[Federal Register Volume 74, Number 234 (Tuesday, December 8, 2009)]
[Proposed Rules]
[Pages 64810-64881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28058]
[[Page 64809]]
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Part II
Environmental Protection Agency
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40 CFR Parts 50, 53, and 58
Primary National Ambient Air Quality Standard for Sulfur Dioxide;
Proposed Rule
Federal Register / Vol. 74, No. 234 / Tuesday, December 8, 2009 /
Proposed Rules
[[Page 64810]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 50, 53, and 58
[EPA-HQ-OAR-2007-0352; FRL-8984-3]
RIN 2060-A048
Primary National Ambient Air Quality Standard for Sulfur Dioxide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: Based on its review of the air quality criteria for oxides of
sulfur and the primary national ambient air quality standard (NAAQS)
for oxides of sulfur as measured by sulfur dioxide (SO2),
EPA is proposing to revise the primary SO2 NAAQS to provide
requisite protection of public health with an adequate margin of
safety. Specifically, EPA proposes to establish a new 1-hour
SO2 standard within the range of 50-100 parts per billion
(ppb), based on the 3-year average of the annual 99th percentile (or
4th highest) of 1-hour daily maximum concentrations. The EPA also
proposes to revoke both the existing 24-hour and annual primary
SO2 standards.
DATES: Comments must be received on or before February 8, 2010. Under
the Paperwork Reduction Act, comments on the information collection
provisions must be received by OMB on or before January 7, 2010.
Public Hearings: A public hearing is scheduled for this proposed
rule. The public hearing will be held on January 5, 2010 in Atlanta,
Georgia.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-0352 by one of the following methods:
http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: [email protected].
Fax: 202-566-9744.
Mail: Docket No. EPA-HQ-OAR-2007-0352, Environmental
Protection Agency, Mail Code 6102T, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. Please include a total of two copies.
Hand Delivery: Docket No. EPA-HQ-OAR-2007-0352,
Environmental Protection Agency, EPA West, Room 3334, 1301 Constitution
Ave., NW, Washington, DC. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
Public Hearings: A public hearing is scheduled for this proposed
rule. The public hearing will be held on January 5, 2010 in Atlanta,
Georgia. The hearing will be held at the following location: Sam Nunn
Atlanta Federal Center, Conference Rooms B and C, 61 Forsyth Street,
SW., Atlanta, GA 30303, Telephone: (404) 562-9077.
Note: All persons entering the Atlanta Federal Center must have
a valid picture ID such as a Driver's License and go through Federal
security procedures. All persons must go through a magnetometer and
all personal items must go through x-ray equipment, similar to
airport security procedures. After passing through the equipment,
all persons must sign in at the guard station and show their picture
ID.
See the SUPPLEMENTARY INFORMATION under ``Public Hearing'' for
further information.
Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2007-0352. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air and Radiation Docket
and Information Center, EPA/DC, EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744 and the
telephone number for the Air and Radiation Docket and Information
Center is (202) 566-1742.
FOR FURTHER INFORMATION CONTACT: Dr. Michael J. Stewart, Health and
Environmental Impacts Division, Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Mail Code C504-06,
Research Triangle Park, NC 27711; telephone: 919-541-7524; fax: 919-
541-0237; e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
General Information
What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for Preparing Your Comments. When submitting comments,
remember to:
Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
Follow directions--the agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
Explain why you agree or disagree, suggest alternatives,
and substitute language for your requested changes.
[[Page 64811]]
Describe any assumptions and provide any technical
information and/or data that you used.
Provide specific examples to illustrate your concerns, and
suggest alternatives.
Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
Make sure to submit your comments by the comment period
deadline identified.
Availability of Related Information
A number of the documents that are relevant to this rulemaking are
available through EPA's Office of Air Quality Planning and Standards
(OAQPS) Technology Transfer Network (TTN) Web site at http://www.epa.gov/ttn/naaqs/standards/so2/s_so2_index.html. These documents
include the Integrated Review Plan and the Health Assessment Plan,
available at, the Integrated Science Assessment (ISA), available at
http://www.epa.gov/ttn/naaqs/standards/so2/s_so2_cr_isa.html, and
the Risk and Exposure Assessment (REA), available at http://www.epa.gov/ttn/naaqs/standards/so2/s_so2_cr_rea.html. These and
other related documents are also available for inspection and copying
in the EPA docket identified above.
Public Hearing
The public hearing on January 5, 2010 will provide interested
parties the opportunity to present data, views, or arguments concerning
the proposed rule. The EPA may ask clarifying questions during the oral
presentations, but will not respond to the presentations at that time.
Written statements and supporting information submitted during the
comment period will be considered with the same weight as any oral
comments and supporting information presented at the public hearing.
Written comments must be received by the last day of the comment
period, as specified in this proposed rulemaking.
The public hearing will begin at 10 a.m. and continue until 7 p.m.
(local time) or later, if necessary, depending on the number of
speakers wishing to participate. The EPA will make every effort to
accommodate all speakers that arrive and register before 7 p.m. A lunch
break is scheduled from 12:30 p.m. until 2 p.m.
If you would like to present oral testimony at the hearing, please
notify Ms. Tricia Crabtree (C504-02), U.S. EPA, Research Triangle Park,
NC 27711. The preferred method for registering is by e-mail
([email protected]). Ms. Crabtree may be reached by telephone at
(919) 541-5688. She will arrange a general time slot for you to speak.
The EPA will make every effort to follow the schedule as closely as
possible on the day of the hearing.
Oral testimony will be limited to five (5) minutes for each
commenter to address the proposal. We will not be providing equipment
for commenters to show overhead slides or make computerized slide
presentations unless we receive special requests in advance. Commenters
should notify Ms. Crabtree if they will need specific audiovisual (AV)
equipment. Commenters should also notify Ms. Crabtree if they need
specific translation services for non-English speaking commenters. The
EPA encourages commenters to provide written versions of their oral
testimonies either electronically on computer disk, CD-ROM, or in paper
copy.
The hearing schedule, including lists of speakers, will be posted
on EPA's Web site for the proposal at http://www.epa.gov/ttn/naaqs/standards/so2/s_so2_index.html prior to the hearing. Verbatim
transcripts of the hearing and written statements will be included in
the rulemaking docket.
Table of Contents
The following topics are discussed in this preamble:
I. Background
A. Legislative requirements
B. Related SO2 control programs
C. History of reviews of the primary NAAQS for sulfur oxides
II. Rationale for proposed decisions on the primary standards
A. Characterization of SO2 air quality
1. Anthropogenic sources and current patterns of SO2
air quality
2. SO2 monitoring
B. Health effects information
1. Respiratory effects and 5-10 minute exposure to
SO2
a. Respiratory symptoms
b. Lung function decrements
c. Adversity of 5-10 minute respiratory effects
2. Respiratory effects and 1 to 24-hour exposures to
SO2
a. Respiratory symptoms
b. Emergency department visits and hospitalizations
3. ISA conclusions regarding short-term (5-minutes to 24-hour)
SO2 exposures
4. Health effects and long-term exposures to SO2
5. SO2-related impacts on public health
a. Pre-existing respiratory disease
b. Genetics
c. Age
d. Time spent outdoors
e. Ventilation rate
f. Socioeconomic status
g. Size of at-risk population
C. Human exposure and health risk characterization
1. Evidence base for the risk characterization
2. Overview of approaches
3. Key limitations and uncertainties
D. Considerations in review of the standards
1. Background on the current standards
2. Approach for reviewing the need to retain or revise the
current standards
E. Adequacy of the current standards
1. Adequacy of the current 24-hour standard
a. Evidence-based considerations
b. Air quality, exposure, and risk-based considerations
c. Summary of considerations from the REA regarding the 24-hour
standard
2. Adequacy of the current annual standard
a. Evidence-based considerations
b. Air quality, exposure, and risk-based considerations
c. Summary of considerations from the REA regarding the annual
standard
3. CASAC views regarding adequacy of the current 24-hour and
annual standards
4. Administrator's conclusions regarding adequacy of the current
24-hour and annual standards
F. Conclusions on the elements of a proposed new short-term
standard
1. Indicator
2. Averaging time
a. Evidence and air quality, exposure, and risk-based
considerations
b. CASAC views
c. Administrator's conclusions on averaging time
3. Form
a. Evidence, air quality, and risk-based considerations
b. CASAC views
c. Administrator's conclusions on form
4. Level
a. Evidence-based considerations
b. Air quality, exposure and risk-based considerations
c. Observations based on evidence and risk-based considerations
d. CASAC views
e. Administrator's conclusions on level for a 1-hour standard
5. Implications for retaining or revoking current standards
G. Summary of proposed decisions on primary standards
III. Proposed Amendments to Ambient Monitoring and Reporting
Requirements
A. Monitoring methods
1. Background
2. Proposed new FRM measurement technique
3. Technical description of the proposed UVF FRM
4. Implications to air monitoring networks
5. Proposed revisions to 40 CFR Part 53
B. Network design
1. Background
2. Proposed changes
a. Population Weighted Emissions Index (PWEI) Triggered
Monitoring
b. State-level emissions triggered monitoring
c. Monitor placement and siting
d. Monitoring required by the Regional Administrator
e. Alternative Network Design
C. Data Reporting
IV. Proposed Appendix T--Interpretation of the Primary NAAQS for
Oxides of Sulfur
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and Proposed Revisions to the Exceptional Events Rule
A. Background
B. Interpretation of the NAAQS for Oxides of Sulfur
1. 1-hour standard based on the annual 4th highest daily value
form
2. 1-hour primary standard based on the 99th percentile value
form
C. Exceptional events information submission schedule
V. Designations for the SO2 NAAQS
VI. Clean Air Act Implementation Requirements
A. How this rule applies to tribes
B. Attainment dates
1. Attaining the NAAQS
2. Consequences of failing to attain by the Statutory Attainment
Date
C. Section 110(a)(2) NAAQS Infrastructure Requirements
D. Attainment planning requirements
1. SO2 Nonattainment area SIP requirements
2. New source review and prevention of significant deterioration
requirements
3. General conformity
E. Transition from the existing SO2 NAAQS to a
revised SO2 NAAQS
VII. Communication of public health information
VIII. Statutory and executive order reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
G. Executive Order 13045: Protection of Children from
Environmental Health & Safety Risks
H. Executive Order 13211: Actions that Significantly Affect
Energy Supply, Distribution or Use
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations
References
I. Background
A. Legislative requirements
Two sections of the Clean Air Act (Act or CAA) govern the
establishment and revision of National Ambient Air Quality Standards
NAAQS. Section 108 of the Act directs the Administrator to identify and
list air pollutants that meet certain criteria, including that the air
pollutant ``in his judgment, cause[s] or contribute[s] to air pollution
which may reasonably be anticipated to endanger public health and
welfare'' and ``the presence of which in the ambient air results from
numerous or diverse mobile or stationary sources.'' CAA section 108
(a)(1)(A) & (B). For those air pollutants listed, section 108 requires
the Administrator to issue air quality criteria that ``accurately
reflect the latest scientific knowledge useful in indicating the kind
and extent of all identifiable effects on public health or welfare
which may be expected from the presence of [a] pollutant in ambient air
* * *'' Section 108 (a) (2).
Section 109(a) of the Act directs the Administrator to promulgate
``primary'' and ``secondary'' NAAQS for pollutants for which air
quality criteria have been issued. Section 109(b)(1) defines a primary
standard as one ``the attainment and maintenance of which in the
judgment of the Administrator, based on [the air quality] criteria and
allowing an adequate margin of safety, are requisite to protect the
public health.'' \1\ Section 109(b)(1). A secondary standard, in turn,
must ``specify a level of air quality the attainment and maintenance of
which, in the judgment of the Administrator, based on [the air quality]
criteria, is requisite to protect the public welfare from any known or
anticipated adverse effects associated with the presence of such
pollutant in the ambient air.'' \2\ Section 109(b)(2) This proposal
concerns exclusively the primary NAAQS for oxides of sulfur.
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\1\ The legislative history of section 109 indicates that a
primary standard is to be set at ``the maximum permissible ambient
air level * * * which will protect the health of any [sensitive]
group of the population,'' and that for this purpose ``reference
should be made to a representative sample of persons comprising the
sensitive group rather than to a single person in such a group.'' S.
Rep. No. 91-1196, 91st Cong., 2d Sess. 10 (1970).
\2\ EPA is currently conducting a separate review of the
secondary SO2 NAAQS jointly with a review of the
secondary NO2 NAAQS (see http://www.epa.gov/ttn/naaqs/standards/no2so2sec/index.html for more information).
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The requirement that primary standards include an adequate margin
of safety is intended to address uncertainties associated with
inconclusive scientific and technical information available at the time
of standard setting. It is also intended to provide a reasonable degree
of protection against hazards that research has not yet identified.
Lead Industries Association v. EPA, 647 F.2d 1130, 1154 (DC Cir 1980),
cert. denied, 449 U.S. 1042 (1980); American Petroleum Institute v.
Costle, 665 F.2d 1176, 1186 (DC Cir. 1981), cert. denied, 455 U.S. 1034
(1982). Both kinds of uncertainties are components of the risk
associated with pollution at levels below those at which human health
effects can be said to occur with reasonable scientific certainty.
Thus, in selecting primary standards that include an adequate margin of
safety, the Administrator is seeking not only to prevent pollution
levels that have been demonstrated to be harmful but also to prevent
lower pollutant levels that may pose an unacceptable risk of harm, even
if the risk is not precisely identified as to nature or degree.
In addressing the requirement for a margin of safety, EPA considers
such factors as the nature and severity of the health effects involved,
the size of the at-risk population(s), and the kind and degree of the
uncertainties that must be addressed. The selection of any particular
approach to providing an adequate margin of safety is a policy choice
left specifically to the Administrator's judgment. Lead Industries
Association v. EPA, 647 F.2d at 1161-62.
In setting standards that are ``requisite'' to protect public
health and welfare, as provided in section 109(b), EPA's task is to
establish standards that are neither more nor less stringent than
necessary for these purposes. In so doing, EPA may not consider the
costs of implementing the standards. Whitman v. American Trucking
Associations, 531 U.S. 457, 471, 475-76 (2001).
Section 109(d)(1) of the Act requires the Administrator to
periodically undertake a thorough review of the air quality criteria
published under section 108 and the NAAQS and to revise the criteria
and standards as may be appropriate. The Act also requires the
Administrator to appoint an independent scientific review committee
composed of seven members, including at least one member of the
National Academy of Sciences, one physician, and one person
representing State air pollution control agencies, to review the air
quality criteria and NAAQS and to ``recommend to the Administrator any
new * * * standards and revisions of existing criteria and standards as
may be appropriate under section 108 and subsection (b) of this
section.'' CAA section 109 (d)(2). This independent review function is
performed by the Clean Air Scientific Advisory Committee (CASAC) of
EPA's Science Advisory Board.
B. Related SO2 control programs
States are primarily responsible for ensuring attainment and
maintenance of ambient air quality standards once EPA has established
them. Under section 110 of the Act, and related provisions, States are
to submit, for EPA approval, State implementation plans (SIPs) that
provide for the attainment and maintenance of such standards through
control programs directed to sources of the pollutants involved. The
States, in conjunction with EPA, also administer the prevention of
significant deterioration program that covers these
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pollutants. See CAA sections 160-169. In addition, Federal programs
provide for nationwide reductions in emissions of these and other air
pollutants through the Federal motor vehicle and motor vehicle fuel
control program under title II of the Act, (CAA sections 202-250) which
involves controls for emissions from all moving sources and controls
for the fuels used by these sources; new source performance standards
under section 111; and title IV of the Act (CAA sections 402-416),
which specifically provides for major reductions in SO2
emissions. EPA has also promulgated the Clean Air Interstate Rule
(CAIR) to define additional SO2 emission reductions needed
in the Eastern United States to address the interstate impact
provisions of CAA section 110(a)(2)(D), a rule which EPA is
reevaluating pursuant to court remand.
Currently, there are several areas designated as being in
nonattainment of the primary SO2 NAAQS (see section VI). If
the SO2 NAAQS is revised as a result of this review;
however, some additional areas could be classified as non-attainment.
Certain States would then be required to develop SIPs that identify and
implement specific air pollution control measures to reduce ambient
SO2 concentrations to attain and maintain the revised
SO2 NAAQS, most likely by requiring air pollution controls
on sources that emit oxides of sulfur (SOX).
C. History of reviews of the primary NAAQS for sulfur oxides
On April 30, 1971, the EPA promulgated primary SO2 NAAQS
(36 FR 8187). These primary standards, which were based on the findings
outlined in the original 1969 Air Quality Criteria for Sulfur Oxides,
were set at 0.14 parts per million averaged over a 24-hour period, not
to be exceeded more than once per year, and 0.030 ppm annual arithmetic
mean. In 1982, EPA published the Air Quality Criteria for Particulate
Matter and Sulfur Oxides (EPA, 1982) along with an addendum of newly
published controlled human exposure studies, which updated the
scientific criteria upon which the initial standards were based (EPA,
1982). In 1986, EPA published a second addendum presenting newly
available evidence from epidemiologic and controlled human exposure
studies (EPA, 1986). In 1988, EPA published a proposed decision not to
revise the existing standards (53 FR 14926) (April 26, 1988). However,
EPA specifically requested public comment on the alternative of
revising the current standards and adding a new 1-hour primary standard
of 0.4 ppm (400 ppb) to protect against 5-10 minute peak SO2
concentrations.
As a result of public comments on the 1988 proposal and other post-
proposal developments, EPA published a second proposal on November 15,
1994 (59 FR 58958). The 1994 re-proposal was based in part on a
supplement to the second addendum of the criteria document, which
evaluated new findings on 5-10 minute SO2 exposures in
asthmatics (EPA, 1994a). As in the 1988 proposal, EPA proposed to
retain the existing 24-hour and annual standards. EPA also solicited
comment on three regulatory alternatives to further reduce the health
risk posed by exposure to high 5-minute peaks of SO2 if
additional protection were judged to be necessary. The three
alternatives were: (1) Revising the existing primary SO2
NAAQS by adding a new 5-minute standard of 0.6 ppm (600 ppb)
SO2; (2) establishing a new regulatory program under section
303 of the Act to supplement protection provided by the existing NAAQS,
with a trigger level of 0.6 ppm (600 ppb) SO2, one expected
exceedance; and (3) augmenting implementation of existing standards by
focusing on those sources or source types likely to produce high 5-
minute peak concentrations of SO2.
On May 22, 1996, EPA announced its final decision not to revise the
NAAQS for SOX (61 FR 25566). EPA found that asthmatics (a
susceptible population group) could be exposed to such short-term
SO2 bursts resulting in repeated `exposure events' such that
tens or hundreds of thousands of asthmatics could be exposed annually
to lung function effects ``distinctly exceeding * * * [the] typical
daily variation in lung function'' that asthmatics routinely
experience, and found further that repeated occurrences should be
regarded as significant from a public health standpoint. 61 FR at
25572, 25573. Nonetheless, the agency concluded that ``the likelihood
that asthmatic individuals will be exposed * * * is very low when
viewed from a national perspective'', that ``5-minute peak
SO[2] levels do not pose a broad public health problem when
viewed from a national perspective'', and that ``short-term peak
concentrations of SO[2] do not constitute the type of
ubiquitous public health problem for which establishing a NAAQS would
be appropriate.'' Id. at 25575. EPA concluded, therefore, that it would
not revise the existing standards or add a standard to specifically
address 5-minute exposures. EPA also announced an intention to propose
guidance, under section 303 of the Act, to assist states in responding
to short-term peak of SO2 and later initiated a rulemaking
to do so (62 FR 210 (Jan. 2, 1997).
The American Lung Association and the Environmental Defense Fund
challenged EPA's decision not to establish a 5-minute standard. On
January 30, 1998, the Court of Appeals for the District of Columbia
found that EPA had failed to adequately explain its determination that
no revision to the SO2 NAAQS was appropriate and remanded
the determination back to EPA for further explanation. American Lung
Ass'n v. EPA, 134 F. 3d 388 (DC Cir. 1998). Specifically, the court
held that EPA had failed to adequately explain the basis for its
conclusion that short-term SO2 exposures to asthmatics do
not constitute a public health problem, noting that the agency had
failed to explain the link between its finding that repeated short-term
exposures were significant, and that there would be tens to hundreds of
thousands of such exposures annually to a susceptible subpopulation,
but that a NAAQS was found not be appropriate. 134 F. 3d at 392. The
court also rejected the explanation that short-term SO2
bursts were ``localized, infrequent, and site-specific'' as a rational
basis for the conclusion that no public health problem existed:
``[N]othing in the Final Decision explains why `localized', `site-
specific', or even `infrequent' events might nevertheless create a
public health problem, particularly since, in some sense, all pollution
is local and site-specific * * *''. Id. The court accordingly remanded
the case to EPA to adequately explain its determination or otherwise
take action in accordance with the opinion. In response, EPA has
collected and analyzed additional air quality data focused on 5-minute
concentrations of SO2. These air quality analyses conducted
since the last review will help inform the current review, which will
address the issues raised in the court's remand of the Agency's last
decision.
EPA formally initiated the current review of the air quality
criteria for oxides of sulfur and the SO2 primary NAAQS on
May 15, 2006 (71 FR 28023) with a general call for information. EPA's
draft Integrated Review Plan for the Primary National Ambient Air
Quality Standards for Sulfur Dioxide (EPA, 2007a) was made available in
April 2007 for public comment and was discussed by the CASAC via a
publicly accessible teleconference on May 11, 2007. As noted in that
plan, SOX includes multiple gaseous (e.g., SO3)
and particulate (e.g., sulfate) species. Because the health effects
associated with particulate species of SOx have been
considered within the context of
[[Page 64814]]
the health effects of ambient particles in the Agency's review of the
NAAQS for particulate matter (PM), the current review of the primary
SO2 NAAQS is focused on the gaseous species of
SOx and does not consider health effects directly associated
with particulate species.
The first draft of the Integrated Science Assessment for Oxides of
Sulfur-Health Criteria (ISA) and the Sulfur Dioxide Health Assessment
Plan: Scope and Methods for Exposure and Risk Assessment (EPA, 2007b)
were reviewed by CASAC at a public meeting held on December 5-6, 2007.
Based on comments received from CASAC and the public, EPA developed the
second draft of the ISA and the first draft of the Risk and Exposure
Assessment to Support the Review of the SO2 Primary National
Ambient Air Quality Standard (Risk and Exposure Assessment (REA)).
These documents were reviewed by CASAC at a public meeting held on July
30-31, 2008. Based on comments received from CASAC and the public at
this meeting, EPA released the final ISA in September of 2008 (EPA,
2008a; henceforth referred to as ISA). In addition, comments received
were considered in developing the second draft of the REA. Importantly,
the second draft of the REA contained a draft staff policy assessment
that considered the evidence presented in the final ISA and the air
quality, exposure, and risk characterization results presented in the
second draft REA, as they related to the adequacy of the current
SO2 NAAQS and potential alternative primary SO2
standards. This document was reviewed by CASAC at a public meeting held
on April 16-17, 2009. In preparing the final REA report, which included
the final staff policy assessment, EPA considered comments received
from CASAC and the public at and subsequent to that meeting. The final
REA containing the final staff policy assessment was completed in
August 2009 (EPA 2009a; henceforth referred to as REA).
The schedule for completion of this review is governed by a
judicial order resolving a lawsuit filed in September 2005, concerning
the timing of the current review. Center for Biologic Diversity v.
Johnson (Civ. No. 05-1814) (D.D.C. 2007). The order that now governs
this review, entered by the court in August 2007 and amended in
December 2008, provides that the Administrator will sign, for
publication, notices of proposed and final rulemaking concerning the
review of the primary SO2 NAAQS no later than November 16,
2009 and June 2, 2010, respectively.
This action presents the Administrator's proposed decisions on the
current primary SO2 standards. Throughout this preamble a
number of conclusions, findings, and determinations proposed by the
Administrator are noted. Although they identify the reasoning that
supports this proposal, they are not intended to be final or
conclusive. EPA invites general, specific, and/or technical comments on
all issues involved with this proposal, including all such proposed
judgments, conclusions, findings, and determinations. In addition to
requesting comment on the overall approach, EPA invites specific
comment on the level, or range of levels, appropriate for such a
standard, as well as on the rationale that would support that level or
range of levels.
II. Rationale for proposed decisions on the primary standards
This section presents the rationale for the Administrator's
proposed decision to revise the existing SO2 primary
standards by replacing the current 24-hour and annual standards with a
1-hour standard and to specify this 1-hour standard to the nearest
parts per billion (ppb). As discussed more fully below, this rationale
takes into account: (1) Judgments and conclusions presented in the ISA
and the REA; (2) CASAC advice and recommendations, as reflected in the
CASAC panel's discussions of drafts of the ISA and REA at public
meetings, in separate written comments, and in CASAC letters to the
Administrator (Henderson 2008; Samet, 2009); and (3) public comments
received at CASAC meetings during the development of the ISA and the
REA.
In developing this rationale, EPA has drawn upon an integrative
synthesis of the entire body of evidence on human health effects
associated with the presence of SO2 in the ambient air, and
upon the results of quantitative exposure and risk assessments
reflecting this evidence. As discussed below, this body of evidence
addresses a broad range of health endpoints associated with exposure to
SO2 in the ambient air. In considering this entire body of
evidence, EPA chose to focus in particular on those health endpoints
for which the ISA finds associations with SO2 to be causal
or likely causal (see section II.B below). Thus, the focus of this
proposal will be on respiratory morbidity following short-term (5
minutes to 24 hours) exposure to SO2, for which the ISA
found a causal relationship.
