fuels may impact compliance
generally expressed the view that these policy alternative. with a lowered ozone NAAQS standard.
assessments are based on a number of Some commenters also have raised For example, the Agency recently
studies that should not be used in concerns about potential uncertainties promulgated final regulations pursuant
quantitative risk assessment. For with regard to estimating policy- to section 211(o) of the Clean Air Act,
which was enacted as part of the Energy E. Proposed Decision on the Primary The AQI establishes a nationally
Policy Act of 2005. This provision Standard uniform system of indexing pollution
requires the use of 7.5 billion gallons of For the reasons discussed above, and levels for O3, carbon monoxide, nitrogen
renewable fuel by 2012, a level which taking into account information and dioxide, particulate matter and sulfur
will be greatly exceeded in practice. In assessments presented in the Criteria dioxide. The AQI converts pollutant
the Regulatory Impact Analysis which Document and Staff Paper, the advice concentrations in a community’s air to
accompanied the renewable fuel and recommendations of CASAC, and a number on a scale from 0 to 500.
regulations, the Agency recognized the the public comments to date, the Reported AQI values enable the public
impact of this program on emissions Administrator proposes to revise the to know whether air pollution levels in
related to ozone, toxics and greenhouse existing 8-hour primary O3 standard. a particular location are characterized as
gases and otherwise reviewed the good (0–50), moderate (51–100),
Specifically, the Administrator proposes
impacts on energy security. The unhealthy for sensitive groups (101–
to revise: (1) The level of the primary O3
Administrator requests comment on 150), unhealthy (151–200), very
standard to within a range from 0.070 to
such factors and any relationship to this unhealthy (201–300), or hazardous
0.075 ppm and (2) the degree of
rulemaking, including the extent of (300–500). The AQI index value of 100
precision to which the level of the
EPA’s discretion under the Clean Air typically corresponds to the level of the
standard is specified to the thousandth
Act to take such factors into account short-term NAAQS for each pollutant.
ppm. The proposed 8-hour primary
(see section I.A). For the current O3 NAAQS, an 8-hour
standard, with a level in the range of
In general, these commenters’ average concentration of 0.084 ppm
0.070 to 0.075 ppm, would be met at an
concerns are consistent with the view corresponds to an AQI value of 100. An
ambient air monitoring site when the 3- AQI value greater than 100 means that
that adopting a more stringent 8-hour year average of the annual forth-highest
standard now, without a better a pollutant is in one of the unhealthy
daily maximum 8-hour average O3 categories (i.e., unhealthy for sensitive
understanding of the health effects concentration is less than or equal to the
associated with O3 exposure at lower groups, unhealthy, very unhealthy, or
level of the standard that is hazardous) on a given day; an AQI value
levels, would have an uncertain public promulgated. Data handling
health benefit. The Administrator at or below 100 means that a pollutant
conventions are specified in the concentration is in one of the
recognizes that commenters have raised proposed creation of Appendix P, as
numerous concerns regarding various satisfactory categories (i.e., moderate or
discussed in section V below. good). Decisions about the pollutant
types of uncertainties in the available However, in recognition of alternative
information, including for example concentrations at which to set the
views of the science, the exposure and various AQI breakpoints, that delineate
uncertainties in (1) The assessment of risk assessments and the uncertainties
exposures, (2) the estimation of the various AQI categories, draw
inherent in these assessments, and the directly from the underlying health
concentration-response associations in appropriate policy responses based on
the epidemiological studies, (3) the information that supports the NAAQS
the currently available information, the review.
potential role of co-pollutants in Administrator also solicits comments on The Agency recognizes the
interpreting the reported associations in whether to proceed instead with: (1) importance of revising the AQI in a
epidemiological studies, and (4) the Alternative levels of the 8-hour primary timely manner to be consistent with any
estimation of background O3 standard, within ranges of below revisions to the NAAQS. Therefore EPA
concentrations. The Administrator has 0.070 ppm down to 0.060 ppm and proposes to finalize conforming changes
heard these concerns from Governors above 0.075 ppm up to and including to the AQI, in connection with the
and other commenters and invites retaining the current standard; (2) Agency’s final decision on the O3
comment on whether it would be alternative forms of the standard, NAAQS if revisions to the primary
appropriate to retain the existing including the 3-year average of the standard are promulgated. These
standard and delay considering annual third- and fifth-highest daily conforming changes would include
modification of the 8-hour standard maximum 8-hour average O3 setting the 100 level of the AQI at the
until the next NAAQS review, when a concentrations; and (3) retaining the same level as the revised primary O3
more complete body of information is degree of precision of the current NAAQS, and also making proportional
expected to be available. standard (to the nearest hundredth adjustments to AQI breakpoints at the
Consistent with the goal of soliciting ppm). Based on the comments received lower end of the range (i.e., AQI values
comment on a wide array of views, the and the accompanying rationales, the of 50, 150 and 200). EPA does not
Administrator also solicits comments on Administrator may adopt other propose to change breakpoints at the
these alternative approaches and views, standards within the range of the higher end of the range (from 300 to
and on related standard levels, alternative levels and forms identified 500), which would apply to state
including levels down to 0.060 ppm and above in lieu of the standards he is contingency plans or the Significant
up to retaining the level of the current proposing today. Harm Level (40 CFR 51.16), because the
8-hour standard (i.e., effectively 0.084 information from this review does not
ppm with the current rounding III. Communication of Public Health
Information inform decisions about breakpoints at
convention). The Administrator those higher levels.
recognizes that these sharply divergent Information on the public health
views on the appropriate level of the implications of ambient concentrations IV. Rationale for Proposed Decision on
standard are based on very different of criteria pollutants is currently made the Secondary Standard
interpretations of the science itself, available primarily through EPA’s Air This section presents the rationale for
including its relative strengths and Quality Index (AQI) program. The the Administrator’s proposed decision
limitations, very different judgments as current Air Quality Index has been in to revise the existing 0.08 ppm, 8-hour
to how such scientific evidence should use since its inception in 1999 (64 FR O3 secondary NAAQS. The
be used in making policy decisions on 42530). It provides accurate, timely, and Administrator proposes to revise the
proposed standards, and very different easily understandable information about current secondary standard by replacing
public health policy judgments. daily levels of pollution (40 CFR 58.50). it with one of two standard options. One
option is to adopt a new cumulative, the 12-hour daylight period (8 a.m. to 8 as the sum of sigmoidally weighted
seasonal concentration-weighted form, p.m.) during the consecutive 3-month hourly O3 concentrations over a
set at an annual level in the range of 7 period within the O3 monitoring season specified period, where the daily
to 21 ppm-hours. This standard would with the maximum index value. This sigmoidal weighting function is defined
be expressed as a sum of weighted concentration-weighted form is as:
hourly concentrations, cumulated over commonly called W126, and is defined
i < 7 PM
1
W126 = ∑
i = 8 AM
w Ci Ci , where Ci = hourly O3 at hour i, and w Ci =
1 + 4403e −126 Ci
.
The other option is to revise the current effects associated with exposure to deliberate. In the judgment of the
secondary standard by making it ambient levels of O3 (EPA, 2006a, Administrator, the intensive evaluation
identical to the proposed 8-hour chapter 9). In addition, because O3 can of the scientific evidence that has
primary standard, within the proposed also indirectly affect other ecosystem occurred in this review has provided an
range of 0.070 to 0.075 ppm. For this components such as soils, water, and adequate basis for regulatory decision-
option, EPA also solicits comment on a wildlife, and their associated ecosystem making at this time. This review also
wider range of 8-hour secondary goods and services, through its effects provides important input to EPA’s
standard levels, including down to on vegetation, a qualitative discussion research plan for improving our future
0.060 ppm and up to and including of these other indirect impacts is also understanding of the effects of ambient
retaining the current 8-hour secondary included, though these effects are not O3 at lower levels.
standard of 0.08 ppm. The quantifiable at this time. As was
Administrator has also considered and concluded in the 1997 review, and A. Vegetation Effects Information
solicits comment on an alternative based on the body of scientific literature This section outlines key information
approach to setting a cumulative, assessed in the current Criteria contained in the Criteria Document
seasonal standard(s). Document, the Administrator believes (chapter 9) and in the Staff Paper
As discussed more fully below, the that it is reasonable to conclude that a (chapter 7) on known or potential effects
rationale for these proposed options is secondary standard protecting the on public welfare which may be
based on a thorough review of the latest public welfare from known or expected from the presence of O3 in
scientific information on vegetation anticipated adverse effects to trees, ambient air. The information
effects associated with exposure to native vegetation and crops would also highlighted here summarizes: (1) New
ambient levels of O3, as assessed in the afford increased protection from adverse information available on potential
Criteria Document. This rationale also effects to other environmental mechanisms for vegetation effects
takes into account: (1) Staff assessments components relevant to the public associated with exposure to O3; (2) the
of the most policy-relevant information welfare, including ecosystem services nature of effects on vegetation that have
in the Criteria Document regarding the and function. The peer-reviewed been associated with exposure to O3 and
evidence of adverse effects of O3 to literature includes studies conducted in consequent potential impacts on
vegetation and ecosystems, information the U.S., Canada, Europe, and many ecosystems; and (3) considerations in
on biologically-relevant exposure other countries around the world. In its characterizing what constitutes an
metrics, and staff analyses of air quality, assessment of the evidence judged to be adverse welfare impact of O3.
vegetation exposure and risks, presented most relevant to making decisions on Exposures to O3 have been associated
in the Staff Paper and described in the level of the O3 secondary standard, quantitatively and qualitatively with a
greater detail in the associated however, EPA has placed greater weight wide range of vegetation effects. The
Technical Report on Ozone Exposure, on U.S. studies, due to the often decision in the last review to set a more
Risk, and Impact Assessments for species-, site- and climate-specific protective secondary standard primarily
Vegetation (Abt, 2007), upon which staff nature of O3-related vegetation response. reflected consideration of the
recommendations for revisions to the As with virtually any policy-relevant quantitative information on vegetation
secondary O3 standard are based; (2) vegetation effects research, there is effects available at that time,
CASAC advice and recommendations as uncertainty in the characterization of particularly growth impairment (e.g.,
reflected in discussion of drafts of the vegetation effects attributable to biomass loss) in sensitive forest tree
Criteria Document and Staff Paper at exposure to ambient O3. As discussed species during the seedling growth stage
public meetings, in separate written below, however, research conducted and yield loss in important commercial
comments, and in CASAC’s letters to since the last review provides important crops. This information, derived mainly
the Administrator (Henderson, 2006a, b, information coming from field-based using the OTC exposure method, found
c; 2007); (3) public comments received exposure studies, including free air, cumulative, seasonal O3 exposures were
during development of these documents gradient and biomonitoring surveys, in most strongly associated with observed
either in conjunction with CASAC addition to the more traditional vegetation response. The Criteria
meetings or separately; and (4) controlled open top chamber (OTC) Document prepared for this review
consideration of the degree of protection studies. Moreover, the newly available discusses a number of additional studies
to vegetation potentially afforded by the studies evaluated in the Criteria that support and strengthen key
proposed 8-hour primary standard. Document have undergone intensive conclusions regarding O3 effects on
In developing this rationale, EPA has scrutiny through multiple layers of peer vegetation and ecosystems found in the
again focused on direct O3 effects on review and many opportunities for previous Criteria Document (EPA,
vegetation, specifically drawing upon an public review and comment. While 1996a, 2006a), including further
integrative synthesis of the entire body important uncertainties remain, the clarification of the underlying
of evidence, published through early review of the vegetation effects mechanistic and physiological processes
2006, on the broad array of vegetation information has been extensive and at the subcellular, cellular, and whole
EP11JY07.001</GPH>
system levels within the plant. More which further modifies ambient air the plant is able to repair or compensate
importantly, however, in the context of exchange with individual leaves. Not all for the O3 impacts (Tingey and Taylor,
this review, new quantitative O3 entering a plant canopy is absorbed 1982; U.S. EPA, 1996a). A few studies
information is now available across a into the leaf stomata, but may be have documented direct stomatal
broader array of vegetation effects (e.g., adsorbed to other surfaces e.g., leaf closure or restriction in the presence of
growth impairment during seedlings, cuticles, stems, and soil (termed non- O3 in some species. This response may
saplings and mature tree growth stages, stomatal deposition) or scavenged by be initiated ranging from within
visible foliar injury, and yield loss in reactions with intra-canopy biogenic minutes to hours or days of exposure
annual crops) and across a more diverse VOCs and naturally occurring NOX (Moldau et al., 1990; Dann and Pell,
set of exposure methods, including emissions from soils. Because O3 does 1989; Weber et al., 1993). However,
chamber, free air, gradient, model, and not penetrate the leaf’s cuticle, it must exclusion of O3 simultaneously restricts
field-based observation. These non- reach the stomatal openings in the leaf the uptake of CO2, which also limits
chambered, field-based study results for absorption to occur. The movement photosynthesis and growth. In addition,
begin to address one of the key data of O3 and other gases such as CO2 into antioxidants present in plants can
gaps cited by the Administrator in the and out of leaves is controlled by effectively protect tissue against damage
last review. stomatal guard cells that regulate the from low levels of oxidants by
The following discussion of the size of the stomatal apertures. These dissipating excess oxidizing power.
policy-relevant science regarding guard cells respond to a variety of Since 1996, the role of detoxification in
vegetation effects associated with internal species-specific factors as well providing a level of resistance to O3 has
cumulative, seasonal exposures to as external site specific environmental been further investigated. A number of
ambient levels of O3 integrates factors such as light, temperature, antioxidants have been found in plants.
information from the Criteria Document humidity, CO2 concentration, soil However, the pattern of changes in the
(chapter 9) and the Staff Paper (chapter fertility and water status, and in some amounts of these antioxidants varies
7). cases the presence of air pollutants, greatly among different species and
1. Mechanisms Governing Plant including O3. These modifying factors conditions. Most recent reports indicate
Response to Ozone produce stomatal conductance that vary that ascorbate within the cell wall
between leaves of the same plant, provides the first significant
The interpretation of predictions of individuals and genotypes within a opportunity for detoxification to occur.
risk associated with vegetation response species and diurnally and seasonally. In spite of the new research, however,
at ambient O3 exposure levels can be
b. Cellular to Systemic Response it is still not clear as to what extent
informed by scientific understanding
detoxification protects against O3 injury.
regarding O3 impacts at the genetic, Once inside the leaf, O3 can react with
physiological, and mechanistic levels. Specifically, data are needed on
a variety of biochemical compounds
In most cases, the mechanisms of potential rates of antioxidant
that are exposed to the air spaces within
response are similar regardless of the production, subcellular location(s) of
the leaf or it can be dissolved into the
degree of sensitivity of the species. The antioxidants, and whether generation of
water lining the cell wall of the air
evidence assessed in the 2006 Criteria these antioxidants in response to O3-
spaces. Having entered the aqueous
Document (EPA, 2006a) regarding the induced stress potentially diverts
phase, O3 can be rapidly altered to form
O3-induced changes in physiology resources and energy away from other
oxidative products that can diffuse more
continues to support the information readily into and through the cell and vital uses. Thus, the Criteria Document
discussed in the last review (EPA, react with many biochemical concludes that scientific understanding
1996a, 2006a). In addition, during the compounds. An early step in a series of of the detoxification mechanisms is not
last decade understanding of the O3-induced events that leads to leaf yet complete and requires further
cellular processes within plants has injury seems to involve alteration in cell investigation (EPA, 2006a).
been further clarified and enhanced. membrane function, including Once O3 injury has occurred in leaf
Therefore, this section reviews the key membrane transport properties (EPA, tissue, some plants are able to repair or
scientific conclusions identified in 1996 2006a). One such signaling molecule is compensate for the impacts. In general,
Criteria Document (EPA, 1996a), and hydrogen peroxide (H2O2). The presence plants have a variety of compensatory
incorporates new information from the of higher-than-normal levels of H2O2 mechanisms for low levels of stress
current Criteria Document (EPA, 2006a). within the leaf is a potential trigger for including reallocation of resources,
This section describes: (1) Plant uptake a set of metabolic reactions that include changes in root/shoot ratio, production
of O3, (2) O3-induced cellular to those typical of the well documented of new tissue, and/or biochemical shifts,
systemic response, (3) plant ‘‘wounding’’ response or pathogen such as increased photosynthetic
compensation and detoxification defense pathway generated by cutting of capacity in new foliage and changes in
mechanisms, (4) O3-induced changes to the leaf or by pathogen/insect attack. respiration rates, indicating possible
plant metabolism, and (5) plant Ethylene is another compound repair or replacement of damaged
response to chronic O3 exposures. produced when plants are subjected to membranes or enzymes. Since these
biotic or abiotic stressors. Increased mechanisms are genetically determined,
a. Plant Uptake of Ozone not all plants have the same
ethylene production by plants exposed
To cause injury, O3 must first enter to O3 stress was identified as a complement or degree of tolerance, nor
the plant through openings in the leaves consistent marker for O3 exposure in are all stages of a plant’s development
called stomata. Leaves exist in a three studies conducted decades ago (Tingey equally sensitive to O3. At higher levels
dimensional environment called the or over longer periods of O3 stress, some
et al., 1976).
plant canopy, where each leaf has a of these compensatory mechanisms,
unique orientation and receives a c. Compensation and Detoxification such as a reallocation of resources away
different exposure to ambient air, Ozone injury will not occur if (1) the from storage in the roots in favor of
microclimatological conditions, and rate and amount of O3 uptake is small leaves or shoots, could occur at a cost
sunlight. In addition, a plant may be enough for the plant to detoxify or to the overall health of the plant.
located within a stand of other plants metabolize O3 or its metabolites or (2) However, it is not yet clear to what
degree or how the use of plant resources fully understood how chronic O3 affects implications for the below-ground
for repair or compensatory processes long-term growth and resistance to other communities at those sites. Because
affects the overall carbohydrate budget biotic and abiotic insults in long-lived effects on leaf and needle carbohydrate
or subsequent plant response to O3 or trees, accumulation of these carry-over content under O3 stress can range from
other stresses (EPA, 1996a, EPA, 2006a). effects over time could affect survival a reduction (Barnes et al., 1990; Miller
and reproduction. et al., 1989), to no effect (Alscher et al.,
d. Changes to Plant Metabolism
1989), to an increase (Luethy-Krause
Ozone inhibits photosynthesis, the 2. Nature of Effects
and Landolt, 1990), studies that
process by which plants produce energy Ozone injury at the cellular level, examine only above-ground vegetative
rich compounds (e.g., carbohydrates) in when it has accumulated sufficiently, components may miss important O3-
the leaves. This impairment can result will be propagated to the level of the induced changes below ground. These
from direct impact to chloroplast whole leaf or plant. These larger scale below-ground changes could signal a
function and/or O3-induced stomatal effects can include: Reduced shift in nutrient cycling with
closure resulting in reduced uptake of carbohydrate production and/or significance at the ecosystem level
CO2. A large body of literature reallocation; reduced growth and/or (Young and Sanzone, 2002).
published since 1996 has further reproduction; visible foliar injury and/
elucidated the mechanism of the effect or premature senescence; and reduced b. Growth Effects on Trees
of O3 within the chloroplast. Pell et al. plant vigor. Much of what is now Studies comparing the O3-related
(1997) showed that O3 exposure results known about these O3-related effects, as growth response of different vegetation
in a loss of the central carboxylating summarized below, is based on research types (coniferous and deciduous) and
enzyme that plays an important role in that was available in the last review. growth stages (e.g., seedling and mature)
the production of carbohydrates. Due to Recent studies continue to support and have established that on average,
its central importance, any decrease in expand this knowledge (EPA, 2006a). individual coniferous trees are less
this enzyme may have severe sensitive than deciduous trees, and
a. Carbohydrate Production and
consequences for the plant’s deciduous trees are generally less
Allocation
productivity. Several recent studies sensitive to O3 than most annual plants,
have found that O3 has a greater effect When total plant photosynthesis is with the exception of a few fast growing
as leaves age, with the greatest impact sufficiently reduced, the plant will deciduous tree species (e.g., quaking
of O3 occurring on the oldest leaves respond by reallocating the remaining aspen, black cherry, and cottonwood),
(Fiscus et al., 1997; Reid and Fiscus, carbohydrate at the level of the whole which are highly sensitive and, in some
1998; Noormets et al., 2001; Morgan et organism. Many studies have cases, as much or more sensitive to O3
al., 2004). The loss of this key enzyme demonstrated that root growth is more than sensitive annual plants. In
as a function of increasing O3 exposure sensitive to O3 exposure than stem or addition, studies have shown that the
is also linked to an early senescence or leaf growth (EPA, 2006a). When fewer relationship between O3 sensitivity in
a speeding up of normal development carbohydrates are present in the roots, seedling and mature growth stages of
leading to senescence. If total plant less energy will be available for root- trees can vary widely, with seedling
photosynthesis is sufficiently reduced, related functions such as acquisition of growth being more sensitive to O3
the plant will respond by reallocating water and nutrients. In addition, by exposures in some species, while in
the remaining carbohydrate at the level inhibiting photosynthesis and the others, the mature growth stage is the
of the whole organism (EPA, 1996a, amount of carbohydrates available for more O3 sensitive. In general, mature
2006a). This reallocation of transfer to the roots O3 can disrupt the deciduous trees are likely to be more
carbohydrate away from the roots into association between soil fungi and host sensitive to O3 than deciduous
above ground vegetative components plants. Fungi in the soil form a seedlings, and mature evergreen trees
can have serious implications for symbiotic relationship with many are likely to be less sensitive to O3 than
perennial species. terrestrial plants. For host plants, these their seedling counterparts. Based on
fungi improve the uptake of nutrients, these results, stomatal conductance, O3
e. Plant Response to Chronic Ozone protect the roots against pathogens, uptake, and O3 effects cannot be
Exposures produce plant growth hormones, and assumed to be equivalent in seedlings
Though many changes that occur with may transport carbohydrates from one and mature trees.
O3 exposure can be observed within plant to another (EPA, 1996a). These In the last review (EPA, 1996b),
hours, or perhaps days, of the exposure, below-ground effects have recently been analyses of the effects of O3 on trees
including those connected with documented in the field (Grulke et al., were limited to 11 tree species for
wounding, other effects take longer to 1998; Grulke and Balduman, 1999). Data which concentration-response (C–R)
occur and tend to become most obvious from a long-studied pollution gradient functions for the seedling growth stage
after chronic exposures to low O3 in the San Bernardino Mountains of had been developed from OTC studies
concentrations. These chronic southern California suggest that O3 conducted by the National Health and
exposures have been linked to substantially reduces root growth in Environmental Effects Research Lab,
senescence or some other physiological natural stands of Ponderosa pine (Pinus Western Ecology Division (NHEERL–
response very closely linked to ponderosa). Root growth in mature trees WED). A number of replicate studies
senescence. In perennial plant species, was decreased at least 87 percent in a were conducted on these species,
a reduction in carbohydrate storage in high-pollution site as compared to a leading to a total of 49 experimental
one year may result in the limitation of low-pollution site (Grulke et al., 1998), cases. The Staff Paper presented a graph
growth the following year (Andersen et and a similar pattern was found in a of the composite regression equation
al., 1997). Such ‘‘carry-over’’ effects separate study with whole-tree harvest that combines the results of the C–R
have been documented in the growth of along this gradient (Grulke and functions developed for each of the 49
tree seedlings (Hogsett et al., 1989; Balduman, 1999). Though effects on cases. The NHEERL–WED study
Sasek et al., 1991; Temple et al., 1993; other ecosystem components were not predicted relative yield loss at various
EPA, 1996a) and in roots (Andersen et examined, a reduction of root growth of exposure levels in terms of a 12-hour
al., 1991; EPA, 1996a). Though it is not this magnitude could have significant W126. For example, 50 percent of the
tree seedling cases would be protected from a series of orifices placed along the important support for the
from greater than 10 percent biomass length of the vertical pipes surrounding appropriateness of continued use of the
loss at a 3-month, 12-hour W126 of a circular field plot and uses the C–R functions derived using OTC from
approximately 24 ppm-hrs, while 75 prevailing wind to distribute it. This the NHEERL–WED studies to estimate
percent of cases would be protected exposure method has many risk to these tree seedlings under
from 10 percent biomass loss at a 3- characteristics that differ from those ambient field exposure conditions.
month, 12-hour W126 level of associated with the OTC. These studies make a significant
approximately 16 ppm-hrs. Most significantly, this exposure contribution to the coherence in the
Since the 1996 review, only a few method more closely replicates weight of evidence available in this
studies have developed C–R functions conditions in the field than did OTCs. review and provide additional evidence
for additional tree seedling species This is because, except for O3 levels that O3-induced effects observed in
(EPA, 2006a). One such study is of which are varied across co-located plots, chambers also occur in the field.
particular importance in that it plants are exposed to the same ambient Trees and other perennials, in
documented growth effects from O3 growing conditions that occur naturally addition to cumulating the effects of O3
exposure in the field without the use of in the field (e.g., location-specific exposures over the annual growing
chambers or other fumigation methods pollutant mixtures; climate conditions season, can also cumulate effects across
that were as great as those seen in OTC such as light, temperature and multiple years. It has been reported that
studies (Gregg et al., 2003). This study precipitation; insect pests, pathogens). effects can ‘‘carry over’’ from one year
placed Eastern cottonwood (Populus By using one of several co-located plots to another (EPA, 2006a). Growth
deltoides) saplings at sites along a as a control (e.g., receives no additional affected by a reduction in carbohydrate
continuum of ambient O3 exposures that O3), and by exposing the other rings to storage in one year may result in the
gradually increased from urban to rural differing levels of elevated O3, the limitation of growth in the following
areas in the New York City area (Gregg growth response signal that is due solely year (Andersen, et al., 1997). Carry-over
et al., 2003). Eastern cottonwood was to the change in O3 exposure can be effects have been documented in the
selected because it is fast growing, O3 clearly determined. Furthermore, the growth of some tree seedlings (Hogsett
sensitive and important ecologically, FACE system can expand vertically with et al. 1989; Simini et al., 1992; Temple
along stream banks, and commercially the growth of trees, allowing for et al., 1993) and in roots (Andersen et
for pulpwood, furniture manufacturing, exposure experiments to span numerous al., 1991; EPA, 1996a). On the basis of
and as a possible new source for energy years, an especially useful capability in past and recent OTC and field study
biomass (Burns and Hankola, 1990). forest research. data, ambient O3 exposures that occur
Gregg et al. (2003) found that the On the other hand, the FACE during the growing season in the United
cottonwood saplings grown in New methodology also has the undesirable States are sufficient to potentially affect
York City grew faster than saplings characteristic of potentially creating the annual growth of a number of
grown in downwind rural areas. hotspots near O3 gas release orifices or sensitive seedling tree species.
Because these saplings were grown in gradients of exposure in the outer ring However, because most studies do not
pots with carefully controlled soil of trees within the plots, such that take into account the possibility of carry
nutrient and moisture levels, the averaging results across the entire ring over effects on growth in subsequent
authors were able to control for most of potentially overestimates the response. years, the true implication of these
the differences between sites. After In recognition of this possibility, annual biomass losses may be missed. It
carefully considering these and other researchers at the AspenFACE is likely that under ambient exposure
factors, the authors concluded the experimental site only measured trees in conditions, some sensitive trees and
primary explanation for the difference the center core of each ring, (e.g., at least perennial plants could experience
in growth was the gradient of 5–6 meters away from the emission sites compounded impacts that result from
cumulative O3 exposures that increased of O3) (Dickson et al., 2000; Karnosky et multiple year exposures.
as one moved downwind from urban to al. 2005). By taking this precaution, it is c. Visible Foliar Injury
less urban and more rural sites. It was unlikely that their measurements were
determined that the lower O3 exposure Cellular injury can and often does
influenced by any potential hotspots or become visible. Acute injury usually
within the city center was due to NOX gradients of exposure within the FACE
titration reactions which removed O3 appears within 24 hours after exposure
rings. Taking all of the above into to O3 and, depending on species, can
from the ambient air. The authors were
account, results from the Wisconsin occur under a range of exposures and
able to reproduce the growth responses
FACE site on quaking aspen appear to durations from 0.040 ppm for a period
observed in the field in a companion
demonstrate that the detrimental effects of 4 hours to 0.410 ppm for 0.5 hours
OTC experiment, confirming O3 as the
of O3 exposure seen on tree growth and for crops and 0.060 ppm for 4 hours to
stressor inducing the growth loss
symptom expression in OTCs can be 0.510 ppm for 1 hour for trees and
response (Gregg et al., 2003).
Another recent set of studies observed in the field using this exposure shrubs (Jacobson, 1977). Chronic injury
employed a modified Free Air CO2 method (Karnosky et al., 1999; 2005). may be mild to severe. In some cases,
Enrichment (FACE) methodology to The Staff Paper thus concluded that cell death or premature leaf senescence
expose vegetation to elevated O3 the combined evidence from the may occur. The significance of O3 injury
without the use of chambers. This AspenFACE 56 and Gregg et al. (2003) at the leaf and whole plant levels
exposure method was originally field studies provide compelling and depends on how much of the total leaf
developed to expose vegetation to 56 Only a few northern forest types in the U.S.
area of the plant has been affected, as
elevated levels of CO2, but has been well as the plant’s age, size,
have been well studied with respect to O3