As discussed below, a substantial amount of new research has been
conducted since EPA's last review of the SO2 NAAQS, with
important new information coming from epidemiologic studies in
particular. The newly available research studies evaluated in the ISA
have undergone intensive scrutiny through multiple layers of peer
review and opportunities for public review and comment. Although
important uncertainties remain in the qualitative and quantitative
characterizations of health effects attributable to exposure to ambient
SO2, the review of this information has been extensive and
deliberate.
The remainder of this section discusses the Administrator's
rationale for the proposed decisions on the primary standard. Section
II.A presents a discussion of the principal emitting sources and
current patterns of SO2 air quality, as well as the current
SO2 monitoring network from which those air quality patterns
are obtained. Section II.B includes an overview of the scientific
evidence related to the respiratory effects associated with ambient
SO2 exposure. This overview includes a discussion of the at-
risk populations considered in the ISA. Section II.C discusses the
approaches taken by EPA to assess exposures and health risks associated
with exposure to ambient SO2, including a discussion of key
uncertainties associated with the analyses. Section II.D presents the
approach that is being used in the current review of the SO2
NAAQS with regard to consideration of the scientific evidence and the
air quality, exposure, and risk-based results related to the adequacy
of the current standards and potential alternative standards. Sections
II.E and II.F discuss the scientific evidence and the air quality,
exposure, and risk-based results specifically as they relate to the
current and potential alternative standards, including discussion of
the Administrator's proposed decisions on the standards. Section II.G
summarizes the Administrator's proposed decisions with regard to the
SO2 primary NAAQS.
A. Characterization of SO2 air quality
1. Anthropogenic sources and current patterns of SO2 Air
Quality
Anthropogenic SO2 emissions originate chiefly from point
sources, with fossil fuel combustion at electric utilities (~66%) and
other industrial facilities (~29%) accounting for the majority of total
emissions (ISA, section 2.1). Other anthropogenic sources of
SO2 include both the extraction of metal from ore as well as
the burning of high sulfur-containing fuels by locomotives, large
ships, and equipment utilizing diesel engines. SO2 emissions
and
[[Page 64815]]
ambient concentrations follow a strong east to west gradient due to the
large numbers of coal-fired electric generating units in the Ohio River
Valley and upper Southeast regions. In the 12 Consolidated Metropolitan
Statistical Areas (CMSAs) that had at least four SO2
regulatory monitors from 2003-2005, 24-hour average concentrations in
the continental U.S. ranged from a reported low of ~1 ppb in Riverside,
CA and San Francisco, CA to a high of ~12 ppb in Pittsburgh, PA and
Steubenville, OH (ISA, section 2.5.1). In addition, outside or inside
all CMSAs from 2003-2005, the annual average SO2
concentration was 4 ppb (ISA, Table 2-8). However, spikes in hourly
concentrations occurred; the mean 1-hour maximum concentration outside
or inside CMSAs was 13 ppb, with a maximum value of greater than 600
ppb outside CMSAs and greater than 700 ppb inside CMSAs (ISA, Table 2-
8).
Temporal and spatial patterns of 5-minute peaks of SO2
are also important given that human clinical studies have demonstrated
that exposure to these peaks can result in adverse respiratory effects
in exercising asthmatics (see section II.B). For those monitors which
voluntarily reported 5-minute block average data,\3\ when maximum 5-
minute concentrations were reported, the absolute highest concentration
over the ten-year period exceeded 4000 ppb, but for all individual
monitors, the 99th percentile was below 200 ppb (ISA, section 2.5.2
Table 2-10). Median concentrations from these monitors reporting 5-
minute data ranged from 1 ppb to 8 ppb, and the average for each
maximum 5-minute level ranged from 3 ppb to 17 ppb. Delaware,
Pennsylvania, Louisiana, and West Virginia had mean values for maximum
5-minute data exceeding 10 ppb. Among aggregated within-state data for
the 16 monitors from which all 5-minute average intervals were
reported, the median values ranged from 1 ppb to 5 ppb, and the means
ranged from 3 ppb to 11 ppb (ISA, section 2.5.2). The highest reported
concentration was 921 ppb, but the 99th percentile values for
aggregated within-state data were all below 90 ppb (ISA, section
2.5.2).
---------------------------------------------------------------------------
\3\ A small number of sites, 98 total from 1997 to 2007 of the
approximately 500 SO2 monitors, and not the same sites in
all years, voluntarily reported 5-minute block average data to AQS
(ISA, section 2.5.2). Of these, 16 reported all twelve 5-minute
averages in each hour for at least part of the time between 1997 and
2007. The remainder reported only the maximum 5-minute average in
each hour.
---------------------------------------------------------------------------
2. SO2 monitoring
Although the SO2 standard was established in 1971,
uniform minimum monitoring requirements for SO2 monitoring
did not appear until May 1979. From the time of the implementation of
the 1979 monitoring rule through 2008, the SO2 network has
steadily decreased in size from approximately 1496 sites in 1980 to the
approximately 488 sites operating in 2008. At present, except for
SO2 monitoring required at National Core Monitoring Stations
(NCore stations), there are no minimum monitoring requirements for
SO2 in 40 CFR part 58 Appendix D, other than a requirement
for EPA Regional Administrator approval before removing any existing
monitors and that any ongoing SO2 monitoring must have at
least one monitor sited to measure the maximum concentration of
SO2 in that area. EPA removed the specific minimum
monitoring requirements for SO2 in the 2006 monitoring rule
revisions, based on the fact that there were no SO2
nonattainment areas at that time, coupled with trends evidence showing
an increasing gap between national average SO2
concentrations and the current 24-hour and annual standards.
Additionally, the minimum requirements were removed to provide State,
local, and tribal air monitoring agencies flexibility in meeting higher
priority monitoring needs for pollutants such as ozone and
PM2.5, or implementing the new multi-pollutant sites (NCore
network) required by the 2006 rule revisions, by allowing them to
discontinue lower priority monitoring. More information on
SO2 monitoring can be found in section III.
B. Health effects information
During the last review, EPA retained the current 24-hour and annual
averaging times for the primary SO2 NAAQS. The 24-hour NAAQS
was largely based on epidemiologic studies that observed associations
between 24-hour average SO2 levels and adverse respiratory
effects and daily mortality (EPA 1982, 1994a, 1994b). The annual
standard was supported by a few epidemiologic studies that found an
association between adverse respiratory effects and annual average
SO2 concentrations (EPA 1982, 1994a, 1994b). However, it was
noted that in the locations where these epidemiologic studies were
conducted, high SO2 levels were usually accompanied by high
levels of PM, thus making it difficult to disentangle the individual
contribution each pollutant had on these health outcomes. Moreover, EPA
noted that rather than 24-hour or annual average SO2 levels,
the health effects observed in these studies may have been related, at
least in part, to the occurrence of shorter-term peaks of
SO2 within a 24-hour period (53 FR 14930; April 26, 1988).
In the current review, the ISA along with its associated annexes,
provided a comprehensive review and assessment of the scientific
evidence related to the health effects associated with SO2
exposures. For these health effects, the ISA characterized judgments
about causality with a hierarchy that contains five levels (ISA,
section 1-3): sufficient to infer a causal relationship, sufficient to
infer a likely causal relationship (i.e., more likely than not),
suggestive but not sufficient to infer a causal relationship,
inadequate to infer the presence or absence of a causal relationship,
and suggestive of no causal relationship. Judgments about causality
were informed by a series of aspects that are based on those set forth
by Sir Austin Bradford Hill in 1965 (ISA, Table 1-1). These aspects
include strength of the observed association, availability of
experimental evidence, consistency of the observed association,
biological plausibility, coherence of the evidence, temporal
relationship of the observed association, and the presence of an
exposure-response relationship.
Judgments made in the ISA about the extent to which relationships
between various health endpoints and exposure to SO2 are
likely causal have been informed by several factors. As discussed in
the ISA in section 1.3, these factors include the nature of the
evidence (i.e., controlled human exposure, epidemiologic, and/or
toxicological studies) and the weight of evidence. The weight of
evidence takes into account such considerations as biological
plausibility, coherence of the evidence, strength of associations, and
consistency of the evidence. Controlled human exposure studies provide
directly applicable information for determining causality because these
studies are not limited by differences in dosimetry and species
sensitivity, which would need to be addressed in extrapolating animal
toxicology data to human health effects, and because they provide data
relating health effects specifically to SO2 exposures, in
the absence of the co-occurring pollutants present in ambient air.
Epidemiologic studies provide evidence of associations between
SO2 concentrations and more serious health endpoints (e.g.,
hospital admissions and emergency department visits) that cannot be
assessed in controlled human exposure studies. For these studies the
degree of uncertainty introduced by confounding variables (e.g., other
pollutants) affects the level of confidence that the health effects
being investigated are attributable to
[[Page 64816]]
SO2 exposures alone and/or in combination with co-occurring
pollutants.
In using a weight of evidence approach to inform judgments about
the degree of confidence that various health effects are likely to be
caused by exposure to SO2, confidence increases with the
number of studies consistently reporting a particular health endpoint,
with increasing support for the biological plausibility of the health
effects, and with the strength and coherence of the evidence.
Conclusions regarding biological plausibility, consistency, and
coherence of evidence of SO2-related health effects are
drawn from the integration of epidemiologic studies with controlled
human exposure studies and with mechanistic information from animal
toxicological studies. As discussed below, the weight of evidence is
strongest for respiratory morbidity endpoints (e.g., lung function
decrements, respiratory symptoms, hospital admissions, and emergency
department visits) associated with short-term (5-minutes to 24-hours)
exposure to ambient SO2.
For epidemiologic studies, strength of association refers to the
magnitude of the association and its statistical strength, which
includes assessment of both effect estimate size and precision. In
general, when associations yield large relative risk estimates, it is
less likely that the association could be completely accounted for by a
potential confounder or some other bias. Consistency refers to the
persistent finding of an association between exposure and outcome in
multiple studies of adequate power in different persons, places,
circumstances and times.
Being mindful of the considerations discussed above, the ISA
concluded that there was sufficient evidence to infer a causal
relationship between respiratory morbidity and short-term (5-minutes to
24-hours) exposure to SO2 (ISA, section 5.2). The ISA based
this conclusion on the consistency, coherence, and plausibility of
findings observed in controlled human exposure studies of 5-10 minutes,
epidemiologic studies mostly using 1-hour daily maximum and 24-hour
average SO2 concentrations, and animal toxicological studies
using exposures of minutes to hours (ISA, section 5.2). The ISA judged
evidence of an association between SO2 exposure and other
health categories to be less convincing; other associations were judged
to be suggestive but not sufficient to infer a causal relationship
(i.e., short-term exposure to SO2 and mortality) or
inadequate to infer the presence or absence of a causal relationship
(i.e., short-term exposure to SO2 and cardiovascular
morbidity, and long-term exposure to SO2 and respiratory
morbidity, other morbidity, and mortality). Key conclusions from the
ISA are described in greater detail in Table 5-3 of the ISA.
As summarized above, the ISA found a ``causal'' association between
short-term (5 minutes to 24 hour) exposure to SO2 and
respiratory morbidity. The evidence leading to this conclusion will be
discussed throughout this section as well as in the context of the
adequacy of the current and proposed alternative standards (see section
II.E and II.F) The ISA also found ``suggestive but not sufficient''
evidence to infer a causal relationship between short-term
SO2 exposure and mortality. EPA considered this suggestive
evidence within the context of proposing a new 1-hour averaging time
(see section II.F.2). The association between short- and long-term
SO2 exposure and other health categories was found to be
inadequate to infer the presence or absence of a causal relationship
and thus, will not be discussed in detail in this notice.
Section II.B.1 discusses the results of controlled human exposure
studies demonstrating respiratory effects in exercising asthmatics
following 5-10 minute exposures to SO2, and conclusions in
the REA regarding the adversity of such effects. Section II.B.2
discusses the respiratory effects reported in U.S. epidemiologic
studies of respiratory symptoms, as well as emergency department visits
and hospital admissions for all respiratory causes and asthma. Section
II.B.3 discusses ISA conclusions regarding short-term (5 minutes to 24-
hours) exposure to SO2 and respiratory effects, and section
II.B.4 discusses long-term SO2 exposure and potentially
adverse health effects. Finally, section II.B.5 discusses
SO2-related impacts on public health.
1. Respiratory effects and 5-10 minute exposure to SO2
As noted above, the ISA concluded that there was sufficient
evidence to infer a causal relationship between respiratory morbidity
and short-term (5-minutes to 24-hours) exposure to SO2 (ISA,
section 5.2). This determination was primarily based on controlled
human exposure studies demonstrating a relationship between 5-10 minute
peak SO2 exposures and adverse effects on the respiratory
system in exercising asthmatics. The ISA described the controlled human
exposure results as being the ``definitive evidence'' for its causal
finding (ISA, section 5.2; p. 5-2).
Since the last review, several additional controlled human exposure
studies have been published that provide supportive evidence of
SO2-induced decrements in lung function and increases in
respiratory symptoms among exercising asthmatics (see ISA, Annex Table
D-2). However, based in part on recent guidance from the American
Thoracic Society (ATS) regarding what constitutes an adverse health
effect of air pollution (ATS, 2000), a much larger body of key older
studies described in the prior review were analyzed in the ISA along
with studies published since the last review. In their official
statement, the ATS concluded that an air pollution-induced shift in a
population distribution of a given health-related endpoint (e.g., lung
function) should be considered adverse, even if this shift does not
result in the immediate occurrence of illness in any one individual in
the population (ATS 2000). The ATS also recommended that transient loss
in lung function with accompanying respiratory symptoms attributable to
air pollution should be considered adverse. However, it was noted in
the ISA that symptom perception is highly variable among asthmatics
even during severe episodes of asthmatic bronchoconstriction, and that
an asymptomatic decrease in lung function may pose a significant health
risk to asthmatic individuals as it is less likely that these
individuals will seek treatment (ISA, section 3.1.3). Therefore,
whereas the conclusions in the prior review of the SO2 NAAQS
were based on SO2 exposure concentrations which resulted in
large decrements in lung function and moderate to severe respiratory
symptoms, the ISA's current review of data from controlled human
exposure studies focused on moderate to large SO2-induced
decrements in lung function and/or respiratory symptoms ranging from
mild (perceptible wheeze or chest tightness) to severe (breathing
distress requiring the use of a bronchodilator). See also section
II.B.1.c below discussing adversity of effects. Key controlled human
exposure studies of respiratory symptoms and lung function are
described briefly below and in more detail in section 3.1.3 of the ISA.
a. Respiratory symptoms
Numerous free-breathing controlled human exposure studies have
evaluated respiratory symptoms (e.g. cough, wheeze, or chest tightness)
in exercising asthmatic following 5-10 minute SO2 exposures.
Linn et al. (1983) reported that 5-minute exposures to SO2
levels as low as 400 ppb resulted in exercising asthmatics experiencing
statistically significant increases in respiratory symptoms (e.g.,
wheeze, chest tightness,
[[Page 64817]]
cough, substernal irritation). In a separate study, exercising
asthmatics exhibited respiratory symptoms following a 10-minute
exposure to 400-600 ppb SO2 (Linn et al., (1987); Smith
(1993)). Gong et al., (1995) exposed SO2-sensitive
asthmatics to 0, 500 and 1000 ppb SO2 for 10 minutes while
performing different levels of exercise (light, medium, or heavy) and
reported that respiratory symptoms increased with increasing
SO2 concentrations. The authors further reported that
exposure to 500 ppb SO2 during light exercise evoked a more
severe symptomatic response than heavy exercise in clean air.
In addition to these free breathing chamber results described
above, studies using mouthpiece exposure systems have reported
respiratory symptoms within minutes of SO2 exposure.\4\
Balmes et al. (1987) reported that 7 out of 8 exercising asthmatics
developed respiratory symptoms following a 500 ppb 3-minute exposure to
SO2 via mouthpiece (ISA section 3.1.3.1). In an additional
study, Trenga et al. (1999) reported increases in respiratory symptoms
in exercising asthmatics following 10-minute exposures to 500 ppb
SO2. Although not directly comparable to the free-breathing
chamber results described above, these mouthpiece exposure results
nonetheless support an association between SO2 exposure and
respiratory symptoms.
---------------------------------------------------------------------------
\4\ Studies utilizing a mouthpiece exposure system cannot be
directly compared to studies involving freely breathing subjects, as
nasal absorption of SO2 is bypassed during oral
breathing, thus allowing a greater fraction of inhaled
SO2 to reach the tracheobronchial airways. As a result,
individuals exposed to SO2 through a mouthpiece are
likely to experience greater respiratory effects from a given
SO2 exposure.
---------------------------------------------------------------------------
b. Lung function decrements
The ISA found that in free-breathing chamber studies, asthmatic
individuals exposed to SO2 concentrations as low as 200-300
ppb for 5-10 minutes during exercise have been shown to experience
moderate or greater bronchoconstriction, measured as a decrease in
Forced Expiratory Volume in the first second (FEV1) of >=
15%, or an increase in specific airway resistance (sRaw) of >= 100%
after correction for exercise-induced responses in clean air (Bethel et
al., 1985; Linn et al., 1983, 1987; 1988; 1990; Roger et al., 1985).\5\
In addition, the ISA concluded that among asthmatics, both the
percentage of individuals affected, and the severity of the response
increases with increasing SO2 concentrations. That is, at
concentrations ranging from 200-300 ppb, the lowest levels tested in
free breathing chamber studies,\6\ approximately 5-30% of exercising
asthmatics experience moderate or greater decrements in lung function
(ISA, Table 3-1). At concentrations of 400-600 ppb, moderate or greater
decrements in lung function occur in approximately 20-60% of exercising
asthmatics, and compared to exposures at 200-300 ppb, a larger
percentage of asthmatics experience severe decrements in lung function
(i.e., >= 200% increase in sRaw, and/or a >= 20% decrease in
FEV1) (ISA, Table 3-1). The ISA also noted that at
SO2 concentrations >= 400 ppb, moderate or greater
decrements in lung function are frequently accompanied by respiratory
symptoms (e.g., cough, wheeze, chest tightness, shortness of breath)
(ISA, Table 3-1). Further analysis and discussion of the individual
studies presented above can be found in Sections 3.1.1 to 3.1.3.5 of
the ISA.
---------------------------------------------------------------------------
\5\ FEV1 and sRaw are measures of
bronchoconstriction. Decreases in FEV1 or increases in
sRaw can result in difficulty breathing.
\6\ The ISA cites one chamber study with intermittent exercise
where healthy and asthmatic children were exposed to 100 ppb
SO2 in a mixture with ozone and sulfuric acid. The ISA
notes that compared to exposure to filtered air, exposure to the
pollutant mix did not result in statistically significant changes in
lung function or respiratory symptoms (ISA section 3.1.3.4)
---------------------------------------------------------------------------
In addition to the evidence from free-breathing chamber studies,
the ISA notes very limited evidence of decrements in lung function in
exercising asthmatics exposed to lower levels of SO2 via
mouthpiece. That is, the ISA cites two studies where some exercising
asthmatics had small changes in FEV1 or sRaw following
exposure to 100 ppb SO2 via mouthpiece (Koenig et al., 1990
and Sheppard et al., 1981).
c. Adversity of 5-10 minute respiratory effects
The ATS has previously defined adverse respiratory health effects
as ``medically significant physiologic changes generally evidenced by
one or more of the following: (1) Interference with the normal activity
of the affected person or persons, (2) episodic respiratory illness,
(3) incapacitating illness, (4) permanent respiratory injury, and/or
(5) progressive respiratory dysfunction'' (ATS 1985). The ATS has also
recommended that transient loss in lung function with accompanying
respiratory symptoms, or detectable effects of air pollution on
clinical measures (e.g., medication use) be considered adverse (ATS
1985). In addition, the REA noted that during the last O3
NAAQS review, the Criteria Document (CD) and Staff Paper indicated that
for many people with lung disease (e.g., asthma), even moderate
decrements in lung function (e.g., FEV1 decrements > 10% but
< 20% and/or >= 100% increases in sRaw) or respiratory symptoms would
likely interfere with normal activities and result in additional and
more frequent use of medication (EPA 2006, EPA 2007d). The REA also
noted that CASAC has previously indicated that in the context of
standard setting, a focus on the lower end of the range of moderate
functional responses is most appropriate for estimating potentially
adverse lung function decrements in people with lung disease (73
FR16463). Finally, the REA noted that in the current SO2
NAAQS review, clinicians on the CASAC Panel again advised that moderate
or greater decrements in lung function can be clinically significant in
some individuals with respiratory disease (hearing transcripts from
USEPA Clean Air Scientific Advisory Committee (CASAC), July 30-31,
2008, Sulfur Oxides-Health Criteria (part 3 of 4) pages 211-213).\7\
---------------------------------------------------------------------------
\7\ These transcripts can be found in Docket ID No. EPA-HQ-ORD-
2006-0260. Available at www.regulations.gov.
---------------------------------------------------------------------------
As previously mentioned, the ATS published updated guidelines on
what constitutes an adverse health effect of air pollution in 2000
(ATS, 2000). Among other considerations, the 2000 guidelines stated
that measurable negative effects of air pollution on quality of life
should be considered adverse (ATS 2000). These updated guidelines also
indicated that exposure to air pollution that increases the risk of an
adverse effect to the entire population is adverse, even though it may
not increase the risk of any individual to an unacceptable level (ATS
2000). For example, a population of asthmatics could have a
distribution of lung function such that no individual has a level
associated with significant impairment. Exposure to air pollution could
shift the distribution to lower levels that still do not bring any
individual to a level that is associated with clinically relevant
effects. However, this would be considered adverse because individuals
within the population would have diminished reserve function, and
therefore would be at increased risk if affected by another agent (ATS
2000).
At SO2 concentrations >= 400 ppb, controlled human
exposure studies have reported decrements in lung function that are
often statistically significant at the group mean level, and that are
frequently accompanied by respiratory symptoms. Being mindful that the
ATS
[[Page 64818]]
guidelines described above specifically indicate decrements in lung
function with accompanying respiratory symptoms as being adverse,
exposure to 5-10 minute SO2 concentrations >= 400 ppb are
clearly adverse.
The ISA has also reported that exposure to SO2
concentrations as low as 200-300 ppb for 5-10 minutes results in
approximately 5-30% of exercising asthmatics experiencing moderate or
greater decrements in lung function (defined in terms of a >= 15%
decline in FEV1 or 100% increase in sRaw; ISA, Table 3-1).
Considering the 2000 ATS guidelines mentioned above, the REA found that
these results could reasonably indicate an SO2-induced shift
in these lung function measurements for this population. As a result, a
significant percentage of exercising asthmatics exposed to
SO2 concentrations as low as 200 ppb would have diminished
reserve lung function and would be at greater risk if affected by
another respiratory agent (e.g., viral infection). Importantly,
diminished reserve lung function in a population that is attributable
to air pollution is an adverse effect under ATS guidance. In addition
to the 2000 ATS guidelines, the REA was also mindful of: (1) Previous
CASAC recommendations (Henderson 2006) and NAAQS review conclusions
(EPA 2006, EPA 2007d) indicating that moderate decrements in lung
function can be clinically significant in some asthmatics; and (2)
subjects participating in these controlled human exposure studies not
likely including the most severe asthmatics. Taken together, the REA
concluded that exposure to SO2 concentrations at least as
low as 200 ppb can result in adverse health effects in asthmatics.
Importantly, the final REA noted that this conclusion was in
agreement with CASAC comments following the first draft SO2
REA (REA section 4.3). The first draft SO2 REA focused its
analyses on exposures and risk associated with 5-minute SO2
concentrations >= 400 ppb. However, CASAC strongly advised the
Administrator that effects to exercising asthmatics at levels at least
as low as 200 ppb can be adverse, and thus, should be considered in the
second draft and final REAs (Henderson 2008).
2. Respiratory effects and 1- to 24-hour exposure to SO2
In addition to the controlled human exposure evidence described
above, the ISA based its causal finding of an association between
short-term (5-minutes to 24-hours) exposure to SO2 and
respiratory morbidity on results from epidemiologic studies of
respiratory symptoms, as well as ED visits and hospital admissions for
all respiratory causes and asthma. More specifically, the ISA describes
the results from these epidemiologic studies as providing ``supporting
evidence'' for its determination of causality (ISA section 5.2). Key
epidemiologic studies of respiratory symptoms, as well as ED visits and
hospital admissions are discussed below.
a. Respiratory symptoms
The ISA found that the strongest epidemiologic evidence of an
association between short-term SO2 concentrations and
respiratory symptoms was in children. Studies conducted in North
America and abroad generally reported positive associations between
ambient SO2 concentrations and respiratory symptoms in
children. U.S. studies of respiratory symptoms in children (identified
from Table 5-4 of the ISA), including three large multi-city studies,
are described briefly below and in more detail in section 3.1.4.1 of
the ISA.
The National Cooperative Inner-City Asthma Study (NCICAS, Mortimer
et al. 2002) included asthmatic children (n = 846) from eight U.S.
urban areas and examined the relationship between respiratory symptoms
and summertime air pollution levels. The strongest associations were
found between morning symptoms (e.g., morning cough) and the median 3-
hour average SO2 concentrations during morning hours (8 a.m.
to 11 a.m.)--following a 1- to 2-day lag (ISA, Figure 3-2). Three-hour
average concentrations in the morning hours ranged from 17 ppb in
Detroit to 37 ppb in East Harlem, NY. This relationship remained robust
and statistically significant in multi-pollutant models with ozone
(O3), and nitrogen dioxide (NO2). When
PM10 was also added to the model, the effect estimate
remained relatively unchanged, although was no longer statistically
significant (ISA, Figure 3-2). However, the ISA noted that the loss of
statistical significance could have been the result of reduced
statistical power since only three of the eight cities were included in
the multi-pollutant analysis with PM (ISA, section 3.1.4.1).