modified to include O3 exposure in exposures using the FACE method, though these developmental stage, and degree of
Illinois (SoyFACE) and Wisconsin systems are being used to expose numerous other functional redundancy among the
(AspenFACE) for soybean and ecosystem types to elevated levels of CO2. existing leaf area. As a result, it is not
Additional FACE studies with O3 on other U.S.
deciduous trees, respectively (Dickson forest types would provide a better understanding
presently possible to determine, with
et al., 2000; Morgan et al., 2004). The of whether these results can be extrapolated to other consistency across species and
FACE method releases gas (e.g., CO2, O3) forest types and mature forest stands. environments, what degree of injury at
the leaf level has significance to the results show that O3-induced foliar ecosystem level, functional
vigor of the whole plant. injury incidence is widespread across characteristics include, but are not
The presence of visible symptoms due the country. The visible foliar injury limited to, energy flow; nutrient,
to O3 exposures can, however, by itself, indicator has been identified as a means hydrologic, and biogeochemical cycling;
represent an adverse impact to the to track O3 exposure stress trends in the and maintenance of food chains. The
public welfare. Specifically, it can nation’s natural plant communities as sum of the functions carried out by
reduce the market value of certain leafy highlighted in EPA’s most recent Report ecosystem components provides many
crops (such as spinach, lettuce), impact on the Environment (EPA, 2003a; benefits to humankind, as in the case of
the aesthetic value of ornamentals (such http://www.epa.gov/indicators/roe). forest ecosystems (Smith, 1992). Some
as petunia, geranium, and poinsettia) in Previous Criteria Documents have of these benefits, also termed
urban landscapes, and affect the noted the difficulty in relating visible ‘‘ecosystem goods and services’’,
aesthetic value of scenic vistas in foliar injury symptoms to other include food, fiber production,
protected natural areas such as national vegetation effects such as individual aesthetics, genetic diversity,
parks and wilderness areas. Many tree growth, stand growth, or ecosystem maintenance of water quality, air
businesses rely on healthy looking characteristics (EPA, 1996a) and this quality, and climate, and energy
vegetation for their livelihoods (e.g., difficulty remains to the present day exchange. A conceptual framework for
horticulturalists, landscapers, Christmas (EPA, 2006a). It is important to note that discussing the effects of O3 on
tree growers, farmers of leafy crops) and direct links between O3 induced visible ecosystems was developed by the EPA
a variety of ornamental species have foliar injury symptoms and other Science Advisory Board (Young and
been listed as sensitive to O3 (Abt, adverse effects are not always found. Sanzone, 2002). In this report, the
1993). Though not quantified, there is Therefore, visible foliar injury cannot authors identify six essential ecological
likely some level of economic impact to serve as a reliable surrogate measure for attributes (EEAs) include landscape
businesses and homeowners from O3- other O3-related vegetation effects condition, biotic condition, chemical/
related injury on sensitive ornamental because other effects (e.g., biomass loss) physical condition, ecological
species due to the cost associated with have been reported with and without processes, hydrology/geomorphology,
more frequent replacement and/or visible injury. In a few cases, visible and natural disturbance regime. Each
increased maintenance (fertilizer or foliar symptoms have been correlated EEA is depicted as one of six triangles
pesticide application). In addition, with decreased vegetative growth that together build a hexagon. On the
because O3 not only results in (Karnosky et al., 1996; Peterson et al., outside of each triangle is a list of
discoloration of leaves but can lead to 1987; Somers et al., 1998) and with stressors that can act on the EEA.
more rapid senescence (early shedding impaired reproductive function (Black Tropospheric O3 is listed as a stressor of
of leaves) there potentially could be et al., 2000; Chappelka, 2002). both biotic condition and the chemical/
some lost tourist dollars at sites where Therefore, the lack of visible injury physical condition of ecosystems. As
fall foliage is less available or attractive. should not be construed to indicate a each EEA is linked to all the others, it
The use of sensitive plants as lack of phytotoxic concentrations of O3 is clearly envisioned in this framework
biological indicators to detect nor absence of other non-visible O3 that O3 could either directly or
phytotoxic levels of O3 is a longstanding effects. indirectly impact all of the EEAs
and effective methodology (Chappelka associated with an ecosystem that is
and Samuelson, 1998; Manning and d. Reduced Plant Vigor
being stressed by O3.
Krupa, 1992). Each bioindicator exhibits Though O3 levels over most of the Vegetation often plays an influential
typical O3 injury symptoms when U.S. are not high enough to kill role in defining the structure and
exposed under appropriate conditions. vegetation directly, current levels have function of an ecosystem, as evidenced
These symptoms are considered been shown to reduce the ability of by the use of dominant vegetation forms
diagnostic as they have been verified in many sensitive species and genotypes to classify many types of natural
exposure-response studies under within species to adapt to or withstand ecosystems, e.g., tundra, wetland,
experimental conditions. In recent other environmental stresses. These may deciduous forest, and conifer forest.
years, field surveys of visible foliar include increased susceptibility to Plants simultaneously inhabit both
injury symptoms have become more freezing temperatures, pest infestations above- and below-ground environments,
common, with greater attention to the and/or root disease, and compromised integrating and influencing key
standardization of methods and the use ability to compete for available ecosystem cycles of energy, water, and
of reliable indicator species (Campbell resources. For example, when species nutrients. When a sufficient number of
et al., 2000; Smith et al., 2003). with differing O3-sensitivities occur individual plants within a community
Specifically, the United States Forest together, the resulting decrease in have been affected, O3-related effects
Service (USFS) through the Forest growth in O3-sensitive species may lead can be propagated up to ecosystem-level
Health Monitoring Program (FHM) to an increase in growth of more O3- effects. Thus, through its impact on
(1990–2001) and currently the Forest tolerant species, which are now able to vegetation, O3 can be an important
Inventory and Analysis (FIA) Program better compete for available resources. ecosystem stressor.
collects data regarding the incidence The result of such above effects can
and severity of visible foliar injury on a i. Potential Ozone Alteration of
produce a loss in plant vigor in O3-
variety of O3 sensitive plant species Ecosystem Structure and Function
sensitive species that over time may
throughout the U.S. (Coulston et al. lead to premature plant death. The Criteria Document (EPA, 2006a)
2003, 2004; Smith et al. 2003). outlines seven case studies where O3
Since the conclusion of the 1996 e. Ecosystems effects on ecosystems have either been
NAAQS review, the FIA monitoring Ecosystems are comprised of complex documented or are suspected. The
program network and database has assemblages of organisms and the oldest and clearest example involves the
continued to expand. This network physical environment with which they San Bernardino Mountain forest
continues to document foliar injury interact. Each level of organization ecosystem in California. This system
symptoms in the field under ambient within an ecosystem has functional and experienced chronic high O3 exposures
exposure conditions. Recent survey structural characteristics. At the over a period of 50 or more years. The
O3-sensitive and co-dominant species of however, than in the west, consisting of (Awmack et al., 2004; Holton et al.,
ponderosa and Jeffrey pine a wider diversity of species and uneven 2003; Percy et al., 2002).
demonstrated severe levels of foliar aged stands, and the O3 levels are less Collectively these examples suggest
injury, premature senescence, and severe. Therefore, lower level chronic that O3 is an important stressor in
needle fall that decreased the O3 stress in the east is more likely to natural ecosystems, but it is difficult to
photosynthetic capacity of stressed produce subtle long-term forest quantify the contribution of O3 due to
pines and reduced the production of responses such as shifts in species the combination of other stresses
carbohydrates resulting in a decrease in composition, rather than wide-spread present in ecosystems. In most cases,
radial growth and in the height of community degradation. because only a few components in each
stressed trees. It was also observed that One of the best-documented studies of of these ecosystems have been examined
ponderosa and Jeffrey pines with slight population and community response to and characterized for O3 effects, the full
to severe crown injury lost basal area in O3 effects are the long-term studies of extent of ecosystem changes in these
relation to competing species that are common plantain (Plantago major) in example ecosystems is not fully
more tolerant to O3. Due to a loss of native plant communities in the United understood. Clearly, there is a need for
vigor, these trees eventually succumbed Kingdom (Davison and Reiling, 1995; highly integrated ecosystem studies that
to the bark beetle, leading to elevated Lyons et al., 1997; Reiling and Davison, specifically investigate the effect of O3
levels of tree death. Increased mortality 1992c). Elevated O3 significantly on ecosystem structure and function in
of susceptible trees shifted the decreased the growth of sensitive order to fully determine the extent to
community composition towards white populations of common plantain which O3 is altering ecosystem services.
fir and incense cedar, effectively (Pearson et al., 1996; Reiling and Continued research, employing new
reversing the development of the normal Davison, 1992a, b; Whitfield et al., approaches, will be necessary to fully
fire climax mixture dominated by 1997) and reduced its fitness as understand the extent to which O3 is
ponderosa and Jeffrey pines, and determined by decreased reproductive affecting ecosystem services.
leading to increased fire susceptibility. success (Pearson et al., 1996; Reiling
ii. Effects on Ecosystem Services and
At the same time, numerous other and Davison, 1992a). While spatial
Carbon Sequestration
organisms and processes were also comparisons of population responses to
O3 are complicated by other Since it has been established that O3
affected either directly or indirectly,
environmental factors, rapid changes in affects photosynthesis and growth of
including successional patterns of
O3 resistance were imposed by ambient plants, O3 is most likely affecting the
fungal microflora and their relationship
levels and variations in O3 exposure productivity of forest ecosystems.
to the decomposer community. Nutrient
(Davison and Reiling, 1995). Therefore, it is desirable to link effects
availability was influenced by the heavy
Specifically, in this case study, it on growth and productivity to essential
litter and thick needle layer under ecosystem services. However, it is very
stands with the most severe needle appeared that O3-sensitive individuals
are being removed by O3 stress and the difficult to quantify ecosystem-level
injury and defoliation. The composition productivity losses because of the
of lichens was significantly reduced. In genetic variation represented in the
population could be declining. If genetic amount of complexity in scaling from
this example, O3 appeared to be a the leaf-level or individual plant to the
predisposing factor that led to increased diversity and variation is lost in
ecosystems, there may be increased ecosystem level, and because not all
drought stress, windthrow, root organisms in an ecosystem are equally
diseases, and insect infestation vulnerability of the system to other
biotic and abiotic stressors, and affected by O3.
(Takemoto et al., 2001). Thus, through Terrestrial ecosystems are important
ultimately a change in the EEAs and
its effects on tree water balance, cold in the Earth’s carbon (C) balance and
associated services provided by those
hardiness, tolerance to wind, and could help offset emissions of CO2 by
ecosystems.
susceptibility to insect and disease Recent free-air exposure experiments humans if anthropogenic C is
pests, O3 potentially impacted the have also provided new insight into sequestered in vegetation and soils. The
ecosystem-related EEA of natural how O3 may be altering ecosystem annual increase in atmospheric CO2 is
disturbance regime (e.g., fire, erosion). structure and function (Karnosky et al., less than the total inputs from fossil fuel
Although the role of O3 was extremely 2005). For example, a field O3 exposure burning and land use changes (Prentice
difficult to separate from other experiment at the AspenFACE site in et al., 2001) and much of this
confounding factors, such as high Wisconsin (described in section discrepancy is thought to be attributable
nitrogen deposition, there is evidence IV.A.2.b. above) was designed to to CO2 uptake by plant photosynthesis
that this shift in species composition examine the effects of both elevated CO2 (Tans & White, 1998). Temperate forests
has altered the structure and dynamics and O3 on mixed stands of aspen of the northern hemisphere have been
of associated food webs (Pronos et al., (Populus tremuloides), birch (Betula estimated to be a net sink of C per year
1999) and carbon (C) and nitrogen (N) papyrifera), and sugar maple (Acer (Goodale et al. 2002). Ozone interferes
cycling (Arbaugh et al., 2003). Ongoing saccharum) that are characteristic of with photosynthesis, causes some plants
and new research in this important Great Lakes aspen-dominated forests to senesce leaves prematurely and in
ecosystem is needed to reveal the extent (Karnosky et al., 2003; Karnosky et al., some cases, reduces allocation to stem
to which ecosystem services have been 1999). They found evidence that the and root tissue. Thus, O3 decreases the
affected and to what extent strong effects on above- and below-ground potential for C sequestration. For the
causal linkages between historic and/or growth and physiological processes purposes of this discussion, C
current ambient O3 exposures and have cascaded through the ecosystem, sequestration is defined as the net
observed ecosystem-level effects can be even affecting microbial communities exchange of carbon by the terrestrial
made. (Larson et al., 2002; Phillips et al., biosphere. However, long-term storage
Ozone has also been reported to be a 2002). This study also confirmed earlier in the soil organic matter is considered
selective pressure among sensitive tree observations of O3-induced changes in to be the most stable form of C storage
species (e.g., eastern white pine) in the trophic interactions involving keystone in ecosystems.
east. The nature of community tree species, as well as important insect In a study including all ecosystem
dynamics in eastern forests is different, pests and their natural enemies types, Felzer et al. (2004), estimated that
U.S. net primary production (net flux of two candidate indicators, foliar injury of the cases studied from greater than 10
C into an ecosystem) was decreased by (as described above) and radial growth percent yield loss.
2.6–6.8 percent due to O3 pollution in in trees, have been suggested. Thus, Recent studies continue to find yield
the late 1980’s to early 1990’s. Ozone while at the present time, most O3- loss levels in crop species studied
not only reduces C sequestration in related effects on ecosystems must be previously under NCLAN that reflect
existing forests, it can also affect inferred from observed or predicted O3- the earlier findings57. In other words,
reforestation projects (Beedlow et al. related effects on individual plants, there has been no evidence that crops
2004). This effect, in turn, has been additional research at the ecosystem are becoming more tolerant of O3 (EPA,
found to ultimately inhibit C level could identify new indicators and/ 2006a). For cotton, some newer varieties
sequestration in forest soils which act as or establish stronger causal linkages have been found to have higher yield
long-term C storage (Loya et al., 2003; between O3-induced plant effects and loss due to O3 compared to older
Beedlow et al. 2004). The interaction of ecosystem condition. varieties (Olszyk et al., 1993, Grantz and
rising O3 pollution and rising CO2 McCool, 1992). In a meta-analysis of 53
concentrations in the coming decades f. Yield Reductions in Crops studies, Morgan et al. (2003) found
complicates predictions of future Ozone can interfere with carbon gain consistent deleterious effects of O3
sequestration potential. Models (photosynthesis) and allocation of exposures on soybean from studies
generally predict that, in the future, C carbon with or without the presence of published between 1973 and 2001.
sequestration will increase with visible foliar injury. As a result of Further, early results from the field-
increasing CO2, but often do not account decreased carbohydrate availability, based exposure experiment SoyFACE in
for the decrease in productivity due to fewer carbohydrates are available for Illinois indicate a lack of any apparent
the local effects of tropospheric O3. In plant growth, reproduction, and/or difference in the O3 tolerance of old and
the presence of high O3 levels, the yield. Recent studies have further recent cultivars of soybean in a study of
stimulatory effect of rising CO2 confirmed and demonstrated O3 effects 22 soybean varieties (Long et al., 2002).
concentrations on forest productivity on different stages of plant Thus, the Staff Paper concluded that the
has been estimated to be reduced by reproduction, including pollen recent scientific literature continues to
more that 20 percent (Tingey et al., germination, pollen tube growth, support the conclusions of the 1996
2001; Ollinger et al. 2002; Karnosky et fertilization, and abortion of Criteria Document that ambient O3
al., 2003). reproductive structures, as reviewed by concentrations are reducing the yield of
In summary, it would be anticipated Black et al. (2000). For seed-bearing major crops in the U.S.
that meeting lower O3 standards would plants, these reproductive effects will In addition to the effects described on
increase the amount of CO2 uptake by culminate in reduced seed production annual crop species, several studies
many ecosystems in the U.S. However, or yield. published since the last review have
the amount of this improvement would focused on perennial forage crops (EPA,
be heavily dependent on the species As described in the last review and
2006a). These recent results confirm
composition of those ecosystems. Many again in the current Criteria Document
that O3 is also impacting yields and
ecosystems in the U.S. do have O3 and Staff Paper, the National Crop Loss
quality of multiple-year forage crops at
sensitive plants. For, example forest Assessment Network (NCLAN) studies
sufficient magnitude to have nutritional
ecosystems with dominant species such undertaken in the early to mid-1980’s
and possibly economic implications to
as aspen or ponderosa pine would be provide the largest, most uniform
their use as ruminant animal feed at O3
expected to increase CO2 uptake more database on the effects of O3 on
exposures that occur in some years over
with lower O3 than forests with more O3 agricultural crop yields. The NCLAN
large areas of the U.S.
tolerant species. protocol was designed to produce crop
A recent critique of the secondary exposure-response data representative 3. Adversity of Effects
NAAQS review process published in the of the areas in the U.S. where the crops The Staff Paper recognized that the
report by the National Academy of were typically grown. In total, 15 statute requires that a secondary
Sciences on Air Quality Management in species (e.g., corn, soybean, winter standard be protective against ‘‘adverse’’
the United States (NRC, 2004) stated wheat, tobacco, sorghum, cotton, barley, O3 effects, not all identifiable effects. In
that ‘‘EPA’s current practice for setting peanuts, dry beans, potato, lettuce, considering what constitutes a
secondary standards for most criteria turnip, and hay [alfalfa, clover, and vegetation effect that is adverse to the
pollutants does not appear to be fescue]), accounting for greater than 85 public welfare, the Staff Paper
sufficiently protective of sensitive crops percent of U.S. agricultural acreage recognizes that O3 can cause a variety of
and ecosystems * * *.’’ This report planted at that time, were studied. Of vegetation effects, beginning at the level
made several specific recommendations these 15 species, 13 species including of the individual cell and accumulating
for improving the secondary NAAQS 38 different cultivars were combined in up to the level of whole leaves, plants,
process and concluded that ‘‘There is 54 cases representing unique plant populations, communities and
growing evidence that tighter standards combinations of cultivars, sites, water whole ecosystems, not all of which have
to protect sensitive ecosystems in the regimes, and exposure conditions. Crops been classified in past reviews as
United States are needed * * *.’’ An were grown under typical farm ‘‘adverse’’ to public welfare.
effort has been recently initiated within conditions and exposed in open-top Previous reviews have classified O3
the Agency to identify indicators of chambers to ambient O3 and increased vegetation effects as either ‘‘injury’’ or
ecological condition whose responses O3 above ambient (i.e., modified ‘‘damage’’ to help in determining
can be clearly linked to changes in air ambient). Robust C–R functions were adversity. Specifically, ‘‘injury’’ is
quality that are attributable to Agency developed for each of these crop
environmental programs. Using a single species. These results showed that 50 57 Given the usefulness of generating robust C–R
indicator to represent the complex percent of the studied cases would be functions such as have been developed under
linkages and dynamic cycles that define protected from greater than 10 percent NCLAN, it would be beneficial to employ a similar
protocol to update and expand this research to
ecosystem condition will always have yield loss at a W126 level of 21 ppm- include more recent and additional crop species
limitations. With respect to O3-related hour, while a W126 of 13 ppm-hour and varieties, such as fruit and vegetable species,
impacts on ecosystem condition, only would provide protection for 75 percent as well as recent O3 air quality.
defined as encompassing all plant B. Biologically Relevant Exposure response data taken from OTC
reactions, including reversible changes Indices experiments had found that all
or changes in plant metabolism (e.g., The Criteria Document concluded that performed about equally well and was
altered photosynthetic rate), altered O3 exposure indices that cumulate unable to distinguish between them
plant quality, or reduced growth, that differentially weighted hourly (EPA, 1996a). In selecting between two
does not impair the intended use or concentrations are the best candidates of these cumulative forms, the SUM06 58
value of the plant (Guderian, 1977). In for relating exposure to plant growth and W126, in the absence of biological
contrast, ‘‘damage’’ has been defined to responses (EPA, 2006a). This conclusion evidence to distinguish between them,
include those injury effects that reach follows from the extensive evaluation of the Administrator based her decision on
sufficient magnitude as to also reduce or the relevant studies in the 1996 Criteria both science and policy considerations.
impair the intended use or value of the Document (EPA, 1996a) and the recent Specifically, these were: (1) All
plant. Examples of effects that are evaluation of studies that have been cumulative, peak-weighted exposure
published since that time (EPA, 2006a). indices considered, including W126 and
classified as damage include reductions
The following selections, taken from SUM06, were about equally good as
in aesthetic values (e.g., foliar injury in
section 5.5 the 1996 Criteria Document exposure measures to predict exposure-
ornamental species) as well as losses in response relationships reported in the
terms of weight, number, or size of the (EPA, 1996a), further elucidate the
depth and strength of these conclusions. NCLAN crop studies; and (2) the
plant part that is harvested (reduced SUM06 form would not be influenced
yield or biomass production). Yield loss Specifically, with respect to the
by PRB O3 concentrations (defined at
also may include changes in crop importance of taking into account
the time as 0.03 to 0.05 ppm) under
quality, i.e., physical appearance, exposure duration, the 1996 Criteria
many typical air quality distributions.
chemical composition, or the ability to Document stated, ‘‘when O3 effects are
On the basis of these considerations, the
withstand storage, while biomass loss the primary cause of variation in plant
Administrator chose the SUM06 as the
includes slower growth in species response, plants from replicate studies
most appropriate cumulative, seasonal
harvested for timber or other fiber uses. of varying duration showed greater
form to consider when proposing an
While this construct has proved useful reductions in yield or growth when
alternative secondary standard form (61
exposed for the longer duration’’ and
in the past, it appears to be most useful FR 65716).
‘‘the mean exposure index of Though the scientific justification for
in the context of evaluating effects on
unspecified duration could not account a cumulative, seasonal form was
single plants or species grown in
for the year-to-year variation in generally accepted in the last review, an
monocultures such as agricultural crops response’’ (EPA, 1996a, pg. 5–96).
or managed forests. It is less clear how analysis undertaken by EPA at that time
Further, ‘‘because the mean exposure had shown that there was considerable
it might apply to potential effects on index treats all concentrations equally
natural forests or entire ecosystems overlap between areas that would be
and does not specifically include an expected not to meet the range of
when O3-induced species level impacts exposure duration component, the use
lead to shifts in species composition alternative 8-hour standards being
of a mean exposure index for considered for the primary NAAQS and
and/or associated ecosystem services characterizing plant exposures appears those expected not to meet the range of
such as nutrient cycling or hydrologic inappropriate for relating exposure with values (expressed in terms of the
cycles, where the intended use or value vegetation effects’’ (EPA, 1996a, pg. 5– seasonal SUM06 index) of concern for
of the system has not been specifically 88). Regarding the relative importance vegetation. This result suggested that
identified. of higher concentrations than lower in improvements in national air quality
A more recent construct for assessing determining plant response, the 1996 expected to result from attaining an 8-
risks to forests described in Hogsett et Criteria Document concluded that ‘‘the hour primary standard within the
al. (1997) suggests that ‘‘adverse effects ultimate impact of long-term exposures recommended range of levels would
could be classified into one or more of to O3 on crops and seedling biomass also be expected to significantly reduce
the following categories: (1) Economic response depends on the integration of levels of concern for vegetation in those
production, (2) ecological structure, (3) repeated peak concentrations during the same areas. Thus, in the notice of
genetic resources, and (4) cultural growth of the plant’’ (EPA, 1996a, pg. 5– proposed rulemaking, the Administrator
values.’’ This approach expands the 104). Further, ‘‘at this time, exposure proposed two alternatives for
context for evaluating the adversity of indices that weight the hourly O3 consideration: one alternative was to
O3-related effects beyond the species concentrations differentially appear to make the secondary standard equal in
be the best candidates for relating every way to the proposed 8-hour, 0.08
level. Another recent publication, A
exposure with predicted plant ppm primary standard; and the second
Framework for Assessing and Reporting
response’’ (EPA, 1996a, pgs. 5–136). was to establish a cumulative, seasonal
on Ecological Condition: an SAB report At the conclusion of the last review,
(Young and Sanzone, 2002), provides secondary standard in terms of a SUM06
the biological basis for a cumulative, form as also appropriate to protect
additional support for expanding the seasonal form was not in dispute. There
consideration of adversity beyond the public welfare from known or
was general agreement between the EPA anticipated adverse effects given the
species level by making explicit the staff, CASAC, and the Administrator,
linkages between stress-related effects available scientific knowledge and that
based on their review of the air quality such a seasonal standard ‘‘* * * is more
(e.g., O3 exposure) at the species level criteria, that a cumulative, seasonal biologically relevant * * *’’ (61 FR
and at higher levels within an form was more biologically based than 65716).
ecosystem hierarchy. Taking this recent the then current 1-hour and newly
In the 1997 final rule, the

literature into account, the Staff Paper proposed 8-hour average form. Administrator decided to make the
concludes that a determination of what However, in selecting a specific form secondary standard identical to the
constitutes an ‘‘adverse’’ welfare effect appropriate for a secondary standard, primary standard. She acknowledged,
in the context of the secondary NAAQS there was less agreement. An evaluation
review can appropriately occur within of the performance of several seasonal 58 SUM06: Sum of all hourly O concentrations
3
this broader paradigm. cumulative forms in predicting plant greater or equal to 0.06 ppm over a specified time.
however, that ‘‘it remained uncertain as using interpolation and included to monitor O3 exposure in populated
to the extent to which air quality information from ambient monitoring areas, there was limited measured data
improvements designed to reduce 8-hr networks and results from air quality available to characterize O3 air quality
average O3 concentrations averaged over modeling. The vegetation risk in rural and remote sites. Since the last
a 3-year period would reduce O3 assessment included both tree and crop review, there has been a small increase
exposures measured by a seasonal analyses. The tree risk analysis includes in the number of CASTNET sites (from
SUM06 index.’’ (62 FR 38876) In other three distinct lines of evidence: (1) approximately 52 sites in 1992 to 84
words, it was uncertain as to whether Observations of visible foliar injury in sites in 2004), however these monitors
the 8-hour average form would, in the field linked to recent monitored O3 are not used for attainment
practice, provide sufficient protection air quality for the years 2001–2004; (2) designations.
for vegetation from the cumulative, estimates of seedling growth loss under National parks represent areas of
seasonal and concentration-weighted current and alternative O3 exposure nationally recognized ecological and
exposures described in the scientific conditions; and (3) simulated mature public welfare significance, which are
literature as of concern. tree growth reductions using the afforded a higher level of protection.
On the basis of that history, chapter TREGRO model to simulate the effect of Two recent reports presented some
7 of the current Staff Paper revisited the meeting alternative air quality standards discussion of O3 trends in a subset of
issue of whether the SUM06 was still on the predicted annual growth of a national parks: The Ozone Report:
the most appropriate choice of single western species (ponderosa pine) Measuring Progress Through 2003 (EPA,
cumulative, seasonal form for a and two eastern species (red maple and 2004), and 2005 Annual Performance
secondary standard to protect the public tulip poplar). The crop analysis and Progress Report: Air Quality in
welfare from known and anticipated includes estimates of the risks to crop National Parks (NPS, 2005).
adverse vegetation effects in light of the yields from current and alternative O3 Unfortunately, much of this information
new information available in this exposure conditions and the associated is presented only in terms of the current
review. Specifically, the Staff Paper change in economic benefits expected to 8-hr average form. The Staff Paper
considered: (1) The continued lack of accrue in the agriculture sector upon analyzed available air quality data in
evidence within the vegetation effects meeting the levels of various alternative terms of the cumulative 12-hour W126
literature of a biological threshold for standards. Each element of the form from 2001 to 2005 for a subset of
vegetation exposures of concern; and (2) assessment is described below, national parks and other significant
new estimates of PRB that are lower including discussions of known sources natural areas representing 4 general
than in the last review. The W126 form, and ranges of uncertainties associated regions of the U.S. Many of these
also evaluated in the last review, was with the elements of this assessment. national parks and natural areas have
again selected for comparison with the monitored O3 levels above
SUM06 form. Regarding the first 1. Exposure Characterization concentrations that have been shown to
consideration, the Staff Paper noted that Though numerous effects of O3 on decrease plant growth and above the 12-
W126 form, by its incorporation of a vegetation have been documented as hour W126 levels analyzed in this
continuous sigmoidal weighting discussed above, it is important in review. For example, the Great Smokey
scheme, does not create an artificially considering risk to examine O3 air Mountain, Rocky Mountain, Grand
imposed concentration threshold, yet quality patterns in the U.S. relative to Canyon, Yosemite and Sequoia National
also gives proportionally more weight to the location of O3 sensitive species that Parks all had more than one year within
the higher and typically more have a known concentration-response in the 2001–2005 period with a 12-hour
biologically potent concentrations, as order to predict whether adverse effects W126 above 21 ppm-hour. This level of
supported by the scientific evidence. are occurring at current levels of air exposure has been associated with
Second, the index value is not quality, and whether they are likely to approximately no more than 10 percent
significantly influenced by O3 occur under alternative standard forms biomass loss in 50 percent of the 49 tree
concentrations within the range of and levels. seedling cases studied in the NHEERL–
estimated PRB, as the weights assigned The most important information about WED experiments (Lee and Hogsett,
to concentrations in this range are very exposure to vegetation comes from the 1996). Black cherry (Prunus serotina),
small. Thus, it would also provide a O3 monitoring data that are available an important O3-sensitive tree species in
more appropriate target for air quality from two national networks: (1) Air the eastern U.S., occurs in the Great
management programs designed to Quality System (AQS; http:// Smoky Mountain National Park and is
reduce emissions from anthropogenic www.epa.gov/ttn/airs/airsaqs) and (2) estimated to have O3-related seedling
sources contributing to O3 formation. Clean Air Status and Trends Network biomass loss of approximately 40
On the basis of these considerations, the (CASTNET; http://www.epa.gov/ percent when exposed to a 3-month, 12-
Staff Paper concludes that the W126 castnet/). The AQS monitoring network hour W126 O3 level greater than 21
form is the most biologically-relevant currently has over 1100 active O3 ppm-hour. Ponderosa pine (Pinus
cumulative, seasonal form appropriate monitors which are generally sited near ponderosa) which occurs in the Grand
to consider in the context of the population centers. However, this Canyon, Yosemite and Sequoia National
secondary standard review. network also includes approximately 36 Parks has been reported to have
monitors located in national parks. approximately 10 percent biomass
C. Vegetation Exposure and Impact CASTNET is the nation’s primary losses at 3-month, 12-hour W126 O3
Assessment source for data on dry acidic deposition levels as low as 17 ppm-hour (Lee and
The vegetation exposure and impact and rural, ground-level O3. It consists of Hogsett, 1996). Impacts on seedlings
assessment conducted for the current over 80 sites across the eastern and may potentially affect long-term tree
review and described in the Staff paper, western U.S. and is cooperatively growth and survival, ultimately
consisted of exposure, risk and benefits operated and funded with the National affecting the competitiveness of O3-
analyses and improves and builds upon Park Service. In the 1997 final O3 rule, sensitive tree species and genotypes
similar analyses performed in the last it was acknowledged that because the within forest stands.
review (EPA 1996b). The vegetation national air quality surveillance In order to characterize exposures to
exposure assessment was performed network for O3 was designed principally vegetation at the national scale,
however, the Staff Paper concluded that monitoring data, this approach was used multi-state regions in the east (NC, TN,
it could not rely solely on limited site- in developing national vegetation KY, IN, OH, PA, NJ, NY, DE, MD, VA)
specific monitoring data, and that it was exposure and risk assessments that and west (CA, NV, AZ, OK, TX) are
necessary to select an interpolation estimate relative changes in risk for the predicted to have levels of air quality
method that could be used to various alternative standards analyzed. above the W126 level of 21 ppm-hour,
characterize O3 air quality over broad To evaluate changing vegetation which is approximately equal to the
geographic areas. The Staff Paper exposures and risks under selected air secondary standard proposed in 1996
therefore investigated the quality scenarios, the Staff Paper and is associated with approximately no
appropriateness of using the O3 outputs utilized adjusted 2001 base year O3 air more than 10 percent biomass loss in 50
from the EPA/NOAA Community Multi- quality distributions with a rollback percent of tree seedling cases studied.
scale Air Quality (CMAQ) 59 model method (Horst and Duff, 1995; Rizzo, Much of the east and Arizona and
system (http://www.epa.gov/asmdnerl/ 2005 & 2006) to reflect meeting the California have 12-hour W126 O3 levels
CMAQ, Byun and Ching, 1999; Arnold current and alternative secondary above 13 ppm-hour which has been
et al. 2003, Eder and Yu, 2005) to standard options. This technique associated with approximately no more
improve spatial interpolations based combines both linear and quadratic than 10 percent biomass loss in 75
solely on existing monitoring networks. elements to reduce higher O3 percent of tree seedling cases studied.
Due to the significant resources required concentrations more than lower ones. In The results of the exposure assessment
to run CMAQ, model outputs were only this regard, the rollback method indicate that current air quality levels
available for a limited number of years. attempts to account for reductions in could result in significant impacts to
For this review, 2001 outputs from emissions without greatly affecting vegetation in some areas.
CMAQ version 4.5 were the most recent lower concentrations. The following O3 (2) When 2001 air quality is rolled
available. air quality scenarios were analyzed: (1) back to meet the current 8-hour
Based on the significant difference in 4th-highest daily maximum 8-hour secondary standard, the overall 3-month
monitor network density between the average: 0.084 ppm (the effective level 12-hour W126 O3 levels were somewhat
eastern and western U.S., the Staff Paper of the current standard) and 0.070 ppm improved, but not substantially. Under
concluded that it was appropriate to use levels; (2) 3-month, 12-hour. SUM06: 25 this scenario, there were still many
separate interpolation techniques in ppm-hour (proposed in the 1996 review) areas in California with 12-hour W126
these two regions. AQS and CASTNET and 15 ppm-hour levels; and (3) 3- O3 levels above 31 ppm-hour. A broad
monitoring data were solely used for the month, 12-hour. W126: 21 ppm-hour multi-state region in the east (NC, TN,
eastern interpolation since it was and 13 ppm-hour levels. KY, IN, OH, PA, MD) and west (CA, NV,
determined that enhancing the The two 8-hour average levels were
AZ, OK, TX) were still predicted to have
interpolation with CMAQ data did not chosen as possible alternatives of the
O3 levels above the W126 level of 21
add much information to the eastern current form for comparison with the
ppm-hour.
U.S. interpolation. In the western U.S., cumulative, seasonal alternative forms.
The SUM06 scenarios were very similar (3) Exposures generated for just
where rural monitoring is more sparse,
O3 values generated by the CMAQ to the W126 scenarios. Since the W126 meeting a 0.070 ppm, 4th-highest
model were used to develop scaling was judged to be the more biologically- maximum 8-hour average alternative
factors to augment the interpolation. relevant cumulative, seasonal form, only standard showed substantially
In order to characterize uncertainty in the results for the W126 scenarios are improved O3 air quality when compared
the interpolation method, monitored O3 summarized below. For the W126 form, to just meeting the current 0.08 ppm, 8-
concentrations were systematically the two levels were selected on the basis hour standard. Most areas were
compared to interpolated O3 of the associated levels of tree seedling predicted to have O3 levels below the
concentrations in areas where monitors biomass loss and crop yield loss W126 level of 21 ppm-hr, although
were located. In general, the protection identified in the NHEERL– some areas in the east (KY, TN, MI, AR,
interpolation method used in the WED and NCLAN studies, respectively. MO, IL) and west (CA, NV, AZ, UT, NM,
current review performed well in many Specifically, the upper level of W126 CO, OK, TX) were still predicted to have
areas in the U.S., although it under- (21 ppm-hour) was associated with a O3 levels above the W126 level of 13
predicted higher 12-hour W126 level of tree and crop protection of ppm-hour.
exposures in rural areas. Due to the approximately no more than 10 percent These results suggest that meeting a
important influence of higher exposures growth or yield loss in 50 percent of proposed 0.070 ppm, 8-hour secondary
in determining risks to plants, this cases studied. Alternatively, the lower standard would provide substantially
feature of the interpolated surface could level of W126 (13 ppm-hour) was improved protection in some areas for
result in an under-estimation of risks to associated with a level of tree seedling vegetation from seasonal O3 exposures
vegetation in some areas. Taking these and crop protection of approximately no of concern. The Staff Paper recognizes,
uncertainties into account, and given more than 10 percent growth or yield however, that some areas meeting a
the absence of more complete rural loss in 75 percent of studied cases. 0.070 ppm 8-hour standard could
The following discussion highlights continue to have elevated seasonal
59 The CMAQ model is a multi-pollutant, key observations drawn from comparing exposures, including forested park lands
multiscale air quality model that contains state-of- predicted changes in interpolated air and other natural areas, and Class I
the-science techniques for simulating all
atmospheric and land processes that affect the quality under each alternative standard areas which are federally mandated to
transport, transformation, and deposition of form and level scenario for the base preserve certain air quality related
atmospheric pollutants and/or their precursors on year, 2001: values. This is especially important in
both regional and urban scales. It is designed as a (1) Under the base year (2001) ‘‘as is’’ the high elevation forests in the Western
science-based modeling tool for handling many