The Childhood Asthma Management Program (CAMP, Schildcrout et al.
2006) examined the association between ambient air pollution and asthma
exacerbations in children (n = 990) from eight North American cities.
The median 24-hour average SO2 concentrations (collected in
seven of the eight study locations) ranged from 2.2 ppb in San Diego to
7.4 ppb in St. Louis. Positive associations with an increased risk of
asthma symptoms were observed at all lags, but only the association at
the 3-day moving average was statistically significant (ISA, Figure 3-
3). In joint-pollutant models with carbon monoxide (CO) and
NO2, the 3-day moving average effect estimates remained
robust and statistically significant. In a joint-pollutant model with
PM10, the 3-day moving average effect estimate remained
relatively unchanged, but was no longer statistically significant (ISA
Figure 3-3).
A longitudinal study of schoolchildren (n = 1,844) during the
summer months from the Harvard Six Cities Study suggested that the
association between SO2 and respiratory symptoms may
potentially be confounded by PM10 (Schwartz et al., 1994).
It should be noted that unlike the NCICAS and CAMP studies, this study
was not limited to asthmatic children. The median 24-hour average
SO2 concentration during this period was 4.1 ppb.
SO2 concentrations were found to be statistically
significantly associated with cough incidence and lower respiratory
symptoms in single pollutant models. However, the effect of
SO2 was substantially reduced and no longer statistically
significant after adjustment for PM10 in a co-pollutant
model. The ISA noted that because PM10 concentrations were
correlated strongly to SO2-derived sulfate particles (r =
0.80), the reduced SO2 effect estimate may indicate that for
PM10 dominated by fine sulfate particles, PM10
has a slightly stronger association than SO2 to cough
incidence and lower respiratory symptoms (ISA, section 3.1.4.1.1).
In addition to the three U.S. multi-city studies mentioned above,
evidence of an association between ambient SO2 and
respiratory symptoms in children was found in two additional U.S.
respiratory symptom studies. Delfino et al., (2003) reported a
statistically significant positive association between 1-hour daily
maximum SO2 concentrations in Los Angeles and respiratory
symptoms in Hispanic children with asthma (n = 22). Similarly, Neas et
al., (1995) reported a positive association between 12-hour average
SO2 concentrations in Uniontown, PA and incidence of evening
cough in 4th and 5th graders (n = 83; ISA section 3.1.4.1). Neither of
these single city studies employed multi-pollutant models, but given
the consistency of results with other epidemiologic evidence, they
nonetheless support the association between ambient SO2
concentrations and respiratory symptoms in children.
[[Page 64819]]
b. Emergency department visits and hospitalizations
Respiratory causes for ED and hospitalization visits typically
include asthma, pneumonia, Chronic Obstructive Pulmonary Disorder
(COPD), upper and lower respiratory infections, as well as other minor
categories. Since the last review, there have been more than 50 peer
reviewed epidemiologic studies published worldwide and overall, the ISA
concluded that these studies provide evidence to support an association
between ambient SO2 concentrations and ED visits and
hospitalizations for all respiratory causes and asthma (ISA, section
3.1.4.6). Notably, the ISA also found that when analyses of ED visit
and hospitalizations for all respiratory causes were restricted by age,
the results among children (0-14 years) and older adults (65+ years)
were mainly positive, but not always statistically significant (ISA,
section 3.1.4.6). In these same studies, when all age groups were
combined, the ISA found that the results were mainly positive; however,
the excess risk estimates were generally smaller compared to children
and older adults (ISA, Figure 3-6). Results from key ED visit and
hospital admission studies conducted in the U.S. are described in
general below, and a more detailed discussion of both the U.S. and
international literature can be found in the ISA (ISA, section
3.1.4.6).
Of the respiratory ED visit and hospital admission studies reviewed
in the ISA, 10 key studies were conducted in the United States (ISA,
Table 5-5). Of these 10 studies, three evaluated associations with
SO2 using multi-pollutant models (Schwartz et al., (1995) in
Tacoma, WA and New Haven CT; New York Department of Health (NYDOH),
(2006) in Bronx and Manhattan, NY; and Ito et al., (2007) in New York
City), while seven studies evaluated the SO2 effect using
only single pollutant models (Wilson et al., (2005) in Manchester, NH
and Portland, ME; Peel et al., (2005) in Atlanta, GA; Tolbert et al.,
(2007) in Atlanta GA; Jaffe et al., (2003) in Cleveland, Cincinnati and
Columbus, OH; Schwartz et al., (1996) in Cleveland OH; Sheppard et al.,
(2003) in Seattle, WA; and Lin et al., (2004) in Bronx, NY). Taken
together, these studies generally reported positive, but frequently not
statistically significant associations between ambient SO2
and ED visits and hospital admissions for all respiratory causes and
for asthma. With regard to U.S. studies employing multi-pollutant
models, results reported in Bronx, NY (NYDOH 2006) and New York City,
NY (Ito et al., 2007) remained robust and statistically significant in
the presence of PM2.5, [10% (4, 16) and 29.6% (14.3, 46.8),
respectively] while in New Haven, CT (Schwartz et al., 1995) results
remained robust and statistically significant in the presence of
PM10 [2% (1, 3)]. However, in Manhattan, NY (NYDOH 2006)
results reported from single, and multi-pollutant models were negative
(although not statistically significantly negative), and in Tacoma, WA
(Schwartz et al., 1995) the SO2 effect estimate [3% (1,6)]
was reduced and no longer statistically significant in a multi-
pollutant model with PM10 [-1% (-4, 3)]. In models including
gaseous co-pollutants, the SO2 effect estimate in the Bronx,
NY (NYDOH 2006) remained statistically significant in the presence of
NO2 [10% (4,15)], while in NYC (Ito et al., 2007) the
SO2 effect estimate remained statistically significant in
the presence of O3 [26.8% (13.7, 41.5)] and CO [31.1% (16.7,
47.2)], but not in the presence of NO2 [-1.6% (-16.7,
16.1)].
3. ISA conclusions regarding short-term (5-minutes to 24-hours)
SO2 exposures
As noted above, the ISA found that moderate or greater decrements
in lung function occur in some exercising asthmatics exposed to
SO2 concentrations as low as 200-300 ppb for 5-10 minutes.
The ISA also found that among asthmatics, both the percentage of
individuals affected, and the severity of the response increased with
increasing SO2 concentrations. That is, at 5-10 minute
concentrations ranging from 200-300 ppb, the lowest levels tested in
free breathing chamber studies, approximately 5-30% percent of
exercising asthmatics experienced moderate or greater decrements in
lung function (ISA, Table 3-1). At concentrations of 400-600 ppb,
moderate or greater decrements in lung function occurred in
approximately 20-60% of exercising asthmatics, and compared to
exposures at 200-300 ppb, a larger percentage of asthmatics experienced
severe decrements in lung function (i.e., >=200% increase in sRaw, and/
or a >=20% decrease in FEV1) (ISA, Table 3-1). Moreover, at
SO2 concentrations >=400 ppb (5-10 minute exposures),
moderate or greater decrements in lung function were frequently
accompanied by respiratory symptoms.
In addition, the ISA concluded that epidemiologic studies of
respiratory symptoms in children, as well as emergency department
visits and hospitalizations for all respiratory causes and asthma were
consistent and coherent. This evidence was consistent in that
associations were reported in studies conducted in numerous locations
and with a variety of methodological approaches (ISA, section 5.2). It
was coherent in that respiratory symptom results from epidemiologic
studies of short-term (predominantly 1-hour daily maximum or 24-hour
average) SO2 concentrations were generally in agreement with
respiratory symptom results from controlled human exposure studies of
5-10 minutes. These results were also coherent in that the respiratory
effects observed in controlled human exposure studies of 5-10 minutes
provided a basis for a progression of respiratory morbidity that could
lead to the ED visits and hospitalizations observed in epidemiologic
studies (ISA, section 5.2). In addition, the ISA concluded that U.S.
and international epidemiologic studies employing multi-pollutant
models suggested that SO2 had a generally independent effect
on respiratory morbidity outcomes (ISA, section 5.2).
The ISA also found that the respiratory effects of SO2
were consistent with the mode of action as it is currently understood
from animal toxicological and human exposure studies (ISA, section
5.2). The immediate effect of SO2 on the respiratory system
is bronchoconstriction. This response is mediated by chemosensitive
receptors in the tracheobronchial tree. Activation of these receptors
triggers central nervous system reflexes that result in
bronchoconstriction and respiratory symptoms that are often followed by
rapid shallow breathing (ISA, section 5.2). The ISA noted that
asthmatics are likely more sensitive to the respiratory effects of
SO2 due to pre-existing inflammation associated with the
disease. For example, pre-existing inflammation may lead to enhanced
release of inflammatory mediators, and/or enhanced sensitization of the
chemosensitive receptors (ISA, section 5.2).
Taken together, the ISA concluded that the controlled human
exposure, epidemiologic, and toxicological evidence supported its
determination of a causal relationship between respiratory morbidity
and short-term (5-minutes to 24-hours) exposure to SO2.
4. Health effects and long-term exposures to SO2
There were numerous studies published since the last review
examining possible associations between long-term SO2
exposure and mortality and morbidity (respiratory morbidity,
carcinogenesis, adverse prenatal and neonatal outcomes)
[[Page 64820]]
endpoints. However, the ISA concluded that the evidence relating long-
term (weeks to years) SO2 exposure to adverse health effects
was ``inadequate to infer the presence or absence of a causal
relationship'' (ISA, Table 5-3). That is, the ISA found the long-term
health evidence to be of insufficient quantity, quality, consistency,
or statistical power to make a determination as to whether
SO2 was truly associated with these health outcomes (ISA,
Table 1-2).
5. SO2-related impacts on public health
Interindividual variation in human responses to air pollutants
indicates that some subpopulations are at increased risk for the
detrimental effects of ambient exposure to SO2. The NAAQS
are intended to provide an adequate margin of safety for both general
populations and sensitive subpopulations, or those subgroups
potentially at increased risk for health effects in response to ambient
air pollution. To facilitate the identification of subpopulations at
the greatest risk for SO2-related health effects, studies
have identified factors that contribute to the susceptibility and/or
vulnerability of an individual to SO2. Susceptible
individuals are broadly defined as those with a greater likelihood of
an adverse outcome given a specific exposure in comparison with the
general population (American Lung Association, 2001). The
susceptibility of an individual to SO2 can encompass a
multitude of factors which represent normal developmental phases (e.g.,
age) or biologic attributes (e.g., gender); however, other factors
(e.g., socioeconomic status (SES)) may influence the manifestation of
disease and also increase an individual's susceptibility (American Lung
Association, 2001). In addition, subpopulations may be vulnerable to
SO2 in response to an increase in their exposure during
certain windows of life (e.g., childhood or old age) or as a result of
external factors (e.g., SES) that contribute to an individual being
disproportionately exposed to higher concentrations than the general
population. It should be noted that in some cases specific factors may
affect both the susceptibility and vulnerability of a subpopulation to
SO2. For example, a subpopulation that is characterized as
having low SES may have less access to healthcare resulting in the
manifestation of a disease, which increases their susceptibility to
SO2, but they may also reside in a location that results in
exposure to higher concentrations of SO2, increasing their
vulnerability to SO2.
To examine whether SO2 differentially affects certain
subpopulations, stratified analyses are often conducted in
epidemiologic investigations to identify the presence or absence of
effect modification. A thorough evaluation of potential effect
modifiers may help identify subpopulations that are more susceptible
and/or vulnerable to SO2. These analyses require the proper
identification of confounders and their subsequent adjustment in
statistical models, which helps separate a spurious from a true causal
association. Although the design of toxicological and human clinical
studies does not allow for an extensive examination of effect
modifiers, the use of animal models of disease and the study of
individuals with underlying disease or genetic polymorphisms do allow
for comparisons between subgroups. Therefore, the results from these
studies, combined with those results obtained through stratified
analyses in epidemiologic studies, contribute to the overall weight of
evidence for the increased susceptibility and vulnerability of specific
subpopulations to SO2. Those groups identified in the ISA to
be potentially at greater risk of experiencing an adverse health effect
from SO2 exposure are described in more detail below.
a. Pre-existing respiratory disease
In human clinical studies, asthmatics have been shown to be more
responsive to the respiratory effects of SO2 exposure than
healthy non-asthmatics. Although SO2-attributable decrements
in lung function have generally not been demonstrated at concentrations
<= 1000 ppb in non-asthmatics, statistically significant increases in
respiratory symptoms and decreases in lung function have consistently
been observed in exercising asthmatics following 5-10 minute
SO2 exposures at concentrations ranging from 400-600 ppb
(ISA, section 4.2.1.1). Moderate or greater SO2-induced
decrements in lung function have also consistently been observed at
SO2 concentrations ranging from 200-300 ppb in some
asthmatics. The ISA also noted that a number of epidemiologic studies
have reported respiratory morbidity in asthmatics associated with
ambient SO2 concentrations (ISA 4.2.1.1). For example,
numerous epidemiologic studies have observed positive associations
between ambient SO2 concentrations and ED visits and
hospitalizations for asthma (ISA section 4.2.1.1). Overall, the ISA
concluded that epidemiologic and controlled human exposure studies
indicated that individuals with pre-existing respiratory diseases,
particularly asthma, are at greater risk than the general population of
experiencing SO2-associated health effects (ISA, section
4.2.1.1).
b. Genetics
The ISA noted that a consensus now exists among scientists that the
potential for genetic factors to increase the risk of experiencing
adverse health effects due to ambient air pollution merits serious
consideration. Several criteria must be satisfied in selecting and
establishing useful links between polymorphisms in candidate genes and
adverse respiratory effects. First, the product of the candidate gene
must be significantly involved in the pathogenesis of the effect of
interest, which is often a complex trait with many determinants.
Second, polymorphisms in the gene must produce a functional change in
either the protein product or in the level of expression of the
protein. Third, in epidemiologic studies, the issue of effect
modification by other genes or environmental exposures must be
carefully considered (ISA section 4.2.2).
Although many studies have examined the association between genetic
polymorphisms and susceptibility to air pollution in general, only one
study has specifically examined the effects of SO2 exposure
on genetically distinct subpopulations. Winterton et al. (2001) found a
significant association between SO2-induced decrements in
FEV1 and the homozygous wild-type allele in the promoter
region of Tumor Necrosis Factor-[alpha] (TNF- [alpha]; AA, position-
308). However, the ISA concluded that the overall body of evidence was
too limited to reach a conclusion regarding the effects of
SO2 exposure on genetically distinct subpopulations at this
time.
c. Age
The ISA identified children (i.e., < 18 years of age) and older
adults (i.e., > 65 years of age) as groups that are potentially at
greater risk of experiencing SO2-associated adverse health
effects. In children, the developing lung is prone to damage from
environmental toxicants as it continues to develop through adolescence.
The biological basis for increased risk in the elderly is unknown, but
one hypothesis is that it may be related to changes in antioxidant
defenses in the fluid lining the respiratory tract. The ISA found a
number of epidemiologic studies that observed increased respiratory
symptoms in children associated with increasing SO2
concentrations. In addition, several studies have reported
[[Page 64821]]
that the excess risk estimates for ED visits and hospitalizations for
all respiratory causes, and to a lesser extent asthma, associated with
a 10-ppb increase in 24-hour average SO2 concentrations were
higher for children and older adults than for all ages together (ISA,
section 4.2.3). However, the ISA also noted that the evidence from
controlled human exposure studies does not suggest that adolescents are
either more or less at risk than adults to the respiratory effects of
SO2, but rather adolescents may experience similar
respiratory effects at a given exposure concentration (ISA, sections
3.1.3.5 and 4.2.3).\8\ Overall, the ISA found that compared to the
general population, there was limited evidence to suggest that children
and older adults are at greater risk of experiencing SO2-
associated health effects (ISA, section 4.2.3).
---------------------------------------------------------------------------
\8\ Very young children are not included in controlled human
exposure studies and this absence of data on what is likely to be a
sensitive life stage is a source of uncertainty for children's
susceptibility.
---------------------------------------------------------------------------
d. Time spent outdoors
Outdoor SO2 concentrations are generally much higher
than indoor concentrations. Thus, the ISA noted that individuals who
spend a significant amount of time outdoors are likely at greater risk
of experiencing SO2-associated health effects than those who
spend most of their time indoors (ISA section 4.2.5).
e. Ventilation rate
Controlled human exposure studies have demonstrated that decrements
in lung function and respiratory symptoms occur at significantly lower
SO2 exposure levels in exercising subjects compared to
resting subjects. As ventilation rate increases, breathing shifts from
nasal to oronasal, thus resulting in greater uptake of SO2
in the tracheobronchial airways due to the diminished absorption of
SO2 in the nasal passages. Therefore, individuals who spend
a significant amount of time at elevated ventilation rates (e.g. while
playing, exercising, or working) are expected to be at greater risk of
experiencing SO2-associated health effects (ISA section
4.2.5).
f. Socioeconomic status
There is limited evidence that increased risk to SO2
exposure is associated with lower SES (ISA section 4.2.5). Finkelstein
et al. (2003) found that among people with below-median income, the
relative risk for above-median exposure to SO2 was 1.18 (95%
CI: 1.11, 1.26); the corresponding relative risk among subjects with
above-median income was 1.03 (95% CI: 0.83, 1.28). However, the ISA
concluded that there was insufficient evidence to reach a conclusion
regarding SES and exposure to SO2 at this time (ISA section
4.2.5).
g. Size of at-risk populations
Considering the size of the groups mentioned above, large
proportions of the U.S. population are likely to have a relatively high
risk of experiencing SO2-related health effects. In the
United States, approximately 7% of adults and 9% of children have been
diagnosed with asthma. Notably, the prevalence and severity of asthma
is higher among certain ethnic or racial groups such as Puerto Ricans,
American Indians, Alaskan Natives, and African Americans (EPA 2008b).
Furthermore, a higher prevalence of asthma among persons of lower SES
and an excess burden of asthma hospitalizations and mortality in
minority and inner-city communities have been observed. In addition,
population groups based on age comprise substantial segments of
individuals that may be potentially at risk for SO2-related
health impacts. Based on U.S. census data from 2000, about 72.3 million
(26%) of the U.S. population are under 18 years of age, 18.3 million
(7.4%) are under 5 years of age, and 35 million (12%) are 65 years of
age or older. There is also concern for the large segment of the
population that is potentially at risk to SO2-related health
effects because of increased time spent outdoors at elevated
ventilation rates (those who work or play outdoors). Overall, the
considerable size of the population groups at risk indicates that
exposure to ambient SO2 could have a significant impact on
public health in the United States.
C. Human exposure and health risk characterization
To put judgments about SO2-associated health effects
into a broader public health context, EPA has drawn upon the results of
the quantitative exposure and risk assessments. Judgments reflecting
the nature of the evidence and the overall weight of the evidence are
taken into consideration in these quantitative exposure and risk
assessments, discussed below. These assessments provide estimates of
the likelihood that asthmatics at moderate or greater exertion (e.g.
while exercising) would experience SO2 exposures of
potential concern as well as an estimate of the number and percent of
exposed asthmatic individuals likely to experience SO2-
induced lung function responses (i.e., moderate or greater decrements
in lung function defined in terms of sRaw or FEV1) under
varying air quality scenarios (e.g., just meeting the current or
alternative standards). These assessments also characterize the kind
and degree of uncertainties inherent in such estimates.
This section describes the approach taken in the REA to
characterize SO2-related exposures and health risks. Goals
of the REA included estimating short-term exposures and potential human
health risks associated with (1) recent levels of ambient
SO2; (2) SO2 levels adjusted to simulate just
meeting the current standards; and (3) SO2 levels adjusted
to simulate just meeting potential alternative 1-hour standards. This
section discusses the scientific evidence from the ISA that was used as
the basis for the risk characterization (II.C.1), the approaches used
in characterizing exposures and risks (II.C.2), and important
uncertainties associated with these analyses (II.C.3). The results of
the exposure and risk analyses, as they relate to the current and
potential alternative standards, are discussed in subsequent sections
of this proposal (sections II.E and II.F, respectively).
1. Evidence base for the risk characterization
As previously mentioned, the ISA concluded that the evidence for an
association between respiratory morbidity and SO2 exposure
was ``sufficient to infer a causal relationship'' (ISA, section 5.2)
and that the ``definitive evidence'' for this conclusion was from the
results of 5-10 minute controlled human exposure studies demonstrating
decrements in lung function and/or respiratory symptoms in exercising
asthmatics (ISA, section 5.2). Accordingly, the REA concluded that
quantitative exposure and risk analyses should focus on 5-minute levels
of SO2 in excess of potential health effect benchmark values
derived from the controlled human exposure literature (REA, section
6.2). These benchmark levels are not potential standards, but rather
are concentrations which represent ``exposures of potential concern''
which are used in the analyses to estimate potential exposures and
risks associated with 5-minute concentrations of SO2. In
addition, although the REA concluded that the epidemiologic evidence
was not appropriate for use in quantitative risk analyses (REA, section
6.3), these studies were considered in the selection of potential
alternative standards for use in the air quality, exposure and risk
analyses (REA, chapter 5), as well as in
[[Page 64822]]
the REA's assessment of the adequacy of the current and potential
alternative primary standards (REA, sections 10.3; 10.4; and 10.5).
As mentioned above, the health effect benchmark values used in the
REA were derived primarily from the ISA's evaluation of the 5-10 minute
controlled human exposure literature. The ISA concluded that moderate
or greater decrements in lung function occurred in approximately 5-30%
of exercising asthmatics following exposure to 200-300 ppb
SO2 for 5-10 minutes. As explained in section II.B.1.b, the
ISA concluded that moderate or greater decrements in lung function
occurred in approximately 20-60% of exercising asthmatics following
exposure to 400-600 ppb SO2 for 5-10 minutes. The ISA also
concluded that at SO2 concentrations >= 400 ppb,
statistically significant moderate or greater decrements in lung
function at the group mean level have often been reported and are
frequently accompanied by respiratory symptoms (ISA, section 3.1.3.5).
In addition to the health evidence from the ISA presented above,
when considering potential health effect benchmark levels, the REA
noted: (1) Subjects participating in human exposure studies typically
do not include individuals who may be most susceptible to the
respiratory effects of SO2, (e.g., the most severe
asthmatics given the obvious ethical issues of subjecting such persons
to the clinical tests) and (2) given that approximately 5-30% of
exercising asthmatics experienced moderate or greater decrements in
lung function following exposure to 200-300 ppb SO2 (the
lowest levels tested in free-breathing chamber studies), it is likely
that a percentage of exercising asthmatics would also experience
similar decrements in lung function following exposure to levels lower
than 200 ppb (REA, section 6.2). That is, the REA concluded that there
was no evidence to suggest that 200 ppb represented a threshold level
below which no adverse respiratory effects would occur (REA, section
6.2). Moreover, the REA considered that small SO2-induced
lung function decrements have been observed in exercising asthmatics at
concentrations as low as 100 ppb when SO2 is administered
via mouthpiece (ISA, section 3.1.3).
Taken together, the REA concluded it appropriate to examine
potential 5-minute benchmark values in the range of 100-400 ppb (REA,
section 6.2). The lower end of the range considered the factors
mentioned above, while the upper end of the range recognized that 400
ppb represents the lowest concentration at which moderate or greater
decrements in lung function are frequently accompanied by respiratory
symptoms (REA, section 6.2): a combination of effects which would
clearly be considered adverse under ATS guidelines (ATS, 1985).
Although the analysis of exposures of potential concern were
conducted using discrete benchmark levels (i.e., 100, 200, 300, 400
ppb), EPA recognizes that there is no sharp breakpoint within the
continuum ranging from at and above 400 ppb down to 100 ppb. In
considering the concept of exposures of potential concern, it is
important to balance concerns about the potential for health effects
and their severity with the increasing uncertainty associated with our
understanding of the likelihood of such effects at lower SO2
levels. Within the context of this continuum, estimates of exposures of
potential concern at discrete benchmark levels provide some perspective
on the potential public health impacts of SO2-related health
effects that have been demonstrated in controlled human exposure
studies. They also help in understanding the extent to which such
impacts could change by just meeting the current and potential
alternative standards. However, estimates of the number of asthmatics
likely to experience exposures of potential concern cannot be
translated directly into quantitative estimates of the number of people
likely to experience specific health effects. Due to individual
variability in responsiveness, only a subset of asthmatics exposed at
and above a specific benchmark level can be expected to experience
health effects. The amount of weight to place on the estimates of
exposures of potential concern at any of these benchmark levels depends
in part on the weight of the scientific evidence concerning health
effects associated with SO2 exposures at and above that
benchmark level. Such public health policy judgments are embodied in
the NAAQS standard setting criteria (i.e., standards that, in the
judgment of the Administrator, are requisite to protect public health
with an adequate margin of safety).
Since exposures of potential concern cannot be directly translated
into quantitative estimates of the number of individuals likely to
experience specific health effects, the REA not only characterizes
exposure and risks utilizing exposures of potential concern, but also
uses information from the controlled human exposure literature to
conduct a quantitative risk assessment. The quantitative risk
assessment estimated the number and percentage of exposed asthmatics at
moderate or greater exertion expected to experience a moderate or
greater lung function response (in terms of a >= 100% increase in sRaw
and/or a >= 15% decline in FEV1; see section II.C.2).