major pollutants (including photochemical air quality, a large portion of California U.S. where there are few O3 monitors.
oxidants/O3, particulate matter, and nutrient had 12-hr W126 O3 levels above 31 This is because the air quality patterns
deposition) holistically. The CMAQ model can ppm-hour, which has been associated in remote areas can result in relatively
generate estimates of hourly O3 concentrations for
the contiguous U.S., making it possible to express
with approximately no more than 14 low 8-hour averages while still
model outputs in terms of a variety of exposure percent biomass loss in 50 percent of experiencing relatively high cumulative
indices (e.g., W126, 8-hour average). tree seedling cases studies. Broader exposures.
To further characterize O3 air quality It is clear that this analysis is limited considerations in determining whether
in terms of current and alternative by the lack of monitoring in rural areas the current 8-hour form can
secondary standard forms, an analysis where important vegetation and appropriately provide requisite
was performed in the Staff Paper to ecosystems are located, especially at protection for vegetation.
evaluate the extent to which county- higher elevation sites. This is because
2. Assessment of Risk to Vegetation
level O3 air quality measured in terms O3 air quality distributions at high
of various levels of the current 8-hour elevation sites often do not reflect the The Staff Paper presents results from
average form overlapped with that typical urban and near-urban pattern of quantitative and qualitative risk
measured in terms of various levels of low morning and evening O3 assessments of O3 risks to vegetation
the 12-hour W126 cumulative, seasonal concentrations with a high mid-day (EPA, 2007). In the last review, crop
form. The Staff Paper presented this peak, but instead maintain relatively flat yield and seedling biomass loss OTC
analysis using recent (2002–2004) 60 patterns with many concentrations in data provided the basis for staff
county-level O3 air quality data from the mid-range (e.g., 0.05–0.09 ppm) for analyses, conclusions, and
AQS sites and the subset of CASTNET extended periods. These conditions can recommendations (EPA, 1996b). Since
sites having the highest O3 levels for the lead to relatively low daily maximum 8- then, several additional lines of
hour averages concurrently with high evidence have progressed sufficiently to
counties in which they are located.
cumulative values so that there is provide staff with a more complete and
Since the current 8-hour average
potentially less overlap between an 8- coherent picture of the scope of O3-
secondary form is a 3-year average, the
hour average and a cumulative, seasonal related vegetation risks, especially those
analysis initially compared the 3-year
form at these sites. The Staff Paper currently faced by seedling, sapling and
averages of both the 8-hour and W126
concludes that it is reasonable to mature tree species growing in field
forms. In addition, recognizing that settings, and indirectly, forested
some vegetation effects (e.g. crop yield anticipate that additional unmonitored
rural high elevation areas important for ecosystems. Specifically, new research
loss and foliar injury) are driven solely reflects an increased emphasis on field-
by annual O3 exposures and are vegetation may not be adequately
protected even with a lower level of the based exposure methods (e.g., free air
typically evaluated with respect to exposure and ambient gradient),
exposures within the annual growing 8-hour form.
The Criteria Document (EPA, 2006a), improved field survey biomonitoring
season, the Staff Paper also presented a techniques, and mechanistic tree
discusses policy relevant background
comparison of the current 3-year process models. Findings from each of
(PRB) levels for high elevation sites and
average 8-hour form to the annual W126 these research areas are discussed
makes the following observations: (1)
form for the individual years, 2002 and separately below. In conducting these
PRB concentrations of 0.04 to 0.05 ppm
2004. occur occasionally at high-elevation assessments, the Staff Paper analyses
Results of the 3-year average sites (e.g., >1.5 km) in the spring due to relied on both measured and modeled
comparisons showed that of the the free-tropospheric influence, air quality information. For some
counties with air quality meeting the 3- including some limited contribution effects, like visible foliar injury and
year average form of the 0.08 ppm, 8- from hemispheric pollution (O3 modeled mature tree growth response,
hour average standard, 7 counties produced from anthropogenic emissions only monitored air quality information
showed 3-year average W126 values outside North America); and (2) was used. For other effects categories
above the 21 ppm-hour level. At the stratospheric intrusions might (e.g., crop yield and tree seedling
lower W126 level of 13 ppm-hours, 135 occasionally elevate O3 at high-altitude growth), staff relied on interpolated O3
counties with air quality meeting the 3- sites, however, these events are rare. exposures.
year average form of the 0.08 ppm, 8- Therefore, the Staff Paper concludes a. Visible Foliar Injury
hour average standard, would be above that springtime PRB levels in the range
this W126 level. In addition, when the identified above and rare stratospheric As discussed earlier (Section A),
3-year average of the 8-hour form was intrusions of O3 are unlikely to recent systematic injury surveys
compared to annual W126 values, influence 3 month cumulative seasonal continue to document visible foliar
further variability in the degree of W126 values significantly. injury symptoms diagnostic of
overlap between the 8-hour form and It further remains uncertain as to the phytotoxic O3 exposures on sensitive
W126 form became apparent. For extent to which air quality bioindicator plants. These surveys
example, the relatively high 2002 O3 air improvements designed to reduce 8- produced more expansive evidence than
quality year showed a greater degree of hour O3 average concentrations would that available at the time of the last
overlap between those areas that would reduce O3 exposures measured by a review that visible foliar injury is
meet the levels analyzed for the current seasonal, cumulative W126 index. The occurring in many areas of the U.S.
8-hour and alternative levels of the Staff Paper indicated this to be an under current ambient conditions. The
W126 form than did the relatively low important consideration because: (1) Staff Paper presents an assessment
O3 2004 air quality year. This lack of a The biological database stresses the combining recent U.S. Forest Service
consistent degree of overlap between the importance of cumulative, seasonal Forest Inventory and Analysis (FIA)
two forms in different air quality years exposures in determining plant biomonitoring site data with the county
demonstrates that annual vegetation response; (2) plants have not been level air quality data for those counties
would be expected to receive widely specifically tested for the importance of containing the FIA biomonitoring sites.
differing degrees of protection from daily maximum 8-hour O3 This assessment showed that incidence
cumulative seasonal exposures in some concentrations in relation to plant of visible foliar injury ranged from 21 to
response; and (3) the effects of 39 percent during the four-year period
areas from year to year, even when the

3-year average of the 8-hour form was attainment of an 8-hour standard in (2001–2004) across all counties with air
consistently met. upwind urban areas on rural air quality quality levels at or below that of the
distributions cannot be characterized current 0.08 8-hour standard. Of the
60 This analysis was updated using 2003–2005 air with confidence due to the lack of counties that met an 8-hour level of 0.07
quality as it became available, finding similar monitoring data in rural and remote ppm in those years, 11 to 30 percent
results. areas. These factors are important still had incidence of visible foliar
injury. The magnitude of these North Carolina, Tennessee, Indiana, San Bernardino Mountains of California
percentages suggests that phytotoxic Ohio, Pennsylvania, Arizona, Michigan, to simulate ponderosa pine growth over
exposures sufficient to induce visible New York, New Jersey, Maryland and time with the improving air quality
foliar injury would still occur in many Delaware. For ponderosa pine, an using TREGRO (Tingey et al., 2004).
areas after meeting the level of the important tree species in the western The TREGRO model was used to
current secondary standard or U.S., biomass loss was projected to be assess growth of Ponderosa pine in the
alternative 0.07 ppm 8-hour standard. above 10 percent in much of its range San Bernardino Mountains of California
Additionally, the data show that visible in California. Biomass loss still occurred (Crestline) and the growth of yellow
foliar injury occurrence is in many tree species when O3 air quality poplar and red maple in the
geographically widespread and is was adjusted to meet the current 8-hour Appalachian mountains of Virginia and
occurring on a variety of plant species standard. For instance, black cherry, North Carolina, Shenandoah National
in forested and other natural systems. ponderosa pine, eastern white pine, and Park (Big Meadows) and Linville Gorge
Linking visible foliar injury to other aspen had estimated median seedling Wilderness Area (Cranberry),
plant effects is still problematic. biomass losses over portions of their respectively. Total tree growth
However, its presence indicates that growing range as high as 24, 11, 6, and associated with ’as is’ air quality, and
other O3-related vegetation effects could 6 percent, respectively, when O3 air air quality adjusted to just meet
also be present. quality was rolled back to just meet the alternative O3 standards was assessed.
current 8-hour standard. The Staff Paper Ponderosa pine is one of the most
b. Seedling and Mature Tree Biomass widely distributed pines in western
Loss noted that these results are for tree
seedlings and that mature trees of the North America, a major source of
In the last review (EPA, 1996b), same species may have more or less of timber, important as wildlife habitat,
analyses of the effects of O3 on trees a response to O3 exposure. Due to the and valued for aesthetics (Burns and
were limited to 11 tree species for potential for compounding effects over Honkala, 1990). Red maple is one of the
which C–R functions for the seedling multiple years, a consensus workshop most abundant species in the eastern
growth stage had been developed from on O3 effects reported that a biomass U.S. and is important for its brilliant fall
OTC studies conducted by the loss greater than 2 percent annually can foliage and highly desirable wildlife
NHEERL–WED. Important tree species be significant (Heck and Cowling, 1997). browse food (Burns and Honkala, 1990).
such as quaking aspen, ponderosa pine, Decreased seedling root growth and Yellow poplar is an abundant species in
black cherry, tulip poplar were found to survivability could affect overall stand the southern Appalachian forest. It is 10
be sensitive to cumulative seasonal O3 percent of the cove hardwood stands in
health and composition in the long
exposures. Work done since the 1996 southern Appalachians which are
term.
review at the AspenFACE site in widely viewed as some of the country’s
Wisconsin on quaking aspen (Karnosky In addition to the estimation of O3 most treasured forests because the
et al., 2005) and a gradient study effects on seedling growth, recent work protected, rich, moist set of conditions
performed in the New York City area has enhanced our understanding of risks permit trees to grow the largest in the
(Gregg et al. 2003) has confirmed the beyond the seedling stage. In order to eastern U.S. The wood has high
detrimental effects of O3 exposure on better characterize the potential O3 commercial value because of its
tree growth in field studies without effects on mature tree growth, a tree versatility and as a substitute for
chambers and beyond the seedling stage growth model (TREGRO) was used as a increasingly scarce softwoods in
(King et al., 2005). These field studies tool to evaluate the effect of changing O3 furniture and framing construction.
are discussed above in section IV.A. air quality scenarios from just meeting Yellow poplar is also valued as a honey
To update the seedling biomass loss alternative O3 standards on the growth tree, a source of wildlife food, and a
analysis, C–R functions for biomass loss of mature trees. TREGRO is a process- shade tree for large areas (Burns and
for available seedling tree species taken based, individual tree growth Honkala, 1990).
from the CD and information on tree simulation model (Weinstein et al., The Staff Paper analyses found that
growing regions derived from the U.S. 1991) and has been used to evaluate the just meeting the current standard would
Department of Agriculture’s Atlas of effects of a variety of O3 scenarios and likely continue to allow O3-related
United States Trees were combined with linked with concurrent climate data to reductions in annual net biomass gain
projections of air quality based on 2001 account for O3 and climate/meteorology in these species. This is based on model
interpolated exposures, to produce interactions on several species of trees outputs that estimate that as O3 levels
estimated biomass loss for each of the in different regions of the U.S. (Tingey are reduced below those of the current
seedling tree species individually. Maps et al., 2001; Weinstein et al., 1991; standard, significant improvements in
of these biomass loss projections are Retzlaff et al., 2000; Laurence et al., growth would occur. For instance,
presented in the Staff Paper. For 1993; Laurence et al., 2001; Weinstein et estimated growth in red maple
example, quaking aspen had a wide al., 2005). The model provides an increased by 4 and 3 percent at Big
range of O3 exposure across its growing analytical framework that accounts for Meadows and Cranberry sites,
range and therefore, showed significant the nonlinear relationship between O3 respectively, when air quality was
variability in projected seedling biomass exposure and response. The interactions rolled back to just met a W126 value of
loss across its range. Quaking aspen between O3 exposure, precipitation and 13 ppm-hour. Yellow poplar was
seedling biomass loss was projected to temperature are integrated as they affect projected to have a growth increase
be greater than 4 percent over much of vegetation, thus providing an internal between 0.6 and 8 percent under the
its geographic range, though it can reach consistency for comparing effects in same scenario at the two eastern sites.
above 10 percent in areas of Ohio, trees under different exposure scenarios Though there is uncertainty
Pennsylvania, New York, New Jersey and climatic conditions. An earlier associated with the above analyses, this
and California. Biomass loss for black assessment of the effectiveness of information should be given careful
cherry was projected to be greater than national ambient air quality standards consideration in light of several other
20 percent in approximately half its in place since the early 1970s took pieces of evidence. Specifically, new
range. Greater than 30 percent biomass advantage of 40 years of air quality and evidence from experimental studies that
loss for black cherry was projected in climate data for the Crestline site in the go beyond the seedling growth stage
continues to show decreased growth winter wheat and cotton had some standard is whether, in view of the
under elevated O3 (King et al., 2005). projected losses under the 2001 base advances in scientific knowledge
Some mature trees such as red oak have year air quality. Soybean yield losses reflected in the Criteria Document and
shown an even greater sensitivity of were projected to be 2–4 percent in additional information on exposure and
photosynthesis to O3 than seedlings of parts of Pennsylvania, New Jersey, risk discussed in the Staff Paper, the
the same species (Hanson et al., 1994). Maryland and Texas. Winter wheat was existing standard should be revised. The
As indicated above, smaller growth loss projected to have yield losses of 2–6 current secondary standard is a 3-year
increments may be significant for percent in parts of California. average of the annual 4th-highest
perennial species. The potential for Additionally, cotton was projected to maximum 8-hour average O3
cumulative ‘‘carry over’’ effects as well have yield losses of above 6 percent in concentration set at a level of 0.08 ppm.
as compounding must be considered. parts of California, Texas and North In evaluating whether it is appropriate
The accumulation of such ‘‘carry-over’’ Carolina in 2001. The risk assessment to retain or revise the current secondary
effects over time may affect long-term estimated that just meeting the current O3 standard, the Administrator adopts
survival and reproduction of 8-hour standard would still allow O3- an approach in this review that builds
individuals and ultimately the related yield loss to occur in some upon the general approach used in the
abundance of sensitive tree species in commodity crop species and fruit and last review and reflects the broader body
forest stands. vegetable species currently grown in the of evidence now available.
U.S. For example, based on median C– In developing proposed conclusions
c. Crops on the adequacy of the current
R function response, in counties with
As discussed in the Staff Paper, risk the highest O3 levels, potatoes and secondary O3 standard, the
of O3 exposure and associated cotton had estimated yield losses of 9– Administrator has considered a weight-
monetized benefits were estimated for 15 percent and 5–10 percent, of-evidence approach that evaluated
commodity crops, fruits and vegetables. respectively, when O3 air quality just information across the variety of
Similar to the tree seedling analysis, this met the level of the current standard. vegetation-related research areas
analysis combined C–R information on Estimated yield improved in these described in the Criteria Document (e.g.,
crops, crop growing regions and counties when the alternative W126 seedling, sapling and mature forest tree
interpolated exposures during each crop standard levels were met. The very species growth stages and commodity,
growing season. NCLAN crop functions important soybean crop had generally fruit, vegetable and forage crop species),
were used for commodity crops. small yield losses throughout the and included the assessments of air
According to USDA National quality, exposures, and qualitative and
country under just meeting the current
Agricultural Statistical Survey (NASS) quantitative risks associated with
standard (0–4 percent).
data, the 9 commodity crop species (e.g., The Staff Paper also presented alternative air quality scenarios.
cotton, field corn, grain sorghum, estimates of monetized benefits for Evidence-based considerations included
peanut, soybean, winter wheat, lettuce, crops associated with the current and assessment of vegetation effects
kidney bean, potato) included in the alternative standards. The Agriculture evidence obtained from chamber, free
Staff Paper analysis accounted for 69 Simulation Model (AGSIM) (Taylor, air, gradient, model and field-based
percent of 2004 principal crop acreage 1994; Taylor, 1993) was used to observation studies across an array of
planted in the U.S. in 2004.61 The C–R vegetation effects endpoints. Exposure-
calculate annual average changes in
functions for six fruit and vegetable and risk-based considerations were
total undiscounted economic surplus for
species (tomatoes-processing, grapes, drawn from exposure and risk
commodity crops and fruits and
onions, rice, cantaloupes, Valencia assessments that relied upon both
vegetables when current and alternative
oranges) were identified from the monitored and interpolated O3
standard levels were met. Meeting the
California fruit and vegetable analysis exposures as described in the Staff
various alternative standards did show
from the last review (Abt 1995). The Paper. These assessments reflect the
some significant benefits beyond the
Staff Paper noted that fruit and availability of new tools and assessment
current 8-hour standard. However, the
vegetable studies were not part of the methods, as well as the larger and more
Staff Paper recognized the AGSIM
NCLAN program and C–R functions diverse body of evidence available since
were available only in terms of seasonal modeled economic benefits had many
the last review. Specifically, estimates
7-hour or 12-hour mean index. This uncertainties: For example, much of the
of exposures and risks associated with
index form is considered less effective economic benefits were from the fruits
recent O3 air quality levels, as well as
in predicting plant response for a given and vegetables which had uncertain C–
estimates of the relative magnitude of
change in air quality than the R relationships, there was uncertainty in
exposure and risk reductions potentially
cumulative form used with other crops. assumptions about the treatment and
associated with meeting the current 8-
Therefore, the fruit and vegetable C–R effect of government farm payment
hour secondary O3 NAAQS and
functions were considered more programs, and there was also
alternative standards, have also been
uncertain than those for commodity uncertainty about near-term changes in
considered, along with all known
crops. agriculture sector due to the increased
associated uncertainties.
Analyses in the Staff Paper showed use of crops as biofuels. Although the In this review, a series of general
that some of the most important AGSIM model results provided a questions frames the approach to
commodity crops such as soybean, relative comparison of agricultural reaching a proposed decision on the
benefits between alternative standards, adequacy of the current standard,
61 Principal crops as defined by the USDA the uncertainties limited the utility of beginning with: (1) To what extent does
include corn, sorghum, oats, barley, winter wheat, the absolute numbers. newly available information reinforce or
rye, Durum wheat, other spring wheat, rice,

soybeans, peanuts, sunflower, cotton, dry edible D. Conclusions on the Adequacy of the call into question evidence of
beans, potatoes, sugar beets, canola, proso millet, Current Standard associations of O3 exposures with effects
hay, tobacco, and sugarcane. Acreage data for the identified in the last review?; (2) to what
principal crops were taken from the USDA NASS 1. Background extent does newly available information
2005 Acreage Report (http://
usda.mannlib.cornell.edu/reports/nassr/field/pcp- The initial issue to be addressed in reinforce or call into question any of the
bba/acrg0605.pdf). the current review of the secondary O3 basic elements of the current standard?;
and (3) to what extent have important years. Her decision was based on: (1) 2. Evidence- and Exposure/Risk-Based
uncertainties identified in the last Her judgment that the then existing Considerations
review been reduced and have new secondary standard did not provide The new evidence available in this
uncertainties emerged? To the extent the adequate protection for vegetation review as described in the Criteria
available information suggests that against the adverse welfare effects of O3; Document continues to support and
revision of the current standard may be (2) CASAC advice ‘‘that a secondary strengthen key policy-relevant
appropriate, the question of whether the NAAQS, more stringent than the present conclusions drawn in the previous
available information supports primary standard, was necessary to review (EPA, 2006a). Based on this new
consideration of a standard that is either protect vegetation from O3’’ (Wolff, evidence, the current Criteria Document
more or less protective than the current
1996); (3) her judgment that the new 8- once more concludes that: (1) A plant’s
standard is addressed, including: (1)
hour average standard would provide response to O3 depends upon the
Whether there is evidence that
substantially improved protection for cumulative nature of ambient exposure
vegetation effects extend to ambient O3
vegetation from O3-related adverse as well as the temporal dynamics of
concentration levels that are as low as
effects as compared to the level of those concentrations; (2) current
or lower than had previously been
protection provided by the then current ambient concentrations in many areas of
observed, and what are the important
1-hour, 0.12-ppm secondary standard; the country are sufficient to impair
uncertainties associated with that
(4) recognition that significant growth of numerous common and
evidence?; (2) whether vegetation
uncertainties remained with respect to economically valuable plant and tree
exposures and risks of concern
exposure dynamics, air quality species; (3) the entrance of O3 into the
estimated to occur in areas upon
meeting the current standard are relationships, and the exposure, risk, leaf through the stomata is the critical
considered important from a public and monetized valuation analyses step in O3 effects; (4) effects can occur
welfare perspective; and (3) what are the with only a few hourly concentrations
presented in the proposal, resulting in
important uncertainties associated with above 0.08 ppm; (5) other
only rough estimates of the increased
the estimated risks? environmental biotic and abiotic factors
public welfare likely to be afforded by are also influential to the overall impact
The current secondary standard was each of the proposed alternative
selected to provide protection to the of O3 on plants and trees; and (6) a high
standards; (5) her judgment that there degree of uncertainty remains in our
public welfare against a range of O3- was value in allowing more time to
induced vegetation effects, particularly ability to assess the impact of O3 on
obtain additional information to better ecosystem services.
yield loss in agricultural crops and
characterize O3-related vegetation In light of the new evidence, as
biomass loss in tree seedlings. As an
effects under field conditions from described in the Criteria Document, the
introduction to the discussion in this
section of the adequacy of the current additional research and to develop a Staff Paper evaluates the adequacy of
O3 standard, it is useful to summarize more complete rural monitoring the current standard based on
the key factors that formed the basis of network and air quality database from assessments of both the most policy-
the decision in the last review to revise which to evaluate the elements of an relevant vegetation effects evidence and
the averaging time, level and form of the appropriate seasonal secondary exposure and risk-based information, as
then current 1-hour secondary standard. standard; and (6) her judgment that summarized above in sections IV.A and
In the 1996 proposal notice (61 FR there was value in allowing more time IV.C, respectively. In evaluating the
65716), the Administrator proposed to to evaluate more specifically the strength of this information, the Staff
replace the then existing 1-hour O3 improvement in rural air quality and in Paper takes into account the
secondary NAAQS with one of two O3-related vegetation effects resulting uncertainties and limitations in the
alternative new standards: a standard from measures designed to attain the scientific evidence and analyses as well
identical to the proposed and now new primary standard (62 FR 38877– as the views of CASAC. The Staff Paper
current 0.08 ppm, 8-hour primary 78). concludes that progress has been made
standard (described above), or since the last review and generally finds
alternatively, a new seasonal standard, The Administrator further concluded support in the available effects- and
SUM06, expressed as a sum of hourly (62 FR 38877–78) that continued exposure/risk-based information for
concentrations greater than or equal to research on the effects of O3 on consideration of an O3 standard that is
0.06 ppm, cumulated daily over a 12 vegetation under field conditions and more protective than the current
hour daylight window (8 am to 8 pm) on better characterizing the relationship standard. The Staff Paper further
during the maximum consecutive 3- between O3 exposure dynamics and concludes that there is no support for
month period (e.g., the consecutive 3 plant response would be important in consideration of an O3 standard that is
month period with the highest SUM06 the next review because: (1) The less protective than the current
index value) during the O3 monitoring available biological database highlighted standard. This general conclusion is
season, set at a level of 25 ppm-hours. the importance of cumulative, seasonal consistent with the advice and
The latter form and level were selected exposures as a primary determinant of recommendations of CASAC.
to provide protection to vegetation on plant responses; (2) the association a. Evidence-Based Considerations
the basis of annual, rather than 3-year between daily maximum 8-hour O3
average, exposures. concentrations and plant responses had In the last review, crop yield and tree
In the final rule for the O3 NAAQS not been specifically examined in field seedling biomass loss data obtained in
published in July 1997 (62 FR 38877), tests; (3) the impacts of attaining an 8- OTC studies provided the basis for the
the Administrator decided to replace the Administrator’s judgment that the then
hour, 0.08 ppm primary standard in

then current 1-hour, 0.12-ppm current 1-hour, 0.12 ppm secondary
upwind urban areas on rural air quality
secondary NAAQS with a standard that standard was inadequate (EPA, 1996b).
distributions could not be characterized
was identical in every way to the new Since then, several additional lines of
revised primary standard of an 0.08 with confidence due to limited evidence have progressed sufficiently to
ppm annual 4th-highest maximum 8- monitoring data and air quality provide a more complete and coherent
hour average standard averaged over 3 modeling in rural and remote areas. picture of the scope of O3-related
vegetation risks, especially those areas of national significance to more studied with respect to O3 sensitivity,
currently faced by sensitive seedling, fully characterize the spatial extent of those species/genotypes shown to have
sapling and mature growth stage tree this public welfare impact. O3 sensitivity span a broad range of
species growing in field settings, and With respect to O3-induced biomass vegetation types and public use
their associated forested ecosystems. loss in trees, the Staff Paper concludes categories, including direct-use
Specifically, new research reflects an that the significant new body of field- categories like food production for
increased emphasis on field-based based research on trees strengthens the human and domestic animal
exposure methods (e.g., free air, ambient conclusions drawn on tree seedling consumption; fiber, materials, and
gradient, and biomonitoring surveys). In biomass loss from earlier OTC work by medicinal production; urban/private
reaching conclusions regarding the documenting similar seedling responses landscaping. Many of these species also
adequacy of the current standard, the in the field. For example, recent contribute to the structure and
Staff Paper has considered the empirical studies conducted on quaking functioning of natural ecosystems (e.g.,
combined information from all these aspen at the AspenFACE site in the EEAs) and thus, to the goods and
areas together, along with associated Wisconsin have confirmed the services those ecosystems provide
uncertainties, in an integrated, weight- detrimental effects of O3 exposure on (Young and Sanzone, 2002), including
of-evidence approach. tree growth in a field setting without non-use categories such as relevance to
Regarding the O3-induced effect of chambers (Isebrands et al., 2000, 2001). public welfare based on their aesthetic,
visible foliar injury, observations for the In addition, results from an ambient existence or wildlife habitat value.
years 2001 to 2004 at USDA FIA gradient study (Gregg et al., 2003), The Staff Paper therefore concludes
that the current secondary standard is
biomonitoring sites showed widespread which evaluated biomass loss in
inadequate to protect the public welfare
O3-induced leaf injury occurring in the cottonwood along an urban-to-rural
against the occurrence of known adverse
field, including in forested ecosystems, gradient at several locations, found that
levels of visible foliar injury and tree
under current ambient O3 conditions. conditions in the field were sufficient to
seedling biomass loss occurring in tree
For a few studied species, it has been produce substantial biomass loss in
species (e.g., ponderosa pine, aspen,
shown that the presence of visible foliar cottonwood, with larger impacts
black cherry, cottonwood) that are
injury is further linked to the presence observed in downwind rural areas due
sensitive and clearly important to the
of other vegetation effects (e.g., reduced to the presence of higher O3
public welfare.
plant growth and impaired below concentrations. These gradients from
ground root development) (EPA, 2006), low urban to higher rural O3 b. Exposure- and Risk-Based
though for most species, this linkage has concentrations occur when O3 Considerations
not been specifically studied or where precursors generated in urban areas are The Staff Paper also presents the
studied, has not been found. transported to downwind sites and are results of exposure and risk
Nevertheless, when visible foliar injury transformed into O3. In addition,O3 assessments. Due to multiple sources of
is present, the possibility that other O3- concentrations typically fall to near 0 uncertainty, both known and unknown,
induced vegetation effects could also be ppm at night in urban areas due to that continue to be associated with these
present for some species should be scavenging of O3 by NOX and other analyses, the Staff Paper put less weight
considered. Likewise, the absence of compounds. In contrast, rural areas, due on this information in drawing
visible foliar injury should not be to a lack of nighttime scavenging, tend conclusions on the adequacy of the
construed to demonstrate the absence of to maintain elevated O3 concentrations current standard. However, the Staff
other O3-induced vegetation effects. The for longer periods. On the basis of such Paper also recognizes that some progress
Staff Paper concludes that it is not key studies, the Staff Paper concludes has been made since the last review in
possible at this time to quantitatively that the expanded body of field-based better characterizing some of these
assess the degree of visible foliar injury evidence, in combination with the associated uncertainties and, therefore
that should be judged adverse in all substantial corroborating evidence from concluded that the results of the
settings and across all species, and that OTC data, provides stronger evidence exposure and risk assessments continue
other environmental factors can mitigate than that available in the last review to provide information useful to
or exacerbate the degree of O3-induced that ambient levels of O3 are sufficient informing judgments as to the relative
visible foliar injury expressed at any to produce visible foliar injury changes in risks predicted to occur
given concentration of O3. However, the symptoms and biomass loss in sensitive under exposure scenarios associated
Staff Paper also concludes that the vegetative species growing in natural with the different standard alternatives
presence of visible foliar injury alone environments. Further, the Staff Paper considered. Importantly, with respect to
can be adverse to the public welfare, judges that the consistency in response two key uncertainties, the uncertainty
especially when it occurs in protected in studied species/genotypes to O3 associated with continued reliance on
areas such as national parks and under a variety of exposure conditions C–R functions developed from OTC
wilderness areas. Thus, on the basis of and methodologies demonstrates that exposure systems to predict plant
the available information on the these sensitive genotypes and response in the field and the potential
widespread distribution of O3-sensitive populations of plants are susceptible to for changes in tree seedling and crop
species within the U.S. including in adverse impacts from O3 exposures at sensitivities in the intervening period
areas, such as national parks, which are levels known to occur in the ambient since the C–R functions were
afforded a higher degree of protection, air. Due to the potential for developed, the Staff Paper concluded
the Staff Paper concludes that the compounded risks from repeated insults that recent research has provided
current standard continues to allow over multiple years in perennial species, information useful in judging how much
levels of visible foliar injury in some the Staff Paper concludes that these weight to put on these concerns.
locations that could reasonably be sensitive subpopulations are not Specifically, new field-based studies,
considered to be adverse from a public afforded adequate protection under the conducted on a limited number of tree
welfare perspective. Additional current secondary O3 standard. Despite seedling and crop species to date,
monitoring of both O3 air quality and the fact that only a relatively small demonstrate plant growth and visible
foliar injury levels are needed in these portion of U.S. plant species have been foliar injury responses in the field that
are similar in nature and magnitude to The potential for effects to ‘‘carry over’’ iii. Crop Yield Loss
those observed previously under OTC to the following year or cumulate over Exposure and risk assessments in the
exposure conditions, lending qualitative multiple years, including the potential Staff Paper estimated that meeting the
support to the conclusion that OTC for compounding, must be considered. current 8-hour standard would still
conditions do not fundamentally alter The accumulation of such ‘‘carry-over’’ allow O3-related yield loss to occur in
the nature of the O3-plant response. effects over time may affect long-term several fruit and vegetable and
Second, nothing in the recent literature survival and reproduction of individual commodity crop species currently
suggests that the O3 sensitivity of crop trees and ultimately the abundance of grown in the U.S. These estimates of
or tree species studied in the last review sensitive tree species in forest stands. crop yield loss are substantially lower
and for which C–R functions were than those estimated in the last review
developed has changed significantly in ii. Qualitative Ecosystem Risks
as a result of several factors, including
the intervening period. Indeed, in the In addition to the quantifiable risk adjusted exposure levels to reflect the
few recent studies where this is categories discussed above, the Staff presence of a variable O3 gradient
examined, O3 sensitivities were found to Paper presents qualitative discussions between monitor height and crop
be as great as or greater than those on a number of other public welfare canopies, and use of a different
observed in the last review. effects categories. In so doing, the Staff econometric agricultural benefits model
i. Seedling and Mature Tree Biomass Paper concludes that the quantified updated to reflect more recent
Loss risks to vegetation estimated to be agricultural policies (EPA, 2006b).
occurring under current air quality or Though these sources of uncertainty
Biomass loss in sensitive tree upon meeting the current secondary
seedlings is predicted to occur under O3 associated with the crop risk and
standard likely represent only a portion benefits assessments were better
exposures that meet the level of the of actual risks that may be occurring for
current secondary standard. For documented in this review, the Staff
a number of reasons. Paper concludes that the presence of
instance, black cherry, ponderosa pine,
First, as mentioned above, out of the these uncertainties make the risk
eastern white pine, and aspen had
over 43,000 plant species catalogued as estimates suitable only as a basis for
estimated median seedling biomass
growing within the U.S. (USDA understanding potential trends in
losses as high as 24, 11, 6, and 6
PLANTS database, USDA, NRCS, 2006), relative yield loss and economic
percent, respectively, over some
only a small percentage have been benefits. The Staff Paper further
portions of their growing ranges when
air quality was rolled back to meet the studied with respect to O3 sensitivity. recognizes that actual conditions in the
current 8-hr standard with the 10 Most of the studied species were field and management practices vary
percent downward adjustment for the selected because of their commercial from farm to farm, that agricultural
potential O3 gradient between monitor importance or observed O3-induced systems are heavily managed, and that
height and short plant canopies applied. visible foliar injury in the field. Given adverse impacts from a variety of other
The Staff Paper notes that these results that O3 impacts to vegetation also factors (e.g., weather, insects, disease)
are for tree seedlings and that mature include less obvious but often more can be orders of magnitude greater than
trees of the same species may have more significant impacts, such as reduced that of yield impacts predicted for a
or less of a response to O3 exposure. annual growth rates and below ground given O3 exposure. Thus, the relevance
Decreased root growth associated with root loss, the paucity of information on of such estimated impacts on crop
biomass loss has the potential to other species means the number of O3- yields to the public welfare are
indirectly affect the vigor and sensitive species that exists within U.S., considered highly uncertain and less
survivability of tree seedlings. If such could be greater than what is now useful as a basis for assessing the
effects occur on a sufficient number of known. Since no state in the lower 48 adequacy of the current standard. The
seedlings within a stand, overall stand states has less than seven known O3- Staff Paper notes, however, that in some
health and composition can be affected sensitive plant species, with the experimental cases, exposure to O3 has
in the long term. Thus, the Staff Paper majority of states having between 11 made plants more sensitive or
concludes that these levels of estimated and 30 (see Appendix 7J–2 in Staff vulnerable to some of these other
tree seedling growth reduction should Paper), protecting O3 sensitive important stressors, including disease,
be considered significant and vegetation is clearly important to the insect pests, and harsh weather (EPA,
potentially adverse, given that they are public welfare at the national scale. 2006a). The Staff Paper therefore
well above the 2 percent level of Second, the Staff Paper also takes into concluded that this remains an
concern identified by the 1997 consideration the possibility that more important area of uncertainty and that
consensus workshop (Heck and subtle and hidden risks to ecosystems additional research to better
Cowling, 1997). are potentially occurring in areas where characterize the nature and significance
Though there is significant vegetation is being significantly of these interactions between O3 and
uncertainty associated with this impacted. Given the importance of these other plant stressors would be useful.
analysis, the Staff Paper recommends qualitative and anticipated risks to
that this information should be given important public welfare effects c. Summary
careful consideration in light of several categories such as ecosystem impacts In summary, the Staff Paper
other pieces of evidence. Specifically, leading to potential losses or shifts in concludes that the current secondary O3
limited evidence from experimental ecosystem goods and services (e.g., standard is inadequate. This conclusion
studies that go beyond the seedling carbon sequestration, hydrology, and is based on the extensive vegetation
growth stage continues to show fire disturbance regimes), the Staff Paper effects evidence, in particular the recent
decreased growth under elevated O3 concludes that any secondary standard empirical field-based evidence on
levels (King et al., 2005). Some mature set to protect against the known and biomass loss in seedlings, saplings and
trees such as red oak have shown an quantifiable adverse effects to vegetation mature trees, and foliar injury incidence
even greater sensitivity of should also consider the anticipated, that has become available in this review,
photosynthesis to O3 than seedlings of but currently unquantifiable, potential which demonstrates the occurrence of
the same species (Hanson et al., 1994). effects on natural ecosystems. adverse vegetation effects at ambient
levels of recent O3 air quality, as well as the associated uncertainties should be and coherent vegetation effects
evidence and exposure- and risk-based considered in interpreting the results, literature, can also provide substantially
analyses indicating that adverse effects and the views of CASAC and members improved protection to vegetation when
would be predicted to occur under air of the public. On these bases, the set at an appropriate level. Therefore,
quality scenarios that meet the current Administrator proposes that the current the Administrator also considered
standard. secondary standard is inadequate to whether revision to the level of the
protect the public welfare from known current 8-hour secondary standard
3. CASAC Views
and anticipated adverse O3-related might provide the requisite level of
In a letter to the Administrator effects on vegetation and ecosystems. public welfare protection. In light of
(Henderson, 2006c), the CASAC O3 Ozone levels that would be expected to these considerations, as discussed
Panel, with full endorsement of the remain after meeting the current below, the Administrator is proposing
chartered CASAC, unanimously secondary standard are sufficient to two options for revising the current
concluded that ‘‘despite limited recent cause visible foliar injury, seedling and secondary standard: one option is a
research, it has become clear since the mature tree biomass loss, and crop yield cumulative seasonal standard (section
last review that adverse effects on a reductions to degrees that could be IV.E.2) and the other option is an 8-hour
wide range of vegetation including considered adverse depending on the average standard consistent with the
visible foliar injury are to be expected intended use of the plant and its revised 8-hour average standard
and have been observed in areas that are significance to the public welfare, and proposed above for the primary
below the level of the current 8-hour the current secondary standard does not standard (section IV.E.3). The
primary and secondary ozone provide adequate protection from such Administrator has also considered an
standards.’’ Therefore, ‘‘based on the effects. Other O3-induced effects alternative approach to setting a
Ozone Panel’s review of Chapters 7 and described in the literature, including an cumulative, seasonal standard(s) as
8 [of the Staff Paper], the CASAC impaired ability of many sensitive described below in section IV.E.2.
unanimously agrees that it is not species and genotypes within species to
appropriate to try to protect vegetation 1. Indicator
adapt to or withstand other
from the substantial, known or environmental stresses, such as freezing In the last review, EPA focused on a
anticipated, direct and/or indirect, temperatures, pest infestations and/or standard for O3 as the most appropriate
adverse effects of ambient O3 by disease, and to compete for available surrogate for ambient photochemical
continuing to promulgate identical resources, would also be anticipated to oxidants. In this review, while the
primary and secondary standards for O3. occur. In the long run, the result of these complex atmospheric chemistry in
Moreover, the members of the impairments (e.g., loss in vigor) could which O3 plays a key role has been
Committee and a substantial majority of lead to premature plant death in O3 highlighted, no alternatives to O3 have
the Ozone Panel agree with EPA staff sensitive species. Though effects on been advanced as being a more
conclusions and encourage the other ecosystem components have only appropriate surrogate for ambient
Administrator to establish an alternative been examined in isolated cases, effects photochemical oxidants. Thus, as is the
cumulative secondary standard for O3 such as those described above could case for the primary standard,
and related photochemical oxidants that have significant implications for plant (discussed above in section II.D.1.), the
is distinctly different in averaging time, community and associated species Administrator proposes to continue to
form and level from the currently biodiversity and the structure and use O3 as the indicator for a standard
existing or potentially revised 8-hour function of whole ecosystems. These that is intended to address effects
primary standard’’ (Henderson, considerations also support the associated with exposure to O3, alone
2006c).62 proposed conclusion that the current and in combination with related
secondary standard is not adequate and photochemical oxidants. In so doing,
4. Administrator’s Proposed
that revision is needed to provide the Administrator recognizes that
Conclusions Concerning Adequacy of
additional public welfare protection. measures leading to reductions in
Current Standard
vegetation exposures to O3 will also
The Administrator recognizes that the E. Conclusions on the Elements of the reduce exposures to other
secondary standard is to protect against Secondary Standard photochemical oxidants.
‘‘adverse’’ O3 effects, discussed above in Given his proposed conclusion that
section IV.A.3. In considering what 2. Cumulative, Seasonal Standard
the current secondary standard is
constitutes a vegetation effect that is inadequate, the Administrator then The Administrator proposes to
also adverse to the public welfare, the considered what revisions to the replace the current secondary standard
Administrator took into account the standard are appropriate. In so doing, with a new cumulative, seasonal
Staff Paper conclusions regarding the the Administrator has focused on standard expressed as an index of the
nature and strength of the vegetation revisions to the key standard elements annual sum of weighted hourly
effects evidence, the exposure and risk of indicator, form, averaging time, and concentrations (using the W126 form),
assessment results, the degree to which level. On the basis of the strength and set at a level in the range of 7 to 21 ppm-
coherence of the vegetation effects hours. The index would be cumulated
62 One CASAC Panel member reached different
evidence suggesting that a biologically- over the 12-hour daylight period (8 a.m.
conclusions from those of the broader Panel
regarding certain aspects of the vegetation effects
based standard for vegetation, at a to 8 p.m.) during the consecutive 3-
information and the appropriate degree of emphasis minimum, should cumulate exposures month period within the O3 season with
that should be placed on the associated and differentially-weight higher O3 the maximum index value. In addition,
uncertainties. These concerns related to how the concentrations, the Administrator as discussed below, the Administrator is
results of O3/vegetation exposure experiments

carried out in OTC can be extrapolated to the judges that it is appropriate to consider considering an alternative approach to
ambient environment and how C–R functions revisions to the secondary standard that setting a cumulative, seasonal
developed in the 1980’s can be used today given reflect this understanding. In addition, standard(s) that would afford differing
that he did not expect that current crop species/
cultivars in use in 2002 would have the same O3
the Administrator also judges that the degrees of protection for O3-related
sensitivity as those studied in NCLAN (Henderson, current 8-hour average form, though not impacts on different types of vegetation
2007, pg. C–18). based on the most biologically relevant with different intended uses.
a. Form secondary standard for O3 and related for plant response. Exposure periods are
The current Criteria Document and photochemical oxidants that is discussed below in terms of a seasonal
Staff Paper concluded that the recent distinctly different in averaging time, window, a diurnal window, and an
vegetation effects literature evaluated in form, and level from the current or annual versus 3-year average standard.
this review strengthens and reaffirms potentially revised 8-hour primary (1) In considering an appropriate
conclusions made in the last review that standard. The CASAC also stated that seasonal window, the Staff Paper
‘‘the recommended metric for the recognizes that, in general, many annual
the use of a cumulative exposure index
secondary ozone standard is the crops are grown for periods of a few
that differentially-weights ambient
(sigmoidally-weighted) W126 index’’ months before being harvested. In
concentrations is best able to relate
(Henderson, 2007).63 contrast, other annual and perennial
ambient exposures to vegetation
The Administrator agrees with the species may be photosynthetically
response at this time (EPA, 2006a, b; see
conclusions drawn in the Criteria active longer, and for some species and
also discussion in IV.B. above). The
Document, Staff Paper and by CASAC locations, throughout the entire year. In
1996 review focused in particular on
that the scientific evidence available in general, the period of maximum
two of these cumulative forms, the
the current review continues to physiological activity and thus,
SUM06 and W126. As described in the
demonstrate the cumulative nature of maximum potential O3 uptake for
last review (EPA, 1996a, b) it was O3-induced plant effects and the need to annual crops, herbaceous species, and
concluded that, based on statistical give greater weight to higher deciduous trees and shrubs coincides
reanalysis of the NCLAN data, these concentrations. Thus, the Administrator with some or all of the intra-annual
different cumulative forms performed concludes that a cumulative exposure period defined as the O3 season, which
equally well in predicting crop yield index that differentially-weights O3 varies on a state-by-state basis. This is
loss response to O3 exposure. Given that concentrations represents a reasonable because the high temperature and high
the data available at that time were policy choice for a seasonal secondary light conditions that promote the
unable to distinguish between these standard to protect against the effects of formation of tropospheric O3 also
forms, the Administrator, based on the O3 on vegetation. The Administrator promote physiological activity in
policy consideration of not including O3 further agrees with both the Staff Paper vegetation.
concentrations considered to be within and CASAC that the most appropriate The Staff Paper notes that the
the PRB, concluded that the SUM06 cumulative, concentration-weighted selection of any single seasonal
form was the more appropriate choice form to consider in this review is the exposure period for a national standard
for a secondary standard. sigmoidally weighted W126 form, due would represent a compromise, given
In this review, the Staff Paper to his recognition that there is no the significant variability in growth
evaluated the continued evidence in the literature for an patterns and lengths of growing seasons
appropriateness of the SUM06 form in exposure threshold that would be among the wide range of vegetation
light of two key pieces of information: appropriate across all O3-sensitive species occurring within the U.S. that
new estimates of PRB that are lower vegetation and that this form is unlikely may experience adverse effects
than in the last review, and continued to be significantly influenced by O3 air associated with O3 exposures. However,
lack of evidence within the vegetation quality within the range of PRB levels the Staff Paper further concludes that
effects literature of a biological identified in this review. Thus, the the consecutive 3-month period within
threshold for vegetation exposures of Administrator proposes as one option to the O3 season with the highest W126
concern. On the basis of those policy replace the current 8-hour average index value (e.g., maximum 3 month
and science-related considerations, the secondary standard form with the period) would, in most cases, likely
Staff Paper concluded that the W126 cumulative, seasonal W126 form. coincide with the period of greatest
form was more appropriate in the plant sensitivity on an annual basis.
context of this review. Specifically, the b. Averaging Times 64 Therefore, the Staff Paper again
W126, by its incorporation of a The Staff Paper, in addition to form, concludes, as it did in 1996, that the
sigmoidal weighting scheme, does not also considers what ‘‘averaging’’ periods annual maximum consecutive 3-month
create an artificially imposed or exposure durations are most relevant period is a reasonable seasonal time
concentration threshold, gives for vegetation, which, unlike people, is period, when combined with a
proportionally more weight to the exposed to ambient air continuously cumulative, concentration weighted
higher and typically more biologically throughout its lifespan. For annual form, for protection of sensitive
potent concentrations, and is not species, this lifespan encompasses a vegetation.
significantly influenced by O3 period of only one year or less; while for (2) In considering an appropriate
concentrations within the range of perennials, lifespans can range from a diurnal window, the Staff Paper
estimated PRB. few years to decades or centuries. recognizes that over the course of the
The CASAC, based on its assessment However, because O3 levels are not 24-hour diurnal period, plant stomatal
of the same vegetation effects science, continuously elevated and plants are conductance varies in response to
agreed with the Criteria Document and not equally sensitive to O3 over the changes in light level, soil moisture and
Staff Paper and unanimously concluded course of a day, season or lifetime, it other environmentally and genetically
that it is not appropriate to try to protect becomes necessary to identify periods of controlled factors. In general, stomata
vegetation from the known or exposure that have the most relevance are most open during daylight hours in
anticipated adverse effects of ambient order to allow sufficient CO2 uptake for
O3 by continuing to promulgate 63 One CASAC Panel member expressed the view
use in carbohydrate production through
identical primary and secondary that the O3 exposure indices, SUM06 and W126, are the light-driven process of
simply mathematical expressions of exposure and,

standards for O3. Moreover, the thus, cannot be said to have a biological basis photosynthesis. At most locations, O3
members of CASAC and a substantial (Henderson, 2007, pg. C–18). concentrations are also highest during
majority of the CASAC O3 Panel agreed 64 While the term ‘‘averaging time’’ is used, for
the daytime, and thus, most likely to
with Staff Paper conclusions and the cumulative, seasonal standard the time period coincide with maximum stomatal
at issue is one over which exposures during a
encouraged the Administrator to specified period of time are cumulated, not uptake. It is also known however, that
establish an alternative cumulative averaged. in some species, stomata may remain
open sufficiently at night to allow for (3) In considering whether an annual being careful to consider what is needed
some nocturnal uptake to occur. In or 3-year averaging period is more to provide the requisite degree of
addition, at some rural, high elevation appropriate, the Staff Paper recognized protection, no more and no less,
sites, the O3 concentrations remain that though most cumulative seasonal proposes that the 3-month seasonal
relatively flat over the course of the day, exposure levels of concern for period and 12-hour daylight period are
often at levels above estimated PRB. At vegetation have been expressed in terms appropriate. Based on the Staff Paper
these sites, nighttime W126 values can of the annual timeframe, it may be conclusions discussed above, the
be of similar magnitude as daytime appropriate to consider a 3-year Administrator is mindful that there is
values, though the significance of these averaging period for purposes of the potential for under-protection with
exposures is much less certain. This is standard stability. However, the Staff a 12-hour diurnal window in areas with
because O3 uptake during daylight Paper notes that for certain welfare sufficiently elevated nighttime levels of
hours is known to impair the light- effects of concern (e.g., foliar injury, O3 where sensitive species with a high
driven process of photosynthesis, which yield loss for annual crops, growth degree of nocturnal stomatal
can then lead to impacts on effects on other annual vegetation and conductance occur. On the other hand,
carbohydrate production, plant growth, potentially tree seedlings), an annual the Administrator also recognizes that a
reproduction (yield) and root function. time frame may be a more appropriate longer diurnal window (e.g., 24-hour)
It is less clear at this time to what extent period in which to assess what level has the possibility of over-protecting
and by what mechanisms O3 uptake at would provide the requisite degree of vegetation in areas where nighttime O3
night adversely impacts plant function. protection, while for other welfare levels remain relatively high but where
In addition, many species do not take effects (e.g., mature tree biomass loss), a no species having significant nocturnal
up O3 at night or occur in areas with 3-year averaging period may also be uptake exist. In weighing these
elevated nighttime O3 concentrations. appropriate. Thus, the Staff Paper considerations, the Administrator agrees
In light of a recent work on this topic concludes that it is appropriate to with the Staff Paper conclusion that
conducted by Musselman and Minnick consider both an annual and a 3-year until additional information is available
(2000), the Staff Paper again revisited averaging period. Further, the Staff about the extent to which this co-
the issue of what diurnal period is of Paper concludes that should a 3-year occurrence of sensitive species and
average of the 12-hour W126 form be elevated nocturnal O3 exposures exists,
most relevance in influencing O3-
selected, a potentially lower level and what levels of nighttime uptake are
induced effects on vegetation. This work
should be considered to reduce the adverse to affected species, this
reports that some species take up O3 at
potential of adverse impacts to annual information does not provide a basis for
night, but that the degree of nocturnal
species from a single high O3 year that reaching a different conclusion at this
stomatal conductance varies widely
could still occur while attaining a time. The Administrator also considered
between species and its relevance to
standard on average over 3-years. to what extent the 3-month period
overall O3-induced vegetation effects The CASAC, in considering what
remain unclear. In considering this within the O3 season was appropriate,
seasonal and diurnal time periods are recognizing that many species of
information, the Staff Paper concludes most appropriate when combined with
that for the vast majority of studied vegetation have longer growing seasons.
a cumulative, concentration-weighted The Administrator further proposes that
species, daytime exposures represent form to protect vegetation from
the majority of diurnal plant O3 uptake the maximum 3-month period is
exposures of concern, agreed that the sufficient and appropriate to
and are responsible for inducing the Staff Paper conclusion regarding the 3-
plant response of most significance to characterize O3 exposure levels
month seasonal period and 12-hour
the health and productivity of the plant associated with known levels of plant
daylight window was appropriate, with
(e.g., reduced carbohydrate production). response. Therefore, the Administrator
the distinction that both time
Until additional information is available proposes that the most appropriate
designations likely represents the
about the extent to which co-occurrence exposure periods for a cumulative,
minimum time periods of importance.
of sensitive species and elevated seasonal form is the daytime 12-hour
In particular, one O3 Panel member
nocturnal O3 exposures exists, and what window (8 a.m. to 8 p.m.) during the
commented that for some species,
levels of nighttime uptake are adverse to consecutive 3-month period within the
additional O3 exposures of importance
affected species, the Staff Paper O3 monitoring season with the
were occurring outside the 3-month
concludes that this information seasonal and 12-hour diurnal windows. maximum W126 index value.
continues to be preliminary, and does Further, the CASAC concluded that The Administrator also proposes an
not provide a basis for reaching a multi-year averaging to promote a annual rather than a multi-year
different conclusion at this time. The ‘‘stable’’ secondary standard is less cumulative, seasonal standard. In
Staff Paper further notes that additional appropriate for a cumulative, seasonal proposing this alternative, the
research is needed to address the degree secondary standard than for a primary Administrator also believes that it is
to which a 12-hour diurnal window may standard based on maximum 8-hour appropriate to consider the benefits to
be under protective in areas where concentrations. CASAC further the public welfare that would accrue
elevated nighttime levels of O3 co-occur concluded that if multi-year averaging is from establishing a 3-year average
with sensitive species with a high employed to increase the stability of the secondary standard, and solicits
degree of nocturnal stomatal secondary standard, the level of the comment on this alternative. In so
conductance. Thus, as in the last standard should be revised downward doing, the Administrator also agrees
review, the Staff Paper again concludes to assure that the desired degree of with Staff Paper and CASAC
that based on the available science, the protection is not exceeded in individual conclusions that should a 3-year
daytime 12-hour window (8 a.m. to 8 years. standard be finalized, the level of the
p.m.) is the most appropriate period The Administrator, in determining standard should be set so as to provide
over which to cumulate diurnal O3 which seasonal and diurnal time the requisite degree of protection for
exposures, specifically those most periods are most appropriate to propose, those vegetation effects judged to be
relevant to plant growth and yield took into account Staff Paper and adverse to the public welfare within a
responses. CASAC views. The Administrator, in single annual period.
c. Level seedlings like black cherry from growth scientific research in this area, the
and foliar injury effects. results of which could be important in
The Staff Paper, in identifying a range In addition to the currently future reviews of the O3 secondary
of levels for a 3-month, 12-hour W126 quantifiable risks to trees from ambient standard’’ (62 FR 38856).
annual form appropriate to protect the exposures, the Staff Paper also considers Given the importance the
public welfare from adverse impacts to the more subtle impacts of O3 acting in Administrator put on the consensus
vegetation from O3 exposures, considers synergy with other natural and man- report in the last review, the Staff Paper
what information from the array of made stressors to adversely affect considered to what extent new research
vegetation effects evidence and individual plants, populations and provided empirical support for the
exposure and risk assessment results whole systems. By disrupting the ranges of levels identified by the experts
was most useful. In regards to the photosynthetic process, decreasing as protective of different types of O3-
vegetation effects evidence, the Staff carbon storage in the roots, increasing induced effects. On the basis of new
Paper finds stronger support than what early senescence of leaves and affecting field-based tree seedling growth loss
was available at the time of the last water use efficiency in trees, O3 and foliar injury data, and including
review for an increased level of exposures could potentially disrupt or both the above quantitative and
protection for trees and ecosystems. change the nutrient and water flow of an qualitative information regarding O3-
Specifically, this expanded body of entire system. Weakened trees can induced effects on sensitive trees and
support includes: (1) Additional field become more susceptible to other forested ecosystems, the Staff Paper
based data from free air, gradient and environmental stresses such as pest and concludes that it is appropriate to
biomonitoring surveys demonstrating pathogen outbreaks or harsh weather consider a range for a 3-month, 12-hour,
adverse levels of O3-induced above and/ conditions. Though it is not possible to W126 standard that includes the
or below-ground growth reductions on quantify all the ecological and societal consensus recommendations for growth
trees at the seedling, sapling and mature benefits associated with varying levels effects in tree seedlings in natural forest
growth stages and incidence of visible of alternative secondary standards, the stands.
foliar injury occurring at biomonitoring Staff Paper concludes that this In considering the newly available
sites in the field at ambient levels of information should be weighed in information on O3-related effects on
exposure; (2) qualitative support from considering the extent to which a crops in this review, the Staff Paper
free air (e.g., AspenFACE) and gradient secondary standard should be set so as observes the following regarding the
studies on a limited number of tree to provide potential protection against strength of the underlying crop science:
species for the continued effects that are anticipated to occur. (1) Nothing in the recent literature
appropriateness of using OTC-derived In addition, the Staff Paper also points to a change in the relationship
C–R functions to predict tree seedling recognizes that in the last review, the between O3 exposure and crop response
response in the field; (3) studies that Administrator took into account the across the range of species and/or
continue to document below-ground results of a 1996 consensus-building cultivars of commodity crops currently
effects on root growth and ‘‘carry-over’’ workshop as described in a January grown in the U.S. that could be
effects occurring in subsequent years 1997 report (Heck and Cowling, 1997). construed to make less appropriate the
from O3 exposures; and (4) increased At this workshop, a group of use of commodity crop C–R functions
recognition and understanding of the independent scientists expressed their developed in the NCLAN program; (2)
structure and function of ecosystems judgments on what standard form(s) and new field-based studies (e.g., SoyFACE)
and the complex linkages through level(s) would provide vegetation with provide qualitative support in a few
which O3, and other stressors, acting at adequate protection from O3-related limited cases for the appropriateness of
the organism and species level can adverse effects. Consensus was reached using OTC-derived C–R functions to
influence higher levels within the with respect to selecting appropriate predict crop response in the field; and
ecosystem hierarchy and disrupt ranges of levels in terms of a (3) refinements in the exposure, risk and
cumulative, seasonal 3-month, 12-hr benefits assessments in this review
essential ecological attributes critical to
SUM06 standard for a number of reduce some of the uncertainties present
the maintenance of ecosystem goods
vegetation effects endpoints. These in 1996. On the basis of these
and services important to the public
ranges are identified below, with the observations, the Staff Paper concludes
welfare.
estimated approximate equivalent W126 that nothing in the newly assessed
Based on the above observations and standard values shown in parentheses. information calls into question the
on the vegetation effects and the results For growth effects to tree seedlings in strength of the underlying science upon
of the exposure and impact assessment natural forest stands, a consensus was which the Administrator based her
summarized above, the Staff Paper reached that a range of 10 to 15 (7 to 13) proposed decision in the last review to
concludes that just meeting the current ppm-hours would be protective. For select a level of a cumulative, seasonal
standard would still allow adverse growth effects to tree seedlings and form associated with protecting 50
levels of tree seedling biomass loss in saplings in plantations, the consensus percent of crop cases from no more than
sensitive commercially and ecologically range was 12 to 16 (9 to 14) ppm-hours. 10 percent yield loss as providing the
important tree species in many regions For visible foliar injury to natural requisite degree of protection for
of the country. Seedling risk assessment ecosystems, the consensus range was 8 commodity crops.
results showed that some tree seedling to 12 (5 to 9) ppm-hours (Heck and The Staff Paper then considered
species are extremely sensitive (e.g., Cowling, 1997). whether any additional information is
cottonwood, black cherry and aspen), Taking these consensus statements available to inform judgments as to the
with annual biomass losses occurring in into account, the Administrator stated adversity of various O3-induced levels
the field of the same or greater in the final rule (62 FR 38856) that ‘‘the of crop yield loss to the public welfare.
magnitude that that of annual crops. report lends important support to the As noted above, the Staff Paper observes
Such information from the tree seedling view that the current secondary that agricultural systems are heavily
risk assessment suggests that air quality standard is not adequately protective of managed, and that in addition to stress
levels would need to be substantially vegetation * * * [and] * * * from O3, the annual productivity of
reduced to protect sensitive tree foreshadows the direction of future agricultural systems is vulnerable to
disruption from many other stressors cumulative, seasonal secondary could be set at a lower, more protective
(e.g., weather, insects, disease), whose standard as expressed in terms of the level to provide the requisite degree of
impact in any given year can greatly maximum 3 month, 12-hour W126 form, protection against a broad array of O3-
outweigh the direct reduction in annual in the range of 7 to 21 ppm-hours. This related effects on important sensitive
productivity resulting from elevated O3 range encompasses the range of levels species in such areas. In contrast, while
exposures. On the other hand, O3 can recommended by CASAC, and also negative impacts on yield production in
also more subtly impact crop and forage includes a higher level as recommended sensitive agricultural crops is also an
nutritive quality and indirectly in the Staff Paper. Given the uncertainty important public welfare effect, O3-
exacerbate the severity of the impact in determining the risk attributable to related reductions in yield may be
from other stressors. Though these latter various levels of exposure to O3, the considered less significant or adverse to
effects currently cannot be quantified, Administrator believes as a public the public welfare, depending on the
they should be considered in judging to welfare policy judgment that this is a degree of impact, since the intended use
what extent a level of protection reasonable range to propose.
In taking into account the uncertainty of such land is to produce optimum
selected to protect commodity crops
associated with the above, the yields and croplands are already heavily
should be precautionary.
Based on the above considerations, Administrator has also considered an managed to achieve that goal. Thus, a
the Staff Paper concludes that the level alternative approach to establishing a secondary standard set to provide the
of protection judged requisite in the last secondary standard(s). This alternative requisite degree of crop protection for
review to protect the public welfare approach would establish a cumulative, such an area could be set at a higher
from adverse levels of O3-induced seasonal standard(s) that would afford level.
reductions in crop yields, as provided differing degrees of protection for O3- The Administrator recognizes that
by a W126 level of 21 ppm-hours, related impacts on different types of variation in vegetation type and
remains appropriate for consideration as vegetation with different intended uses. location, intended use, and impacts
an upper bound of a range of The Administrator recognizes that related to O3 exposure can be diverse,
appropriate levels. known O3-sensitive plant species and believes that it is appropriate to
Thus, the Staff Paper concludes, growing within the U.S experience a consider whether it is appropriate and
based on all the above considerations, variety of O3-induced effects, including feasible to establish a suite of standards
that an appropriate range of 3-month, visible foliar injury, biomass loss and
that accounts more broadly for such
12-hour W126 levels is 7 to 21 ppm- yield loss, and that the public welfare
variation. EPA recognizes that this
hours, recognizing that the level significance of each of these effects can
selected is largely a policy judgment as vary significantly, depending on the approach is unique with regard to
to the requisite level of protection nature of the effect, the intended use of secondary standards and will pose
needed. In determining the requisite the plant, and/or the type of unique challenges, including how to
level of protection for crops and trees, environment or location in which the classify areas according to intended use.
the Staff Paper recognizes that it is plant grows. Any given O3-related effect Some geographic areas have already
appropriate to weigh the importance of on vegetation (e.g., biomass loss, or been identified for specific uses, such as
the predicted risks of these effects in the foliar injury) may be judged to have a Federal Class I areas,65 which are
overall context of public welfare different degree of impact on public intended to conserve unimpaired
protection, along with a determination welfare depending, for example, on natural ecosystems and their associated
as to the appropriate weight to place on whether that effect occurs in a Class I species for the enjoyment of future
the associated uncertainties and area, commercial cropland, or a city generations. Likewise, the USDA has
limitations of this information. park. This variation in the significance classified cultivated areas in the U.S.
The CASAC, in its final letter to the of O3-related vegetation effects from a into certain categories of intended use
Administrator (Henderson, 2007), public welfare perspective across type (such as cropland, rangeland,
agreed with the Staff Paper of effect, intended plant use, and area timberland) that could help inform the
recommendations that the lower bound grown means that the level of ambient setting of a suite of standards.
of the range within which a seasonal O3 that is requisite to protect the public
W126 welfare-based (secondary) O3 EPA is taking comment on all aspects
welfare may also vary. The level of
standard should be considered is of this alternative approach, including
ambient O3 that is requisite in a
approximately 7 ppm-hours; however, it whether it is appropriate to set a suite
federally designated Class I area may be
did not agree with Staff’s lower than the level that is requisite in of secondary standards that varies
recommendation that the upper bound a cropland area. EPA is therefore depending on use, location, and type of
of the range should be as high as 21 considering and soliciting comment on effect on vegetation. EPA invites
ppm-hours. Rather, CASAC an alternative approach for the comment on the appropriateness of this
recommended that the upper bound of secondary O3 standard, with the aim of approach, from the scientific, legal, and
the range considered should be no reasonably reflecting these variations. policy perspectives, and on other factors
higher than 15 ppm-hours, which the Specifically, the Administrator seeks that should be considered in
Panel estimates is approximately comment on an alternative approach determining the applicability of any one
equivalent to a seasonal 12-hour SUM06 that would establish a suite of level within a suite of standards.
level of 20 ppm-hours. The lower end of secondary standards. The suite of
this range (7 ppm-hours) is the same as standards would contain different 65 The Clean Air Act defines Class I areas as
the lower end of the range identified in ambient levels, with each standard at a national parks over 6,000 acres, national wilderness
areas and national memorial parks over 5,000 acres,
the 1997 Consensus Workshop as level that is requisite to protect public
and international parks. The National Park Service