2. Overview of approaches
As noted above, the purpose of the assessments described in the REA
was to characterize air quality, exposures, and health risks associated
with recent ambient levels of SO2, with SO2
levels that could be associated with just meeting the current
SO2 NAAQS, and with SO2 levels that could be
associated with just meeting potential alternative standards. The REA
utilizes three approaches to characterize health risks In the first
approach, for each air quality scenario, statistically estimated \9\
and measured ambient 5-minute SO2 concentrations were
compared to the 5-minute potential health effect benchmark levels
discussed above which (as noted) were derived from the controlled human
exposure literature (REA, chapter 7). In the second approach, modeled
estimates of 5-minute exposures in asthmatics at moderate or greater
exertion (e.g. while exercising) were compared to these 5-minute
potential health effect benchmark levels. In the third approach,
exposure-response relationships from individual level data from
controlled human exposure studies were used in conjunction with the
outputs of the exposure analysis to estimate health impacts under the
air quality scenarios mentioned above. A brief description of these
approaches is provided below and each approach is described in detail
in chapters 7 through 9 of the REA.
---------------------------------------------------------------------------
\9\ Benchmark values derived from the controlled human exposure
literature were associated with a 5-minute averaging time. However,
only 98 ambient monitors located in 13 states from 1997-2007
reported measured 5-minute SO2 concentrations since such
monitoring is not required (see section III). In contrast, 809
monitors in 48 states, DC, Puerto Rico, and the Virgin Islands
reported 1-hour SO2 concentrations over a similar time
period. Therefore, to broaden analyses to areas where measured 5-
minute SO2 concentrations were not available, the REA
utilized a statistical relationship to estimate the highest 5-minute
level in an hour, given a reported 1-hour average SO2
concentration (REA, section 6.4). Then, similar to measured 5-minute
SO2 levels, statistically estimated 5-minute
SO2 concentrations were compared to 5-minute potential
health effect benchmark values.
---------------------------------------------------------------------------
In the first approach, statistically estimated and actual measured
5-minute ambient SO2 concentrations were compared to 5-
minute potential health effect benchmark levels (REA, chapter 7). The
results generated from the air quality analysis were considered a broad
characterization of national air
[[Page 64823]]
quality and human exposures that might be associated with these 5-
minute SO2 concentrations. An advantage of the air quality
analysis is its relative simplicity; however, there is uncertainty
associated with the assumption that SO2 air quality can
serve as an adequate surrogate for total exposure to ambient
SO2. Actual exposures might be influenced by factors not
considered by this approach, including small scale spatial variability
in ambient SO2 concentrations (which might not be captured
by the network of fixed-site ambient monitors) and spatial/temporal
variability in human activity patterns.
In the second approach, an inhalation exposure model was used to
generate more realistic estimates of personal exposures in asthmatics
(REA, chapter 8). This analysis estimated temporally and spatially
variable ambient 5-minute SO2 concentrations and simulated
asthmatics contact with these pollutant concentrations while at
moderate or greater exertion (i.e., while at elevated ventilation
rates). The approach was designed to estimate exposures that are not
necessarily represented by the existing ambient monitoring data.
AERMOD, an EPA dispersion model, was used to estimate 1-hour ambient
SO2 concentrations using emissions estimates from
stationary, non-point, and port sources. The Air Pollutants Exposure
(APEX) model, an EPA human exposure model, was then used to estimate
population exposures using the estimated hourly census block level
SO2 concentrations. From these 1-hour census block
concentrations, 5-minute maximum SO2 concentrations within
each hour were estimated using the statistical relationship mentioned
above. A probabilistic approach was then used to model asthmatics'
exposures considering: (1) Time spent in different microenvironments;
(2) time spent at moderate or greater exertion; and (3) the variable
SO2 concentrations that occur within these microenvironments
across time, space, and microenvironment type. Estimates of personal
exposure to 5-minute SO2 levels were then compared to the 5-
minute potential health benchmark levels (i.e., 5-minute benchmark
levels of 100, 200, 300, and 400 ppb). This approach to assessing
exposures was more resource intensive than using ambient levels as an
indicator of exposure; therefore, the final REA included the analysis
of two locations: St Louis and Greene County, MO. Although the
geographic scope of this analysis was limited, the approach provided
estimates of SO2 exposures in asthmatics and asthmatic
children in St. Louis and Greene Counties and thus, served to
complement the broader air quality characterization.
For the characterization of risks in both the air quality analysis
and the exposure modeling analysis described above, the REA used a
range of 5-minute potential health effect benchmarks: 100, 200, 300,
and 400 ppb. These benchmark values were compared to both
SO2 air quality levels and to estimates of SO2
exposure in asthmatics. When SO2 air quality was used as an
indicator of exposure, a key output of the analysis was an estimate of
the number of days per year specific locations experienced
statistically estimated 5-minute daily maximum levels of SO2
that exceeded one of these 5-minute potential health effect benchmarks.
When personal exposures were simulated, the output of the analysis was
an estimate of the number and percent of asthmatics and asthmatic
children at risk for experiencing, at least once per year, a
statistically estimated 5-minute daily maximum level of SO2
of ambient origin in excess of one of these benchmarks. An advantage of
using the benchmark approach to characterize health risks is that the
effects observed in the controlled human exposure studies clearly
result from SO2 exposure, so the benchmarks are reliable
levels at which effects to asthmatics from exposure to SO2
can occur. A limitation of this approach is that the magnitude of the
SO2 effect on decrements in lung function and respiratory
symptoms can vary considerably from individual to individual and thus,
not all asthmatics would be expected to respond to the same levels of
SO2 exposure. Therefore, numbers of exposures can be
quantified more readily than the number of individuals experiencing
SO2-induced lung function decrements and/or respiratory
symptoms.
The third approach was a quantitative risk assessment. This
approach combined results from the exposure analysis (i.e., the number
of exposed total asthmatics or asthmatic children while at moderate or
greater exertion) with exposure-response functions derived from
individual level data from controlled human exposure studies (see ISA,
Table 3-1 and Johns (2009) \10\) to estimate the percentage and number
of exposed asthmatics and asthmatic children likely to experience a
moderate or greater lung function response (i.e., decrements in lung
function defined in terms of FEV1 and sRaw) under the air
quality scenarios mentioned above (REA, chapter 9). The advantage of
this approach is that it recognizes that not all exposed asthmatics at
moderate or greater exertion will have a lung function response.
Moreover, it is advantageous in that rather than considering discrete
potential health effect benchmark levels, it quantitatively estimates
the number and percent of asthmatics and asthmatic children likely to
experience a moderate or greater lung function response considering the
entire distribution of personal exposures.
---------------------------------------------------------------------------
\10\ EPA recently conducted a complete quality assurance review
of all individual subject data. The results of this review did not
substantively change any of the entries in ISA, Table 3-1, and did
not in anyway affect the conclusions of the ISA (see Johns and
Simmons, 2009).
---------------------------------------------------------------------------
3. Key limitations and uncertainties
The way in which air quality, exposure, and risk results will
inform ultimate decisions regarding the current and potential
alternative SO2 standards will depend upon the weight placed
on each of the analyses when uncertainties associated with those
analyses are taken into consideration. Sources of uncertainty
associated with each of the analyses (air quality, exposure, and
quantitative risk) are briefly presented below and are described in
more detail in chapters 7-9 of the REA.
In the air quality analysis, the REA used ambient SO2
data from both the limited number of monitors reporting 5-minute
concentrations and the broader network of monitors reporting 1-hour
concentrations of SO2 to characterize U.S. air quality.
There was general agreement in the monitor site attributes and
emissions sources potentially influencing ambient monitoring
concentrations for each set of data analyzed. However, the REA noted
that the greatest relative uncertainty was in the spatial
representativeness of both the overall monitoring network and the
subsets of monitors chosen for detailed analyses (REA, section
7.4.2.4).
An additional source of uncertainty in the air quality analysis is
associated with the statistical model used to estimate 5-minute maximum
SO2 concentrations at monitors that reported only 1-hour
SO2 concentrations (REA, section 7.4.2.6). Cross-validation
of statistically estimated 5-minute concentrations with the limited
number of reported 5-minute SO2 measurements indicated that
the greatest difference in the predicted versus observed numbers of
benchmark exceedances occurred at the lower and upper tails of the
distribution. However, the REA noted that overall, the results of the
cross-validation analysis indicated reasonable model performance (REA,
sections 10.3.3.1 and 10.5.2).
The air quality characterization assumes that the ambient
monitoring
[[Page 64824]]
data and the estimated days per year with exceedances of the specified
benchmark levels can serve as an indicator of exposure. Longer-term
personal SO2 exposure (i.e., days to weeks) concentrations
are correlated with and are a fraction of ambient SO2
concentrations. However, uncertainty remains in this relationship when
considering short-term (i.e., 5-minute) averaging times because of the
lack of comparable measurement data (REA, section 7.4.2.7).
The St. Louis and Greene county exposure assessments were also
associated with a number of key uncertainties that should be considered
when interpreting the results with regard to decisions on the standard.
Such uncertainties are highlighted below, and these, as well as other
sources of uncertainty, are also discussed in greater depth in section
8.11 of the REA.
In the exposure analyses, it was necessary to derive an area source
emission profile rather than use a default profile to improve the
agreement between ambient measurements and model predicted 1-hour
SO2 concentrations. The improved model performance reduces
uncertainty in the 1-hour SO2 concentrations predictions,
but nonetheless remains as an important uncertainty in the absence of
actual local source emission profiles (REA, section 8.11.2).
The St. Louis and Greene county exposure assessments were performed
to better reflect both the temporal and spatial representation of
ambient concentrations and to estimate the rate of contact of asthmatic
individuals with 5-minute SO2 concentrations while engaged
in moderate or greater exertion. Estimated annual average
SO2 exposures in the two exposure modeling domains are
consistent with long-term personal exposures (i.e., days to weeks)
measured in other U.S. locations (REA, chapter 8). However, uncertainty
remains in the estimated number of persons with 5-minute SO2
concentrations above benchmark levels because of the lack of comparable
measurement data, particularly considering both the short-term
averaging time and geographic location (REA, section 8.11.2).
In addition, although all 5-minute ambient SO2
concentrations in the exposure analyses were estimated by the exposure
model, each hour was comprised of the maximum 5-minute SO2
concentration and eleven other 5-minute SO2 concentrations
normalized to the 1-hour mean concentration. The REA assumed that this
approach would reasonably estimate the number of individuals exposed to
peak concentrations. Sensitivity analyses revealed that both the number
of persons exposed and where peak exposures occur can vary when
considering an actual 5-minute temporal profile (REA, Section 8.11.2)
A number of key uncertainties should also be considered when
interpreting the results of the St. Louis and Greene County risk
assessment with regard to decisions on the standard. Such uncertainties
associated with the St Louis and Greene County risk assessment are
discussed briefly below and in greater depth in section 9.4 of the REA.
In the quantitative risk assessment, it was necessary to estimate
responses at SO2 levels below the lowest exposure levels
used in the free-breathing controlled human exposure studies (i.e.,
below 200 ppb). Probabilistic exposure-response relationships were
derived in the REA using two different functional forms (i.e., probit
and 2-parameter logistic), but nonetheless there remains greater
uncertainty in responses below 200 ppb because of the lack of
comparable experimental data. Moreover, because the controlled human
exposure studies used in the risk assessment involved only
SO2 exposures, it was assumed in the REA that estimates of
SO2-induced health responses are not affected by the
presence of other pollutants (e.g., PM2.5, O3,
NO2; REA, section 9.4).
The risk assessment assumes that the SO2-induced
responses for individuals are reproducible. The REA noted that this
assumption had some support in that one study (Linn et al., 1987)
exposed the same subjects on two occasions to 600 ppb and the authors
reported a high degree of correlation while observing a much lower
correlation for the lung function response observed in the clean air
with exercise exposure (REA, section 9.4).
Because the vast majority of controlled human exposure studies
investigating lung function responses were conducted with adult
subjects, the risk assessment relies on data from adult asthmatic
subjects to estimate exposure-response relationships that have been
applied to all asthmatic individuals, including children. The ISA
(section 3.1.3.5) indicates that there is a strong body of evidence
that suggests adolescents may experience many of the same respiratory
effects at similar SO2 levels, but recognizes that these
studies administered SO2 via inhalation through a mouthpiece
(which can result in an increase in lung SO2 uptake) rather
than in an exposure chamber. Therefore, the uncertainty is greater in
the risk estimates for asthmatic children (REA, section 9.4) \11\.
---------------------------------------------------------------------------
\11\ Very young children were not included in the controlled
human exposure data which served as the basis for the exposure-
response relationships used in the risk assessment. This absence of
data on what is likely to be a sensitive life stage is an additional
source of uncertainty in the risk assessment.
---------------------------------------------------------------------------
D. Considerations in review of the standards
This section presents the integrative synthesis of the evidence and
information contained in the ISA and the REA with regard to the current
and potential alternative standards. EPA notes that the final decision
on retaining or revising the current primary SO2 standards
is a public health policy judgment to be made by the Administrator. The
Administrator's final decision will draw upon scientific information
and analyses related to health effects, population exposures, and
risks; as well as judgments about the appropriate response to the range
of uncertainties that are inherent in the scientific evidence and
analyses; and comments received in response to this proposal.
1. Background on the current standards
There are currently two SO2 primary standards. The 24-
hour average standard is 0.14 ppm not to be exceeded more than once per
year and the annual average standard is 0.03 ppm. In the last review of
the SO2 NAAQS, both the 24-hour and annual standards were
retained. The rationale for the retention of these standards is
discussed briefly below.
In the last review, retention of the 24-hour standard was based
largely on epidemiologic studies conducted in London in the 1950s and
1960s. The results of those studies suggested an association between
24-hour average levels of SO2 and increased daily mortality
and aggravation of bronchitis when in the presence of elevated levels
of PM (53 FR 14927). Additional epidemiologic evidence suggested that
elevated SO2 levels were associated with the possibility of
small, reversible declines in children's lung function (53 FR 14927).
However, it was noted that in the locations where these epidemiologic
studies were conducted, high SO2 levels were usually
accompanied by high levels of PM, thus making it difficult to
disentangle the individual contribution each pollutant had on these
health outcomes. It was also noted that rather than 24-hour average
SO2 levels, the health effects observed in these studies may
have been related, at least in part, to the
[[Page 64825]]
occurrence of shorter-term peaks of SO2 within a 24-hour
period (53 FR 14927).
Retention of the annual standard in the last review was largely
based on an assessment of qualitative evidence gathered from a limited
number of epidemiologic studies. The strongest evidence for an
association between annual SO2 concentrations and adverse
health effects in the 1982 AQCD was from a study conducted by Lunn et
al (1967). The authors found that among children, a likely association
existed between chronic upper and lower respiratory tract illnesses and
annual SO2 levels of 70-100 ppb in the presence of 230-301
[micro]g/m\3\ black smoke. Three additional studies described in the
1986 Second Addendum also suggested that long-term exposure to
SO2 was associated with adverse respiratory effects.
Notably, studies conducted by Chapman et al. (1985) and Dodge et al.
(1985) found associations between long-term SO2
concentrations (with or without high particle concentrations) and cough
in children and young adults. However, it was noted that there was
considerable uncertainty associated with these studies because they
were conducted in locations subject to high, short-term peak
SO2 concentrations (i.e., locations near point sources);
therefore it was difficult to discern whether this increase in cough
was the result of long-term, low level SO2 exposure, or
repeated short-term peak SO2 exposures.
It was concluded in the last review that there was no quantitative
rationale to support a specific range for an annual standard (EPA,
1994b). However, it was also found that although no single
epidemiologic study provided clear quantitative conclusions, there
appeared to be some consistency across studies indicating the
possibility of respiratory effects associated with long-term exposure
to SO2 just above the level of the existing annual standard
(EPA, 1994b). In addition, air quality analyses conducted during the
last review indicated that the short-term standards being considered
(1-hour and/or 24-hour) could not by themselves prevent long-term
concentrations of SO2 from exceeding the level of the
existing annual standard in several large urban areas. Ultimately, both
the scientific evidence and the air quality analyses were used by the
Administrator to conclude that retaining the existing annual standard
was requisite to protect human health.\12\
---------------------------------------------------------------------------
\12\ Section I.C above discusses potential standards considered
but not adopted in the last review, notably some type of standard to
deal with effects of 5 to 10 minute exposures.
---------------------------------------------------------------------------
2. Approach for reviewing the need to retain or revise the current
standards
The decision in the present review on whether the current 24-hour
and/or annual standards are requisite to protect public health with an
adequate margin of safety will be informed by a number of scientific
studies and analyses that were not available in the 1996 review.
Specifically, as discussed above (section II.B), a large number of
epidemiologic studies have been published since the 1996 review. Many
of these studies evaluated associations between SO2 and
adverse respiratory endpoints (e.g., respiratory symptoms, emergency
department visits, hospital admissions) in locations where 24-hour and
annual average SO2 concentrations were below the levels
allowed by the current standards. In addition, with respect to adverse
health effects associated with 5-minute SO2 concentrations,
the REA described estimates of SO2-associated health risks
that could be present in counties that just meet the current 24-hour or
annual standards, whichever was controlling in a given county.\13\ The
approach for considering this scientific evidence and exposure/risk
information is discussed below.
---------------------------------------------------------------------------
\13\ As noted in the REA, the controlling standard by definition
would be the standard that allows air quality to just meet either
the annual concentration level of 30.4 ppb (i.e., the annual
standard is the controlling standard) or the 2nd highest 24-hour
concentration level of 144 ppb (i.e., the 24-hour standard is the
controlling standard). The factor selected is derived from a single
monitor within each county (even if there is more than one monitor
in the county) for a given year. A different (or the same) monitor
in each county could be used to derive the factor for other years;
the only requirement for selection is that it be the lowest factor,
whether derived from the annual or 24-hour standard level.
---------------------------------------------------------------------------
To evaluate whether the current primary SO2 standards
are adequate or whether consideration of revisions is appropriate, EPA
is using an approach in this review described in chapter 10 of the REA
which builds upon the approaches used in reviews of other criteria
pollutants, including the most recent reviews of the NO2,
Pb, O3, and PM NAAQS (EPA, 2008c; EPA, 2007c; EPA, 2007d;
EPA, 2005), and reflects the body of evidence and information that is
currently available. As in other recent reviews, EPA's considerations
will include the implications of placing more or less weight or
emphasis on different aspects of the scientific evidence and the
exposure/risk-based information, recognizing that the weight to be
given to various elements of the evidence and exposure/risk information
is part of the public health policy judgments that the Administrator
will make in reaching decisions on the standard.
A series of general questions frames this approach to considering
the scientific evidence and exposure-/risk-based information. First,
EPA's consideration of the scientific evidence and exposure/risk
information with regard to the adequacy of the current standards is
framed by the following questions:
To what extent does evidence that has become available
since the last review reinforce or call into question evidence for
SO2-associated effects that were identified in the last
review?
To what extent has evidence for different health effects
and/or sensitive populations become available since the last review?
To what extent have uncertainties identified in the last
review been reduced and/or have new uncertainties emerged?
To what extent does evidence and exposure-/risk-based
information that has become available since the last review reinforce
or call into question any of the basic elements of the current
standard?
To the extent that the available evidence and exposure-/risk-based
information suggests it may be appropriate to consider revision of the
current standards, EPA considers that evidence and information with
regard to its support for consideration of a standard that is either
more or less stringent than the current standards. This evaluation is
framed by the following questions:
Is there evidence that associations, especially causal or
likely causal associations, extend to ambient SO2
concentrations as low as, or lower than, the concentrations that have
previously been associated with health effects? If so, what are the
important uncertainties associated with that evidence?
Are exposures above benchmark levels and/or health risks
estimated to occur in areas that meet the current standard? If so, are
the estimated exposures and health risks important from a public health
perspective? What are the important uncertainties associated with the
estimated risks?
To the extent that there is support for consideration of a revised
standard, EPA then considers the specific elements of the standard
(indicator, averaging time, form, and level) within the context of the
currently available information. In so doing, the Agency addresses the
following questions regarding the elements of the standard:
Does the evidence provide support for considering a
different indicator for gaseous SOX?
[[Page 64826]]
Does the evidence provide support for considering
different, or additional averaging times?
What ranges of levels and forms of alternative standards
are supported by the evidence, and what are the associated
uncertainties and limitations?
To what extent do specific averaging times, levels, and
forms of alternative standards reduce the estimated exposures above
benchmark levels and risks attributable to exposure to ambient
SO2, and what are the uncertainties associated with the
estimated exposure and risk reductions?
The questions outlined above have been addressed in the REA. The
following sections present considerations regarding the adequacy of the
current standards and potential alternative standards, as discussed in
chapter 10 of the REA, in terms of indicator, averaging time, form, and
level.
E. Adequacy of the current standards
In considering the adequacy of the current standards, the policy
assessment chapter of the REA considered the scientific evidence
assessed in the ISA, as well as the air quality, exposure, and risk-
based information presented in the REA. A summary of this evidence and
information as well as CASAC recommendations and the Administrator's
conclusions regarding the adequacy of the current standards are
presented below. Section II.E.1 will discuss the adequacy of the
current 24-hour standard and Section II.E.2 will then discuss adequacy
of the current annual standard. Section II.E.3 will discuss CASAC views
and finally, section II.E.4 discusses the Administrator's conclusions
regarding the adequacy of the current 24-hour and annual standards.
1. Adequacy of the current 24-hour standard
a. Evidence-based considerations
In considering the SO2 epidemiologic studies as they
relate to the adequacy of the current 24-hour standard, the REA noted
that 24-hour average SO2 concentrations were below the
current 24-hour average SO2 NAAQS in many locations where
positive and sometimes statistically significant associations were
observed (REA, section 10.3). As discussed previously (see section
II.B.3), the ISA characterized the epidemiologic evidence for
respiratory effects as being consistent and coherent (ISA, section
5.2). The evidence is consistent in that positive associations are
reported in studies conducted in numerous locations and with a variety
of methodological approaches (ISA, section 5.2). It is coherent in the
sense that respiratory symptom results from epidemiologic studies
predominantly using 1-hour daily maximum or 24-hour average
SO2 concentrations are generally in agreement with the
respiratory symptom results from controlled human exposure studies of
5-10 minutes. These results are also coherent in that the respiratory
effects observed in controlled human exposure studies of 5-10 minutes
provide a basis for a progression of respiratory morbidity that could
lead to the ED visits and hospitalizations observed in epidemiologic
studies (ISA, section 5.2). The ISA also noted that when the
epidemiologic literature is considered as a whole, there are generally
positive associations between SO2 and respiratory symptoms
in children, hospital admissions, and emergency department visits.
Moreover, some of these associations were statistically significant,
particularly the more precise effect estimates (ISA, section 5.2).
The interpretation of these SO2 epidemiologic studies is
complicated by the fact that SO2 is but one component of a
complex mixture of pollutants present in the ambient air. In order to
provide some perspective on this uncertainty, the ISA evaluates
epidemiologic studies that employ multi-pollutant models. Specifically,
the ISA noted that a number of SO2 epidemiologic studies
have attempted to disentangle the effects of SO2 from those
of co-occurring pollutants by utilizing multi-pollutant models. When
evaluated as a whole, SO2 effect estimates in these models
generally remained positive and relatively unchanged when co-pollutants
were included. Therefore, although recognizing the uncertainties
associated with separating the effects of SO2 from those of
co-occurring pollutants, the ISA concluded that the limited available
evidence indicates that the effect of SO2 on respiratory
health outcomes appears to be generally robust and independent of the
effects of gaseous co-pollutants, including NO2 and
O3, as well as particulate co-pollutants, particularly
PM2.5 (ISA, section 5.2; p. 5-9).
In drawing broad conclusions regarding the evidence, the ISA
considered the epidemiologic and experimental evidence as well as the
uncertainties associated with that evidence. When this evidence and its
associated uncertainties were taken together, the ISA concluded that
the results of epidemiologic and experimental studies form a plausible
and coherent data set that supports a relationship between
SO2 exposures and respiratory endpoints, including
respiratory symptoms and ED visits, at ambient concentrations that are
present in areas that meet the current 24-hour SO2 NAAQS
(ISA, section 5.5). Thus, taking into consideration the evidence
discussed above, particularly the epidemiologic studies reporting
SO2-associated health effects in locations that meet the
current 24-hour standard, the REA concluded that the epidemiologic
evidence calls into question the adequacy of the current 24-hour
standard to protect public health (REA, section 10.3.4).
b. Air quality, exposure, and risk-based considerations
As previously mentioned, the ISA found the evidence for an
association between respiratory morbidity and SO2 exposure
to be ``sufficient to infer a causal relationship'' (ISA, section 5.2)
and that the ``definitive evidence'' for this conclusion comes from the
results of controlled human exposure studies demonstrating decrements
in lung function and/or respiratory symptoms in exercising asthmatics
(ISA, section 5.2). Accordingly, the exposure and risk analyses
presented in the REA focused on exposures and risks associated with 5-
minute peaks of SO2 in excess of the potential health effect
benchmark values of 100, 200, 300, and 400 ppb SO2. In
considering the results presented in these analyses, the REA
particularly noted exceedances or exposures with respect to the 200 and
400 ppb 5-minute benchmark levels. These benchmark levels were
highlighted in the REA because (1) 400 ppb represents the lowest
concentration in controlled human exposure studies where moderate or
greater lung function decrements which were often statistically
significant at the group mean level, were frequently accompanied by
respiratory symptoms; and (2) 200 ppb is the lowest level at which
moderate or greater decrements in lung function in free-breathing human
exposure studies have been observed (notably, 200 ppb is also the
lowest level that has been tested). The REA also recognized that there
was very limited evidence demonstrating small decrements in lung
function at 100 ppb from two mouthpiece exposure studies. However, as
previously noted (see section II.B.1.b), the results of these studies
are not directly comparable to free-breathing chamber studies, and
thus, the REA primarily considered exceedences of the 200 ppb and 400
ppb benchmark levels in its evaluation of the adequacy of the current
24-hour (as well
[[Page 64827]]
as the annual; see section II.E.2) standard.