protective of tree seedlings in natural welfare for that variation in plant effect, was created in 1916 by Congress through the
forest stands from growth effects (Heck use, and/or location. For example, a National Park Service Organic Act in order to
and Cowling, 1997). secondary standard intended to provide ‘‘conserve the scenery and the natural and historic
objects and the wild life therein and to provide for
The Administrator, taking Staff Paper protection to natural systems valued for the enjoyment of the same in such manner and by
and CASAC views into account, their aesthetic beauty and/or important such means as will leave them unimpaired for the
proposes a range of levels for a ecological functions they might serve enjoyment of future generations.’’
3. 8-Hour Average Standard quality expressed in terms of the 8-hour review; and (2) the exposure assessment
The Administrator is also proposing average form in the absence of parallel is inaccurate and too uncertain due to
to revise the current secondary standard W126 information. This caution is due the use of low estimates of PRB, an
by making it identical to the proposed to the concern that the analysis in the arbitrary rollback method that is
8-hour primary standard, which is Staff Paper may not be an accurate uninformed by atmospheric chemistry
proposed to be within the range of 0.070 reflection of the true situation in non- from photochemical models, and the
to 0.075 ppm. For this option, EPA also monitored, rural counties due to the use of the CMAQ model in the west,
solicits comment on a wider range of 8- lack of more complete monitor coverage whose biases and uncertainties are
hour standard levels, including levels in many rural areas. Further, of the insufficiently characterized and
down to 0.060 ppm and up to the counties that did not show overlap evaluated.
between the two standard forms, most In considering the appropriateness of
current standard (i.e., effectively 0.084
were located in rural/remote high proposing a revised secondary standard
ppm with the current rounding
elevation areas which have O3 air that would be identical to the proposed
convention).
quality patterns that are typically primary standard, the Administrator
In the last review, the Staff Paper
different from those associated with took into account the approach used by
included an analysis to compare the
urban and near urban sites at lower the Agency in the last review, the
degree of overlap between areas that
elevations. Because the majority of such conclusions of the Staff Paper, CASAC
would be expected not to meet the range
areas are currently not monitored, it is advice, and the views of public
of alternative 8-hour standards being
believed there are likely to be additional commenters. The Administrator first
considered for the primary NAAQS and considered the Staff Paper analysis of
areas that have similar air quality
those expected not to meet the range of the projected degree of overlap between
distributions that would lead to the
values (expressed in terms of the counties with air quality expected to
same disconnect between forms. Thus,
seasonal SUM06 index) of concern for meet various alternative levels of an 8-
the Staff Paper concluded that it
vegetation. This result suggested that hour standard and alternative levels of
remains problematic to determine the
improvements in national air quality a W126 standard based on monitored air
appropriate level of protection for
expected to result from attaining an 8- quality data. This analysis showed
vegetation using an 8-hour average form.
hour primary standard within the The CASAC recognized that an significant overlap within the proposed
recommended range of levels would important difference between the effects range of the primary 8-hour form and
also be expected to reduce levels of of acute exposures to O3 on human selected levels of the W126 standard
concern for vegetation in those same health and the effects of O3 exposures form being considered, with the degree
areas. In the 1997 final rule, the on welfare is that vegetation effects are of overlap between these two forms
decision was made, on the basis of both more dependent on the cumulative depending greatly on the levels selected
science and policy considerations, to exposure to, and uptake of, O3 over the and the distribution of hourly O3
make the secondary identical to the course of the entire growing season concentrations within the annual and/or
primary standard. It acknowledged, (Henderson, 2006c). The CASAC O3 3-year average period. On this basis, the
however, that uncertainties remained Panel members were unanimous in Administrator recognizes that a
‘‘as to the extent to which air quality concluding the protection of natural secondary standard set identical to the
improvements designed to reduce 8- terrestrial ecosystems and managed proposed primary standard would
hour average O3 concentrations agricultural crops requires a secondary provide a significant degree of
averaged over a 3-year period would O3 standard that is substantially additional protection for vegetation as
reduce O3 exposures measured by a different from the primary O3 standard compared to that provided by the
seasonal SUM06 index’’ (62 FR 38876). in averaging time, level, and form current secondary standard. The
On the basis of that history, the (Henderson, 2007). Administrator also recognizes that lack
current Staff Paper analyzed the degree A number of public commenters also of rural monitoring data makes
of overlap expected between alternative presented views for the Administrator’s uncertain the degree to which the
8-hour and cumulative seasonal consideration regarding the adequacy of proposed 8-hour or W126 alternatives
secondary standards (as discussed above the current standard and whether or not would be protective, and that there
in section IV.C.1) using recent air revisions to that standard were would be the potential for not providing
quality. Based on the results, the Staff warranted. These commenters did not the appropriate degree of protection for
Paper concluded that the degree to support adopting an alternative, vegetation in areas with air quality
which the current 8-hour standard form cumulative form for the secondary distributions that result in a high
and level would overlap with areas of standard. These commenters stated that cumulative, seasonal exposure but do
concern for vegetation expressed in ‘‘though directionally a cumulative form not result in high 8-hour average
terms of the 12-hour W126 standard is of the standard may better match the exposures. While this potential for
inconsistent from year to year and underlying data,’’ they believed further under-protection is clear, the number
would depend greatly on the level of the work is needed to determine whether a and size of areas at issue and the degree
12-hour W126 and 8-hour standards cumulative exposure index for the form of risk is hard to determine. However,
selected and the distribution of hourly of the secondary standard is necessary. such a standard would also tend to
O3 concentrations within the annual These commenters identified a number avoid the potential for providing more
and/or 3-year average period. of key concerns regarding the available protection than is necessary, a risk that
Thus, though the Staff Paper evidence that, in their view, make it would arise from moving to a new form
recognized again that meeting the inappropriate to revise the secondary for the secondary standard despite
current or alternative levels of the 8- standard at this time. In particular they significant uncertainty in determining
hour average standard could result in air assert that (1) The key uncertainties, the degree of risk for any exposure level
quality improvements that would cited by the Administrator in the 1997 and the appropriate level of protection,
potentially benefit vegetation in some review as reasons for deciding it was not as well as uncertainty in predicting
areas, it urges caution be used in appropriate to move forward with a exposure and risk patterns.
evaluating the likely vegetation impacts seasonal secondary, have not been The Administrator also considered
associated with a given level of air materially reduced in the current the views and recommendations of
CASAC, and agrees that a cumulative, above. This Appendix would explain provide a mechanism for adjusting for
seasonal standard is the most the computations necessary for missing data. Because this alternative is
biologically relevant way to relate determining when the proposed primary a seasonal cumulative index,
exposure to plant growth response. and secondary standards are met. More representing a distribution of O3 values
However, as reflected in the public specifically, Appendix P addresses data under a range of meteorological
comments, the Administrator also completeness requirements, data conditions, rather than a peak statistic,
recognizes that there remain significant reporting, handling, and rounding the EPA is proposing a missing data
uncertainties in determining or conventions, and example calculations. procedure that would require the
quantifying the degree of risk Although EPA is proposing two monthly total index to be adjusted for
attributable to varying levels of O3 alternative secondary standards, the incomplete data by multiplying the
exposure, the degree of protection that proposed Appendix has been written to unadjusted W126 value by the ratio of
any specific cumulative, seasonal address a seasonal secondary standard the number of possible daylight hours
standard would produce, and the expressed in the W126 form. If EPA (8:00 a.m. to 8:00 p.m.) to the number
associated potential for error in adopts a secondary standard identical to of hours with valid ambient hourly
determining the standard that will the primary standard, Appendix P will concentrations. This adjustment is
provide a requisite degree of be modified accordingly. The proposed analogous to calculating an estimated
protection—i.e. sufficient but not more Appendix also reflects the final rule number of exceedances contained
than what is necessary. Given this promulgated on March 22, 2007 for the within part 50 Appendix I for the one
uncertainty, the Administrator also treatment of data influenced by hour O3 standard.
believes it is appropriate to consider the exceptional events (72 FR 13560). B. Data Handling and Rounding
degree of protection that would be
Key elements of the proposed revisions Conventions
afforded by a secondary standard that is
identical to the proposed primary to Appendix P are outlined below. Almost all State agencies now report
standard. Based on his consideration of A. Data Completeness hourly O3 concentrations to three
the full range of views as described decimal places, in ppm, since the
The data completeness requirements typical incremental sensitivity of
above, the Administrator proposes as a
in Appendix P proposed here for the currently used O3 monitors is 0.001
second option to revise the secondary
proposed 8-hr primary standard ppm. Consistent with the current
standard to be identical in every way to
the proposed primary standard. secondary standards are the same as approach for computing 8-hr averages,
those in Appendix I to 40 CFR part 50 in calculating 8-hr average O3
F. Proposed Decision on the Secondary required for the current standard. To concentrations from such hourly data,
Standard satisfy the date completeness any calculated digits past the third
The Administrator proposes to requirement, Appendix P would require decimal place would be truncated to
replace the current secondary standard 90% data completeness, on average, for preserve the number of significant digits
with one of two options. One option is the 3-year period at a monitoring site, in the reported data. In calculating 3-
a new cumulative, seasonal standard with no single year within the period year averages of the fourth highest
expressed as an index of the annual sum having less than 75% data maximum 8-hr average concentrations,
of weighted hourly concentrations completeness. This data completeness EPA is proposing to require the result to
(using the W126 form), set at a level in requirement would have to be satisfied be reported to the third decimal place
the range of 7 to 21 ppm-hours. The in order to determine that the with digits to the right of the third
index would be cumulated over the 12- standard(s) have been met at a decimal place truncated to preserve the
hour daylight period (8 a.m. to 8 p.m.) monitoring site. A site could be found number of significant digits in the
during the consecutive 3-month period not to have met the standard(s) with less reported data, as prescribed by the
within the O3 season with the maximum than complete data. EPA concluded in current standard. Analyses discussed in
index value. The other option is to adopting these same data completeness the Staff Paper demonstrated that taking
revise the current secondary standard by requirements in Appendix I in 1997 that into account the precision and bias in 1-
making it identical to the proposed 8- these proposed requirements are hour O3 measurements, the 8-hour
hour primary standard, which is reasonable based on its earlier analysis design value had an uncertainty of
proposed to be within the range of 0.070 of available air quality data that showed approximately 0.001 ppm. Thus, EPA
to 0.075 ppm. For this option, EPA also that 90% of all monitoring sites that are considers any value less than 0.001 ppm
solicits comment on a wider range of 8- operated on a continuous basis to be highly uncertain and, therefore,
hour standard levels, including levels routinely meet this objective. The EPA proposes truncating both the individual
down to 0.060 ppm and up to the is seeking comment, however, on 8-hour averages used to determine the
current standard (i.e., effectively 0.084 whether meteorological data would annual fourth maximum as well as the
ppm with the current rounding provide an objective basis for 3-year average of the fourth maxima to
convention. The Administrator is also determining, on a day for which there the third decimal place. Nevertheless,
soliciting comment on an alternative is missing data, that the meteorological EPA solicits comment on the
approach for a setting cumulative, conditions were not conducive to high appropriateness of rounding to the third
seasonal standard(s) that would afford O3 concentrations, and therefore, that decimal place as well as the policy
differing degrees of protection for O3- the day could be assumed to have an O3 reasons behind either truncating or
related impacts on different types of concentration less than 0.070 to 0.075 rounding the 3-year average to the third
vegetation with different intended uses. ppm. decimal place (with 0.0005 and greater
We are proposing separate data rounding up). EPA is also seeking
V. Creation of Appendix P— completeness requirements for the comment on the scientific validity of
Interpretation of the NAAQS for Ozone proposed seasonal secondary standard truncating the three year average as
The EPA is proposing to create expressed in the W126 form. For such opposed to rounding it as well as the
Appendix P to 40 CFR part 50 to reflect a standard, Appendix P would require policy reasons behind either truncating
the proposed revisions to the primary a site to have 75% data completeness in or rounding the average to the third
and secondary standards discussed a given month. Appendix P would also decimal place.
To determine whether the proposed requirements, because we believe these a network of about 56 O3 monitors as
standard is met, the calculated value of requirements would continue to be part of its Clean Air Status and Trends
the fourth highest maximum 8-hour appropriate to support implementation Network (CASTNET). The National Park
average concentrations, averaged over of a revised O3 NAAQS. Service (NPS) operates about 27
three years, would be compared to the Presently, States (including the monitors at other CASTNET sites. The
level of the standard. As discussed in District of Columbia, Puerto Rico, and NPS also has O3 monitoring stations in
section II, the EPA is proposing to issue the Virgin Islands, and including local parks that are not part of the CASTNET
an 8-hr standard extending to three agencies when so delegated by the State) dry deposition monitoring effort
decimal places, based on the staff’s are required to operate minimum including multiple O3 stations in Great
analysis and conclusions discussed in numbers of EPA-approved O3 monitors Smoky Mountains, Sequoia, Yosemite,
the Staff paper that expressing the based on the population of each of their and Joshua Tree National Parks.
proposed standard to the third decimal Metropolitan Statistical Areas (MSA) Required quality assurance
place is consistent with the precision and the most recently measured O3 procedures for O3 monitoring are given
requirements of the current O3 levels in each area. Each State (or in in 40 CFR Part 58 Appendix A, Quality
monitoring technology. Given that both some cases portions of a State) also has Assurance Requirements for State and
the proposed standard and the a required O3 monitoring season based local air monitoring stations (SLAMS),
calculated value of the 3-year average of on historical experience on when O3 special purpose monitors (SPM), and
the fourth highest maximum 8-hr O3 levels are high enough to be of prevention of significant deterioration
concentration are expressed to three regulatory or public health concern. (PSD) Air Monitoring. The EPA does not
decimal places, the two values can be These requirements are contained in 40 intend to propose any changes to these
compared directly. This is different than CFR part 58 Appendix D, Network quality assurance requirements, because
the approach for determining Design Criteria for Ambient Air Quality we believe that the current
compliance with the current standard Monitoring. See section 4.1, especially measurement uncertainty goals and
O3 standard. In comparing the Tables D–2 and D–3. These related procedures for assessing
calculated 3-year average (which is requirements were last revised on precision and bias as documented in
expressed to three decimal places) to the October 17, 2006 as part of a paragraph 2.3.1.2 of Appendix A are
current standard O3 standard (which is comprehensive review of ambient appropriate to support the
expressed to only two decimal places), monitoring requirements for all criteria implementation of a revised O3 NAAQS.
Appendix I requires the calculated 3- pollutants. (71 FR 61236) Certain States are required to report O3 data
year average to be rounded to two deviations including minimum quarterly to EPA’s Air Quality System
decimal places. This additional step monitoring requirements and/or (AQS), and most also voluntarily report
would not be necessary for the proposed monitoring season requirements may be their pre-validated O3 data on an hourly
standard given that the standard and the approved by the EPA Regional basis to EPA’s real time AirNow data
3-year average are each expressed to Administrator on a case-by-case basis. system, where the data are used to
three decimal places. Required O3 monitoring seasons range forecast O3 concentrations and to
For the proposed seasonal secondary from four to 12 months. The minimum provide public advisories. The National
standard, the annual maximum 3-month number of monitors in an MSA ranges Park Service and many other
W126 value computed on a calendar from zero (for an area with population organizations also report their O3 data to
year basis using the three highest, under 350,000 and no recent history of AQS and/or AirNow. The locations of
consecutive monthly W126 values an O3 design value greater than 85 currently operating O3 monitors which
would be used as the summary statistic. percent of the NAAQS) to four (for an report data to EPA’s Air Quality System
The resulting value would then be area with population greater than 10 are available through the EPA AirData
compared to the level of the secondary million and an O3 design value greater Web site http://www.epa.gov/air/data/
O3 standard. The Agency is also than 85 percent of the NAAQS). Because index.html.
interested in receiving comments these requirements apply at the MSA Data from O3 monitors at CASTNET
regarding a 3-year average form level, large urban areas consisting of stations are currently kept in a separate
summary statistic. multiple MSAs can require more than national data base.66
four monitors. For example, the New The EPA invites comments on O3
VI. Ambient Monitoring Related to York-Newark-Bristol NY-NJ-CT-PA
Proposed Revised O3 Standards monitoring issues (other than O3
combined statistical area requires about monitoring methods and quality
The EPA is not proposing any specific 14 monitors. In total, about 400 assurance requirements), including the
changes to existing requirements for monitors are required in MSAs, but following:
monitoring of O3 in the ambient air. about 1100 are actually operating in (1) Ozone monitoring network
However, we invite comment on a MSAs because most States operate more requirements in urban areas. Table D–2
number of issues which naturally arise than the minimum required number of of 40 CFR Part 58 Appendix D is based
in connection with the proposed monitors. on the percentage of the O3 NAAQS,
revision of the O3 NAAQS. The EPA There are no EPA requirements for O3 with a break point at 85 percent of the
may propose changes to some of the monitoring in less populated areas NAAQS. Therefore, a revision of the
existing requirements at a later date. outside of MSA boundaries (e.g., NAAQS would automatically increase
Current requirements regarding EPA- Metropolitan Statistical Areas) or in the required number of O3 monitors. For
approved measurement methods for rural areas. However, there are about example, assuming a final NAAQS of
ambient O3 are stated in 40 CFR part 50 250 O3 monitors in counties that are not
Appendix D, Measurement Principle part of MSAs. Some required State
66 At present, not all ozone monitors at CASTNET