A key output of the air quality analysis was the predicted number
of statistically estimated 5-minute daily maximum SO2
concentrations above benchmark levels given air quality simulated to
just meet the level of the current 24-hour or annual SO2
standard, whichever was controlling for a given county. Under this
scenario, in 40 counties selected for detailed analysis, the REA found
that the predicted yearly mean number of statistically estimated 5-
minute daily maximum concentrations > 400 ppb ranges from 1-102 days
per year,\14\ with most counties in this analysis experiencing a mean
of at least 20 days per year when statistically estimated 5-minute
daily SO2 concentrations exceed 400 ppb (REA, Table 7-14).
In addition, the predicted yearly mean number of statistically
estimated 5-minute daily maximum concentrations > 200 ppb ranged from
21-171 days per year, with about half of the counties in this analysis
experiencing >= 70 days per year when 5-minute daily maximum
SO2 concentrations exceed 200 ppb (REA, Table 7-12).
---------------------------------------------------------------------------
\14\ Air quality estimates presented in this section represent
the mean number of days per year when 5-minute daily maximum
SO2 concentrations exceed a particular benchmark level
given 2001-2006 air quality adjusted to just meet the current
standards (see REA, Tables 7-11 to 7-14).
---------------------------------------------------------------------------
The REA also generated exposure and risk estimates for two study
areas in Missouri (i.e., Greene County and several counties
representing the St. Louis urban area) which had significant emission
sources of SO2. As noted in REA section 8.10, there were
differences in the number of exposures above benchmark values when the
results of the Greene County and St. Louis exposure assessments were
compared. In addition, given that the results of the exposure
assessment were used as inputs into the quantitative risk assessment,
it was not surprising that there were also differences in the number of
asthmatics at elevated ventilation rates estimated to have a moderate
or greater lung function response in Greene County when compared to St.
Louis. The REA noted that the differences in the St. Louis and Greene
County exposure and quantitative risk results are likely indicative of
the different types of locations they represent (see section 8.10).
Greene County is a rural county with much lower population and emission
densities, compared to the St. Louis study area which has population
and emissions density similar to other urban areas in the U.S. It
therefore follows that there would be greater exposures, and hence
greater numbers and percentages of asthmatics at elevated ventilation
rates experiencing moderate or greater lung function responses in the
St. Louis study area. Thus, when considering the risk and exposure
results as they relate to the adequacy of the current standards, the
REA concluded that the St. Louis results were more informative in terms
of ascertaining the extent to which the current standards protect
against effects linked to the various benchmarks (linked in turn to 5-
minute exposures). The results in fact suggested that the current
standards may not adequately protect public health (REA, section
10.3.3). Moreover, the REA judged that the exposure and risk estimates
for the St. Louis study area provided useful insights into exposures
and risks for other urban areas in the U.S. with similar population and
SO2 emissions densities (REA, section 10.3.3).
When considering the St. Louis exposure results as they relate to
the adequacy of the current standards, results discussed in the policy
chapter of the REA included the percent of asthmatic children at
moderate or greater exertion estimated to experience at least one
exceedance of either the 200 or 400 ppb benchmark given air quality
that was adjusted upward to simulate just meeting the current 24-hour
standard (i.e., the controlling standard in St. Louis).\15\ Given this
scenario, the REA found that approximately 24% of asthmatic children in
that city would be estimated to experience at least one SO2
exposure concentration greater than or equal to the 400 ppb benchmark
level per year while at moderate or greater exertion (e.g., while
exercising; REA, Figure 8-19). Similarly, the REA found that
approximately 73% of asthmatic children would be expected to experience
at least one SO2 exposure greater than or equal to a 200 ppb
benchmark level while at moderate or greater exertion (REA, Figure 8-
19).
---------------------------------------------------------------------------
\15\ Exposure and risk results presented in this notice are with
respect to asthmatic children, results for all asthmatics are
presented in REA chapters, 8, 9, and 10.
---------------------------------------------------------------------------
When considering the St. Louis risk results as they relate to the
adequacy of the current 24-hour standard, the policy assessment chapter
of the REA included the percent of asthmatic children at elevated
ventilation rates likely to experience at least one lung function
response given air quality that is adjusted upward to simulate just
meeting the current standards. Under this scenario, 19.1% to 19.2% of
exposed asthmatic children at elevated ventilation rates were estimated
to experience at least one moderate lung function response per year
(defined as an increase in sRaw >= 100% (REA, Table 9-
8)).\16\ \17\ Furthermore, 7.9% to 8.1% of exposed asthmatic
children at moderate or greater exertion were estimated to experience
at least one large lung function response per year (defined as an
increase in sRaw >= 200% (REA, Table 9-8)).
---------------------------------------------------------------------------
\16\ The risk results presented represent the median estimate of
exposed asthmatics expected to experience moderate or greater lung
function decrements. Results are presented for both the probit and
2-parameter logistic functional forms. The full range of estimates
can be found in chapter 9 of the REA, and in all instances the
smaller estimate is a result of using the probit function to
estimate the exposure-response relationship.
\17\ In this notice, risk results with respect to moderate or
greater lung function responses are presented in terms of sRaw
(i.e., >= 100% increases in sRaw). Risk results with respect to
decrements in lung function defined in terms of FEV1 can
be found in chapter 9 of the REA.
---------------------------------------------------------------------------
c. Summary of considerations from the REA regarding the 24-hour
standard
As noted above, the policy chapter of the REA considered several
lines of scientific evidence when evaluating the adequacy of the
current 24-hour standard to protect the public health. These included
causality judgments made in the ISA, as well as the human exposure and
epidemiologic evidence supporting those judgments. In particular, the
REA concluded that numerous epidemiologic studies reporting positive
associations between ambient SO2 and respiratory morbidity
endpoints were conducted in locations that met, or were below the
current 24-hour standard (REA, section 10.3.4). The REA concluded that
to the extent that these considerations are emphasized, the adequacy of
the current 24-hour standard to protect the public health would clearly
be called into question (REA, section 10.3.4). The REA found this
suggested consideration of a revised 24-hour standard and/or that an
additional shorter-averaging time standard may be needed to provide
additional health protection for sensitive groups, including asthmatics
and individuals who spend time outdoors at elevated ventilation rates
(REA, section 10.3.4). This also suggested that an alternative
SO2 standard(s) should protect against health effects
ranging from lung function responses and increased respiratory symptoms
following 5-10 minute peak SO2 exposures, to increased
respiratory symptoms and respiratory-related ED visits and hospital
admissions associated with 1-hour daily maximum or 24-hour average
[[Page 64828]]
SO2 concentrations (REA, section 10.3.4).
In examining the air quality, exposure, and risk-based information
with regard to the adequacy of the current 24-hour SO2
standard to protect the public health, the REA found that the results
described above (and in more detail in chapters 7-9 of the REA)
indicated that 5-minute exposures that could reasonably be judged
important from a public health perspective (see section II.B.1.c) were
associated with air quality adjusted upward to simulate just meeting
the current 24-hour standard. These exposures were judged in the REA to
be significant from a public health perspective due to their frequency:
approximately 24% of child asthmatics at moderate or greater exertion
in St. Louis are estimated to be exposed at least once per year to air
quality exceeding the 5-minute 400 ppb benchmark, a level associated
with lung function decrements in the presence of respiratory symptoms.
Additionally, approximately 73% of child asthmatics in St. Louis would
be expected to be exposed at least once per year to air quality
exceeding the 5-minute 200 ppb benchmark. Moreover, slightly over 19%
of exposed child asthmatics in St. Louis would be expected to
experience at least one adverse lung function response (defined in
terms of a >= 100% increase in sRaw) each year. Therefore, the REA
concluded that the air quality, exposure, and risk-based considerations
reinforced the epidemiologic evidence in supporting the conclusion that
consideration should be given to revising the current 24-hour standard
and/or setting a new shorter averaging time standard (e.g., 1-hour or
less) to provide increased public health protection, especially for
sensitive groups (e.g., asthmatics), from SO2-related
adverse health effects (REA, section 10.3.4).
2. Adequacy of the current annual standard
In considering the adequacy of the current annual standard, the
policy assessment chapter of the REA considered the scientific evidence
assessed in the ISA and the air quality, exposure, and risk-based
information presented in the REA. A summary of this evidence and
information is presented below.
a. Evidence-based considerations
As an initial consideration with regard to the adequacy of the
current annual standard, the REA noted that evidence relating long-term
(weeks to years) SO2 exposure to adverse health effects
(respiratory morbidity, carcinogenesis, adverse prenatal and neonatal
outcomes, and mortality) was judged by the ISA to be ``inadequate to
infer the presence or absence of a causal relationship'' (ISA, Table 5-
3). That is, the ISA found the health evidence to be of insufficient
quantity, quality, consistency, or statistical power to make a
determination as to whether SO2 is truly associated with
these health endpoints (ISA, Table 1-2). With respect specifically to
respiratory morbidity in children (in part, the basis for the current
annual standard; see section II.D.1), the ISA presented recent
epidemiologic evidence of an association with long-term exposure to
SO2 (ISA, section 3.4.2). However, the ISA found the
strength of these epidemiologic studies to be limited because of (1)
variability in results across studies with respect to specific
respiratory morbidity endpoints; (2) high correlations between long-
term average SO2 and co-pollutant concentrations,
particularly PM; and (3) a lack of evaluation of potential confounding
(ISA, section 3.4.2.1).
The REA also noted that many epidemiologic studies demonstrating
positive associations between 1-hour daily maximum or 24-hour average
SO2 concentrations and respiratory symptoms, ED visits, and
hospitalizations were conducted in areas where ambient SO2
concentrations were well below the level of the current annual NAAQS
(REA, section 10.4.2). The REA noted that this evidence suggested that
the current annual standard was not providing adequate protection
against health effects associated with shorter-term SO2
concentrations found in epidemiologic studies (REA, section 10.4.2).
b. Air quality, exposure, and risk-based considerations
Results of the risk characterization based on the air quality
assessment provided additional insight into whether there is a need to
revise the current annual standard, focusing again on the extent to
which the annual standard may be providing protection against effects
associated with short-term exposures. In general, analyses presented in
the REA described the extent to which the current annual standard
provided protection against 5-minute peaks of SO2 in excess
of potential health effect benchmark levels (REA, chapter 7). The REA
found that many of the monitors where frequent 5-minute exceedances
were reported had annual average SO2 concentrations well
below the level of the current annual standard. Moreover, the REA found
that there was little to no correlation between the annual average
SO2 concentration and the number of 5-minute daily maximum
concentrations above potential health effect benchmark levels at these
monitors (REA section 7.3.1). Thus, the REA concluded that the annual
standard adds little in the way of protection against 5-minute peaks of
SO2 (REA, section 10.4.4).
c. Summary of considerations from the REA regarding the annual standard
As noted above, the ISA concluded that the evidence relating long-
term (weeks to years) SO2 exposure to adverse health effects
(respiratory morbidity, carcinogenesis, adverse prenatal and neonatal
outcomes, and mortality) was ``inadequate to infer the presence or
absence of a causal relationship'' (ISA, Table 5-3). The ISA also
reported that many epidemiologic studies demonstrating positive
associations between short-term (e.g., 1-hour daily maximum, 24-hour
average) SO2 concentrations and respiratory symptoms, as
well as ED visits and hospitalizations, were conducted in areas where
annual ambient SO2 concentrations were well below the level
of the current annual NAAQS. In addition, analyses conducted in the REA
suggested that the current annual standard is not providing protection
against 5-10 minute peaks of SO2. Thus, the scientific
evidence and the risk and exposure information suggest that the current
annual SO2 standard: (1) Is likely not needed to protect
against health risks associated with long term exposure to
SO2; and 2) does not provide adequate protection from the
health effects associated with shorter-term (i.e. <= 24-hours)
SO2 exposures. Thus, the policy chapter of the REA
accordingly concluded that consideration should be given to either
revoking the annual standard or retaining it without revision, in
conjunction with setting an appropriate short-term standard(s) (REA,
section 10.4.4).
3. CASAC views regarding the adequacy of the current 24-hour and annual
standards
With regard to the adequacy of the current standards, CASAC
conclusions were consistent with the views expressed in the policy
assessment chapter of the REA.\18\ CASAC agreed
[[Page 64829]]
that the primary concern in this review is to protect against health
effects that have been associated with short-term SO2
exposures, particularly those of 5-10 minutes (Samet 2009). CASAC also
agreed that the current 24-hour and annual standards are not sufficient
to protect public health against the types of exposures that could lead
to these health effects. Given these considerations, and as noted in
their letter to the EPA Administrator, CASAC agreed ``that the current
24-hour and annual standards are not adequate to protect public health,
especially in relation to short term exposures to SO2 (5-10
minutes) by exercising asthmatics'' (Samet, 2009, p. 15). CASAC also
noted: ``assuming that EPA adopts a one hour standard in the range
suggested, and if there is evidence showing that the short-term
standard provides equivalent protection of public health in the long-
term as the annual standard, the panel is supportive of the REA
discussion of discontinuing the annual standard'' (Samet 2009, p. 15).
With regard to the current 24-hour standard, CASAC was generally
supportive of using the air quality analyses in the REA as a means of
determining whether the current 24-hour standard was needed in addition
to a new 1-hour standard to protect public health. CASAC stated: ``the
evidence presented [in REA Table 10-3] was convincing that some of the
alternative one-hour standards could also adequately protect against
exceedences of the current 24-hour standard'' (Samet 2009, p. 15)
Discussion regarding CASAC's views on how the standard should be
revised is provided below within the context of discussions on the
elements (i.e., indicator, averaging time, form, level) of a new short-
term standard.
---------------------------------------------------------------------------
\18\ CASAC views with respect to the current 24-hour and annual
standards, as well as with respect to potential alternative
standards are those following their review of the second draft
SO2 REA, which contained a staff policy assessment
chapter. EPA did not solicit, nor did it receive CASAC comments on
the final policy assessment chapter contained in the final REA.
---------------------------------------------------------------------------
4. The Administrator's conclusions regarding adequacy of the current
24-hour and annual standards
Based on the epidemiologic evidence, the risk and exposure data set
out in this section, as well as CASAC's advice and recommendations, the
Administrator concludes (subject to consideration of public comment)
that the current standards are not adequate to protect public health
with an adequate margin of safety. The basis for this conclusion is as
follows. First, the Administrator accepts and agrees with the ISA's
conclusion that the results of controlled human exposure and
epidemiologic studies form a plausible and coherent data set that
supports a causal relationship between short-term (5-minutes to 24-
hours) SO2 exposures and adverse respiratory effects. The
Administrator further agrees that the epidemiologic evidence
(buttressed by the clinical evidence) indicates that the effects seen
in the epidemiologic studies are attributable to exposure to
SO2. She also accepts and agrees with the conclusion of the
ISA that ``[i]n the epidemiologic studies, respiratory effects were
observed in areas where the maximum ambient 24-h avg SO2
concentration was below the current 24-h avg NAAQS level * * *'' (ISA,
section 5.2, p. 5-2.) and so would occur at ambient SO2
concentrations that are present in locations meeting the current 24-
hour NAAQS. The Administrator also notes that these effects occurred in
areas with annual air quality levels considerably lower than those
allowed by the current annual standard, indicating that the annual
standard also is not providing protection against such effects.
Existence of epidemiologic studies showing adverse effects occurring at
levels allowed by the current standards is an accepted justification
for finding that it is appropriate to revise the existing standards.
See, e.g. American Trucking Ass'n v. EPA, 283 F. 3d 355, 370 (DC Cir.
2002).
With regard to the exposure and risk results, the Administrator
notes and agrees with the analyses in the REA supporting that 5-minute
exposures, reasonably judged important from a public health
perspective, were associated with air quality adjusted upward to
simulate just meeting the current standards. The Administrator
especially notes the results of the St. Louis exposure analysis which,
as summarized above, indicates that substantial percentages of
asthmatic children at moderate or greater exertion would be exposed, at
least once annually, to air quality exceeding the 400 and 200 ppb
benchmarks. Moreover, in addition to the health evidence and risk-based
information, the Administrator agrees with CASAC's conclusion that the
current SO2 standards do not adequately protect the public's
health.
In considering approaches to revising the current standards, the
Administrator is proposing that it is appropriate to consider setting a
new short-term standard. The Administrator initially notes that a 1-
hour standard could provide increased public health protection,
especially for members of at-risk groups, from health effects described
in both controlled human exposure and epidemiologic studies, and hence,
health effects associated with 5-minute to 24-hour exposures to
SO2. As discussed in section II.F.5 below, depending on the
degree of protection afforded by such a standard, it may be appropriate
to replace, and not retain, the current 24-hour and annual standards in
conjunction with setting a new short-term standard.
F. Conclusions on the elements of a proposed new short-term standard
In considering alternative SO2 primary NAAQS, the
Administrator notes the need to protect at-risk populations from: (1)
1-hour daily maximum and 24-hour average exposures to SO2
that could cause the types of respiratory morbidity effects reported in
epidemiologic studies; and (2) 5-10 minute SO2 exposure
concentrations reported in controlled human exposure studies to result
in moderate or greater lung function responses and/or respiratory
symptoms. Considerations with regard to potential alternative standards
and the specific options being proposed are discussed in the following
sections in terms of indicator, averaging time, form, and level
(sections II.F.1 to II.F.4).
1. Indicator
In the last review, EPA focused on SO2 as the most
appropriate indicator for ambient SOX. In making a decision
in the current review on the most appropriate indicator, the
Administrator has considered the conclusions of the ISA and REA as well
as the views expressed by CASAC. The REA noted that, although the
presence of gaseous SOX species other than SO2
has been recognized, no alternative to SO2 has been advanced
as being a more appropriate surrogate for ambient gaseous
SOX. Controlled human exposure studies and animal toxicology
studies provide specific evidence for health effects following exposure
to SO2. Epidemiologic studies also typically report levels
of SO2, as opposed to other gaseous SOX. Because
emissions that lead to the formation of SO2 generally also
lead to the formation of other SOX oxidation products,
measures leading to reductions in population exposures to
SO2 can generally be expected to lead to reductions in
population exposures to other gaseous SOX. Therefore,
meeting an SO2 standard that protects the public health can
also be expected to provide protection against potential health effects
that may be independently associated with other gaseous SOX
even though such effects are not discernable from currently available
studies indexed by SO2 alone. See American Petroleum
Institute v. EPA, 665 F, 2d 1176, 1186 (DC Cir. 1981) (reasonable for
EPA to use ozone as the indicator for all photochemical oxidants even
though
[[Page 64830]]
health information on the other photochemical oxidants is unknown;
regulating ozone alone is reasonable since it presents a ``predictable
danger'' and in doing so EPA did not abandon its responsibility to
regulate other photochemical oxidants encompassed by the determination
that photochemical oxidants as a class may be reasonably anticipated to
endanger public health or welfare). Given these key points, the REA
concluded that the available evidence supports the retention of
SO2 as the indicator in the current review (REA, section
10.5.1). Consistent with this conclusion, CASAC stated in a letter to
the EPA Administrator that ``for indicator, SO2 is clearly
the preferred choice'' (Samet 2009, p. 14). The Administrator agrees
with this consensus, and therefore proposes to retain SO2 as
the indicator for oxides of sulfur in the current review.
2. Averaging time
In considering whether it is appropriate to revise the averaging
times of the current standards, the first consideration is what health
effects the standard is addressing, and specifically whether those
effects are associated with short-term (i.e., 5-minutes to 24-hours),
and/or long-term (i.e. weeks to years) exposure to SO2.
There are distinct differences in the causality judgments in the ISA as
to short-term versus long-term health effects of SO2. The
ISA found evidence relating long-term (weeks to years) SO2
exposures to adverse health effects to be ``inadequate to infer the
presence or absence of a causal relationship'' (ISA, Table 5-3). In
contrast, the ISA judged evidence relating short-term (5-minutes to 24-
hours) SO2 exposure to respiratory morbidity to be
``sufficient to infer a causal relationship'' (the strongest possible
conclusion as to causality) and short-term exposure to SO2
and mortality to be ``suggestive of a causal relationship'' (ISA, Table
5-3). Taken together, the REA concluded that these judgments most
directly supported standard averaging time(s) that focus protection on
SO2 exposures from 5-minutes to 24-hours (REA, section,
10.5.2).
a. Evidence and air quality, exposure, and risk-based considerations
In considering the level of support available for specific short-
term averaging times, the REA noted the strength of evidence from human
exposure and epidemiologic studies evaluated in the ISA. As previously
mentioned, controlled human exposure studies exposed exercising
asthmatics to 5-10 minute peak concentrations of SO2 and
consistently found decrements in lung function and/or respiratory
symptoms. Importantly, the ISA described the controlled human exposure
studies as being the ``definitive evidence'' for its conclusion that
there exists a causal association between short-term (5-minutes to 24-
hours) SO2 exposure and respiratory morbidity (ISA, section
5.2). In addition to the controlled human exposure evidence, there is a
relatively small body of epidemiologic studies describing positive
associations between 1-hour daily maximum SO2 levels and
respiratory symptoms as well as hospital admissions and ED visits for
all respiratory causes and asthma (ISA Tables 5.4 and 5.5). In addition
to the evidence from these 1-hour daily maximum epidemiologic studies,
there is a considerably larger body of epidemiologic studies reporting
positive associations between 24-hour average SO2 levels and
respiratory symptoms, as well as hospitalizations and ED visits for all
respiratory causes and asthma. Moreover, with respect to these
epidemiologic studies, there is support that adverse respiratory
effects are more likely to occur at the upper end of the distribution
of ambient SO2 concentrations (see section II.F.3 on Form).
In addition, when describing epidemiologic studies observing positive
associations between ambient SO2 and respiratory symptoms,
the ISA stated ``that it is possible that these associations are
determined in large part by peak exposures within a 24-hour period''
(ISA, section 5.2 at p. 5-5). Similarly, the ISA stated that: ``the
effects of SO2 on respiratory symptoms, lung function, and
airway inflammation observed in the human clinical studies using peak
exposures further provides a basis for a progression of respiratory
morbidity resulting in increased ED visits and hospital admissions''
and makes the associations observed in the epidemiologic studies
``biologica[lly] plausib[le]'' (ISA, section 5.2 at p. 5-5).
The controlled human exposure evidence described above provided
support for an averaging time that protects against 5-10 minute peak
SO2 exposures (REA, section 10.5.2). In addition, the REA
found that results from epidemiologic studies provided support for both
1-hour and 24-hour averaging times (REA, section 10.5.2). In addition,
both the epidemiologic and controlled human exposure evidence suggests
that a new short-term standard should be focused on limiting peak
SO2 exposures. Thus, it can reasonably be concluded from the
ISA and REA that it would be appropriate to consider the degree of
protection potential alternative standards with averaging times under
consideration provide against peak 5-minute to 24-hour SO2
exposures. Moreover, as fully discussed in section II.F.3, this same
information makes it reasonable that the form of a new short-term
standard reflect a strategy to limit peak SO2 exposures.
Thus, with respect to the analyses presented below regarding averaging
time, a 99th percentile form will be considered. See American Petroleum
Institute, 665 F. 2d at 1186 (selection of highest average ozone level
in one hour to determine compliance with ozone NAAQS is reasonable
``because it is calculated to measure the maximum exposure, which has
been found to be a relevant factor in determining the likely
consequences of ozone exposure'').
In considering the level of support available for specific short-
term averaging times, the policy assessment chapter of the REA also
took into account air quality considerations. More specifically, since
the shortest averaging time for the current primary SO2
standard is 24-hours, the REA evaluated the potential for a standard
based on 24-hour average SO2 concentrations to limit 5-
minute peak SO2 exposures (REA, section 10.5.2). The REA
evaluated ratios between 99th percentile 5-minute daily maximum and
99th percentile 24-hour average SO2 concentrations for 42
monitors reporting measured 5-minute data for any year between 2004-
2006 (REA, Table 10-1). Across this set of monitors, ratios of 99th
percentile 5-minute daily maximum to 99th percentile 24-hour average
SO2 concentrations spanned a range of 2.0 to 14.1 (REA,
Table 10-1). These results suggested a standard based on 24-hour
average SO2 concentrations would not likely be an effective
or efficient approach for addressing 5-minute peak SO2
concentrations. That is, the REA concluded using a 24-hour average
standard to address 5-minute peaks would likely result in over-
controlling in some areas, while under-controlling in others (REA,
section 10.5.2). This analysis also suggested that a 5-minute standard
would not likely be an effective or efficient means for controlling 24-
hour average SO2 concentrations (REA, section 10.5.2).
The REA also reported ratios between 99th percentile 5-minute daily
maximum and 99th percentile 1-hour daily maximum SO2 levels
from this set of monitors. Compared to the ratios discussed above (5-
minute daily maximum to 24-hour average), there was far less
variability between 5-
[[Page 64831]]
minute daily maximum and 1-hour daily maximum ratios. More
specifically, 39 of the 42 monitors had 99th percentile 5-minute daily
maximum to 99th percentile 1-hour daily maximum ratios in the range of
1.2 to 2.5 (REA, Table 10-1). The remaining three monitors had ratios
of 3.6, 4.2 and 4.6 respectively. Overall, the REA found that this
relatively narrow range of ratios (compared to the range of ratios
presented above with respect to 5-minute daily maximum to 24-hour
average) suggested that a standard with a 1-hour averaging time would
be more efficient and effective at limiting 5-minute peaks of
SO2 than a standard with a 24-hour averaging time (REA,
section 10.5.2.2). This analysis also suggested that a 5-minute
standard could be a relatively effective means of controlling 1-hour
daily maximum SO2 concentrations.\19\
---------------------------------------------------------------------------
\19\ The analysis of peak to mean ratios was used as an initial
screen to evaluate which averaging times could be suited to control
5-minute peaks of SO2. The more sophisticated analysis
for ultimately determining that a one-hour averaging time set at an
appropriate level could effectively limit these 5-minute peaks was
the air quality, exposure, and risk analyses discussed in section
II.F.4.