and Calibration Procedure for the monitors are placed downwind of the sites are operated in full compliance with the
Measurement of Ozone in the urban center of the MSA of interest in quality assurance requirements of 40 CFR Part 58
Atmosphere, and in 40 CFR part 53, locations that are in some cases in a Appendix D, as they have not been primarily
intended for regulatory use. The EPA is working
Ambient Air Monitoring Reference and county outside the MSA itself; some towards such compliance in the near future and
Equivalent Methods. The EPA does not States also operate a few rural monitors towards making CASTNET ozone data available
intend to propose any changes to these for research purposes. The EPA operates through AQS.
0.070 ppm for purposes of illustration areas, which can combine large consider a limited number of emissions
only, about 70 MSAs with current O3 populations, large emissions of O3- control scenarios that States and
design values in the range of about forming precursors, and O3 Regional Planning Organizations might
0.060 ppm (about 85 percent of the concentrations of concern. The purpose implement to achieve these alternative
current NAAQS) to 0.070 ppm (about 85 of the secondary NAAQS is to protect O3 NAAQS. However, the Clean Air Act
percent of 0.070 ppm) would be against vegetation damage and other (CAA) and judicial decisions make clear
affected, with most changing from no welfare effects, which can occur in both that the economic and technical
required monitors to one, or from one urban and rural areas. States have feasibility of attaining ambient
required monitor to two. Because most largely been given discretion on standards are not to be considered in
of these areas already are operating at whether to add additional monitors setting or revising NAAQS, although
least as many monitors as the possible aimed specifically at achieving the such factors may be considered in the
new requirement, the number of objectives of the previous and current development of State plans to
monitors which would need to be secondary NAAQS. In urban areas, EPA implement the standards. Accordingly,
initiated (or moved from a location of in general believes that an O3 although an RIA has been prepared, the
excess monitors) would be only about monitoring network (and monitoring results of the RIA have not been
five monitors. About 100 MSAs with season) appropriate to support considered in issuing this final rule.
populations less than 350,000 presently implementation of the primary NAAQS
are without any O3 monitors, and hence will also be appropriate for B. Paperwork Reduction Act
they do not have an O3 design value for implementing the secondary NAAQS. This action does not impose an
use with Table D–2. If for the purpose However, rural areas are presently only information collection burden under the
of applying Table D–2, these areas are sparsely monitored for O3 so violations provisions of the Paperwork Reduction
treated as if they have O3 concentrations of the secondary NAAQS in areas with Act, 44 U.S.C. 3501 et seq. There are no
below 85 percent of the revised NAAQS, sensitive vegetation may occur information collection requirements
then a NAAQS revision would not undetected, as a result of transport from directly associated with the
automatically result in a requirement for urban areas with high precursor establishment of a NAAQS under
O3 monitoring in these MSAs.67 EPA emissions and/or O3 concentrations or section 109 of the CAA.
invites comments on the from formation of additional O3 from Burden means the total time, effort, or
appropriateness of the existing precursors emitted from sources outside financial resources expended by persons
minimum monitoring requirements for urban areas. It is conceivable that rural to generate, maintain, retain, or disclose
purposes of implementing the proposed violations of a secondary NAAQS could or provide information to or for a
revised NAAQS, including the occur in areas with sensitive vegetation Federal agency. This includes the time
automatic changes to minimum even though urban monitoring networks needed to review instructions; develop,
monitoring requirements that would be are showing compliance with the acquire, install, and utilize technology
triggered by a NAAQS revision. primary NAAQS, whether the forms and and systems for the purposes of
(2) Ozone monitoring seasons. As levels of the two standards are the same collecting, validating, and verifying
mentioned, the currently required O3 or different. The EPA invites comment information, processing and
monitoring seasons range from four to on the likelihood of this occurring maintaining information, and disclosing
12 months of the year. In some cases, O3 under the possible combinations of and providing information; adjust the
monitoring may start a couple of weeks primary and secondary standards
before and may end a couple of weeks existing ways to comply with any
proposed in this notice, and on whether, previously applicable instructions and
after the required season. With a lower where, and how EPA should require
O3 NAAQS, the issue arises of whether requirements; train personnel to be able
monitoring in rural areas specifically to respond to a collection of
in some areas the required O3 aimed at implementation of the
monitoring season should be made information; search data sources;
secondary NAAQS (and/or promote complete and review the collection of
longer. The EPA notes that under the more voluntary monitoring or conduct
existing regulations, the Regional information; and transmit or otherwise
monitoring itself in rural areas). disclose the information.
Administrator may approve State-
requested deviations from the VII. Statutory and Executive Order An agency may not conduct or
established O3 monitoring season but Reviews sponsor, and a person is not required to
EPA may not increase the length of the respond to a collection of information
A. Executive Order 12866: Regulatory unless it displays a currently valid OMB
season for an area at EPA’s own Planning and Review
initiative other than by notice and control number. The OMB control
comment rulemaking. Under section 3(f)(1) of Executive numbers for EPA’s regulations in 40
(3) Monitoring to support Order (EO) 12866 (58 FR 51735, October CFR are listed in 40 CFR part 9.
implementation of a secondary O3 4, 1993), the O3 NAAQS action is an
C. Regulatory Flexibility Act
NAAQS. It is fair to say that the existing ‘‘economically significant regulatory
O3 monitoring requirements and current action’’ because it is likely to have an The Regulatory Flexibility Act (RFA)
State monitoring practices are primarily annual effect on the economy of $100 generally requires an agency to prepare
oriented towards protecting against million or more. Accordingly, EPA a regulatory flexibility analysis of any
health effects in people, i.e., towards prepared this regulatory impact analysis rule subject to notice and comment
implementation of the primary NAAQS. (RIA) of the potential costs and benefits rulemaking requirements under the
This accounts for the focus on urban associated with this action. The RIA Administrative Procedure Act or any
estimates the costs and monetized other statute unless the agency certifies
67 EPA might instead treat one or more of these human health and welfare benefits of that the rule will not have a significant
counties as having a design value based on a attaining three alternative O3 NAAQS economic impact on a substantial
monitor in a nearby monitored county, in which nationwide. Specifically, the RIA number of small entities. Small entities
case ozone monitoring might become required in
certain currently unmonitored MSAs and the
examines the alternatives of 0.075 ppm, include small businesses, small
number of new required monitors would increase 0.070 ppm, and 0.065 ppm. The RIA organizations, and small governmental
in the illustrative NAAQS example stated above. contains illustrative analyses that jurisdictions.
For purposes of assessing the impacts rule an explanation why that alternative implications.’’ ‘‘Policies that have
of today’s rule on small entities, small was not adopted. Before EPA establishes federalism implications’’ is defined in
entity is defined as: (1) A small business any regulatory requirements that may the Executive Order to include
that is a small industrial entity as significantly or uniquely affect small regulations that have ‘‘substantial direct
defined by the Small Business governments, including Tribal effects on the States, on the relationship
Administration’s (SBA) regulations at 13 governments, it must have developed between the national government and
CFR 121.201; (2) a small governmental under section 203 of the UMRA a small the States, or on the distribution of
jurisdiction that is a government of a government agency plan. The plan must power and responsibilities among the
city, county, town, school district or provide for notifying potentially various levels of government.’’
special district with a population of less affected small governments, enabling This proposed rule does not have
than 50,000; and (3) a small officials of affected small governments federalism implications. It will not have
organization that is any not-for-profit to have meaningful and timely input in substantial direct effects on the States,
enterprise which is independently the development of EPA regulatory on the relationship between the national
owned and operated and is not proposals with significant Federal government and the States, or on the
dominant in its field. intergovernmental mandates, and distribution of power and
After considering the economic informing, educating, and advising responsibilities among the various
impacts of today’s proposed rule on small governments on compliance with levels of government, as specified in
small entities, I certify that this action the regulatory requirements. Executive Order 13132. The rule does
will not have a significant economic Today’s rule contains no Federal not alter the relationship between the
impact on a substantial number of small mandates (under the regulatory Federal government and the States
entities. This proposed rule will not provisions of Title II of the UMRA) for regarding the establishment and
impose any requirements on small State, local, or Tribal governments or implementation of air quality
entities. Rather, this rule establishes the private sector. The rule imposes no improvement programs as codified in
national standards for allowable new expenditure or enforceable duty on the CAA. Under section 109 of the CAA,
concentrations of O3 in ambient air as any State, local or Tribal governments or EPA is mandated to establish NAAQS;
required by section 109 of the CAA. See the private sector, and EPA has however, CAA section 116 preserves the
also American Trucking Associations v. determined that this rule contains no rights of States to establish more
EPA. 175 F. 3d at 1044–45 (NAAQS do regulatory requirements that might stringent requirements if deemed
not have significant impacts upon small significantly or uniquely affect small necessary by a State. Furthermore, this
entities because NAAQS themselves governments. Furthermore, as indicated rule does not impact CAA section 107
impose no regulations upon small previously, in setting a NAAQS EPA which establishes that the States have
entities). We continue to be interested in cannot consider the economic or primary responsibility for
the potential impacts of the proposed technological feasibility of attaining implementation of the NAAQS. Finally,
rule on small entities and welcome ambient air quality standards, although as noted in section E (above) on UMRA,
comments on issues related to such such factors may be considered to a this rule does not impose significant
impacts. degree in the development of State costs on State, local, or Tribal
plans to implement the standards. See governments or the private sector. Thus,
D. Unfunded Mandates Reform Act
also American Trucking Associations v. Executive Order 13132 does not apply
Title II of the Unfunded Mandates EPA, 175 F. 3d at 1043 (noting that to this rule.
Reform Act of 1995 (UMRA), Public because EPA is precluded from However, as also noted in section E
Law 104–4, establishes requirements for considering costs of implementation in (above) on UMRA, EPA recognizes that
Federal agencies to assess the effects of establishing NAAQS, preparation of a States will have a substantial interest in
their regulatory actions on State, local, Regulatory Impact Analysis pursuant to this rule and any corresponding
and Tribal governments and the private the Unfunded Mandates Reform Act revisions to associated SIP requirements
sector. Under section 202 of the UMRA, would not furnish any information and air quality surveillance
EPA generally must prepare a written which the court could consider in requirements, 40 CFR part 51 and 40
statement, including a cost-benefit reviewing the NAAQS). Accordingly, CFR part 58, respectively. Therefore, in
analysis, for proposed and final rules EPA has determined that the provisions the spirit of Executive Order 13132, and
with ‘‘Federal mandates’’ that may of sections 202, 203, and 205 of the consistent with EPA policy to promote
result in expenditures to State, local, UMRA do not apply to this proposed communications between EPA and State
and Tribal governments, in the decision. The EPA acknowledges, and local governments, EPA specifically
aggregate, or to the private sector, of however, that any corresponding solicits comment on this proposed rule
$100 million or more in any 1 year. revisions to associated SIP requirements from State and local officials.
Before promulgating an EPA rule for and air quality surveillance
which a written statement is needed, F. Executive Order 13175: Consultation
requirements, 40 CFR part 51 and 40
section 205 of the UMRA generally and Coordination With Indian Tribal
CFR part 58, respectively, might result
requires EPA to identify and consider a Governments
in such effects. Accordingly, EPA will
reasonable number of regulatory address, as appropriate, unfunded Executive Order 13175, entitled
alternatives and to adopt the least mandates if and when it proposes any ‘‘Consultation and Coordination with
costly, most cost-effective or least revisions to 40 CFR parts 51 or 58. Indian Tribal Governments’’ (65 FR
burdensome alternative that achieves 67249, November 9, 2000), requires EPA
the objectives of the rule. The E. Executive Order 13132: Federalism to develop an accountable process to
provisions of section 205 do not apply Executive Order 13132, entitled ensure ‘‘meaningful and timely input by
when they are inconsistent with ‘‘Federalism’’ (64 FR 43255, August 10, tribal officials in the development of
applicable law. Moreover, section 205 1999), requires EPA to develop an regulatory policies that have tribal
allows EPA to adopt an alternative other accountable process to ensure implications.’’ This rule concerns the
than the least costly, most cost-effective ‘‘meaningful and timely input by State establishment of O3 NAAQS. The Tribal
or least burdensome alternative if the and local officials in the development of Authority Rule gives Tribes the
Administrator publishes with the final regulatory policies that have federalism opportunity to develop and implement
CAA programs such as the O3 NAAQS, from O3 exposure. Because children are J. Executive Order 12898: Federal
but it leaves to the discretion of the considered a potentially susceptible Actions To Address Environmental
Tribe whether to develop these population, we have carefully evaluated Justice in Minority Populations and
programs and which programs, or the environmental health effects of Low-Income Populations
appropriate elements of a program, they exposure to O3 pollution among Executive Order 12898 (59 FR 7629
will adopt. children. These effects and the size of (Feb. 16, 1994)) establishes federal
This proposed rule does not have the population affected are summarized executive policy on environmental
Tribal implications, as specified in in section 8.7 of the Criteria Document justice. Its main provision directs
Executive Order 13175. It does not have and section 3.6 of the Staff Paper, and federal agencies, to the greatest extent
a substantial direct effect on one or the results of our evaluation of the practicable and permitted by law, to
more Indian Tribes, since Tribes are not effects of O3 pollution on children are make environmental justice part of their
obligated to adopt or implement any discussed in sections II.A–C of this mission by identifying and addressing,
NAAQS. Thus, Executive Order 13175 preamble. as appropriate, disproportionately high
does not apply to this rule.
Although Executive Order 13175 does H. Executive Order 13211: Actions That and adverse human health or
not apply to this rule, EPA contacted Significantly Affect Energy Supply, environmental effects of their programs,
tribal environmental professionals Distribution or Use policies, and activities on minority
during the development of this rule. The populations and low-income
This proposed rule is not a populations in the United States.
EPA staff participated in the regularly ‘‘significant energy action’’ as defined in
scheduled Tribal Air call sponsored by EPA has determined that this
Executive Order 13211, ‘‘Actions proposed rule will not have
the National Tribal Air Association Concerning Regulations That
during the spring of 2007 as this disproportionately high and adverse
Significantly Affect Energy Supply, human health or environmental effects
proposal was under development. EPA Distribution, or Use’’ (66 FR 28355 (May
specifically solicits additional comment on minority or low-income populations
22, 2001)) because in the Agency’s because it increases the level of
on this proposed rule from Tribal judgment it is not likely to have a
officials. environmental protection for all affected
significant adverse effect on the supply, populations without having any
G. Executive Order 13045: Protection of distribution, or use of energy. The disproportionately high and adverse
Children From Environmental Health & purpose of this rule is to establish human health or environmental effects
Safety Risks revised NAAQS for O3. The rule does on any population, including any
Executive Order 13045, ‘‘Protection of not prescribe specific pollution control minority or low-income population. The
Children from Environmental Health strategies by which these ambient proposed rule will establish uniform
Risks and Safety Risks’’ (62 FR 19885, standards will be met. Such strategies national standards for O3 air pollution.
April 23, 1997) applies to any rule that: will be developed by States on a case-
by-case basis, and EPA cannot predict References
(1) Is determined to be ‘‘economically
significant’’ as defined under Executive whether the control options selected by Abbey, D. E.; Nishino, N.; McDonnell, W. F.;
Order 12866, and (2) concerns an States will include regulations on Burchette, R. J.; Knutsen, S. F.; Beeson,
energy suppliers, distributors, or users. W. L.; Yang, J. X. (1999) Long-term
environmental health or safety risk that
Thus, EPA concludes that this rule is inhalable particles and other air
EPA has reason to believe may have a pollutants related to mortality in
disproportionate effect on children. If not likely to have any adverse energy
nonsmokers. Am. J. Respir. Crit. Care
the regulatory action meets both criteria, effects and does not constitute a Med. 159: 373–382.
the Agency must evaluate the significant energy action as defined in Abt Associates, Inc. (1995) Ozone NAAQS
environmental health or safety effects of Executive Order 13211. benefits analysis: California crops.
the planned rule on children, and Report to U.S. EPA, July 1995. EPA
I. National Technology Transfer and
explain why the planned regulation is Docket No. A–95–58 Item II–I–3.
Advancement Act Abt Associates, Inc. (2006) Ozone Health
preferable to other potentially effective
Section 12(d) of the National Risk Assessment for Selected Urban
and reasonably feasible alternatives Areas. Prepared for Office of Air Quality
considered by the Agency. Technology Transfer and Advancement
Planning and Standards, U.S.
This proposed rule is subject to Act of 1995 (NTTAA), Public Law No. Environmental Protection Agency,
Executive Order 13045 because it is an 104–113, § 12(d) (15 U.S.C. 272 note) Research Triangle Park, NC. December
economically significant regulatory directs EPA to use voluntary consensus 2006. Available electronically on the
action as defined by Executive Order standards in its regulatory activities internet at: http://www.epa.gov/ttn/
12866, and we believe that the unless to do so would be inconsistent naaqs/standards/ozone/s_o3_cr_td.html.
environmental health risk addressed by with applicable law or otherwise Abt Associates, Inc. (2007) Technical Report
this action may have a disproportionate impractical. Voluntary consensus on Ozone Exposure, Risk, and Impacts
standards are technical standards (e.g., Assessments for Vegetation: Final
effect on children. The proposed rule Report. Prepared for Office of Air Quality
will establish uniform national ambient materials specifications, test methods, Planning and Standards, U.S.
air quality standards for O3; these sampling procedures, and business Environmental Protection Agency,
standards are designed to protect public practices) that are developed or adopted Research Triangle Park, NC. January
health with an adequate margin of by voluntary consensus standards 2007. Available electronically on the
safety, as required by CAA section 109. bodies. The NTTAA directs EPA to internet at: http://www.epa.gov/ttn/
However, the protection offered by these provide Congress, through OMB, naaqs/standards/ozone/s_o3_cr_td.html.
standards may be especially important explanations when the Agency decides EPA–HQ–OAR–2005–0172–0176.
for children because children, especially not to use available and applicable Adams, W. C. (2002) Comparison of chamber
voluntary consensus standards. and face-mask 6.6-hour exposures to
children with asthma, along with other ozone on pulmonary function and
sensitive population subgroups such as This proposed rulemaking does not symptoms responses. Inhalation Toxicol.
all people with lung disease and people involve technical standards. Therefore, 14: 745–764.
active outdoors, are potentially EPA is not considering the use of any Abbey, D. E.; Nishino, N.; McDonnell, W. F.;
susceptible to health effects resulting voluntary consensus standards. Burchette, R. J.; Knutsen, S. F.; Beeson,
W. L.; Yang, J. X. (1999) Long-term of differing air pollution levels. Am. J. pollution and mortality in London 1992–
inhalable particles and other air Respir. Crit. Care Med. 164: 2067–2072. 4. Occup. Environ. Med. 56: 237–244.
pollutants related to mortality in Awmack, C. S.; Harrington, R.; Lindroth, R. Brook, R. D.; Brook, J. R.; Urch, B.; Vincent,
nonsmokers. Am. J. Respir. Crit. Care L. (2004) Aphid individual performance R.; Rajagopalan, S.; Silverman, F. (2002)
Med. 159: 373–382. may not predict population responses to Inhalation of fine particulate air
Adams, W. C. (2003a) Comparison of elevated CO2 or O3. Global Change Biol. pollution and ozone causes acute arterial
chamber and face mask 6.6-hour 10: 1414–1423. vasoconstriction in healthy adults.
exposure to 0.08 ppm ozone via square- Barnes, J. D.; Eamus, D.; Brown, K. A. (1990) Circulation 105: 1534–1536.
wave and triangular profiles on The influence of ozone, acid mist and Brown, J. S. The effects of ozone on lung
pulmonary responses. Inhalation soilnutrient status on Norway spruce function at 0.06 ppm in healthy adults.
Toxicol. 15: 265–281. [Picea abies (L.) Karst.]: II. June 14, 2007. Memo to the Ozone
Adams, W. C. (2003b) Relation of pulmonary photosynthesis, dark respiration and NAAQS Review Docket. EPA–HQ–OAR–
responses induced by 6.6 hour exposures soluble carbohydrates of trees during late 2005–0172–0175.
to 0.08 ppm ozone and 2-hour exposures autumn. New Phytol. 115: 149–156. Burnett, R. T.; Dales, R. E.; Raizenne, M. E.;
to 0.30 ppm via chamber and face-mask Bayram, H.; Rusznak, C.; Khair, O. A.; Krewski, D.; Summers, P. W.; Roberts, G.
inhalation. Inhalation Toxicol. 15: 745– Sapsford, R. J.; Abdelaziz, M. M. (2002) R.; Raad-Young, M.; Dann, T.; Brook, J.
759. Effect of ozone and nitrogen dioxide on (1994) Effects of low ambient levels of
Adams, W. C. (2006) Comparison of chamber the permeability of bronchial epithelial ozone and sulfates on the frequency of
6.6 hour exposures to 0.04–0.08 ppm cell cultures of nonasthmatic and respiratory admissions to Ontario
ozone via square-wave and triangular asthmatic subjects. Clin. Exp. Allergy 32: hospitals. Environ. Res. 65: 172–194.
profiles on pulmonary responses. 1285–1292. Burnett, R. T.; Brook, J. R.; Yung, W. T.;
Inhalation Toxicol. 18: 127–136. Beedlow P.A., Tingey D.T., Phillips D.L., Dales, R. E.; Krewski, D. (1997a)
Alscher, R. G.; Amundson, R. G.; Cumming, Hogsett W.E. & Olszyk D.M. (2004) Association between ozone and
J. R.; Fellows, S.; Fincher, J.; Rubin, G.; Rising atmospheric CO2 and carbon hospitalization for respiratory diseases in
van Leuken, P.; Weinstein, L. H. (1989) sequestration in forests. Frontiers in 16 Canadian cities. Environ. Res. 72: 24–
Seasonal changes in the pigments, Ecology and the Environment 2, 315– 31.
carbohydrates and growth of red spruce 322. Burnett, R. T.; Cakmak, S.; Brook, J. R.;
as affected by ozone. New Phytol. 113: Beeson, W. L.; Abbey, D. E.; Knutsen, S. F. Krewski, D. (1997b) The role of
211–223. (1998) Long-term concentrations of particulate size and chemistry in the
American Academy of Pediatrics, Committee ambient air pollutants and incident lung association between summertime
ambient air pollution and hospitalization
on Environmental Health. (2004) cancer in California adults: results from
for cardiorespiratory diseases. Environ.
Ambient air pollution: health hazards to the AHSMOG study. Environ. Health
Health Perspect. 105: 614–620.
children. Pediatrics 114: 1699–1707. Perspect. 106: 813–823.
Burns, R. M., B. H. Honkala, tech. coords.
American Thoracic Society. (1985) Bell, M. L.; McDermott, A.; Zeger, S. L.;
(1990) Silvics of North America: 1.
Guidelines as to what constitutes an Samet, J. M.; Dominici, F. (2004) Ozone
Conifers; 2. Hardwoods. Agriculture
adverse respiratory health effect, with and short-term mortality in 95 U.S.
Handbook 654. U.S. Department of
special reference to epidemiologic urban communities, 1987–2000. JAMA J. Agriculture, Forest Service, Washington,
studies of air pollution. Am. Rev. Respir. Am. Med. Assoc. 292: 2372–2378. DC. vol. 2, 877 p.
Dis. 131: 666–668. Bell, M. L.; Dominici, F.; Samet, J. M. (2005) Byun, D. W., Ching, J. K. S. (Eds.) (1999)
American Thoracic Society (2000) What A meta-analysis of time-series studies of Science Algorithms of the EPA Models-
constitutes an adverse health effect of air ozone and mortality with comparison to 3 Community Multiscale Air Quality
pollution? Am. J. Respir. Crit. Care Med. the national morbidity, mortality, and air Model (CMAQ) Modeling System. EPA/
161: 665–673. pollution study. Epidemiology 16: 436– 600/R–99/030, U.S. Environmental
Andersen, C. P.; Hogsett, W. E.; Wessling, R.; 445. Protection Agency, Office of Research
Plocher, M. (1991) Ozone decreases Bell, M. L.; Peng, R. D.; Dominici, F. (2006) and Development, Washington, DC
spring root growth and root carbohydrate The exposure-response curve for ozone 20460.
content in ponderosa pine the year and risk of mortality and the adequacy Campbell, S.; Temple, P.; Pronos, J.;
following exposure. Can. J. For. Res. 21: of current ozone regulations. Environ. Rochefort, R.; Andersen, C. (2000)
1288–1291. Health Perspect.: doi:10.1289/ehp.8816. Monitoring for ozone injury in west coast
Anderson, H. R.; Spix, C.; Medina, S.; Available: http://dx.doi.org/ [23 January, (Oregon, Washington, California) forests
Schouten, J. P.; Castellsague, J.; Rossi, G.; 2006]. in 1998. Portland, OR: U.S. Department
Zmirou, D.; Touloumi, G.; Wojtyniak, B.; Black, V. J.; Black, C. R.; Roberts, J. A.; of Agriculture, Forest Service, Pacific
Ponka, A.; Bacharova, L.; Schwartz, J.; Stewart, C. A. (2000) Impact of ozone on Northwest Research Station; general
Katsouyanni, K. (1997) Air pollution and the reproductive development of plants. technical report no. PNW–GTR–495.
daily admissions for chronic obstructive New Phytol. 147: 421–447. Available: http://www.fs.fed.us/pnw/
pulmonary disease in 6 European cities: Borja-Aburto, V. H.; Loomis, D. P.; gtrs.htm [11 April, 2003].
results from the APHEA project. Eur. Bangdiwala, S. I.; Shy, C. M.; Rascon- Centers for Disease Control and Prevention
Respir. J. 10: 1064–1071. Pacheco, R. A. (1997) Ozone, suspended (2004) The health consequences of
Arbaugh, M.; Bytnerowicz, A.; Grulke, N.; particulates, and daily mortality in smoking: a report of the Surgeon
Fenn, M.; Poth, M.; Temple, P.; Miller, Mexico City. Am. J. Epidemiol. 145: 258– General. Atlanta, GA: U.S. Department of
P. (2003) Photochemical smog effects in 268. Health and Human Services, National
mixed conifer forests along a natural Brauer, M.; Blair, J.; Vedal, S. (1996) Effect Center for Chronic Disease Prevention
gradient of ozone and nitrogen of ambient ozone exposure on lung and Health Promotion, Office on
deposition in the San Bernardino function in farm workers. Am. J. Respir. Smoking and Health. Available: http://
Mountains. Environ. Int. 29: 401–406. Crit. Care Med. 154: 981–987. www.cdc.gov/tobacco/sgr/sgr_2004/
Arnold J. R.; R. L. Dennis; G. S. Tonnesen Brauer, M.; Brook, J. R. (1997) Ozone chapters.htm (18 August, 2004).
(2003) Diagnostic evaluation of personal exposures and health effects for Chappelka, A. H.; Samuelson, L. J. (1998)
numerical air quality models with selected groups residing in the Fraser Ambient ozone effects on forest trees of
specialized ambient observations: testing Valley. In: Steyn, D. G.; Bottenheim, J. the eastern United States: a review. New
the Community Multiscale Air Quality W., eds. The Lower Fraser Valley Phytol. 139: 91–108.
modeling system (CMAQ) at selected Oxidants/Pacific ’93 Field Study. Atmos. Chappelka, A. H. (2002) Reproductive
SOS 95 ground sites, Atmospheric Environ. 31: 2113–2121. development of blackberry (Rubus
Environment 37: 1185–1198. Bremner, S. A.; Anderson, H. R.; Atkinson, R. cuneifolius) as influenced by ozone. New
Avol, E. L.; Gauderman, W. J.; Tan, S. M.; W.; McMichael, A. J.; Strachan, D. P.; Phytol. 155: 249–255.
London, S. J.; Peters, J. M. (2001) Bland, J. M.; Bower, J. S. (1999) Short Chen, L.; Jennison, B. L.; Yang, W.; Omaye,
Respiratory effects of relocating to areas term associations between outdoor air S. T. (2000) Elementary school
absenteeism and air pollution. Inhalation Smialowicz, R. J.; Zoetis, T. (2000) Quality Criteria for Ozone and Related
Toxicol. 12: 997–1016. Workshop to identify critical window of Photochemical Oxidants. Research
Chen, C.-Y.; Bonham, A. C.; Plopper, C. G.; exposure for children’s health: immune Triangle Park, NC: National Center for
Joad, J. P. (2003) Plasticity in respiratory and respiratory systems work group Environmental Assessment-RTP Report
motor control: selected contribution: summary. Environ. Health Perspect. no. NCEA–R–1068.
neuroplasticity in nucleus tractus Suppl. 108(3): 483–490. Environmental Protection Agency (2003a)
solitarius neurons following episodic Dockery, D. W.; Pope, C. A., III; Xu, X.; Ozone Injury to Forest Trees. In: EPA’s
ozone exposure in infant primates. J. Spengler, J. D.; Ware, J. H.; Fay, M. E.; Draft Report on the Environment
Appl. Physiol. 94: 819–827. Ferris, B. G., Jr.; Speizer, F. E. (1993) An Technical Document. EPA–600–R–03–
Coulston, J. W., Smith, G. C. and Smith, W. association between air pollution and 050. U.S. EPA, ORD, Washington, DC,
D. (2003) ‘‘Regional assessment of ozone mortality in six U.S. cities. N. Engl. J. page 5–19.
sensitive tree species using bioindicator Med. 329: 1753–1759. Environmental Protection Agency (2003b)
plants.’’ Environmental Monitoring and Dominici, F.; McDermott, A.; Daniels, M.; Clean Air Status and Trends Network
Assessment 83: 113–127. Zeger, S. L.; Samet, J. M. (2003) Mortality (CASTNet) 2001 Quality Assurance
Coulston, J. W., K. H. Riitters and G. C. Smith among residents of 90 cities. In: Revised Report; Research Triangle Park, NC:
(2004) A Preliminary Assessment of the analyses of time-series studies of air Office of Air Quality Planning and
Montréal Process Indicators of Air pollution and health. Special report. Standards. Report from EPA Contract No.
Pollution for the United States. Boston, MA: Health Effects Institute; pp. 68–D–98–112.
Environmental Monitoring and 9–24. Available: http:// Environmental Protection Agency (2004) The
Assessment 95: 57–74. www.healtheffects.org/Pubs/ Ozone Report: Measuring Progress
Cox, W. M.; Camalier, L. (2006) The effect of TimeSeries.pdf [12 May, 2004]. through 2003. EPA/454/K–04–001.
measurement error on 8-hour ozone Duff, M., Horst, R. L., Johnson, T. R. (1998) Office of Air Quality Planning and
design concentrations. Memo to the ‘‘Quadratic Rollback: A Technique to Standards, Research Triangle Park, NC.
Ozone NAAQS Review Docket. EPA– Model Ambient Concentrations Due to Environmental Protection Agency (2005a) Air
HQ–OAR–2005–0172–0026. Undefined Emission Controls.’’ Quality Criteria for Ozone and Related
Dann, M. S.; Pell, E. J. (1989) Decline of Presented at the Air and Waste Photochemical Oxidants (First External
activity and quantity of ribulose Management Annual Meeting. San Review Draft). Washington, DC, EPA/
bisphosphatecarboxylase/oxygenase and Diego, California. June 14–18, 1998. 600/R–05/004aA–cA. Available online
net photosynthesis in ozone-treated Eder, B.; Yu, S. (2005) A performance at: http://cfpub.epa.gov/ncea/cfm/
potato foliage. PlantPhysiol. 91: 427–432. evaluation of the 2004 release of recordisplay.cfm?deid=114523.
Models–3 CMAQ, Atmos. Environ. 40:
David, G. L.; Romieu, I.; Sienra-Monge, J. J.; Environmental Protection Agency (2005b)
4811–4824.
Collins, W. J.; Ramirez-Aguilar, M.; Del Air Quality Criteria for Ozone and
Environmental Protection Agency (1986) Air
Rio-Navarro, B. E.;Reyes-Ruiz, N. I.; Related Photochemical Oxidants (Second
quality criteria for ozone and other
Morris, R. W.; Marzec, J. M.; London, S. External Review Draft). Washington, DC,
photochemical oxidants. Research
J. (2003) Nicotinamide adenine EPA/600/R–05/004aB–cB. Available
Triangle Park, NC: Office of Health and
dinucleotide (phosphate) Environmental Assessment,
online at: http://cfpub.epa.gov/ncea/
reduced:quinone oxidoreductase and Environmental Criteria and Assessment cfm/recordisplay.cfm?deid=137307.
glutathione s-transferase m1 Office; report nos. EPA–600/8–84– Environmental Protection Agency (2005c)
polymorphism and childhood asthma. 020aF–eF. 5v. Available from: NTIS, Review of the national ambient air
Am. J. Respir. Crit. Care Med. 168: 1199– Springfield, VA; PB87–142949. quality standards for ozone: assessment
1204. Environmental Protection Agency (1996a) Air of scientific and technical information.
Davison, A. W.; Reiling, K. (1995) A rapid quality criteria for ozone and related First draft OAQPS staff paper. Research
change in ozone resistance of Plantago photochemical oxidants. Research Triangle Park, NC: Office of Air Quality
major after summers with high ozone Triangle Park, NC: Office of Research Planning and Standards. Available
concentrations. New Phytol. 131: 337– and Development; report nos. EPA/600/ online at: http://epa.gov/ttn/naaqs/
344. AP–93/004aF–cF. 3v. Available from: standards/ozone/s_o3_cr_sp.html.
Devlin, R. B.; McDonnell, W. F.; Koren, H. S.; NTIS, Springfield, VA; PB96–185582, Environmental Protection Agency (2005d)
Becker, S. (1990) Prolonged exposure of PB96–185590, and PB96–185608. Health Assessment Plan for Review of
humans to 0.10 and 0.08 ppm ozone Available: http://cfpub.epa.gov/ncea/ the National Ambient Air Quality
results in inflammation in the lung. cfm/recordisplay.cfm?deid=2831. Standards for Ozone. Office of Air
Presented at: 83rd annual meeting of the Environmental Protection Agency (1996b) Quality Planning and Standards,
Air & Waste Management Association; Review of National Ambient Air Quality Research Triangle Park, NC. April 2005.
June; Pittsburgh, PA. Pittsburgh, PA: Air Standards for Ozone: Assessment of Available electronically on the internet
& Waste Management Association; paper Scientific and Technical Information— at: http://www.epa.gov/ttn/naaqs/
no. 90–150.2. OAQPS Staff Paper. EPA/452/R–96–007. standards/ozone/s_o3_cr_pd.html.
Devlin, R. B.; McDonnell, W. F.; Mann, R.; Office of Air Quality Planning and Environmental Protection Agency (2006a) Air
Becker, S.; House, D. E.; Standards, Research Triangle Park, NC. Quality Criteria for Ozone and Related
Schreinemachers, D.; Koren, H. S. (1991) Available electronically on the internet Photochemical Oxidants (Final).
Exposure of humans to ambient levels of at: http://www.epa.gov/ttn/naaqs/ Washington, DC, EPA/600/R–05/004aB–
ozone for 6.6 hrs causes cellular and standards/ozone/s_o3_pr_sp.html. cB. Available online at: http://
biochemical changes in the lung. Am. J. Environmental Protection Agency. Technical cfpub.epa.gov/ncea/cfm/
Respir. Cell Mol. Biol. 4: 72–81. Assistance Document for the Calibration recordisplay.cfm?deid=149923.
Dickson, R. E., Lewin K. F., Isebrands J. G., of Ambient Ozone Monitors, EPA Environmental Protection Agency (2006b)
Coleman M. D., Heilman W. E., publication number EPA–600/4–79–057, Review of the national ambient air
Riemenschneider D. E., Sober J., Host G. EPA, National Exposure Research quality standards for ozone: assessment
E., Zak D. F., Hendrey G. R., Pregitzer K. Laboratory, Department E, Research of scientific and technical information.
S. and Karnosky D. F. (2000) Forest Triangle Park, NC 27711. Second draft OAQPS staff paper.
atmosphere carbon transfer storage-II Environmental Protection Agency. Transfer Research Triangle Park, NC: Office of Air
(FACTS II)—The aspen free-air CO2 and Standards for Calibration of Ambient Air Quality Planning and Standards.
O3 enrichment (FACE) project in an Monitoring Analyzers for Ozone, EPA Available online at: http://epa.gov/ttn/
overview. USDA Forest Service North publication number EPA–600/4–79–056, naaqs/standards/ozone/s_o3_cr_sp.html.
Central Research Station. General Tech. EPA, National Exposure Research Environmental Protection Agency (2006c)
Rep. NC–214. 68pp. Laboratory, Department E, Research Ozone Population Exposure Analysis for
Dietert, R. R.; Etzel, R. A.; Chen, D.; Halonen, Triangle Park, NC 27711. Selected Urban Areas. Office of Air
M.; Holladay, S. D.; Jarabek, A. M.; Environmental Protection Agency (2002) Quality Planning and Standards,
Landreth, K.; Peden, D. B.; Pinkerton, K.; Project Work Plan for Revised Air Research Triangle Park, NC. July 2006.
Available electronically on the internet J. M. (2002) Association between air exposure effects on growth and biomass
at: http://www.epa.gov/ttn/naaqs/ pollution and lung function growth in allocation in ponderosa pine. Water Air
standards/ozone/s_o3_cr_td.html. southern California children: results Soil Pollut. 116: 235–248.
Environmental Protection Agency (2006d) from a second cohort. Am. J. Respir. Crit. Gryparis, A.; Forsberg, B.; Katsouyanni, K.;
Ozone Population Exposure Analysis for Care Med. 166: 76–84. Analitis, A.; Touloumi, G.; Schwartz, J.;
Selected Urban Areas. Office of Air Gauderman, W. J.; Avol, E.; Gilliland, F.; Samoli, E.; Medina, S.; Anderson, H. R.;
Quality Planning and Standards, Vora, H.; Thomas, D.; Berhane, K.; Niciu, E. M.; Wichmann, H.-E.; Kriz, B.;
Research Triangle Park, NC. December McConnell, R.; Kuenzli, N.; Lurmann, F.; Kosnik, M.; Skorkovsky, J.; Vonk, J. M.;
2006. Available electronically on the Rappaport, E.; Margolis, H.; Bates, D.; Dörtbudak, Z. (2004) Acute effects of
internet at: http://www.epa.gov/ttn/ Peters, J. (2004a) The effect of air ozone on mortality from the ‘‘air
naaqs/standards/ozone/s_o3_cr_td.html. pollution on lung development from 10 pollution and health: a European
Environmental Protection Agency (2007) to 18 years of age. N. Engl. J. Med. 351: approach’’ project. Am. J. Respir. Crit.
Review of the national ambient air 1057–1067. Care Med. 170: 1080–1087.
quality standards for ozone: assessment Gauderman, W. J.; Avol, E.; Gilliland, F. Guderian, R. (1977) Discussion of the
of scientific and technical information. (2004b) Air pollution and lung function suitability of plant responses as a basis
OAQPS staff paper (Final). Research [reply letter]. N. Engl. J. Med. 351: 2653. for air pollution control measures. In:
Triangle Park, NC: Office of Air Quality Gent, J. F.; Triche, E. W.; Holford, T. R.; Billings, W. D.; Golley, F.; Lange, O. L.;
Planning and Standards; EPA report no. Belanger, K.; Bracken, M. B.; Beckett, W. Olson, J. S., eds. Air pollution:
EPA–452/R–07–003. Available online at: S.; Leaderer, B. P. (2003) Association of phytotoxicity of acidic gases and its
http://epa.gov/ttn/naaqs/standards/ low-level ozone and fine particles with significance in air pollution control.
ozone/s_o3_cr_sp.html. respiratory symptoms in children with Berlin, Federal Republic of Germany:
Evans, M. J.; Fanucchi, M. V.; Baker, G. L.; asthma. JAMA J. Am. Med. Assoc. 290: Springer Verlag; pp. 75–97.
Van Winkle, L. S.; Pantle, L. M.; Nishio, 1859–1867. Hanson, P., Samuelson, L., Wullschleger, S.,
S. J.; Schelegle, E. S.; Gershwhin, L. J.; Gilliland, F. D.; Berhane, K.; Rappaport, E. B.; Tabberer, T. and Edwards, G. (1994)
Miller, L. A.; Hyde, D. M.; Sannes, P. L.; Thomas, D. C.; Avol, E.; Gauderman, W. ‘‘Seasonal patterns of light-saturated
Plopper, C. G. (2003) Atypical J.; London, S. J.; Margolis, H. G.; photosynthesis and leaf conductance for
development of the tracheal basement McConnell, R.; Islam, K. T.; Peters, J. M. mature and seedling Quercus rubra L.
membrane zone of infant rhesus (2001) The effects of ambient air foliage: differential sensitivity to ozone
monkeys exposed to ozone and allergen. pollution on school absenteeism due to exposure.’’ Tree Physiology 14:1351–
Am. J. Physiol. 285: L931–L939. respiratory illnesses. Epidemiology 12: 1366.
43–54.
Felzer, B.; Kickligher, D.; Melillo, J.; Wang, Hazucha, M. J.; Folinsbee, L. J.; Seal, E., Jr.
Gong, H., Jr.; Wong, R.; Sarma, R. J.; Linn, W.
C.; Zhuang, Q.; Prinn, R. (2004) Effects (1992) Effects of steady-state and variable
S.; Sullivan, E. D.; Shamoo, D. A.;
of ozone on net primary production and ozone concentration profiles on
Anderson, K. R.; Prasad, S. B. (1998)
carbon sequestration in the pulmonary function. Am. Rev. Respir.
Cardiovascular effects of ozone exposure
conterminous United States using a Dis. 146: 1487–1493.
in human volunteers. Am. J. Respir. Crit.
biogeochemistry model. Tellus B 56 (3), Care Med. 158: 538–546.
Hazucha, M. J.; Folinsbee, L. J.; Bromberg, P.
230–248. Goodale, C. L., Apps, M. J., Birdsey, R. A., A. (2003) Distribution and
Fiscus, E. L.; Reid, C. D.; Miller, J. E.; Heagle, Field, C. B., Heath, L. S., Houghton, R. reproducibility of spirometric response
A. S. (1997) Elevated CO2 reduces O3 A., Jenkins, J. C., Kohlmaier, G. H., Kurz, to ozone by gender and age. J. Appl.
flux and O3-induced yield losses in W., Liu, S., Nabuurs, G.-J., Nilsson, S. Physiol. 95: 1917–1925.
soybeans: possible implications for and Shvidenko, A. Z. (2002) Forest Heck, W. W.; Cowling, E. B. (1997) The need