---------------------------------------------------------------------------
The REA further evaluated the potential of the 1-hour daily maximum
standards analyzed in the air quality, exposure, and risk analyses to
limit peak 24-hour average SO2 exposures (REA, section
10.5.2) since there is epidemiologic evidence to suggest that adverse
respiratory effects are more likely to occur at the upper end of the
distribution of ambient SO2 concentrations. The 99th
percentile 24-hour average SO2 concentrations in cities
where U.S. ED visit and hospitalization studies (for all respiratory
causes and asthma; identified from Table 5-5 of the ISA) were conducted
ranged from 16 ppb to 115 ppb (Thompson and Stewart, 2009). Moreover,
effect estimates that remained statistically significant in multi-
pollutant models with PM were found in cities with 99th percentile 24-
hour average SO2 concentrations ranging from approximately
36 ppb to 64 ppb. The REA found that a 99th percentile 1-hour daily
maximum standard set at a level of 50-100 ppb would generally limit
99th percentile 24-hour average SO2 concentrations in
locations where epidemiologic studies reported statistically
significant results in multi-pollutant models with PM (Table 1). That
is, for 2004, given air quality adjusted to just meet a 50 ppb 99th
percentile 1-hour daily maximum standard, the REA found that no county
included in this analysis was estimated to have 24-hour average
SO2 concentrations >= 36 ppb (Table 1). In addition, given
air quality adjusted to just meet a 100 ppb 99th percentile 1-hour
daily maximum standard, only 6 of the 39 counties (Linn, Union, Bronx,
Fairfax, Hudson, and Wayne) included in this 2004 analysis were
estimated to have 99th percentile 24-hour average SO2
concentrations >= 36 ppb (Table 1). The REA repeated this analysis for
the years 2005 and 2006 and found similar results (REA, Appendix Tables
D1 and D2).\20\
---------------------------------------------------------------------------
\20\ In 2005, given a 99th percentile 1-hour daily maximum
standard at 50 ppb, Wayne County, West Virginia would have an
estimated 99th percentile 24-hour average SO2
concentration > 36 ppb (43 ppb; REA Appendix Table D-1).
Table 1--99th Percentile 24-Hour Average SO2 Concentrations for 2004 Given Just Meeting the Alternative 1-Hour
Daily Maximum 99th and 98th Percentile Potential Standards Analyzed in the Air Quality Assessment
[Source: REA, Table 10-2].\21\
----------------------------------------------------------------------------------------------------------------
1-hour daily maximum standards
----------------------------------------------------------------------------
State County 99th percentile 98th percentile
----------------------------------------------------------------------------
50 100 150 200 250 100 200
----------------------------------------------------------------------------------------------------------------
AZ............ Gila............... 6 12 18 25 31 16 32
DE............ New Castle......... 12 23 35 47 59 28 56
FL............ Hillsborough....... 10 20 30 40 50 28 55
IL............ Madison............ 12 24 36 48 60 28 56
IL............ Wabash............. 7 13 20 27 33 19 38
IN............ Floyd.............. 8 15 23 31 39 20 41
IN............ Gibson............. 9 18 27 36 45 20 41
IN............ Lake............... 12 24 36 48 60 31 62
IN............ Vigo............... 10 19 29 39 48 24 48
IA............ Linn............... 21 42 64 85 106 49 98
IA............ Muscatine.......... 17 34 51 68 85 38 76
MI............ Wayne.............. 17 33 50 66 83 37 74
MO............ Greene............. 12 24 36 48 60 31 62
MO............ Jefferson.......... 9 18 27 36 45 25 51
NH............ Merrimack.......... 17 33 50 66 83 39 79
NJ............ Hudson............. 19 38 57 76 95 48 96
NJ............ Union.............. 18 36 54 72 90 44 89
NY............ Bronx.............. 23 47 70 93 117 54 107
NY............ Chautauqua......... 13 27 40 54 67 32 65
NY............ Erie............... 14 27 41 54 68 30 61
OH............ Cuyahoga........... 17 34 51 67 84 40 80
OH............ Lake............... 10 19 29 39 48 23 47
OH............ Summit............. 12 24 36 48 61 27 55
OK............ Tulsa.............. 16 32 47 63 79 36 72
PA............ Allegheny.......... 12 23 35 47 59 30 60
PA............ Beaver............. 10 20 30 40 51 25 49
PA............ Northampton........ 11 23 34 45 56 36 72
PA............ Warren............. 11 22 33 44 56 28 56
PA............ Washington......... 15 31 46 62 77 36 71
TN............ Blount............. 15 31 46 61 77 35 71
[[Page 64832]]
TN............ Shelby............. 17 34 51 68 85 41 81
TN............ Sullivan........... 8 16 24 32 39 23 46
TX............ Jefferson.......... 9 17 26 35 44 21 41
VA............ Fairfax............ 23 46 69 92 116 52 103
WV............ Brooke............. 12 24 37 49 61 31 62
WV............ Hancock............ 15 29 44 58 73 35 69
WV............ Monongalia......... 10 20 30 40 50 25 51
WV............ Wayne.............. 30 59 89 119 149 67 133
VI............ St Croix........... 14 27 41 54 68 51 101
----------------------------------------------------------------------------------------------------------------
The air quality information presented above strongly support the
likelihood that an alternative 99th percentile (see discussion of form
below in II.F.3) 1-hour daily maximum standard set at an appropriate
level (see discussion of level in II.F.4) can substantially reduce the
upper end of the distribution of SO2 levels more likely to
be associated with adverse respiratory effects; that is: (1) 99th
percentile 1-hour daily maximum air quality concentrations in cities
observing positive effect estimates in epidemiologic studies of
hospital admissions and ED visits for all respiratory causes and
asthma; and (2) 99th percentile 24-hour average air quality
concentrations found in U.S. cities where ED visit and hospitalization
studies (for all respiratory causes and asthma) observed statistically
significant associations in multi-pollutant models with PM (i.e., 99th
percentile 24-hour average SO2 concentration >= 36 ppb). In
addition, based on the air quality and exposure analyses presented in
chapters 7 and 8 of the REA, there is also a strong likelihood that a
99th percentile 1-hour daily maximum standard will limit 5-10 minute
peaks of SO2 shown in human exposure studies to result in
decrements in lung function and/or respiratory symptoms in exercising
asthmatics (see especially: REA Tables 7-11 to 7-14 and Figure 8-19).
Such analyses are also summarized in section II.F.4 of this notice.
Taken together, these results support that a 1-hour daily maximum
standard, with an appropriate form and level, can provide adequate
protection against the range of health outcomes associated with
averaging times from 5-minutes to 24-hours (REA, section 10.5.2.3).
---------------------------------------------------------------------------
\21\ 99th or 98th percentile 1-hour daily maximum concentrations
were determined for each monitor in a given county for the years
complete data were available from 2004-2006. These concentrations
were averaged, and the monitor with the highest average in a given
county was determined. Based on this highest average, all monitors
in a given county were adjusted to just meet the potential
alternative standards defined above, and for each of the years, the
99th percentile 24-hour average SO2 concentration was
identified. Results for the years 2005 and 2006 are presented in the
REA, Appendix D.
---------------------------------------------------------------------------
The REA also considered the possibility of a 5-minute averaging
time based solely on the controlled human exposure evidence. However,
the REA did not favor such an approach (REA 10.5.2.3). As in past NAAQS
reviews, the stability of the design of pollution control programs in
considering the elements of a NAAQS was considered, since more stable
programs are more effective, and hence result in enhanced public
safety. American Trucking Associations v. EPA, 283 F. 3d 355, 375 (DC
Cir. 2002) (choice of 98th percentile form for 24-hour PM NAAQS, which
allows a number of high exposure days per year to escape regulation
under the NAAQS, justifiable as ``promot[ing] development of more
`effective [pollution] control programs' '', since such programs would
otherwise be ``less `stable'--and hence * * * less effective--than
programs designed to address longer-term average conditions'', and
there are other means (viz. emergency episode plans) to control those
high exposure days). In this review, there were concerns about the
stability of a standard using a 5-minute averaging time. Specifically,
there was concern that compared to longer averaging times (e.g., 1-
hour, 24-hour), year-to-year variation in 5-minute SO2
concentrations were likely to be substantially more temporally and
spatially diverse. Thus, it is likely that locations would frequently
shift in and out of attainment thereby reducing public health
protection by disrupting an area's ongoing implementation plans and
associated control programs. Consequently, the REA concluded that a 5-
minute averaging time would not provide a stable regulatory target and
therefore would not be the preferred approach to provide adequate
public health protection. However, as noted above, analyses in the REA
support that a 1-hour averaging time, given an appropriate form and
level (discussed below in sections II.F.3 and II.F.4, respectively) can
adequately limit 5-minute SO2 exposures and provide a more
stable regulatory target than setting a 5-minute standard.
b. CASAC views
CASAC agreed with the conclusions of the policy assessment chapter
of the REA that a primary consideration of the SO2 NAAQS
should be the protection provided against health effects associated
with short-term exposures. In their letter to the EPA Administrator,
CASAC stated that they were ``in agreement with having a short-term
standard and finds that the REA supports a one-hour standard as
protective of public health'' (Samet 2009, p. 1). Furthermore, CASAC
agreed with the REA that a ``one-hour standard is the preferred
averaging time'' (Samet 2009, p.15).''
c. Administrator's conclusions on averaging time
In considering the most appropriate averaging time(s) for the
SO2 primary NAAQS, the Administrator notes the conclusions
and judgments made in the ISA about the available scientific evidence,
conclusions from the REA, and CASAC recommendations discussed above.
Based on these considerations, the Administrator proposes to set a new
standard based on 1-hour daily maximum SO2
[[Page 64833]]
concentrations to provide increased protection against effects
associated with short-term (5-minutes to 24-hours) exposures. First,
the Administrator agrees with the REA's conclusion that the standard
should focus protection on short-term SO2 exposures from 5-
minutes to 24-hours. As noted above, CASAC's strong recommendation
supports this approach as well. Second, the Administrator agrees that
the standard must provide requisite protection from 5-10 minute
exposure events (the critical issue in the previous review), but
believes (subject to consideration of public comment) that this can be
done without having a standard with a 5-minute averaging time. The
Administrator agrees with the REA conclusion that it is likely a 1-hour
standard--with the appropriate form and level--can substantially reduce
5-10 minute peaks of SO2 shown in controlled human exposure
studies to result in respiratory symptoms and/or decrements in lung
function in exercising asthmatics. The Administrator further believes
that a 5-minute averaging time would result in significant and
unnecessary instability and is undesirable for that reason. The
Administrator also notes the statements from CASAC addressing whether a
one-hour averaging time can adequately control 5-10 minute peak
exposures and whether there should be a 5-minute averaging time. CASAC
stated that the REA had presented a ``convincing rationale'' for a one-
hour standard, and that ``a 1-hour standard is the preferred averaging
time'' (Samet 2009, p. 16).
Third, the Administrator agrees that a one-hour averaging time
(again, with the appropriate form and level) would provide protection
against the range of health outcomes associated with averaging times of
one hour to 24 hours. Specifically, the Administrator finds that a 1-
hour standard can substantially reduce the upper end of the
distribution of SO2 levels more likely to be associated with
adverse respiratory effects; that is: (1) 99th percentile 1-hour daily
maximum air quality concentrations in U.S. cities where positive effect
estimates in epidemiologic studies of hospital admissions and ED visits
for all respiratory causes and asthma were observed; and (2) 99th
percentile 24-hour average air quality concentrations found in U.S.
cities where ED visit and hospitalization studies (for all respiratory
causes and asthma) observed statistically significant associations in
multi-pollutant models with PM. Finally, the Administrator notes that
the proposal to establish a new 1-hour averaging time is in agreement
with CASAC recommendations. As noted above, CASAC stated that they were
``in agreement with having a short-term standard and finds that the REA
supports a one-hour standard as protective of public health'' (Samet,
2009, p. 1).
3. Form
When evaluating alternative forms in conjunction with specific
levels, the REA considered the adequacy of the public health protection
provided by the combination of level and form to be the foremost
consideration. In addition, the REA recognized that it is important
that the standard have a form that is reasonably stable. As just
explained in the context of a five-minute averaging time, a standard
set with a high degree of instability could have the effect of reducing
public health protection because shifting in and out of attainment
could disrupt an area's ongoing implementation plans and associated
control programs.
a. Evidence, air quality, and risk-based considerations
As previously mentioned, the policy chapter of the REA (chapter 10)
recognized that the adequacy of the public health protection provided
by a 1-hour daily maximum potential alternative standard will be
dependent on the combination of form and level. It is therefore
important that the particular form selected for a 1-hour daily maximum
potential alternative standard reflect the nature of the health risks
posed by increasing SO2 concentrations. That is, the REA
noted that the form of the standard should reflect results from
controlled human exposure studies demonstrating that the percentage of
asthmatics affected, and the severity of the respiratory response (i.e.
decrements in lung function, respiratory symptoms) increases as
SO2 concentrations increase. Taking this into consideration,
the REA concluded that a concentration-based form, averaged over three
years, is more appropriate than an exceedance-based form (REA, section
10.5.3). This is because a concentration-based form averaged over three
years would give proportionally greater weight to years when 1-hour
daily maximum SO2 concentrations are well above the level of
the standard, than to years when 1-hour daily maximum SO2
concentrations are just above the level of the standard. In contrast,
an expected exceedance form would give the same weight to years when 1-
hour daily maximum SO2 concentrations are just above the
level of the standard, as to years when 1-hour daily maximum
SO2 concentrations are well above the level of the standard.
Therefore, the REA concluded that a concentration-based form, averaged
over three years (which also increases the stability of the standard)
better reflects the continuum of health risks posed by increasing
SO2 concentrations (i.e. the percentage of asthmatics
affected and the severity of the response increases with increasing
SO2 concentrations; REA, section 10.5.3).
The form of the standard should also reflect health information in
the ISA that suggests that adverse respiratory effects are more likely
to occur at the upper end of the distribution of ambient SO2
concentrations. Specifically, a few studies found that the increase in
SO2-related respiratory health effects was observed at the
upper end of the distribution of SO2 concentrations (ISA,
section 5.3, p. 5-9). For example, an epidemiologic study conducted in
Bronx, NY suggested an increased risk of asthma hospitalizations on the
days with the highest SO2 concentrations (Lin et al., 2004).
More specifically, the authors observed an increasing linear trend with
respect to asthma hospitalizations across the range of SO2
concentrations, with more marked effects observed at SO2
concentrations somewhere between the 90th and 95th percentiles (ISA,
section 4.1.2 and ISA, Figure 4-4).
The epidemiologic evidence is consistent with the large body of
controlled human exposure studies of exercising asthmatics exposed to
short-term peak concentrations of SO2; these controlled
human exposure studies provide the ``definitive evidence'' that short
term peak SO2 exposure is associated with respiratory
morbidity (SOx ISA, Section 5.3, page 5-2). These studies
consistently found moderate or greater decrements in lung function
(i.e. >= 100% increase in sRaw and/or >= 15% decline in
FEV1)\22\ and/or respiratory symptoms in exercising
asthmatics following 5-10 minute peak exposures to SO2.
Moreover, as noted in the discussion on averaging time (section
II.F.2), when discussing the possible relationship between effects
observed in controlled human exposure studies and associations reported
in epidemiologic analyses, the ISA stated with respect to epidemiologic
studies of respiratory symptoms: ``it is possible that these
associations are determined in large part by peak exposures within a
24-hour period'' (ISA, section 5.2 at p. 5-5). Similarly, the ISA
stated that: ``the effects of SO2 on respiratory symptoms,
[[Page 64834]]
lung function, and airway inflammation observed in the human clinical
studies using peak exposures further provides a basis for a progression
of respiratory morbidity resulting in increased ED visits and hospital
admissions'' and makes the associations observed in the epidemiologic
studies ``biologica[lly] plausib[le]'' (ISA, section 5.2 at p. 5-5).
Thus, both the epidemiologic and controlled human exposure evidence
suggests that the form of the standard should be focused on limiting
peak SO2 exposures.
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\22\ See section II.B.1.b above explaining sRaw and FEV1.
---------------------------------------------------------------------------
In considering specific concentration-based forms, the REA
recognized the importance of: (1) Minimizing the number of days per
year that an area could exceed the level of the standard and still
attain the standard and thus, limiting the upper end of the
distribution of SO2 levels most likely associated with
adverse respiratory effects (2) limiting the prevalence of 5-minute
peaks of SO2; and (3) providing a stable regulatory target
to prevent areas from frequently shifting in and out of attainment. The
REA focused on 98th and 99th percentile forms averaged over 3 years.
The REA first noted that in most locations analyzed, the 99th
percentile form of a 1-hour daily maximum standard would correspond to
the 4th highest daily maximum concentration in a year, while a 98th
percentile form would correspond approximately to the 7th to 8th
highest daily maximum concentration in a year (REA, Table 10-5 and
Thompson, 2009). In addition, results from the REA air quality analysis
suggested that at a given SO2 standard level, a 99th
percentile form is appreciably more effective at limiting 5-minute peak
SO2 concentrations than a 98th percentile form (REA, section
10.5.3 and REA, Figures 7-27 and 7-28). For example, the REA reported
that compared to the same standard with a 99th percentile form, a 98th
percentile 1-hour daily maximum standard set at a level of 100 ppb
allows for on average, an estimated 90 and 74% more days per year when
SO2 concentrations would likely exceed the 200 and 400 ppb
benchmark values respectively (REA, section 10.5.3 and REA, Figure 7-
28). Moreover, in the counties selected for analysis in the REA air
quality assessment, the estimated number of benchmark exceedances using
a 98th percentile 1-hour daily maximum standard set at a level of 200
ppb was similar to the corresponding 99th percentile standard set at a
level of 250 ppb (REA, section 10.5.3 and REA, Tables 7-11 through 7-
14). Similarly, the estimated number of benchmark exceedances
considering a 98th percentile standard set at a level of 100 ppb fell
within the range of benchmark exceedances estimated for 99th percentile
standards set at levels of 100 and 150 ppb (id.).
As an additional matter, the REA compared trends in 98th and 99th
percentile design values, as well as design values based on the 4th
highest daily maximum from 54 sites located in the 40 counties selected
for the detailed air quality analysis (REA section 10.5.3 and Thompson,
2009). These results suggested that at the vast majority of sites,
there would have been similar changes in 98th and 99th percentile
design values over the last ten years (i.e. based evaluating
overlapping three year intervals over the last ten years; see REA,
Figure 10-1 and Thompson, 2009). These results also demonstrated that
design values based on the 4th highest daily maximum are virtually
indistinguishable from design values based on the 99th percentile (REA,
Figure 10-1 and Thompson, 2009). As part of this analysis, all of the
design values over this ten year period for all 54 sites were
aggregated and the standard deviation calculated (REA, Figure 10-2 and
Thompson, 2009). Results demonstrated similar standard deviations--i.e.
similar stability--based on aggregated 98th or aggregated 99th
percentile design values over the ten year period (see REA, Figure 10-2
and Thompson 2009).
Considering the evidence and air quality analyses presented above,
the REA concluded that a concentration-based form provides the best
protection against the health risks posed by increasing SO2
concentrations (REA, section 10.5.3). Moreover, the REA found that at a
given standard level, a 99th percentile or 4th highest daily maximum
form provides appreciably more public health protection against 5-
minute peaks than a 98th percentile or 7th--8th highest daily maximum
form (REA, section 10.5.3). In addition, over the last 10 years and for
the vast majority of the sites examined, there appears to be little
difference in 98th and 99th percentile design value stability (REA,
section 10.5.3). Thus, the REA ultimately concluded that consideration
should be given primarily to a 1-hour daily maximum standard with a
99th percentile or 4th highest daily maximum form (REA, section
10.5.3.3).
b. CASAC views
CASAC agreed with the importance of considering the public health
protection provided by the combination of form and level. Moreover,
CASAC was in general agreement with the forms being considered. In a
letter to the Administrator, CASAC stated: ``there is adequate
information to justify the use of a concentration-based form averaged
over 3 years'' (Samet 2009, p. 16). Moreover, when considering 98th vs.
99th percentile forms, CASAC encouraged EPA to consider analyses in the
REA (and perhaps additional analyses) with respect to the number of
days per year 98th vs. 99th percentile forms would allow SO2
concentrations to exceed the selected level. CASAC also encouraged EPA
to consider analyses such as those presented above with respect to the
number exceedences of 5-minute benchmarks given 98th vs. 99th
percentile forms at a given standard level (Samet 2009).
c. Administrator's conclusions on form
When considering alternative forms, the Administrator notes and
agrees with the views expressed in the REA and the recommendations from
CASAC, as described above. In particular, she agrees that the standard
should use a concentration-based form averaged over three years in
order to give due weight to years when 1-hour SO2
concentrations are well above the level of the standard, than to years
when 1-hour SO2 concentrations are just above the level of
the standard. The Administrator agrees further, for the reasons given
above, that a 99th percentile (or 4th highest) form could be
appreciably more protective than a 98th (or 7th or 8th highest) form,
and thus, should be utilized. Given these considerations, and in light
of the specific range proposed for level below, the Administrator
proposes to adopt either a 99th percentile or a 4th highest form,
averaged over 3 years.
4. Level
In assessing the level of a one-hour standard with either a 99th
percentile or 4th highest average form (averaged over three years in
either case) to propose, the Administrator has considered the broad
range of scientific evidence assessed in the ISA, including the
epidemiologic studies and controlled human exposure studies, as well as
the results of air quality, exposure, and risk analyses presented in
the REA. In light of this body of evidence and analyses, the
Administrator reiterates that it is necessary to provide increased
public health protection for at-risk populations against an array of
adverse respiratory health effects related to short-term (i.e., 5
minutes to 24 hours) exposures to ambient SO2. In
considering the most appropriate way to provide this protection, the
Administrator is mindful
[[Page 64835]]
of the extent to which the available evidence and analyses can inform a
decision on the level of a standard. Specifically, the range of
proposed standard levels discussed below is informed by epidemiologic
and controlled human exposure studies.
a. Evidence-based considerations
Evidence-based considerations take into account the full body of
scientific evidence assessed in the ISA. When considering the extent to
which this scientific evidence can inform a decision on the level of a
1-hour standard, it is important to note that SO2
concentrations represent different measures of exposure when drawn from
experimental versus epidemiologic studies. Concentrations of
SO2 tested in experimental studies, such as controlled human
exposure studies, represent exposure concentrations in the breathing
zone of the individual test subjects. In cases where controlled human
exposure studies report effects, those effects are caused directly by
exposure to a specified concentration of SO2. In contrast,
concentrations of SO2 drawn from epidemiologic studies are
often based on ambient monitoring data. SO2 concentrations
recorded at these ambient monitors are used as surrogates for the
distribution of SO2 exposures across the study area and over
the time period of the study.
Since the last review, there have been more than 50 peer reviewed
epidemiologic studies published worldwide dealing with SO2
exposure and effects (see ISA Tables 5-4 and 5-5). Overall, the ISA
concluded that these studies provide evidence of an association between
ambient SO2 concentrations and respiratory symptoms, as well
as ED visits and hospitalizations for all respiratory causes and asthma
(ISA, section 3.1.4). Moreover, the ISA indicates that many of these
epidemiologic studies have reported that children and older adults may
be at increased risk for SO2- associated adverse respiratory
effects (ISA, section 5.2). In assessing the extent to which these
studies and their associated air quality information can inform the
level of a new 99th percentile (see sections II.F.2 and II.F.3) 1-hour
daily maximum standard for the U.S., the REA considered U.S. and
Canadian air quality information to be most relevant. EPA sent a
request to the authors of U.S. and Canadian epidemiologic studies
(studies were identified from Tables 5-4 and 5-5 of the ISA) for 99th
(and 98th) percentile 1-hour daily maximum SO2
concentrations from the monitor recording the highest SO2
level in the location and time period corresponding to their studies
(see Thompson and Stewart (2009)). Air quality information was received
from authors of both U.S. and Canadian studies; however, as noted in
the REA (REA, section 5.5), SO2 concentrations reported for
Canadian studies are not directly comparable to those reported for
studies in the U.S. because SO2 levels reported for Canadian
analyses represent the average 1-hour daily maximum level across
multiple monitors in a given city (see REA Figure 5-5), rather than the
concentration from the single monitor that recorded the highest
SO2 concentration (see Thompson and Stewart, 2009). Thus,
the REA noted that SO2 concentrations associated with
Canadian studies would be relatively lower (potentially significantly
lower) than those levels presented for U.S. epidemiologic studies, and
therefore the REA focused on 99th percentile air quality information
from U.S. studies for informing potential 1-hour standard levels.
Figures 1 to 4 present 99th (and 98th) percentile 1-hour daily
maximum SO2 concentrations from ten U.S. epidemiologic
studies (some of which were conducted in multiple cities) of ED visits
and hospital admissions \23\ (Figures 5-1 to 5-4 in the REA). The REA
noted that this information provides evidence for effects in cities
with particular 99th percentile 1-hour SO2 levels, and
hence, was of particular relevance for identifying standard levels that
could protect against the SO2 concentrations observed in
these studies. The air quality information presented in these figures
generally shows that positive associations between ambient
SO2 concentrations and ED visit and hospitalizations have
been reported in cities where 99th percentile 1-hour daily maximum
SO2 concentrations ranged from approximately 50-460 ppb.
More specifically, seven of these studies were in cities where 99th
percentile 1-hour daily maximum SO2 concentrations ranged
from approximately 75-150 ppb. Among these epidemiologic studies in the
range of 75-150 ppb, there is a cluster of three studies reporting
statistically significant results in multi-pollutant models with PM.
Specifically, in epidemiologic studies conducted in the Bronx, NY
(NYDOH 2006), and in NYC, NY (Ito et al., 2007), the SO2
effect estimate remained positive and statistically significant in
multi-pollutant models with PM2.5 in these locations when
99th percentile 1-hour daily maximum SO2 levels were 78 and
82 ppb respectively. (ISA, Table 5-5). Moreover, in an epidemiologic
study conducted in New Haven, CT (Schwartz et al., 1995), the
SO2 effect estimate remained positive and statistically
significant in a multi-pollutant model with PM10 in this
location when the 99th percentile 1-hour daily maximum SO2
concentration was 150 ppb. The REA noted that although
statistical significance in co-pollutant models is an important
consideration, it is not necessary for appropriate consideration of and
reliance on such epidemiologic evidence.\24\ However, as noted earlier,
there is special sensitivity in this review in disentangling PM-related
effects (especially sulfate PM) from SO2-related effects in
interpreting the epidemiologic studies; thus, these studies are of
particular relevance here, lending strong support both to the
conclusion that SO2 effects are generally independent of PM
(ISA, section 5.2) and that these independent adverse effects of
SO2 have occurred in cities with 1-hour daily maximum, 99th
percentile concentrations in the range of 78-150 ppb.
---------------------------------------------------------------------------
\23\ In some cases, U.S. authors provided the AQS monitor IDs
used in their studies and the statistics from the highest reporting
monitor were calculated by EPA. In cases where U.S. authors were
unable to provide the requested data (Schwartz 1995, Schwartz 1996,
and Jaffe 2003), EPA identified the maximum reporting monitor from
all monitors located in the study area and calculated the 98th and
99th percentile statistics (see Thompson and Stewart 2009). Results
presented from study locations for which effect estimates were
reported.
\24\ For example, evidence of a pattern of results from a group
of studies that find effect estimates similar in direction and
magnitude would warrant consideration of and reliance on such
studies even if the studies did not all report statistically
significant associations in single- or multi-pollutant models. The
SO2 epidemiologic studies fit this pattern, and are
buttressed further by the results of the clinical studies. ISA,
section 5.2.
---------------------------------------------------------------------------
In addition to the study locations where SO2
concentrations ranged from 75-150 ppb, the REA noted that two
epidemiologic studies included cities reporting positive associations
between ambient SO2 levels and ED visits when 99th
percentile 1-hour daily maximum SO2 concentrations were
approximately 50 ppb (Wilson et al., (2005) in Portland, ME and Jaffe
et al., (2003) in Columbus, OH). These studies reported generally
positive and sometimes statistically significant results using single
pollutant models (Figures 1 and 2), and did not evaluate potential
confounding through the use of multi-pollutant models. Nonetheless,
these studies provide limited evidence of an association between ED
visits and 99th percentile 1-hour daily maximum SO2
concentrations in locations where SO2 levels were
approximately 50 ppb. Finally, the REA noted that studies
[[Page 64836]]
conducted in Cleveland and Cincinnati, OH (Schwartz et al. 1996 and
Jaffe et al. 2003) reported positive associations between ambient
SO2 levels and ED visits and hospital admissions when 99th
percentile 1-hour daily maximum SO2 concentrations in these
cities ranged from 170-457 ppb (REA, section 5.5). The REA found the
SO2 level in Cincinnati (Jaffe et al., 2003; REA section
5.5) to be of particular concern. The 99th percentile 1-hour daily
maximum SO2 level in Cincinnati was > 400 ppb (Figure 2),
which in 5-10 minute controlled human exposure studies, was an
SO2 concentration range consistently shown to result in
clearly adverse health effects in exercising asthmatics (i.e.,
decrements in lung function accompanied by respiratory symptoms).
Taken together, the epidemiologic evidence described above suggests
that standard levels at and below 75 ppb should be considered to limit
SO2 concentrations such that the upper end of the
distribution of daily maximum hourly concentrations would likely be
below that observed in most of these U.S. studies. Notably, a standard
at or below 75 ppb would be lower than the SO2 air quality
levels found in the cluster of three epidemiologic studies finding
statistically significant effects in multi-pollutant models with PM
(i.e., 99th percentile 1-hour daily maximum SO2
concentrations >= 78 ppb). Moreover, standard levels at or below 75 ppb
recognize the limited evidence from two epidemiologic studies reporting
mostly positive and sometimes statistically significant associations in
single pollutant models when 99th percentile 1-hour daily maximum
SO2 concentrations were approximately 50 ppb (Wilson et al.,
(2005) in Portland, ME and Jaffe et al., (2003) in Columbus, OH; see
Figures 1 and 2). Judgments about the weight to place on uncertainties
inherent in such studies should also inform selection of a specific
standard level.
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The REA also considered findings from controlled human exposure
studies when evaluating potential alternative standard levels. The ISA
found that the most consistent evidence of decrements in lung function
and/or respiratory symptoms was from controlled human exposure studies
exposing exercising asthmatics to SO2 concentrations >= 400
ppb for 5-10 minute durations (ISA, section 3.1.3.5). As previously
mentioned, at SO2 concentrations ranging from 400-600 ppb,
moderate or greater decrements in lung function occur in approximately
20-60% of exercising asthmatics, and compared to exposures at 200-300
ppb, a larger percentage of subjects experience severe decrements in
lung function. Moreover, at concentrations >= 400 ppb, decrements in
lung function are often statistically significant at the group mean
level, and are frequently accompanied by respiratory symptoms (ISA,
Table 5-1).
---------------------------------------------------------------------------
\25\ There were no U.S. hospitalization studies with 1-hour
effect estimates identified in Table 5-5 of the ISA.
---------------------------------------------------------------------------
Controlled human exposure studies have also demonstrated decrements
in lung function in exercising asthmatics following 5-10 minute
SO2 exposures starting as low as 200-300 ppb in free-
breathing chamber studies. At concentrations ranging from 200-300 ppb,
the lowest levels tested in free breathing chamber studies,
approximately 5-30% percent of exercising asthmatics are likely to
experience moderate or greater decrements in lung function in these
studies. Moreover, although these individuals experienced lung function
decrements, they were not frequently accompanied by respiratory
symptoms and at these SO2 concentrations, group mean changes
in lung function have not been shown to be statistically significant.
However, the ISA and REA noted that for evident ethical reasons, the
subjects participating in the controlled human exposure studies
described above do not include the most severe asthmatics. Thus, the
REA found it is reasonable to anticipate that individuals who are more
sensitive to SO2 would have a greater response at 200-300
ppb SO2, and/or would respond to SO2
concentrations even lower than 200 ppb (REA, section 10.5.4).
Similarly, the REA noted that there is no evidence to suggest that 200
ppb represents a threshold below which no adverse respiratory effects
occur (REA, section 10.5.4). In fact, limited evidence from two
mouthpiece exposure studies suggests that exposure to 100 ppb
SO2 can result in small decrements in lung function.\26\
---------------------------------------------------------------------------
\26\ Although not directly comparable to free-breathing chamber
studies, findings from these mouthpiece studies may be particularly
relevant to those asthmatics who breathe oronasally even at rest
(EPA, 1994b).
---------------------------------------------------------------------------
Considering the controlled human exposure evidence presented above,
the ISA concluded that as SO2 concentrations increase the
percentage of asthmatics affected increases as does the severity of the
response. Moreover, as previously noted, effects associated with
SO2 concentrations >= 400 ppb are clearly considered adverse
effects of air pollution under ATS guidelines, while effects at 200-300
ppb were considered adverse in the REA based on interpretation of ATS
guidelines, CASAC recommendations, and previous conclusions from
comparable situations in other NAAQS reviews (see section II.B.1.c).
Taken together, the REA concluded that the level of a new 99th
percentile 1-hour daily maximum
[[Page 64840]]
standard should provide substantial protection against SO2
concentrations >= 400 ppb, and appreciable protection against 5-minute
SO2 concentrations >= 200 ppb (REA, section 10.5.4).
b. Air quality, exposure and risk-based considerations
In evaluating the extent to which 99th percentile 1-hour daily
maximum alternative standard levels limit 5-minute SO2
concentrations >= 400 and >= 200 ppb, the REA first considered key
results of the air quality analysis. As previously noted, the results
generated from the air quality analysis were from 40 counties and
considered a broad characterization of national air quality and human
exposures that might be associated with these 5-minute SO2
concentrations (see section II.C). However, there is uncertainty
associated with the assumption that SO2 air quality measured
at fixed site monitors can serve as an adequate surrogate for total
exposure to ambient SO2. Actual exposures might be
influenced by factors not considered in this analysis including small
scale spatial variability in ambient SO2 concentrations
(which might not be captured by the network of fixed-site ambient
monitors) and spatial/temporal variability in human activity patterns.
Table 2 reports the maximum mean number of days per year 5-minute
daily maximum SO2 levels would be expected to exceed a given
5-minute potential health effect benchmark level in any of the 40
counties included in the air quality analysis, given air quality
simulated to just meet the current, and potential alternative 99th
percentile 1-hour daily maximum standards analyzed in the REA. In
addition, although not directly analyzed in the REA, these tables
include air quality results given a 99th percentile 1-hour daily
maximum standard at 75 ppb; this concentration was included in these
tables because as mentioned above, the epidemiologic evidence suggested
consideration of a standard level at or below 75 ppb.\27\ Table 2 shows
that at standard levels ranging from 50-100 ppb, there would be at most
two days per year when statistically estimated 5-minute SO2
concentrations in these counties exceed the 400 ppb benchmark, while at
standard levels of 150 ppb and above there is a marked increase in the
maximum number of days per year the 400 ppb benchmark is exceeded.
Similar trends are seen with respect to the 300 ppb benchmark level.
With respect to the 200 and 100 ppb benchmarks, the 50 ppb standard is
clearly the most effective at limiting these 5-minute SO2
concentrations. However, compared to standards at 150 ppb and above,
standards in the range of 75-100 ppb would allow considerably less
exceedence of the 200 and 100 ppb benchmarks. Additional and more
detailed results from the air quality analysis can be found in chapter
7 of the REA.
---------------------------------------------------------------------------
\27\ Air quality, exposure, and risk numbers reported in Chapter
10 of the REA for a 75 ppb standard were bound by the estimates from
air quality adjusted to just meet 99th percentile 1-hour daily
maximum standards at 50 and 100 ppb.
Table 2--Maximum Mean Number of Days Per Year in Any of the Counties Included in the Air Quality Analysis When 5-Minute Daily Maximum SO2 Concentrations
Exceed the 100, 200, 300, and 400 ppb Potential Health Effect Benchmark Values Given Air Quality Adjusted To Just Meet the Current Standards, or
Alternative 99th Percentile 1-Hour Daily Maximum Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
Air quality scenarios
------------------------------------------------------------------------------------------
Just 99th percentile 1-hour daily maximum standards
Exposure benchmarks (5-minute exposures) meeting -----------------------------------------------------------------------------
current
standards 50 ppb 75 ppb 100 ppb 150 ppb 200 ppb 250 ppb
--------------------------------------------------------------------------------------------------------------------------------------------------------
400 ppb...................................................... 102 0 (0-2) 2 7 13 18
300 ppb...................................................... 130 0 (0-5) 5 13 20 27
200 ppb...................................................... 171 2 (2-13) 13 24 42 69
100 ppb...................................................... 234 13 (13-43) 43 93 133 180
--------------------------------------------------------------------------------------------------------------------------------------------------------
While the air quality analysis results presented in Table 2 used
estimated 5-minute SO2 concentrations as a surrogate for
exposure, the results from the exposure analysis considered the
likelihood that an asthmatic at elevated ventilation rate would come
into contact with a 5-minute SO2 concentration at or above a
given benchmark level one or more times per year. As previously noted,
this resource intensive analysis was performed for St. Louis and Greene
County, MO, but results from the St. Louis analysis were found to be
more informative with respect to informing standard levels given that
the St. Louis results: (1) Suggested that the current standards were
not adequate to protect public health; and (2) likely provide useful
insights into exposures and risk for other urban areas in the U.S. with
similar population and SO2 emissions density (i.e., areas
where SO2 exposures are more likely).
Table 3 reports the estimated percent of asthmatic children at
moderate or greater exertion in St. Louis, that would be expected to
experience at least one SO2 exposure per year, at or above a
health effect benchmark level in scenarios in which air quality was
adjusted to meet the current, and alternative 99th percentile 1-hour
daily maximum standards. This analysis estimates that standard levels
ranging from 50-100 ppb would protect > 99% of asthmatic children, at
moderate or greater exertion, from experiencing at least one
SO2 exposure >= 400 ppb per year.\28\ Similarly, a standard
at 150 ppb is estimated to protect ~ 99% of asthmatic children at
moderate or greater exertion from experiencing at least one
SO2 exposure >= 400 ppb. Compared to standards ranging from
50-150 ppb, standards at 200 and 250 ppb are estimated to allow
appreciably more exposures >= 400 ppb (Table 3). With respect to the
300 ppb benchmark, standards at 50, 75, and 100 ppb provide similar
protection, while there is a marked increase in exposures of asthmatic
children at moderate or greater exertion at standard levels >= 150 ppb
(Table 3). Considering the 200 ppb benchmark level, it is estimated
that 1-hour standard levels ranging from 50-100 ppb limit 5-minute
SO2 exposures >= 200 ppb considerably more than 1-hour
standard levels >= 150 ppb. More
[[Page 64841]]
specifically, standards in the range of 50-100 ppb are estimated to
protect approximately 97 to > 99% of asthmatic children at moderate or
greater exertion from experiencing at least one 5-minute exposure >=
200 ppb per year, while standards ranging from 150-250 ppb are
estimated to protect approximately 60 to 88% of these children from
experiencing at least one 5-minute SO2 exposure >= 200 ppb
per year. Finally, similar to the air quality analysis, a standard at
50 ppb is clearly most effective at limiting 5-minute SO2
exposures >= 100 ppb. Additional and more detailed results from the
exposure assessment can be found in chapter 8 of the REA.
---------------------------------------------------------------------------
\28\ Table 3 reports that given a 99th percentile 1-hour daily
maximum standard in the range of 50-100 ppb, < 1% of asthmatic
children at moderate or greater exertion would be estimated to
experience an SO2 exposure >= 400 ppb, hence it can be
stated that this range of levels would protect > 99% of asthmatic
children at moderate or greater exertion from experiencing at least
one SO2 exposure >= 400 ppb per year.
Table 3--Estimated Percent of Asthmatic Children in St. Louis at Moderate or Greater Exertion Expected to Experience at Least One 5-Minute Exposure
Above the 100, 200, 300, and 400 ppb Potential Health Effect Benchmark Levels Given Air Quality Adjusted To Just Meet the Current Standards, or
Alternative 99th Percentile 1-Hour Daily Maximum Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
Air quality scenarios
------------------------------------------------------------------------------------------------------------
Just 99th Percentile 1-hour daily maximum standards
Exposure benchmarks (5-minute exposures) meeting -----------------------------------------------------------------------------------------------
current
standards 50 ppb 75 ppb 100 ppb 150 ppb 200 ppb 250 ppb
--------------------------------------------------------------------------------------------------------------------------------------------------------
400 ppb.................................... 24% < 1% < 1%......................... < 1% ~1% 2.7% 6.3%
300 ppb.................................... 43.8% < 1% < 1%......................... < 1% 2.7% 8% 16%
200 ppb.................................... 73.1% < 1% (~1 to 2.7%)................. 2.7% 11.6% 24.5% 40%
100 ppb.................................... 96.7% 2.7% (2.7 to 24.5%)............... 24.5% 54.5% 73.6% 84.8%
--------------------------------------------------------------------------------------------------------------------------------------------------------
In evaluating the extent to which alternative standard levels
provide protection against the health effects associated with 5-minute
SO2 exposures, the REA also considered key results from the
quantitative risk assessment (REA, chapter 9). Table 4 presents the
percent of exposed asthmatic children at moderate or greater exertion
in St. Louis expected to experience at least one moderate or greater
lung function response per year, in terms of sRaw, given the 99th
percentile 1-hour daily maximum standards analyzed in the REA. Results
presented in Table 4 show that standard levels in the range of 100 to
150 ppb would generally be expected to protect approximately 95 to 98%
of exposed asthmatic children at moderate or greater exertion from
experiencing at least one >= 100% increase in sRaw per year, while
standards around and below 75 ppb would be estimated to provide exposed
asthmatic children with protection approaching 99% or greater.
Additional and more detailed risk analyses can be found in chapter 9 of
the REA.
Table 4--Estimated Percent of Asthmatic Children in St. Louis at Moderate or Greater Exertion Expected To
Experience a >= 100% Increase in sRaw Given Air Quality Adjusted To Just Meet Either the Current Standards, or
Alternative 99th Percentile 1-Hour Daily Maximum Standards
----------------------------------------------------------------------------------------------------------------
Air quality scenarios
-----------------------------------------------------------------------------------------------------------------
99th Percentile 1-hour daily maximum standards
Just meeting current standards -----------------------------------------------------------------------------
50 ppb 75 ppb 100 ppb 150 ppb 200 ppb 250 ppb
----------------------------------------------------------------------------------------------------------------
19.1-19.2%........................ 0.4-0.9% (0.4-2.9%) 2.1-2.9% 4.6-5.4% 7.4-8.1% 10.4-10.9%
----------------------------------------------------------------------------------------------------------------
c. Observations based on evidence and risk-based considerations
The policy assessment chapter of the REA considered the scientific
evidence and the air quality, exposure, and risk information as they
relate to considering alternative 1-hour SO2 standards that
could be judged to be requisite to protect public health with an
adequate margin of safety. This evidence and information supports the
following conclusions:
Given the U.S. epidemiologic evidence and their associated
air quality levels (see Figures 1-4), 99th percentile 1-hour standard
levels at and below 75 ppb should be considered to limit SO2
concentrations such that the upper end of the distribution of daily
maximum hourly concentrations would likely be below that observed in
most of the U.S. studies. Judgments about the weight to place on
uncertainties inherent in such studies should also inform selection of
a specific standard level.
Based on the air quality and exposure results, 1-hour
standard levels in the range of 50-100 ppb should be considered to
substantially limit 5-minute SO2 concentrations >= 400 ppb
and appreciably limit 5-minute SO2 concentrations >= 200
ppb.
Based on the air quality and exposure results, compared to
a 1-hour standard in the range of 50-100 ppb, a 1-hour standard level
at 150 ppb would be expected similarly limit 5-minute SO2
concentrations >= 400 ppb, but would limit 5-minute SO2
concentrations >= 200 ppb considerably less.
If relatively more weight is placed on certain types of
uncertainties in the epidemiologic and controlled human exposure
evidence, levels up to 150 ppb could be considered, recognizing the
questions as to the adequacy of protection that would be raised by
levels at the higher end of this range.
Placing relatively more weight on the consideration that
participants in controlled human exposure studies do not include the
most severe asthmatics would add support to considering standard levels
down to 50 ppb.
d. CASAC views
CASAC expressed their views on potential levels for a standard in a
letter to the EPA Administrator (Samet, 2009) within the context of
their review of the 2nd draft REA, which also contained the draft
policy assessment chapter. In drawing conclusions regarding the level
of a short-term standard, CASAC considered the scientific evidence
[[Page 64842]]
evaluated in the ISA, the air quality, exposure, and risk results
presented in the 2nd draft REA, and the evidence- and risk-based
considerations presented in the policy assessment chapter of the 2nd
draft REA. CASAC concurred with the conclusion from the policy
assessment chapter for a range of standard levels beginning at 50 ppb:
``[that chapter 10] clearly provides sufficient rationale for the range
of levels beginning at a lower limit of 50 ppb'' (Samet 2009, p. 16).
For instance, CASAC has previously indicated that EPA should consider
in its analyses the uncertainty that asthmatics participating in
controlled human exposure studies do not represent the most
SO2 sensitive asthmatics (Henderson 2008 p. 6). With respect
to the upper end of the range, CASAC stated, ``an upper limit of 150
ppb posited in Chapter 10 could be justified under some interpretations
of weight of evidence, uncertainties, and policy choices regarding
margin of safety,'' (Samet 2009, p. 16) although the letter did not
provide any indication of what interpretations, uncertainties, or
policy choices might support selection of a level as high as 150 ppb.
Further, CASAC stated that ``the draft REA appropriately implies that
levels greater than 150 ppb are not adequately supported'' (id).
Moreover, CASAC stated that: ``the panel agrees that the posited range
of 50 to 150 ppb and the exposition of factors to consider when
comparing values within the range are appropriately conveyed (Samet
2009, p. 16).''
e. Administrator's conclusions on level for a 1-hour standard
As discussed above, in sections II.F.2 and II.F.3, the
Administrator has proposed setting a 1-hour standard with a 99th
percentile form. For the reasons discussed below, the Administrator
proposes to set a level for a new 99th percentile 1-hour daily maximum
primary SO2 standard within the range from 50 to 100 ppb. In
reaching this proposed decision, the Administrator has considered: (1)
The evidence-based considerations from the final ISA and the final REA;
(2) the results of the air quality, exposure, and risk assessments
discussed above and in the final REA; (3) CASAC advice and
recommendations on both the ISA and REA discussed above and provided in
CASAC's letters to the Administrator; and (4) public comments received
on the first and second drafts of the ISA and REA. In considering what
level of a 1-hour SO2 standard is requisite to protect
public health with an adequate margin of safety, the Administrator is
mindful that this choice requires judgments based on an interpretation
of the evidence and other information that neither overstates nor
understates the strength and limitations of that evidence and
information.
The Administrator notes that the most direct evidence of
respiratory effects from exposure to SO2 comes from the
controlled human exposure studies. These studies exposed groups of
exercising asthmatics to defined concentrations of SO2 for
5-10 minutes and found adverse respiratory effects. As discussed above,
SO2 exposure levels which resulted in respiratory effects in
controlled human exposure studies were used in the REA as 5-minute
benchmark exposures of potential concern. With respect to these 5-
minute benchmarks, the Administrator focused on exceedences of the 400
and 200 ppb benchmarks. She notes that under ATS guidelines (ATS 1985,
2000) exposure to 5-10 minute SO2 concentrations >= 400 ppb
results in health effects which are clearly adverse: moderate or
greater decrements in lung function (in terms of FEV1 or
sRaw \29\) that are frequently accompanied by respiratory symptoms.\30\
---------------------------------------------------------------------------
\29\ Decreases of 10-20% in FEV1 (forced expiratory
volume) and/or 100-200% increases in sRaw (specific airway
resistance) are defined as moderate decrements in lung function.
\30\ The ISA concluded that collective evidence from controlled
human exposure studies considered in the previous review, along with
a limited number of new controlled human exposure studies,
consistently indicates that with elevated ventilation rates a large
percentage of asthmatic individuals tested in a given chamber study
(up to 60%, depending on the study) experience moderate or greater
decrements in lung function, frequently accompanied by respiratory
symptoms, following peak exposures to SO2 at
concentrations of 0.4-0.6 ppm. (ISA, p 3-9).
---------------------------------------------------------------------------
The Administrator also focused on exceedences of the 200 ppb
benchmark, the lowest SO2 concentration tested in free-
breathing chamber studies. In these studies, moderate or greater
decrements in lung function occurred in approximately 5 to 30% of
exercising asthmatics, depending on the study. The Administrator
further notes that while concentrations as low as 200 ppb have not been
frequently accompanied by respiratory symptoms, she considers these
effects to be adverse in light of CASAC advice and ATS guidelines. The
REA concluded that these controlled human exposure studies could
reasonably be interpreted to indicate an SO2-induced shift
in lung function for this population of asthmatics (REA, section 4.3),
such that asthmatics would have diminished reserve lung function and
would be at greater risk if affected by another respiratory agent
(e.g., viral infection). Importantly, diminished reserve lung function
in a population that is attributable to air pollution is an adverse
effect under ATS guidelines as discussed in section II.B.1.c.
As discussed below, the Administrator also considered the results
of the air quality, exposure, and risk analyses, as they serve to
estimate the extent to which a given 1-hour standard limits peaks of
SO2 above the 5-minute benchmark concentrations derived from
controlled human exposure studies. In considering these results as they
relate to limiting 5-minute SO2 concentrations >= 400 ppb
and >= 200 ppb, and being mindful that more severe effects occur
following 5-minute SO2 exposures >= 400 ppb, the
Administrator finds the most support for 99th percentile 1-hour daily
maximum standard levels up to 100 ppb to protect against 5-minute
SO2 exposures >= 200 ppb. She notes that the 40-county air
quality analysis estimates that a 100 ppb 1-hour standard would allow
at most 2 days per year on average when estimated 5-minute daily
maximum SO2 concentrations exceed the 400 ppb benchmark, and
at most 13 days per year on average when 5-minute SO2
concentrations exceed the 200 ppb benchmark (Table 2). Furthermore,
given a simulated 1-hour 100 ppb standard level, most counties in the
air quality analysis were estimated to experience 0 days per year on
average when 5-minute SO2 concentrations exceed the 400 ppb
benchmark and <= 3 days per year on average when 5-minute
SO2 concentrations were estimated to exceed the 200 ppb
benchmark (see REA, Tables 7-14 and 7-12).