elevated CO2 studies. J. Exp. Bot. 48: carbon sinks in the northern hemisphere. for a long term cumulative secondary
307–313. Ecol. Appl. 12, 891–899. ozone standard—an ecological
Folinsbee, L. J.; McDonnell, W. F.; Horstman, Gouveia, N.; Fletcher, T. (2000) Time series perspective. EM (January): 23–33.
D. H. (1988) Pulmonary function and analysis of air pollution and mortality: Henderson, R. (2006a) Letter from CASAC
symptom responses after 6.6-hour effects by cause, age and socioeconomic Chairman Rogene Henderson to EPA
exposure to 0.12 ppm ozone with status. J. Epidemiol. Community Health Administrator Stephen Johnson,
moderate exercise. JAPCA 38: 28–35. 54: 750–755. February 16, 2006, EPA–CASAC–06–
Folinsbee, L. J.; Horstman, D. H.; Kehrl, H. R.; Graham, D. E.; Koren, H. S. (1990) 003.
Harder, S.; Abdul-Salaam, S.; Ives, P. J. Biomarkers of inflammation in ozone- Henderson, R. (2006b) Letter from CASAC
(1994) Respiratory responses to repeated exposed humans: comparison of the Chairman Rogene Henderson to EPA
prolonged exposure to 0.12 ppm ozone. nasal and bronchoalveolar lavage. Am. Administrator Stephen Johnson, June 5,
Am. J. Respir. Crit. Care Med. 149: 98– Rev. Respir. Dis. 142: 152–156. 2006, EPA–CASAC–06–007.
105. Grantz, D.A., McCool, P.H. (1992) Effect of Henderson, R. (2006c) Letter from CASAC
Folinsbee, L. J.; Hazucha, M. J. (2000) Time ozone on Pima and Acala cottons in the Chairman Rogene Henderson to EPA
course of response to ozone exposure in San Joaquin Valley. In: Herber, D.J., Administrator Stephen Johnson, October
healthy adult females. Inhalation Richter, D.A. (Eds.), Proceedings 1992 24, 2006, EPA–CASAC–07–001.
Toxicol. 12: 151–167. Beltwide Cotton Conferences, vol 3. Henderson, R. (2007) Letter from CASAC
Galizia, A.; Kinney, P. L. (1999) Long-term National Cotton Council of America, Chairman Rogene Henderson to EPA
residence in areas of high ozone: Memphis, TN, pp. 1082–1084. Administrator Stephen Johnson, March
associations with respiratory health in a Greer, J. R.; Abbey, D. E.; Burchette, R. J. 26, 2007, EPA–CASAC–07–002.
nationwide sample of nonsmoking young (1993) Asthma related to occupational Hiltermann, J. T. N.; Lapperre, T. S.; Van
adults. Environ. Health Perspect. 107: and ambient air pollutants in Bree, L.; Steerenberg, P. A.; Brahim, J. J.;
675–679. nonsmokers. J. Occup. Med. 35: 909–915. Sont, J. K.; Sterk, P. J.; Hiemstra, P. S.;
Gauderman, W. J.; McConnell, R.; Gilliland, Gregg, J. W., C.G. Jones and T.E. Dawson Stolk, J. (1999) Ozone-induced
F.; London, S.; Thomas, D.; Avol, E.; (2003) ‘‘Urbanization effects on tree inflammation assessed in sputum and
Vora, H.; Berhane, K.; Rappaport, E. B.; growth in the vicinity of New York bronchial lavage fluid from asthmatics: a
Lurmann, F.; Margolis, H. G.; Peters, J. City.’’ Nature 424: 183–187. new noninvasive tool in epidemiologic
(2000) Association between air pollution Grulke, N. E.; Andersen, C. P.; Fenn, M. E.; studies on air pollution and asthma. Free
and lung function growth in southern Miller, P. R. (1998) Ozone exposure and Radical Biol. Med. 27: 1448–1454.
California children. Am. J. Respir. Crit. nitrogen deposition lowers root biomass Hoek, G. (2003) Daily mortality and air
Care Med. 162: 1383–1390. of ponderosa pine in the San Bernardino pollution in The Netherlands. In:
Gauderman, W. J.; Gilliland, G. F.; Vora, H.; Mountains, California. Environ. Pollut. Revised analyses of time-series studies of
Avol, E.; Stram, D.; McConnell, R.; 103: 63–73. air pollution and health. Special report.
Thomas, D.; Lurmann, F.; Margolis, H. Grulke, N. E.; Balduman, L. (1999) Deciduous Boston, MA: Health Effects Institute; pp.
G.; Rappaport, E. B.; Berhane, K.; Peters, conifers: high N deposition and O3 133–142. Available: http://
www.healtheffects.org/Pubs/ R. A.; Hom, J., eds. Responses of mortality in Seoul, Korea, 1995–1999.
TimeSeries.pdf [12 May, 2004]. northern U.S. forests to environmental Environ. Res. 94: 113–119.
Hoek, G.; Brunekreef, B.; Verhoeff, A.; Van change. New York, NY: Springer-Verlag; King, J.S., M. E. Kubiske, K. S. Pregitzer, G.
Wijnen, J.; Fischer, P. (2000) Daily pp. 149–180. (Ecological studies: v. 139). R. Hendrey, E. P. McDonald, C. P.
mortality and air pollution in the Isebrands, J. G.; McDonald, E. P.; Kruger, E.; Giardina, V. S. Quinn, D. F. Karnosky.
Netherlands. J. Air Waste Manage. Assoc. Hendrey, G.; Percy, K.; Pregitzer, K.; (2005) Tropospheric O3 compromises net
50: 1380–1389. Sober, J.; Karnosky, D. F. (2001) Growth primary production in young stands of
Hoek, G.; Brunekreef, B.; Fischer, P.; Van responses of Populus tremuloides clones trembling aspen, paper birch and sugar
Wijnen, J. (2001) The association to interacting carbon dioxide and maple in response to elevated
between air pollution and heart failure, tropospheric ozone. Environ. Pollut. 115: atmospheric CO2. New Phytologist. 168:
arrhythmia, embolism, thrombosis, and 359–371. 623–636.
other cardiovascular causes of death in a Ito, K.; De Leon, S. F.; Lippmann, M. (2005) Kinney, P. L.; Thurston, G. D.; Raizenne, M.
time series study. Epidemiology 12: 355– Associations between ozone and daily (1996) The effects of ambient ozone on
357. mortality, analysis and meta-analysis. lung function in children: a reanalysis of
Hogsett, W. E.; Tingey, D. T.; Hendricks, C.; Epidemiology 16: 446–457. six summer camp studies. Environ.
Rossi, D. (1989) Sensitivity of western Jacobson, J. S. (1977) The effects of Health Perspect. 104: 170–174.
conifers to SO2 and seasonal interaction photochemical oxidants on vegetation. Kinney, P. L.; Aggarwal, M.; Nikiforov, S. V.;
of acid fog and ozone. In: Olson, R. K.; In: Ozon und Begleitsubstanzen im Nadas, A. (1998) Methods development
Lefohn, A. S., eds. Effects of air pollution photochemischen Smog: das Kolloquium for epidemiologic investigations of the
on western forests [an A&WMA [Ozone and related substances in health effects of prolonged ozone
symposium; June; Anaheim, CA]. Air photochemical smog: the colloquium]; exposure. Part III: an approach to
Pollution Control Association; pp. 469– September 1976; Dusseldorf, Federal retrospective estimation of lifetime
491 (APCA transactions series: no. 16). Republic of Germany. Dusseldorf, ozone exposure using a questionnaire
Hogsett, W. E., Weber, J. E., Tingey, D., Federal Republic of Germany: VDI- and ambient monitoring data (U.S. sites).
Herstrom, A., Lee, E. H., Laurence, J. A. Verlag GmbH; pp. 163–173. (VDI- Cambridge, MA: Health Effects Institute;
(1997) ‘‘Environmental auditing: an Berichte nr. 270). research report no. 81; pp. 79–108.
approach for characterizing tropospheric Johnson, T. (1997) ‘‘Sensitivity of Exposure Korrick, S. A.; Neas, L. M.; Dockery, D. W.;
ozone risk to forests.’’ Environ. Manage. Estimates to Air Quality Adjustment Gold, D. R.; Allen, G. A.; Hill, L. B.;
21: 105–120. Procedure,’’ Letter to Harvey Richmond, Kimball, K. D.; Rosner, B. A.; Speizer, F.
Holton, M. K.; Lindroth, R. L.; Nordheim, E. Office of Air Quality Planning and E. (1998) Effects of ozone and other
V. (2003) Foliar quality influences tree- Standards, U.S. Environmental pollutants on the pulmonary function of
herbivore-parisitoid interactions: effects Protection Agency, Research Triangle adult hikers. Environ. Health Perspect.
of elevated CO2, O3, and plant genotype. Park, North Carolina. 106: 93–99.
Oecologia 137: 233–244. Jörres, R.; Nowak, D.; Magnussen, H.; Kreit, J. W.; Gross, K. B.; Moore, T. B.;
Holz, O.; Mücke, M.; Paasch, K.; Böhme, S.; Speckin, P.; Koschyk, S. (1996) The Lorenzen, T. J.; D’Arcy, J.; Eschenbacher,
Timm, P.; Richter, K.; Magnussen, H.; effect of ozone exposure on allergen W. L. (1989) Ozone-induced changes in
Jörres, R. A. (2002) Repeated ozone responsiveness in subjects with asthma pulmonary function and bronchial
exposures enhance bronchial allergen or rhinitis. Am. J. Respir. Crit. Care Med. responsiveness in asthmatics. J. Appl.
responses in subjects with rhinitis or 153: 56–64. Physiol. 66: 217–222.
asthma. Clin. Exp. Allergy. 32: 681–689. Karnosky, D. F., Z.E. Gagnon, R.E. Dickson, Krewski, D.; Burnett, R. T.; Goldberg, M. S.;
Höppe, P.; Praml, G.; Rabe, G.; Lindner, J.; M.D. Coleman, E.H. Lee, J.G. Isebrands, Hoover, K.; Siemiatycki, J,; Jerrett, M.;
Fruhmann, G.; Kessel, R. (1995) (1996) ‘‘Changes in growth, leaf Abrahamowicz, M.; White, W. H. (2000)
Environmental ozone field study on abscission, biomass associated with Reanalysis of the Harvard Six Cities
pulmonary and subjective responses of seasonal tropospheric ozone exposures Study and the American Cancer Society
assumed risk groups. Environ. Res. 71: of Populus tremuloides clones and Study of particulate air pollution and
109–121. seedlings.’’ Can. J. For. Res. 26: 23–37. mortality. A special report of the
Höppe, P.; Peters, A.; Rabe, G.; Praml, G.; Karnosky, D.F., B. Mankovska, K. Percy, R.E. Institute’s particle epidemiology
Lindner, J.; Jakobi, G.; Fruhmann, G.; Dickson, G.K. Podila, J. Sober, A. reanalysis project. Cambridge, MA:
Nowak, D. (2003) Environmental ozone Noormets, G. Hendrey, M.D. Coleman, Health Effects Institute.
effects in different population subgroups. M. Kubiske, K.S. Pregitzer, and J.G. Künzli, N.; Lurmann, F.; Segal, M.; Ngo, L.;
Int. J. Hyg. Environ. Health 206: 505– Isebrands (1999) ‘‘Effects of tropospheric Balmes, J.; Tager, I. B. (1997) Association
516. O3 on trembling aspen and interaction between lifetime ambient ozone
Horst, R.; Duff, M. (1995) Concentration data with CO2: Results from an O3-gradient exposure and pulmonary function in
transformation and the quadratic and a FACE experiment.’’ J. Water, Air college freshmen—results of a pilot
rollback methodology (Round 2, and Soil Pollut. 116: 311–322. study. Environ. Res. 72: 8–23.
Revised). Unpublished memorandum to Karnosky, D. F.; Zak, D. R.; Pregitzer, K. S.; Lamb, C.; Dixon, R. A. (1997) The oxidative
R. Rodrguez, U.S. EPA, June 8, 1995. Awmack, C. S.; Bockheim, J. G.; Dickson, burst in plant disease resistance. Ann.
EPA Docket No. A–95–58 Item II–I–199. R. E.; Hendrey, G. R.; Host, G. E.; King, Rev. Plant Physiol. Mol. Biol. 48: 251–
Horstman, D. H.; Folinsbee, L. J.; Ives, P. J.; J. S.; Kopper, B. J.; Kruger, E. L.; Kubiske, 275.
Abdul-Salaam, S.; McDonnell, W. F. M. E.; Lindroth, R. L.; Mattson, W. J.; Langstaff, J. (2007) Analysis of Uncertainty in
(1990) Ozone concentration and McDonald, E. P. (2003) Tropospheric O3 Ozone Population Exposure Modeling.
pulmonary response relationships for moderates responses of temperate January 31, 2007. Memo to the Ozone
6.6-hr exposures with five hours of hardwood forests to elevated CO2: A NAAQS Review Docket. EPA-HQ-OAR–
moderate exercise to 0.08, 0.10, and 0.12 synthesis of molecular to ecosystem 2005–0172–0174.
ppm. Am. Rev. Respir. Dis. 142: 1158– results from the Aspen FACE project. Larson, J. L.; Zak, D. R.; Sinsabaugh, R. L.
1163. Funct. Ecol. 17: 289–304. (2002) Extracellular enzyme activity
Huang, Y.; Dominici, F.; Bell, M. L. (2005) Karnosky, D.F., Pregitzer, K.S., Zak, D.R., beneath temperate trees growing under
Bayesian hierarchical distributed lag Kubiske, M.E., Hendrey, G.R., Weinstein, elevated carbon dioxide and ozone. Soil
models for summer ozone exposure and D., Nosal, M. & Percy, K.E. (2005) Scaling Sci. Soc. Am. J. 66: 1848–1856.
cardio-respiratory mortality. ozone responses of forest trees to the Laurence, J.A.,Kohut, R.J., Amundson, R.G.,
Environmetrics 16: 547–562. ecosystem level in a changing climate. (1993) Use of TREGRO to simulate the
Isebrands, J. G.; Dickson, R. E.; Rebbeck, J.; Plant Cell Environ. 28, 965–981. effects of ozone on the growth of red
Karnosky, D. F. (2000) Interacting effects Kim, S.-Y.; Lee, J.-T.; Hong, Y.-C.; Ahn, K.- spruce seedlings. Forest Science. 39:
of multiple stresses on growth and J.; Kim, H. (2004) Determining the 453–464.
physiological processes in northern threshold effect of ozone on daily Laurence, J. A.; Retzlaff, W. A.; Kern, J. S.;
forest trees. In: Mickler, R. A.; Birsdey, mortality: an analysis of ozone and Lee, E. H.; Hogsett, W. E.; Weinstein, D.
A. (2001) Predicting the regional impact Nutrition Examination. Am. J. Med. 114: J. G.; Karnosky, D. F. (2001) Stomatal and
of ozone and precipitation on the growth 758–762. non-stomatal limitation to
of loblolly pine and yellow poplar using McCluney, L. (2007) Ozone 1-Hour to 8-Hour photosynthesis in two trembling aspen
linked TREGRO and ZELG models. For. Ratios for the 2002–2004 Design Value (Populus tremuloides Michx) clones
Ecol. Manage. 146: 247–263. Period. January 18, 2007. Memo to the exposed to elevated CO2 and/or O3. Plant
Lee, E. H.; Hogsett, W. E. (1996) Methodology Ozone NAAQS Review Docket. EPA-HQ- Cell Environ. 24: 327–336.
for calculating inputs for ozone OAR–0172–0073. NPS (2005) 2005 Annual Performance &
secondary standard benefits analysis: McConnell, R.; Berhane, K.; Gilliland, F.; Progress Report: Air Quality in National
part II. Report prepared for Office of Air London, S. J.; Islam, T.; Gauderman, W. Parks. National Park Service. http://
Quality Planning and Standards, Air J.; Avol, E.; Margolis, H. G.; Peters, J. M. www2.nature.nps.gov/air/Pubs/pdf/gpra/
Quality Strategies and Standards (2002) Asthma in exercising children Gpra2005_Report_03202006_Final.pdf.
Division, U.S. Environmental Protection exposed to ozone: a cohort study. Lancet NRC (2004) Air quality management—United
Agency, Research Triangle Park, N.C., 359: 386–391. States. I. National Research Council
March. EPA Docket No. A–95–58 Item McDonnell, W. F.; Kehrl, H.R.; Abdul- (U.S.). Committee on Air Quality
II–I–265. Salaam, S.; Ives, P.J.; Folinsbee, L.J.; Management in the United States.
Levy, J. I.; Chemerynski, S. M.; Sarnat, J. A. Devlin, R.B.; O’Neil, J.J.; Horstman, D. H. TD883.2.A64325 2004 363.739′25′0973—
(2005) Ozone exposure and mortality, an (1991) Respiratory response of humans dc222004014594 http://www.nap.edu/
empiric Bayes metaregression analysis. exposed to low levels of ozone for 6.6 openbook/0309089328/html/.
Epidemiology 16: 458–468. hours. Arch. Environ. Health 46: 145– Odum, E. P. (1963) Ecology. New York, NY:
Lipfert, F. W.; Perry, H. M., Jr.; Miller, J. P.; 150. Holt, Rinehart and Winston. (Modern
Baty, J. D.; Wyzga, R. E.; Carmody, S. E. McDonnell, W. F. (1996) Individual biology series).
(2000) The Washington University-EPRI variability in human lung function Ollinger, S. V., Aber, J. D., Reich, P. B. and
veterans’ cohort mortality study: responses to ozone exposure. Environ. Freuder, R. J. (2002) Interactive effects of
preliminary results. In: Grant, L. D., ed. Toxicol. Pharmacol. 2: 171–175. nitrogen deposition, tropospheric ozone,
PM2000: particulate matter and health. McDonnell, W. F.; Stewart, P. W.; Andreoni, elevated CO2 and land use history on the
Inhalation Toxicol. 12 (suppl. 4): 41–73. S.; Seal, E., Jr.; Kehrl, H. R.; Horstman, carbon dynamics of northern hardwood
Lipfert, F. W.; Perry, H. M., Jr.; Miller, J. P.; D. H.; Folinsbee, L. J.; Smith, M. V. forests. Glob. Change Biol. 8(6), 545–562.
Baty, J. D.; Wyzga, R. E.; Carmody, S. E. (1997) Prediction of ozone-induced FEV1 Olszyk, D., Bytnerowlez, A., Kats, G., Reagan,
(2003) Air pollution, blood pressure, and changes: effects of concentration, C., Hake, S., Kerby, T., Millhouse, D.,
their long-term associations with duration, and ventilation. Am. J. Respir. Roberts, B., Anderson, C., Lee, H. (1993)
mortality. Inhalation Toxicol. 15: 493– Crit. Care Med. 156: 715–722. Cotton yield losses and ambient ozone
512. McDonnell, W. F.; Abbey, D. E.; Nishino, N.; concentrations in California’s San
Linn, W. S.; Shamoo, D. A.; Anderson, K. R.; Lebowitz, M. D. (1999) Long-term Joaquin Valley. Journal of Environmental
Peng, R.-C.; Avol, E. L.; Hackney, J. D.; ambient ozone concentration and the Quality 22, 602–611.
Gong, H., Jr. (1996) Short-term air incidence of asthma in nonsmoking O’Neill, M. S.; Loomis, D.; Borja-Aburto, V.
pollution exposures and responses in adults: the ahsmog study. Environ. Res. H. (2004) Ozone, area social conditions,
Los Angeles area schoolchildren. J. 80: 110–121. and mortality in Mexico City. Environ.
Exposure Anal. Environ. Epidemiol. 6: Moldau, H.; Söber, J.; Söber, A. (1990) Res. 94: 234–242.
449–472. Differential sensitivity of stomata and Pearson, S.; Davison, A. W.; Reiling, K.;
Long, S., Nelson, R.L., Ainsworth, L., Hollis, mesophyll tosudden exposure of bean Ashenden, T.; Ollerenshaw, J. H. (1996)
K., Mies, T., Morgan, P., Naidu, S., Ort, shoots to ozone. Photosynthetica 24: The effects of different ozone exposures
D.R., Webster, R., Zhu, X. Adapting 446–458. on three contrasting populations of
Soybean To Current And Future Change Morgan, P. B.; Ainsworth, E. A.; Long, S. P. Plantago major. New Phytol. 132: 493–
In Atmospheric Composition. Do We (2003) How does elevated ozone impact 502.
Need More Than Field Selection Under soybean? A meta-analysis of Peel, J. L.; Tolbert, P. E.; Klein, M.; Metzger,
Current Conditions. Cellular and photosynthesis, growth and yield. Plant K. B.; Flanders, W. D.; Knox, T.;
Molecular Biology Of Soybean Biennial Cell Environ. 26: 1317–1328. Mulholland, J. A.; Ryan, P. B.; Frumkin,
Conference. (2002) p. 401. http:// Morgan, P.B., Bernacchi, C.J., Ort, D.R., Long, H. (2005) Ambient air pollution and
www.ars.usda.gov/research/ S.P. (2004) An in vivo analysis of the respiratory emergency department visits.
publications/ effect of season-long open-air elevation Epidemiology 16: 164–174.
publications.htm?SEQ_NO_115=142752. of ozone to anticipated 2050 levels on Pell, E. J.; Schlagnhaufer, C. D.; Arteca, R. N.
Loya W.M., Pregitzer K.S., Karberg N.J., King photosynthesis in soybean. Plant (1997) Ozone-induced oxidative stress:
J.S. & Giardina C.P. (2003) Reduction of Physiology 135: 2348–2357. mechanisms of action and reaction.
soil carbon formation by tropospheric Mortimer, K. M.; Neas, L. M.; Dockery, D. W.; Physiol. Plant. 100: 264–273.
ozone under elevated carbon dioxide. Redline, S.; Tager, I. B. (2002) The effect Percy, K. E.; Awmack, C. S.; Lindroth, R. L.;
Nature 425, 705–707. of air pollution on inner-city children Kubiske, M. E.; Kopper, B. J.; Isebrands,
Luethy-Krause, B.; Landolt, W. (1990) Effects with asthma. Eur. Respir. J. 19: 699–705. J. G.; Pregitzer, K. S.; Hendry, G. R.;
of ozone on starch accumulation in Mudway, I. S.; Kelly, F. J. (2004) An Dickson, R. E.; Zak, D. R.; Oksanen, E.;
Norway spruce (Picea abies). Trees 4: investigation of inhaled ozone dose and Sober, J.; Harrington, R.; Karnosky, D. F.
107–110. the magnitude of airway inflammation in (2002) Altered performance of forest
Lyons, T. M.; Barnes, J. D.; Davison, A. W. healthy adults. Am. J. Respir. Crit. Care pests under atmospheres enriched with
(1997) Relationships between ozone Med. 169: 1089–1095. CO2 and O3. Nature (London) 420: 403–
resistance and climate in European Navidi, W.; Thomas, D.; Langholz, B.; Stram, 407.
populations of Plantago major. New D. (1999) Statistical methods for Peters, J. M.; Avol, E.; Navidi, W.; London,
Phytol. 136: 503–510. epidemiologic studies of the health S. J.; Gauderman, W. J.; Lurmann, F.;
Manning, W. J.; Krupa, S. V. (1992) effects of air pollution. Cambridge, MA: Linn, W. S.; Margolis, H.; Rappaport, E.;
Experimental methodology for studying Health Effects Institute; research report Gong, H., Jr.; Thomas, D. C. (1999a) A
the effects of ozone on crops and trees. no. 86. study of twelve southern California
In: Lefohn, A. S., ed. Surface level ozone Neufeld, H. S.; Lee, E. H.; Renfro, J. R.; communities with differing levels and
exposures and their effects on vegetation. Hacker, W. D. (2000) Seedling types of air pollution. I. Prevalence of
Chelsea, MI: Lewis Publishers, Inc.; pp. insensitivity to ozone for three conifer respiratory morbidity. Am. J. Respir. Crit.
93–156. species native to Great Smoky Mountains Care Med. 159: 760–767.
Mannino, D. M.; Ford, E. S.; Redd, S. C. National Park. Environ. Pollut. 108: 141– Peters, J. M.; Avol, E.; Gauderman, W. J.;
(2003) Obstructive and restrictive lung 151. Linn, W. S.; Navidi, W.; London, S. J.;
disease and markers of inflammation: Noormets, A.; Sober, A.; Pell, E. J.; Dickson, Margolis, H.; Rappaport, E.; Vora, H.;
data from the Third National Health and R. E.; Posila, G. K.; Sober, J.; Isebrands, Gong, H., Jr.; Thomas, D. C. (1999b) A
study of twelve southern California growth of a white fir tree. Tree Physiol. Gerriets, J. E.; Walby, W. F.; Mitchell, V.;
communities with differing levels and 20: 195–202. Tarkington, B. K.; Wong, V. J.; Baker, G.
types of air pollution. II. Effects on Rizzo, M. (2005) Evaluation of a quadratic L.; Pantle, L. M.; Joad, J. P.; Pinkerton,
pulmonary function. Am. J. Respir. Crit. approach for adjusting distributions of K. E.; Wu, R.; Evans, M. J.; Hyde, D. M.;
Care Med. 159: 768–775. hourly ozone concentrations to meet air Plopper, C. G. (2003) Repeated episodes
Peterson, D. L.; Arbaugh, M. J.; Wakefield, V. quality standards. November 7, 2005. of ozone inhalation amplifies the effects
A.; Miller, P. R. (1987) Evidence of Memo to the Ozone NAAQS Review of allergen sensitization and inhalation
growth reduction in ozone-injured Docket. EPA–HQ–OAR–0172–0005. on airway immune and structural
Jeffrey pine (Pinus jeffreyi Grev and Balf) Rizzo, M. (2006) A distributional comparison development in Rhesus monkeys.
in Sequoia and Kings Canyon National between different rollback Toxicol. Appl. Pharmacol. 191: 74–85.
Parks. JAPCA 37: 906–912. methodologies applied to ambient ozone Schierhorn, K.; Hanf, G.; Fischer, A.;
Phillips, R. L.; Zak, D. R.; Holmes, W. E.; concentrations. May 31, 2006. Memo to Umland, B.; Olze, H.; Kunkel, G. (2002)
White, D. C. (2002) Microbial community the Ozone NAAQS Review Docket. EPA– Ozone-induced release of neuropeptides
composition and function beneath HQ–OAR–0172–0027. from human nasal mucosa cells. Int.
temperate trees exposed to elevated Romieu, I.; Meneses, F.; Ruiz, S.; Sienra, J. J.; Arch. Allergy Immunol. 129: 145–151.
atmospheric carbon dioxide and ozone. Huerta, J.; White, M. C.; Etzel, R. A. Schwartz, J. (2005) How sensitive is the
Oecologia 131: 236–244. (1996) Effects of air pollution on the association between ozone and daily
Plopper, C. G.; Fanucchi, M. V. (2000) Do respiratory health of asthmatic children deaths to control for temperature? Am. J.
urban environmental pollutants living in Mexico City. Am. J. Respir. Crit. Respir. Crit. Care Med. 171: 627–631.
exacerbate childhood lung diseases? Care Med. 154: 300–307. Sheppard, L.; Slaughter, J. C.; Schildcrout, J.;
Environ. Health Perspect. 108: A252– Romieu, I.; Meneses, F.; Ruiz, S.; Huerta, J.; Liu, L.-J. S.; Lumley, T. (2005) Exposure
A253. Sienra, J. J.; White, M.; Etzel, R.; and measurement contributions to
Pope, C. A., III; Thun, M. J.; Namboodiri, M. Hernandez, M. (1997) Effects of estimates of acute air pollution effects. J.
M.; Dockery, D. W.; Evans, J. S.; Speizer, intermittent ozone exposure on peak Exposure Anal. Environ. Epidemiol. 15:
F. E.; Heath, C. W., Jr. (1995) Particulate expiratory flow and respiratory 366–376.
air pollution as a predictor of mortality symptoms among asthmatic children in Simini, M.; Skelly, J. M.; Davis, D. D.; Savage,
in a prospective study of U.S. adults. Mexico City. Arch. Environ. Health 52: J. E.; Comrie, A. C. (1992) Sensitivity of
Am. J. Respir. Crit. Care Med. 151: 669– 368–376. four hardwood species to ambient ozone
674. Romieu, I.; Sienra-Monge, J. J.; Ramı́rez- in north central Pennsylvania. Can. J.
Pope, C. A., III; Burnett, R. T.; Thun, M. J.; Aguilar, M.; Moreno-Macias, H.; Reyes- For. Res. 22: 1789–1799.
Calle, E. E.; Krewski, D.; Ito, K.; Ruiz, N. I.; Estela del Rio-Navarro, B.; Simpson, R. W.; Williams, G.;
Thurston, G. D. (2002) Lung cancer, Hernández-Avila, M.; London, S. J. Petroeschevsky, A.; Morgan, G.;
cardiopulmonary mortality, and long- (2004) Genetic polymorphism of GSTM1 Rutherford, S. (1997) Associations
term exposure to fine particulate air and antioxidant supplementation between outdoor air pollution and daily
pollution. JAMA J. Am. Med. Assoc. 287: influence lung function in relation to mortality in Brisbane, Australia. Arch.
1132–1141. ozone exposure in asthmatic children in Environ. Health 52: 442–454.
Prentice I. C., Farquhar G. D., Fasham M. J. Mexico City. Thorax 59: 8–10. Sin, D. D.; Man, S. F. P. (2003) Why are
R., et al. (2001) The Carbon Cycle and Samet, J. M.; Zeger, S. L.; Dominici, F.; patients with chronic obstructive
Atmospheric Carbon Dioxide. In Climate Curriero, F.; Coursac, I.; Dockery, D. W.; pulmonary disease at increased risk of
Change 2001: The Scientific Basis. Schwartz, J.; Zanobetti, A. (2000) The cardiovascular diseases? Circulation 107:
Contribution of Working Group I to the national morbidity, mortality, and air 1514–1519.
Third Assessment Report of the pollution study. Part II: morbidity, Smith, W. H. (1992) Air pollution effects on
Intergovernmental Panel on Climate mortality, and air pollution in the United ecosystem processes. In: Barker, J. R.;
Change. (ed J. T. Houghton YD, D. J. States. Cambridge, MA: Health Effects Tingey, D. T., eds. Air pollution effects
Griggs, M. Noguer, P. J. van der Linder, Institute; research report no. 94, part II. on biodiversity. Van Nostrand Reinhold;
X. Dai, K. Maskell, and C. A. Johnson), Sarnat, J. A.; Schwartz, J.; Catalano, P. J.; Suh, pp. 234–260.
pp. 241–280. Cambridge University H. H. (2001) Gaseous pollutants in Smith, G., Coulston J., Jepsen, J. and
Press, Cambridge, United Kingdom and particulate matter epidemiology: Prichard, T. (2003) ‘‘A national ozone
New York, NY, USA. confounders or surrogates? Environ. biomonitoring program: Results from
Pronos, J.; Merrill, L.; Dahlsten, D. (1999) Health Perspect. 109: 1053–1061. field surveys of ozone sensitive plants in
Insects and pathogens in a pollution- Sarnat, J. A.; Brown, K. W.; Schwartz, J.; northeastern forest (1994–2000)’’
stressed forest. In: Miller, P. R.; McBride, Coull, B. A.; Koutrakis, P. (2005) Environmental Monitoring and
J. R., eds. Oxidant air pollution impacts Ambient gas concentrations and personal Assessment 87(3): 271–291.
in the montane forests of southern particulate matter exposures: Somers, G. L.; Chappelka, A. H.; Rosseau, P.;
California. Springer, pp. 317–337. implications for studying the health Renfro, J. R. (1998) Empirical evidence of
Reid, C. D.; Fiscus, E. L. (1998) Effects of effects of particles. Epidemiology 16: growth decline related to visible ozone
elevated [CO2] and/or ozone on 385–395. injury. For. Ecol. Manage. 104: 129–137.
limitations to CO2 assimilation in Sartor, F.; Snacken, R.; Demuth, C.; Sunyer, J.; Basagaña, X.; Belmonte, J.; Antó,
soybean (Glycine max). J. Exp. Bot. 49: Walckiers, D. (1995) Temperature, J. M. (2002) Effect of nitrogen dioxide
885–895. ambient ozone levels, and mortality and ozone on the risk of dying in
Reiling, K.; Davison, A. W. (1992a) Effects of during summer, 1994, in Belgium. patients with severe asthma. Thorax 57:
a short ozone exposure given at different Environ. Res. 70: 105–113. 687–693.
stages in the development of Plantago Sasek, T. W.; Richardson, C. J.; Fendick, E. Tager, I. B.; Künzli, N.; Lurmann, F.; Ngo, L.;
major L. New Phytol. 121: 643–647. A.; Bevington, S. R.; Kress, L. W. (1991) Segal, M.; Balmes, J. (1998) Methods
Reiling, K.; Davison, A. W. (1992b) The Carryover effects of acid rain and ozone development for epidemiologic
response of native, herbaceous species to on the physiology of multiple flushes of investigations of the health effects of
ozone: growth and fluorescence loblolly pine seedlings. For. Sci. 37: prolonged ozone exposure. Part II: an
screening. New Phytol. 120: 29–37. 1078–1098. approach to retrospective estimation of
Reiling, K.; Davison, A. W. (1992c) Spatial Scannell, C.; Chen, L.; Aris, R. M.; Tager, I.; lifetime ozone exposure using a
variation in ozone resistance of British Christian, D.; Ferrando, R.; Welch, B.; questionnaire and ambient monitoring
populations of Plantago major. L. New Kelly, T.; Balmes, J. R. (1996) Greater data (California sites). Cambridge, MA:
Phytol. 122: 699–708. ozone-induced inflammatory responses Health Effects Institute; research report
Retzlaff, W. A.; Arthur, M. A.; Grulke, N. E.; in subjects with asthma. Am. J. Respir. no. 81; pp. 27–78.
Weinstein, D. A.; Gollands, B. (2000) Use Crit. Care Med. 154: 24–29. Takemoto, B. K.; Bytnerowicz, A.; Fenn, M.
of a single-tree simulation model to Schelegle, E. S.; Miller, L. A.; Gershwin, L. E. (2001) Current and future effects of
predict effects of ozone and drought on J.; Fanucchi, M. V.; Van Winkle, L. S.; ozone and atmospheric nitrogen
deposition on California’s mixed conifer Weber, J. A.; Clark, C. S.; Hogsett, W. E. unmeasured explanatory variables in
forests. For. Ecol. Manage. 144: 159–173. (1993) Analysis of the relationship(s) environmental epidemiology with
Tans P. P., White J. W .C. (1998) In balance, among O3 uptake, conductance, and application to health impact analysis of
with a little help from the plants. photosynthesis in needles of Pinus air pollution. Environ. Ecol. Stat. 5: 99–
Science, 281, 183–184. ponderosa. Tree Physiol. 13: 157–172. 115.
Taylor, C. R. ‘‘AGSIM: Model Description Weinstein, D.A., Beloin, R.M., R.D. Yanai
and Documentation.’’ Agricultural Sector (1991) ‘‘Modeling changes in red spruce List of Subjects in 40 CFR Part 50
Models for the United States. C. R. carbon balance and allocation in Environmental protection, Air
Taylor, K. H. Reichelderfer, and S. R. response to interacting ozone and
Johnson, eds. Ames IA: Iowa State nutrient stress.’’ Tree Physiology 9: 127– pollution control, Carbon monoxide,
University Press, (1993). 146. Lead, Nitrogen dioxide, Ozone,
Taylor R. (1994) ‘‘Deterministic versus Weinstein, D.A., J.A. Laurence, W.A. Retzlaff, Particulate matter, Sulfur oxides.
stochastic evaluation of the aggregate J.S. Kern, E.H. Lee, W.E. Hogsett, J. Dated: June 20, 2007.
economic effects of price support Weber (2005) Predicting the effects of
programs’’ Agricultural Systems 44: 461– tropospheric ozone on regional Stephen L. Johnson,
473. productivity of ponderosa pine and Administrator.
Temple, P. J.; Riechers, G. H.; Miller, P. R.; white fir. Forest Ecology and For the reasons stated in the
Lennox, R. W. (1993) Growth responses Management 205: 73–89. preamble, title 40, chapter I of the code
of ponderosa pine to long-term exposure Whitfield, R., Biller, W., Jusko, M., and of Federal regulations is proposed to be
to ozone, wet and dry acidic deposition, Keisler, J. (1996) A Probabilistic
and drought. Can. J. For. Res. 23: 59–66. Assessment of Health Risks Associated
amended as follows:
Thurston, G. D.; Ito, K.; Kinney, P. L.; with Short- and Long-Term Exposure to
Lippmann, M. (1992) A multi-year study Tropospheric Ozone. Argonne National PART 50—NATIONAL PRIMARY AND
of air pollution and respiratory hospital Laboratory, Argonne, IL. SECONDARY AMBIENT AIR QUALITY
admissions in three New York State Whitfield, R. (1997) A Probabilistic STANDARDS
metropolitan areas: results for 1988 and Assessment of Health Risks Associated
1989 summers. J. Exposure Anal. with Short-term Exposure to 1. The authority citation for part 50
Environ. Epidemiol. 2: 429–450. Tropospheric Ozone: A Supplement. continues to read as follows:
Tingey, D. T.; Standley, C.; Field, R. W. Argonne National Laboratory, Argonne, Authority: 42 U.S.C. 7401 et seq.
(1976) Stress ethylene evolution: a IL.
measure of ozone effects on plants. Whitfield, C. P.; Davison, A. W.; Ashenden, 2. Section 50.15 is added to read as
Atmos. Environ. 10: 969–974. T. W. (1997) Artificial selection and follows:
Tingey, D. T.; Taylor, G. E., Jr. (1982) heritability of ozone resistance in two
Variation in plant response to ozone: a populations of Plantago major. New § 50.15 National primary and secondary
conceptual model of physiological Phytol. 137: 645–655. ambient air quality standards for ozone.
events. In: Unsworth, M. H.; Ormrod, D. Whitfield, R.G., Richmond, H.M. and (a) The level of the national 8-hour
P., eds. Effects of gaseous air pollution in Johnson, T.R. (1998) ‘‘Overview of Ozone
agriculture and horticulture. London, Human Exposure and Health Risk
primary ambient air quality standard for
United Kingdom: Butterworth Scientific; Analyses Used in the U.S. EPA’s Review O3 is (0.070–0.075) parts per million
pp. 113–138. of the Ozone Air Quality Standard,’’ (ppm), daily maximum 8-hour average,
Tingey, D. T.; Laurence, J. A.; Weber, J. A.; pp.483–516 in: T. Schneider, ed. Air measured by a reference method based
Greene, J.; Hogsett, W. E.; Brown, S.; Lee, Pollution in the 21st Century: Priority on Appendix D to this part and
E. H. (2001) Elevated CO2 and Issues and Policy Elsevier; Amsterdam. designated in accordance with part 53 of
temperature alter the response of Pinus Wiley, J. A.; Robinson, J. P.; Piazza, T.; this chapter.
ponderosa to ozone: A simulation Garrett, K.; Cirksena, K.; Cheng, Y.-T.; (b) The 8-hour primary O3 ambient air
analysis. Ecol. Appl. 11: 1412–1424. Martin, G. (1991a) Activity patterns of
Tingey, D. T.; Hogsett, W. E.; Lee, E. H.; California residents. Final report.
quality standard is met at an ambient air
Laurence, J. A. (2004) Stricter ozone Sacramento, CA: California Air quality monitoring site when the
ambient air quality standard has Resources Board; report no. ARB/R93/ average of the annual fourth-highest
beneficial effect on Ponderosa pine in 487. Available from: NTIS, Springfield, daily maximum 8-hour average O3
California. Environ. Manage. 34: 397– VA.; PB94–108719. concentration is less than or equal to
405. Wiley, J. A.; Robinson, J. P.; Cheng, Y.-T.; (0.070–0.075) ppm, as determined in
Touloumi, G.; Katsouyanni, K.; Zmirou, D.; Piazza, T.; Stork, L.; Pladsen, K. (1991b) accordance with appendix P to this part.
Schwartz, J.; Spix, C.; Ponce de Leon, A.; Study of children’s activity patterns:
(c) The level of the national secondary
Tobias, A.; Quennel, P.; Rabczenko, D.; final report. Sacramento, CA: California
Bacharova, L.; Bisanti, L.; Vonk, J. M.; Air Resources Board; report no. ARB–R– ambient air quality standard for O3 is a
Ponka, A. (1997) Short-term effects of 93/489. cumulative index value of (7–21) ppm-
ambient oxidant exposure on mortality: Wolff, G.T. (1996) Letter from Chairman of hours, measured by a reference method
a combined analysis within the APHEA Clean Air Scientific Advisory Committee based on Appendix D to this part and
project. Am. J. Epidemiol. 146: 177–185. to the EPA Administrator, dated April 4, designated in accordance with part 53 of
Ultman, J. S.; Ben-Jebria, A.; Arnold, S. F. 1996. EPA–SAB–CASAC–LTR–96–006. this chapter.
(2004) Uptake distribution of ozone in Young, T. F.; Sanzone, S., eds. (2002) A (d) The secondary O3 ambient air
human lungs: intersubject variability in framework for assessing and reporting on
physiologic response. Boston, MA: ecological condition: an SAB report.
quality standard is a seasonal standard
Health Effects Institute. Washington, DC: U.S. Environmental expressed as a sum of weighted hourly
Vagaggini, B.; Taccola, M.; Clanchetti, S.; Protection Agency, Science Advisory concentrations, cumulated over the 12
Carnevali, S.; Bartoli, M. L.; Bacci, E.; Board; report no. EPA–SAB–EPEC–02– hour daylight period from 8 a.m. to 8
Dente, F. L.; Di Franco, A.; Giannini, D.; 009. Available: http://www.epa.gov/sab/ p.m. local standard time, during the
Paggiaro, P. L. (2002) Ozone exposure pdf/epec02009.pdf [9 December, 2003]. consecutive 3-month period within the
increases eosinophilic airway response Zeger, S. L.; Thomas, D.; Dominici, F.; Samet, O3 monitoring season with the
induced by previous allergen challenge. J. M.; Schwartz, J.; Dockery, D.; Cohen, maximum index value. The secondary
Am. J. Respir. Crit. Care Med. 166: 1073– A. (2000) Exposure measurement error in
1077. time-series studies of air pollution:
O3 standard is met at an ambient air
Vedal, S.; Brauer, M.; White, R.; Petkau, J. concepts and consequences. Environ. quality monitoring site when the annual
(2003) Air pollution and daily mortality Health Perspect. 108: 419–426. maximum consecutive 3-month
in a city with low levels of pollution. Zidek, J. V.; White, R.; Le, N. D.; Sun, W.; cumulative index value (W126) is less
Environ. Health Perspect. 111: 45–51. Burnett, R. T. (1998) Imputing than or equal to (7–21) ppm-hours, as
determined in accordance with Year refers to calendar year. 2.2 Primary Standard-Related Summary
appendix P to this part. Statistic
2. Primary Ambient Air Quality Standard
3. Appendix P is added to read as for Ozone The standard-related summary statistic is
follows: the annual fourth-highest daily maximum 8-
2.1 Data Reporting and Handling hour O3 concentration, expressed in parts per
Appendix P to Part 50—Interpretation Conventions million, averaged over three years. The 3-year
of the Primary and Secondary National Computing 8-hour averages. Hourly average shall be computed using the three
Ambient Air Quality Standards for average concentrations shall be reported in most recent, consecutive calendar years of
Ozone parts per million (ppm) to the third decimal monitoring data meeting the data
place, with additional digits to the right completeness requirements described in this
1. General
being truncated. Running 8-hour averages appendix. The computed 3-year average of
(a) This appendix explains the data shall be computed from the hourly O3 the annual fourth-highest daily maximum 8-
handling conventions and computations concentration data for each hour of the year hour average O3 concentrations shall be
necessary for determining whether the and the result shall be stored in the first, or reported to three decimal places (the
national 8-hour primary and secondary start, hour of the 8-hour period. An 8-hour insignificant digits to the right of the third
ambient air quality standards for O3 specified average shall be considered valid if at least decimal place are truncated, consistent with
in § 50.14 are met at an ambient O3 air 75% of the hourly averages for the 8-hour the data handling procedures for the reported
quality monitoring site. Ozone is measured in period are available. In the event that only 6 data).
the ambient air by a Federal reference (or 7) hourly averages are available, the 8-
method (FRM) based on appendix D of this hour average shall be computed on the basis 2.3 Comparisons With the Primary Ozone
part, as applicable, and designated in of the hours available using 6 (or 7) as the Standard
accordance with part 53 of this chapter, or by divisor (8-hour periods with three or more (a) The primary O3 ambient air quality
a Federal equivalent method (FEM) missing hours shall not be ignored if, after standard is met at an ambient air quality
designated in accordance with part 53 of this substituting one-half the minimum detectable monitoring site when the 3-year average of
chapter, or by an Approved Regional Method limit for the missing hourly concentrations,
the annual fourth-highest daily maximum 8-
(ARM) designated in accordance with part 58 the 8-hour average concentration is greater
hour average O3 concentration is less than or
of this chapter. Data reporting, data handling, than the level of the standard). The computed
equal to [0.070 to 0.075] ppm.
and computation procedures to be used in 8-hour average O3 concentrations shall be
making comparisons between reported O3 reported to three decimal places (the (b) This comparison shall be based on three
concentrations and the level of the O3 insignificant digits to the right of the third consecutive, complete calendar years of air
standard are specified in the following decimal place are truncated, consistent with quality monitoring data. This requirement is
sections. Whether to exclude, retain, or make the data handling procedures for the reported met for the three year period at a monitoring
adjustments to the data affected by data). site if daily maximum 8-hour average
exceptional events, including stratospheric Daily maximum 8-hour average concentrations are available for at least 90%,
O3 intrusion and other natural events, is concentrations. (a) There are 24 possible on average, of the days during the designated
subject to the requirements under § 50.1, running 8-hour average O3 concentrations for O3 monitoring season, with a minimum data
§ 50.14 and § 51.930. each calendar day during the O3 monitoring completeness in any one year of at least 75%
(b) The terms used in this appendix are season. The daily maximum 8-hour of the designated sampling days. When
defined as follows: concentration for a given calendar day is the computing whether the minimum data
8-hour average is the rolling average of highest of the 24 possible 8-hour average completeness requirements have been met,
hourly O3 concentrations as explained in concentrations computed for that day. This meteorological or ambient data may be
section 2 of this appendix. process is repeated, yielding a daily sufficient to demonstrate that meteorological
Annual fourth highest daily maximum maximum 8-hour average O3 concentration conditions on missing days were not
refers to the fourth highest value measured at for each calendar day with ambient O3 conducive to concentrations above the level
a monitoring location during the O3 season monitoring data. Because the 8-hour averages of the standard. Missing days assumed less
for a particular year. are recorded in the start hour, the daily than the level of the standard are counted for
Daily maximum 8-hour average maximum 8-hour concentrations from two the purpose of meeting the data completeness
concentration refers to the maximum consecutive days may have some hourly requirement, subject to the approval of the
calculated 8 hour average for a particular day concentrations in common. Generally, appropriate Regional Administrator.
as explained in section 2 of this appendix. overlapping daily maximum 8-hour averages (c) Years with concentrations greater than
Design values are the metrics (i.e., are not likely, except in those non-urban the level of the standard shall not be ignored
statistics) that are compared to the NAAQS monitoring locations with less pronounced on the ground that they have less than
levels to determine compliance, calculated as diurnal variation in hourly concentrations. complete data. Thus, in computing the 3-year
shown in sections 3 and 4 of this appendix. (b) An O3 monitoring day shall be counted average fourth maximum concentration,
Ozone monitoring season refers to the span as a valid day if valid 8-hour averages are calendar years with less than 75% data
of time within a calendar year when available for at least 75% of possible hours completeness shall be included in the
individual States are required to measure in the day (i.e., at least 18 of the 24 averages). computation if the average annual fourth
ambient O3 concentrations as listed in part 58 In the event that less than 75% of the 8-hour maximum 8-hour concentration is greater
appendix D to this chapter. averages are available, a day shall also be than the level of the standard.
W126 is the weighted hourly O3 counted as a valid day if the daily maximum (d) Comparisons with the primary O3
concentrations based on seasonal 8-hour average concentration for that day is standard is demonstrated by examples 1 and
measurements as explained in section 4 of greater than the level of the ambient 2 in paragraphs (d)(1) and (d)(2) respectively
this appendix. standard. as follows:
EXAMPLE 1.—AMBIENT MONITORING SITE ATTAINING THE PRIMARY O3 STANDARD

1st Highest 2nd Highest 3rd Highest 4th Highest 5th Highest
Percent valid daily max daily max daily max daily max daily max
Year days
8-hour Conc. 8-hour Conc. 8-hour Conc. 8-hour Conc. 8-hour Conc.
(percent) (ppm) (ppm) (ppm) (ppm) (ppm)
2004 ......................................................... 100 0.092 0.090 0.085 0.079 0.078

2005 ......................................................... 96 0.084 0.083 0.075 0.072 0.070
2006 ......................................................... 98 0.080 0.079 0.073 0.061 0.060
EXAMPLE 1.—AMBIENT MONITORING SITE ATTAINING THE PRIMARY O3 STANDARD

Year days 8-hour Conc. 8-hour Conc. 8-hour Conc. 8-hour Conc. 8-hour Conc.
Average ............................................. 98 ........................ ........................ ........................ 0.070 ........................
(1) As shown in example 1, the primary truncated to 0.070 ppm) is less than or equal 90%, and no single year has less than 75%
standard is met at this monitoring site to [0.070 to 0.75] ppm. The data data completeness. In Example 1, the
because the 3-year average of the annual completeness requirement is also met individual 8-hour averages used to determine
fourth-highest daily maximum 8-hour because the average percent of days with the annual fourth maximum are truncated to
average O3 concentrations (i.e., 0.0707 ppm, valid ambient monitoring data is greater than the third decimal place.
EXAMPLE 2.—AMBIENT MONITORING SITE FAILING TO MEET THE PRIMARY O3 STANDARD

Year days 8-hour Conc. 8-hour Conc. 8-hour Conc. 8-hour Conc. 8-hour Conc.
2004 ......................................................... 96 0.105 0.103 0.103 0.102 0.102

2005 ......................................................... 74 0.104 0.103 0.092 0.091 0.088
2006 ......................................................... 98 0.103 0.101 0.101 0.095 0.094
Average ............................................. 89 ........................ ........................ ........................ 0.096 ........................
As shown in example 2, the primary standard. For a concentration-based standard, million (ppm) to the third decimal place,
standard is not met at this monitoring site the air quality design value is simply the with additional digits to the right being
because the 3-year average of the fourth- standard-related test statistic. Thus, for the truncated. The first step in computing the
highest daily maximum 8-hour average O3 primary standard, the 3-year average annual daily index value, D.I., for the daylight hours
concentrations (i.e., 0.0960 ppm, truncated to fourth-highest daily maximum 8-hour is to apply a sigmoidal weighting function in
0.096 ppm) is greater than [0.070 to 0.075] average O3 concentration is also the air
the form of Equation 1 in this appendix:
ppm. Note that the O3 concentration data for quality design value for the site.
2005 is used in these computations, even 4. Secondary Ambient Air Quality Standard
though the data capture is less than 75%,
Equation 1
for Ozone
because the average fourth-highest daily
4.1 Data Reporting and Handling
 1 
maximum 8-hour average concentration is O3 ∗  
greater than [0.070 to 0.075] ppm. In Example
2, the individual 8-hour averages used to
Conventions
Computing the daily index value (D.I.). The  (
 1 + 4403 ∗ e −126 ∗ O3 ) 

determine the annual fourth maximum are secondary O3 standard is a seasonal standard to each measurement of hourly average
truncated to the third decimal place. expressed as the sum of weighted hourly concentration, where O3 is the average hourly
concentrations, cumulated over the 12 hour
3. Design Values for Primary Ambient Air O3 concentration expressed in ppm. The
daylight period, 8 a.m. to 8 p.m. local
Quality Standards for Ozone standard time (LST), during the maximum computed value of the sigmoidally weighted
The air quality design value at a consecutive 3-month period within the O3 hourly concentration shall be expressed to
monitoring site is defined as that monitoring season. Hourly average three decimal places (the remaining digits to
concentration that when reduced to the level concentrations for each hour from 8 a.m. to the right are truncated). An illustration of
of the standard ensures that the site meets the 8 p.m. LST shall be reported in parts per computing a daily index value is below:
EXAMPLE 3.—DAILY INDEX VALUE CALCULATION FOR AN AMBIENT O3 MONITORING SITE

Weighted
Concentration
Start hour concentration
(ppm) (ppm)
8:00 AM ................................................................................................................................................................... 0.045 0.002

9:00 AM ................................................................................................................................................................... 0.060 0.018
10:00 AM ................................................................................................................................................................. 0.075 0.055
11:00 AM ................................................................................................................................................................. 0.080 0.067
12:00 PM ................................................................................................................................................................. 0.079 0.065
1:00 PM ................................................................................................................................................................... 0.082 0.071
2:00 PM ................................................................................................................................................................... 0.085 0.077
3:00 PM ................................................................................................................................................................... 0.088 0.082
4:00 PM ................................................................................................................................................................... 0.083 0.073
5:00 PM ................................................................................................................................................................... 0.081 0.069

6:00 PM ................................................................................................................................................................... 0.065 0.029
7:00 PM ................................................................................................................................................................... 0.056 0.011
EP11JY07.002</GPH>
Daily index value (D.I.) = 0.002 + 0.018 + Equation 2 Specifically, the annual W126 value is
0.055 + 0.067 + 0.065 + 0.071 + 0.077 + computed on a calendar year basis using the
n
0.082 + 0.073 + 0.069 + 0.029 + 0.011 =
0.619 ppm-hours M.I. = ∑ (D.I.) ∗ (n ∗12)/ v three highest, consecutive monthly W126
values.
Computing the monthly cumulative index j=1
(W126). The daily index value is computed Where, 4.3 Comparisons with the Secondary Ozone
at each monitoring site for each calendar day Standard
in each month during the O3 monitoring. At M.I. = the monthly sum of the weighted
an individual monitoring site, a month is daylight hours, The secondary ambient O3 air quality
counted as a valid O3 monitoring month if D.I. = the daily sum of the weighted daylight standard is met when the annual maximum
hourly average O3 concentrations are hours, W126 value based on a consecutive 3-month
available for at least 75% of the possible n = the number of days in the calendar period at an O3 air quality monitoring site is
index hours in the month. For months with month, less than or equal to [7 to 21] ppm-hours. The
less than 75% data completeness, the v = the number of daylight hours (8:00 a.m.— number of significant figures in the level of
monthly cumulative index value shall be 8:00 p.m. LST) with valid hourly O3 the standard dictates the rounding
adjusted for incomplete sampling by concentrations. convention for comparing the computed
multiplying the unadjusted W126 cumulative W126 value with the level of the standard.
index value by the ratio of the number of 4.2 Secondary Standard-related Summary
Statistic The first decimal place of the computed
possible daylight hours to the number of
hours with valid ambient hourly The standard-related summary statistic is W126 value is rounded, with values equal to
concentrations using Equation 2 in this the annual maximum consecutive 3-month or greater than of 0.5 rounding up.
appendix: W126 value expressed in ppm-hours.
EXAMPLE 4.—CALCULATION OF THE MAXIMUM 3-MONTH W126 VALUE AT AN AMBIENT AIR QUALITY MONITORING SITE
FAILING TO MEET THE SECONDARY O3 STANDARD
April May June July August September October
Monthly W126 ........................................... 4.442 9.124 12.983 16.153 13.555 4.364 1.302
3-Month Total ............................................ na na 26.549 38.260 42.691 34.072 19.221
As shown in example 4, the maximum is 43 ppm-hours. Because 43 ppm-hours is secondary standard is not met at this ambient
consecutive 3-month W126 value for this site greater than [7 to 21] ppm-hours, the air quality monitoring site.
[FR Doc. E7–12416 Filed 7–10–07; 8:45 am]
BILLING CODE 6560–50–P
EP11JY07.003</GPH>

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Wednesday,

July 11, 2007

1. Background ‘‘reference should be made to a representative

combustion sources, coating categories,

5 EPA plans to make available corrected versions

2002). to reconsider its decision. 1:03CV00778, D.D.C. 2003).

7 In its assessment of the epidemiological

ppm for 6-to 8-hour exposures * * * including

epidemiological studies have examined including asthma, children and older

the O3 and other NAAQS, EPA has used the phrase

the Staff Paper.

studies, short-term and sub-chronic

general public. Excess respiratory-

those more directly induced by O3 (EPA,

section of this notice. containing a chapter discussing the exposure

a chapter discussing the risk assessment and first

levels resulted in increased estimates of non-

Paper conclusion that consideration

long-term primary O3 standard was not risk of experiencing health effects

study). simulate just meeting the current and selected

have been well studied with respect to O3

In the 1997 final rule, the

science-based modeling tool for handling many

areas from year to year, even when the

rye, Durum wheat, other spring wheat, rice,

hour, 0.08 ppm primary standard in

results of O3/vegetation exposure experiments

simply mathematical expressions of exposure and,

and international parks. The National Park Service

66 At present, not all ozone monitors at CASTNET

EXAMPLE 1.—AMBIENT MONITORING SITE ATTAINING THE PRIMARY O3 STANDARD

2004 ......................................................... 100 0.092 0.090 0.085 0.079 0.078

EXAMPLE 1.—AMBIENT MONITORING SITE ATTAINING THE PRIMARY O3 STANDARD

Average ............................................. 98 ........................ ........................ ........................ 0.070 ........................

EXAMPLE 2.—AMBIENT MONITORING SITE FAILING TO MEET THE PRIMARY O3 STANDARD

2004 ......................................................... 96 0.105 0.103 0.103 0.102 0.102

Average ............................................. 89 ........................ ........................ ........................ 0.096 ........................

EXAMPLE 3.—DAILY INDEX VALUE CALCULATION FOR AN AMBIENT O3 MONITORING SITE

8:00 AM ................................................................................................................................................................... 0.045 0.002

5:00 PM ................................................................................................................................................................... 0.081 0.069

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