In addition, the St. Louis exposure analysis estimates that a 99th
percentile 1-hour standard at a level of 100 ppb would likely protect >
99% of asthmatic children at moderate or greater exertion from
experiencing at least one 5-minute exposure >= 400 ppb per year, and
approximately 97% of asthmatic children at moderate or greater exertion
from experiencing at least one exposure >= 200 ppb per year. In
contrast, the Administrator notes that the St. Louis exposure analysis
estimates a 99th percentile 1-hour daily maximum standard at a level of
150 ppb would likely protect only about 88% of asthmatic children at
moderate or greater exertion from experiencing at least one 5-minute
exposure >= 200 ppb per year. Finally, the Administrator notes that the
St. Louis risk assessment estimates that a 99th percentile 1-hour
standard level at 100 ppb would likely protect about 97-98% of exposed
asthmatic children from experiencing at least one moderate or greater
lung function response (defined as a >= 100% increase in sRaw). Based
on these
[[Page 64843]]
considerations, she concludes that there is support for a 99th
percentile 1-hour daily maximum standard level at or below 100 ppb to
appreciably limit 5-minute exposures to SO2 above the 200
ppb benchmark level.
Turning to the epidemiologic evidence, the Administrator notes that
epidemiologic studies have reported associations between more serious
health outcomes (i.e. respiratory-related ED visits and
hospitalizations) and ambient SO2 concentrations. Unlike the
controlled human exposure studies however, results from epidemiologic
studies can be complicated by the fact that SO2 is but one
component of a complex mixture of pollutants in the ambient air. This
uncertainty is addressed by the ISA which concluded that the limited
available evidence indicates that the effect of SO2 on
respiratory health outcomes appears to be generally robust and
independent of the effects of gaseous co-pollutants, including
NO2 and O3, as well as particulate co-pollutants,
particularly PM2.5 (ISA, section 5.2; p. 5-9).
The Administrator also notes that in general, associations reported
in epidemiologic analyses are not associated with a defined exposure
level of a pollutant (unlike the controlled human exposure studies),
but represent concentrations of a pollutant taken from ambient
monitoring data during the study period. These concentrations are used
as surrogates for the distribution of pollutant exposures across the
study area over the time period of the study. This introduces a degree
of uncertainty in the interpretation of epidemiologic results in that
it can be difficult to discern what part of the distribution of
pollutant levels are likely most linked to the associations reported in
epidemiologic analyses.
With respect to SO2 specifically, the Administrator
notes that adverse respiratory effects in epidemiologic studies are
especially likely to occur at the upper end of the distribution of
ambient SO2 concentrations. Although some epidemiologic
studies reported a linear relationship across the entire range of
SO2 concentrations, a few other studies found that the
increase in SO2-related respiratory health effects was
observed at the upper end of the distribution of SO2
concentrations (ISA, section 5.3, p. 5-9). For example, an
epidemiologic study conducted in Bronx, NY suggested an increased risk
of asthma hospitalizations on the days with the highest SO2
concentrations (Lin et al., 2004). More specifically, these authors
observed increased risk of asthma hospitalizations at SO2
concentrations somewhere between the 90th and 95th percentiles (ISA,
section 4.1.2 and ISA, Figure 4-4).
This epidemiologic evidence, though not independently sufficient to
draw conclusions regarding causation, is consistent with, and informed
by, the large body of controlled human exposure studies of exercising
asthmatics exposed to short-term peak concentrations of SO2;
these controlled human exposure studies provide the ``definitive
evidence'' that short-term peak SO2 exposure is associated
with respiratory morbidity (ISA, Section 5.3, page 5-8). These studies
consistently found moderate or greater decrements in lung function
(i.e. >= 100% increase in sRaw and/or >= 15% decline in
FEV1) and/or respiratory symptoms in exercising asthmatics
following 5-10 minute peak exposures to SO2. Discussing the
possible relationship between effects observed in these controlled
human exposure studies and the associations reported in the
epidemiologic studies, the ISA stated: ``it is possible that these
associations [in the epidemiologic studies] are determined in large
part by peak exposures within a 24-hour period'' (ISA, section 5.2 at
p. 5-5). Similarly, the ISA stated that: ``the effects of
SO2 on respiratory symptoms, lung function, and airway
inflammation observed in the human clinical studies using peak
exposures further provides a basis for a progression of respiratory
morbidity resulting in increased ED visits and hospital admissions''
and makes the associations observed in the epidemiologic studies
``biologica[lly] plausib[le]'' (ISA, section 5.2 at p. 5-5). Thus,
considered together, the epidemiologic and controlled human exposure
evidence suggest that it is a reasonable approach to move the air
quality distribution lower in a manner that targets control of both
hourly and 5-10 minute peak SO2 exposures.
For the reasons discussed above in section II.F.3, the
Administrator has proposed a 99th percentile of the 1-hour daily
maximum concentration as an appropriate form.\31\ Moreover, as just
discussed, there is support for the Agency's view that adverse
respiratory effects in epidemiologic studies are especially likely to
occur at the upper end of the distribution of ambient SO2
concentrations. Therefore, the Administrator finds it reasonable to
focus on limiting the 99th percentile SO2 levels reported in
locations where positive associations were found in key epidemiologic
studies. Adjusting the distribution of SO2 levels in this
manner will target control of those hourly and 5-10 minute peak
SO2 concentrations that are of most concern.
---------------------------------------------------------------------------
\31\ As previously discussed in section II.F.3, a 99th
percentile form was proposed to: (1) Minimize the number of days per
year that an area could exceed the level of the standard and still
attain the standard; (2) limit the prevalence of 5-minute peaks of
SO2; and (3) provide a stable regulatory target to
prevent areas from frequently shifting in and out of attainment.
---------------------------------------------------------------------------
In considering the epidemiologic evidence with regard to level, the
Administrator notes that there have been more than 50 peer reviewed
epidemiologic studies evaluating SO2 published worldwide
(ISA, Tables 5-4 and 5-5). The Administrator finds that in assessing
the extent to which these studies and their associated air quality
information can inform the level of a new 99th percentile 1-hour daily
maximum standard, U.S. and Canadian air quality information is most
relevant. As described in section II.F.4.a, SO2
concentrations reported for Canadian studies are not directly
comparable to those reported for U.S. studies. That is, concentrations
reported for Canadian analyses represent the average 99th percentile 1-
hour daily maximum level across multiple monitors in a given city (REA
Figure 5-5), rather than the concentration from the single monitor that
recorded the highest SO2 level (see Thompson and Stewart,
2009). Thus, the Administrator focused on 99th percentile air quality
information from U.S. studies for informing potential 1-hour standard
levels.
The Administrator notes that Figures 1 to 4 include 99th percentile
1-hour daily maximum SO2 concentrations from ten U.S.
epidemiologic studies of ED visits and hospital admissions (Figures 5-1
to 5-4 in the REA). The Administrator agrees with the REA finding that
this information provides evidence of associations between ambient
SO2 and ED visits and hospital admissions in cities with
particular 99th percentile 1-hour SO2 levels. This
information is relevant for identifying standard levels that could
significantly limit SO2 concentrations so that the upper end
of the distribution of daily maximum hourly concentrations would likely
be below that observed in most of these studies. These figures report
mostly positive, and sometimes statistically significant, associations
between ambient SO2 concentrations and ED visit and hospital
admissions in locations where 99th percentile 1-hour daily maximum
SO2 levels ranged from 50-460 ppb. Moreover, within this
broader range of SO2 concentrations, seven of these studies
were in locations where the 99th percentile of the 1-hour daily maximum
SO2 concentrations were in the range of 75-150 ppb. The
Administrator particularly notes the
[[Page 64844]]
cluster of three epidemiologic studies between 78-150 ppb (for the 99th
percentile of the 1-hour SO2 concentrations) where the
SO2 effect estimate remained positive and statistically
significant in multi-pollutant models with PM (NYDOH (2006), Ito et
al., (2007), and Schwartz et al., (1995)). The Administrator also notes
the limited evidence from two epidemiologic studies employing single
pollutant models that found mostly positive, and sometimes
statistically significant, associations between ambient SO2
and ED visits in locations where 1-hour SO2 concentrations
were approximately 50 ppb (Figures 1 and 2). Based on the
interpretation of the epidemiologic evidence discussed above, the
Administrator concludes that this evidence provides support for
consideration of a 99th percentile 1-hour daily maximum standard level
at or below 75 ppb to limit SO2 concentrations such that the
upper end of the distribution of daily maximum hourly concentrations
would likely be below that observed in most of the U.S. studies. The
Administrator also recognizes that judgments about the weight to place
on uncertainties inherent in such studies should inform selection of a
specific standard level.
Based on the epidemiologic and controlled human exposure
information presented above, the Administrator considered what range of
standard levels would be requisite to protect public health, including
the health of at-risk groups, with an adequate margin of safety that is
sufficient but not more than necessary to achieve that result. The
assessment of a standard level calls for consideration of both the
degree of risk to public health at alternative levels of the standard
as well as the certainty that such risk will occur at any specific
level. Based on the information available in the ISA, there is no
evidence-based bright line that indicates a single appropriate level.
Moreover, given that a 1-hour averaging time is being used to control
5-minute peaks of SO2, the Administrator also recognizes
that the results of the air quality, exposure, and risk analyses will
have to be considered given that these analyses indicate the extent to
which a particular 99th percentile 1-hour daily maximum standard will
likely limit 5-minute SO2 peaks of a given concentration.
Thus, the combination of scientific evidence and air quality, exposure,
and risk-based information needs to be considered as a whole in making
this public health policy judgment.
In selecting a level that would serve as an appropriate upper end
for a range of levels to propose, the Administrator has considered a
cautious approach to interpreting the available evidence and exposure/
risk-based information--that is, an approach that places relatively
more weight on those types of uncertainties and limitations in the
information that would lead to placing less reliance on the results of
the epidemiologic studies. This approach would tend to avoid
potentially overestimating public health risks and the degree of
protection likely to be associated with just meeting a particular
standard level. This approach would place more weight in particular on
uncertainties in epidemiologic evidence such as concerns related to
exposure measurement error, the possible role of co-pollutants and
effects modifiers, and interindividual differences in susceptibility to
SO2-related effects.
In applying this approach, the Administrator has selected an upper
end of a range of levels to propose at 100 ppb. The selection of this
level focuses on the results of the controlled human exposure studies
and is primarily based on the results of the air quality and exposure
analyses which suggest that a 1-hour standard should be at or below 100
ppb to appreciably limit 5-minute SO2 benchmark
concentrations >= 200 ppb. That is, as mentioned above, the St. Louis
exposure analysis indicates that a 1-hour standard at 100 ppb would
still be estimated to protect about 97% of asthmatic children at
moderate or greater exertion from experiencing at least one 5-minute
SO2 exposure >= 200 ppb. In contrast, the St. Louis exposure
analysis estimates that a 1-hour standard at 150 ppb would likely only
protect about 88% of asthmatic children at moderate or greater exertion
from experiencing at least one 5-minute SO2 exposure >= 200
ppb.
In selecting a level that would serve as an appropriate lower end
for a range of levels to propose, the Administrator has considered a
precautionary approach to interpreting the available evidence and
exposure/risk-based information--that is, an approach that places
relatively more weight on the results of the epidemiological studies,
as well as more weight on those types of uncertainties that may be
associated with potentially underestimating health effects in the most
sensitive populations. This approach would tend to avoid potentially
underestimating public health risks and the degree of protection likely
to be associated with just meeting a particular standard level. This
approach would place more weight on the consideration that the
participants in controlled human exposure studies did not include
individuals with severe asthma.
In applying this approach, she has selected 50 ppb as the lower end
of a range of levels to propose, which is consistent with CASAC's
advice. The selection of this level focuses in part on the
epidemiologic evidence. With respect to the epidemiologic studies,
seven of ten U.S. ED visit and hospital admission studies reporting
generally positive associations with ambient SO2 were
conducted in locations where 99th percentile 1-hour daily maximum
SO2 levels were about 75-150 ppb, and three of these studies
observed statistically significant positive associations between
ambient SO2 and respiratory-related ED visits and
hospitalizations in multi-pollutant models with PM (NYDOH (2006), Ito
et al., (2007), and Schwartz et al., (1995)). Further, the
Administrator notes that a 99th percentile 1-hour daily maximum
standard set at a level of 50 ppb is well below the 99th percentile 1-
hour daily maximum SO2 concentrations reported in locations
where these studies were conducted (i.e. well below 99th percentile 1-
hour daily maximum SO2 levels of 78-150 ppb). Finally, the
Administrator notes that two epidemiologic studies reported generally
positive associations between ambient SO2 and ED visits in
cities when 99th percentile 1-hour daily maximum SO2
concentrations were approximately 50 ppb, but does not consider that
evidence strong enough to set a lower standard level.
In considering the results of the air quality and exposure
analyses, the Administrator also notes that the 40-county air quality
analysis estimates that a 99th percentile 1-hour daily maximum standard
set at a level of 50 ppb would result in zero days per year when
estimated 5-minute SO2 concentrations exceed the 400 ppb 5-
minute benchmark level and at most 2 days per year when modeled 5-
minute SO2 concentrations exceed the 200 ppb 5-minute
benchmark level. In addition, the St. Louis exposure analysis estimates
that a 99th percentile 1-hour daily maximum standard set at a level of
50 ppb would likely protect > 99% of asthmatic children at moderate or
greater exertion from experiencing at least one 5-minute exposure both
>= 400 and >= 200 ppb per year.
The Administrator thus proposes to set the level of a new 1-hour
standard that would protect public health with an adequate margin of
safety between 50 ppb and 100 ppb. In so doing, the Administrator is
relying on reported findings from both epidemiologic and controlled
human exposure studies, as well as the results of air quality and
exposure analyses. The Administrator
[[Page 64845]]
solicits comment on this proposed range of standard levels as well as
on the approach she has used to identify the range. Specifically, the
Administrator solicits comment on the following:
The weight she has placed on the epidemiologic evidence,
the controlled human exposure evidence, and the air quality, exposure,
and risk information, the benchmark used to select the proposed range,
and the uncertainties associated with each of these.
The most appropriate level within this proposed range
given the available scientific evidence, and air quality, exposure, and
risk information, and the uncertainties associated with each.
With regard to the proposed range of standard levels, the
Administrator notes that the lower end of the proposed range is
consistent with CASAC advice that there is clearly sufficient evidence
for consideration of standard levels starting at 50 ppb (Samet 2009).
With respect to the upper end of the proposed range, the Administrator
notes that CASAC concluded that standards up to 150 ppb ``could be
justified under some interpretations of weight of evidence,
uncertainties, and policy choices regarding margin of safety'' (Samet
2009, p. 16), although the letter did not provide any indication of
what interpretations, uncertainties, or policy choices might support
selection of a level as high as 150 ppb.
In light of the range of levels included in CASAC's advice, the
Administrator solicits comment on setting a standard level above 100
ppb and up to 150 ppb. In so doing, the Administrator again recognizes
that there are uncertainties with the scientific evidence, such as
attributing effects reported in epidemiologic studies specifically to
SO2 given the presence of co-occurring pollutants,
especially PM, and the uncertainties associated with using ambient
SO2 concentrations as a surrogate for exposure. Any comments
should specifically address the cluster of epidemiologic studies that
remained statistically significant in co-pollutant models with PM, two
of which had 99th percentile levels appreciably lower than 150 ppb.
Commenters should also address the conclusion in the ISA that the
respiratory effects seen in the epidemiologic studies are generally
robust and independent of co-pollutants. In addition, the Administrator
notes that compared to the proposed range of 50-100 ppb, a standard
level as high as 150 ppb would not comparably limit 5-minute
SO2 exposures >= 200 ppb. She notes that the St. Louis
exposure analysis estimates that a 150 ppb standard would protect
approximately 88% of asthmatic children at moderate or greater exertion
from experiencing at least one SO2 exposure >= 200 ppb per
year (compared to > 99% and approximately 97% given standards at 50 and
100 ppb respectively; see Table 3). There are also questions as to
whether a standard set at this level would provide an adequate margin
of safety. Thus, with respect to considering whether it would be
appropriate to set a standard level as high as 150 ppb, the
Administrator invites comment on the extent to which it is appropriate
to emphasize uncertainties with respect to the epidemiologic evidence.
She also invites comment on the implications such considerations would
have on limiting 5-minute SO2 exposures >= 200 ppb.
5. Implications for retaining or revoking current standards
The REA recognized that the particular level selected for a new 1-
hour daily maximum standard would have implications for reaching
decisions on whether to retain or revoke the current 24-hour and annual
standards. That is, with respect to SO2-induced respiratory
morbidity, the lower the level selected for a 99th percentile 1-hour
daily maximum standard, the less additional public health protection
the current standards would be expected to provide. As previously
mentioned (see section II.E.3), CASAC expressed a similar view
following their review of the 2nd draft REA: ``assuming that EPA adopts
a one hour standard in the range suggested, and if there is evidence
showing that the short-term standard provides equivalent protection of
public health in the long-term as the annual standard, the panel is
supportive of the REA discussion of discontinuing the annual standard''
(Samet 2009, p. 15). With regard to the current 24-hour standard, CASAC
was generally supportive of using the air quality analyses in the REA
as a means of determining whether the current 24-hour standard was
needed in addition to a new 1-hour standard to protect public health.
CASAC stated: ``the evidence presented [in REA Table 10-3] was
convincing that some of the alternative one-hour standards could also
adequately protect against exceedances of the current 24-hour
standard'' (Samet 2009, p. 15).
In accordance with the REA findings and CASAC recommendations
mentioned above, the Administrator notes that the 1-hour standards
being proposed (i.e., 99th percentile 1-hour daily maximum
SO2 standards at 50-100 ppb) would have the effect of
maintaining 24-hour and annual SO2 concentrations generally
well below the levels of the current 24-hour and annual NAAQS (see REA
Tables 10-3 and 10-4 and REA Appendix Tables D-3 to D-6). Thus, if a
new 99th percentile 1-hour daily maximum standard is set in the
proposed range of 50-100 ppb, than the Administrator proposes to revoke
the current 24-hour and annual standards. However, if a standard is set
at a level >100 ppb and up to 150 ppb, then the Administrator proposes
to retain the existing 24-hour standard, recognizing that a 99th
percentile 1-hour daily maximum standard at 150 ppb would not have the
effect of maintaining 24-hour average SO2 concentrations
below the level of the current 24-hour standard in all locations
analyzed (see REA Appendix Table D-4). However, the Administrator would
revoke the current annual standard recognizing: (1) 99th percentile 1-
hour daily maximum standards in the range of 50-150 ppb would maintain
annual average SO2 concentrations below the level of the
current annual standard (see REA Table 10-4 and REA Appendix tables D-5
and D-6); and (2) the lack of sufficient evidence linking long-term
SO2 exposure to adverse health effects.
G. Summary of proposed decisions on the primary standard
For the reasons discussed above, and taking into account
information and assessments presented in the ISA and REA as well as the
advice and recommendations of CASAC, the Administrator proposes that
the current 24-hour and annual standards are not requisite to protect
public health with an adequate margin of safety. The Administrator
proposes to establish a new 1-hour standard that will afford increased
protection for asthmatics and other at-risk populations against an
array of adverse respiratory health effects related to short-term (5-
minutes to 24-hours) SO2 exposure. These effects include
increased decrements in lung function (defined in terms of sRaw and
FEV1), increases in respiratory symptoms, and related
serious indicators of respiratory morbidity including emergency
department visits and hospital admissions for respiratory causes.
Specifically, the Administrator proposes to set a new short-term
primary SO2 standard with a 1-hour (daily maximum) averaging
time and a form defined as the 3-year average of the 99th percentile or
the 4th highest daily maximum concentration. The level for the new
standard is proposed to be within the range of 50-100 ppb. The
Administrator also solicits comment on levels as high as 150 ppb. In
addition to
[[Page 64846]]
setting a new 1-hour standard in the proposed rage of 50-100 ppb, the
Administrator proposes to revoke the current 24-hour and annual
standards recognizing that a 1-hour standard set in the proposed range
of 50-100 ppb will have the effect of generally maintaining 24-hour and
annual SO2 concentrations well below the levels of the
current 24-hour and annual standards. Moreover, the Administrator notes
that there is little health evidence to support an annual standard for
the purpose of protecting against health effects associated with long-
term SO2 exposures.
III. Proposed Amendments to Ambient Monitoring and Reporting
Requirements
EPA is proposing changes to the ambient air monitoring, reporting,
and network design requirements for the SO2 NAAQS. This
section discusses the changes we are proposing that are intended to
support the proposed 1-hour NAAQS, and the possible retention of the
existing 24-hour NAAQS depending on the selected level of the 1-hour
NAAQS, as described in Section II above. Ambient SO2
monitoring data are used to determine whether an area is in violation
of the SO2 NAAQS. Ambient SO2 monitoring data are
collected by state, local, and tribal monitoring agencies (``monitoring
agencies'') in accordance with the monitoring requirements contained in
40 CFR parts 50, 53, and 58.
A. Monitoring methods
To be used in a determination of compliance with the SO2
NAAQS, SO2 data must be collected using either a Federal
Reference Method (FRM) or a Federal Equivalent Method (FEM) as defined
in 40 CFR Parts 50 and 53. The current monitoring methods in use by
most State and local monitoring agencies are FEM analyzers based on the
ultraviolet fluorescence (UVF) measurement principle. These continuous
analyzers were implemented into the SO2 monitoring networks
in the early 1980s, and the current manual FRM for SO2 is no
longer used for field monitoring. The current list of all approved FRMs
and FEMs capable of providing ambient SO2 data for use in
attainment designations may be found on the EPA Web site http://www.epa.gov/ttn/amtic/files/ambient/criteria/reference-equivalent-methods-list.pdf.
For reasons explained subsequently, EPA proposes to establish a new
FRM for measuring SO2 in the ambient air. This proposed new
FRM for SO2 would be an automated method based on UVF (the
same type of analyzers now in widespread use), and it would be
specified in the form of a reference measurement principle and a
calibration procedure. It would be in a new Appendix A-1 to 40 CFR Part
50. Analyzers approved as FRMs for SO2 after the effective
date of the final rule would be subject to performance specifications
and other requirements set forth in 40 CFR Part 53, under associated
amendments proposed for Part 53. The existing FRM for SO2 (a
wet-chemical, manual method) would be retained for some period of time,
thereby permitting continued use of currently designated FEMs to avoid
any disruption to existing SO2 monitoring networks.
1. Background
FRMs, as set forth in several appendices to 40 CFR Part 50, serve
either or both of two primary purposes. The first is to provide a
specified, definitive methodology for routinely measuring
concentrations of various ambient air pollutants for comparison to the
NAAQS in Part 50 and for other air monitoring objectives. The second is
to provide a standard of comparison for determining equivalence to the
specified reference method of alternative and perhaps more practical
pollutant measurement methods (FEMs) that can be used in lieu of the
FRM for routine monitoring.
Some of the FRMs contained in appendices to Part 50 (such as the
current SO2 FRM) are manual methods that are completely
specified within their respective appendices. Others (such as the ozone
FRM) are in the form of a measurement principle and associated
calibration procedure that must be implemented in a commercial FRM
analyzer model. Such FRM analyzers must be tested and shown to meet
explicit performance and other requirements that are set forth in 40
CFR Part 53 (Ambient Air Monitoring Reference and Equivalent Methods).
Each of these analyzer models is considered to be an FRM only upon
specific designation as such by EPA under the provisions of Part 53.
From time to time, as pollutant measurement technology advances,
the reference methods in these Part 50 appendices need to be assessed
to determine if improved or more suitable measurement technology has
become available to better meet current FRM needs as well as potential
future FRM requirements. Such new technology can either be presented to
EPA for evaluation by an FEM applicant under Sec. 53.16, or (as in
this case) EPA can originate the process itself as provided in Sec.
53.7. If, after reviewing a new methodology, the Administrator
determines that the new methodology is substantially superior, Sec.
53.16 of Part 53 provides for supersession of FRMs under these
circumstances.
The FRM for measuring SO2 in the ambient air was
promulgated on April 30, 1971 (36 FR 8186), in conjunction with EPA's
establishment (originally as 42 CFR Part 410) of the first national
ambient air quality standards (NAAQS) for six pollutants (including
sulfur dioxide) as now set forth in 40 CFR Part 50. This SO2
FRM is specified in Appendix A of Part 50 and identified as the
pararosaniline method. It is a manual, wet-chemical method requiring
sample air to be bubbled through an absorbing reagent
(tetrachloromecurate), which is then returned to a laboratory for
chemical analysis. At the time of its promulgation, the method was
considered the best available method and was in considerable use for
monitoring SO2 in the air. However, newly developed
automated continuous analyzers approved as FEMs rapidly supplanted use
of this manual method for air monitoring in the U.S. By the 1990's, the
FRM was no longer used at all in domestic air monitoring (EPA, 2009b),
and since then the method has been used mainly as a comparison
reference method for the testing and designation of candidate FEMs for
SO2 in accordance with 40 CFR Part 53.
The pararosaniline manual FRM has served its role for many years,
but now a better method is needed that more fully meets the needs of
contemporary SO2 monitoring. The existing FRM is primarily a
24-hour integrated method, whereas a 1-hour SO2 FRM
measurement capability would be needed to implement the proposed 1-hour
SO2 NAAQS. Existing FEM analyzers can and do provide 1-hour
measurement capability, but EPA wishes to facilitate the approval of
new monitoring technologies as well. While the existing manual
reference method can produce 1-hour averages, it is clearly impractical
for routine use in making 1-hour SO2 measurements. Also, the
1-hour mode of the manual method is not a good standard for approving
new FEMs with 1-hour measurement capability, because scores of 1-hour
measurements would be needed during equivalency testing. Further, the
existing FRM is cumbersome to use and requires a mercury-containing
reagent that is potentially hazardous to operators or to the
environment if it is mishandled.
These operational shortcomings suggest that the existing FRM should
be replaced with a more suitable
[[Page 64847]]
methodology. Fortunately, the existing SO2 instrumental
measurement technique based on the UVF measurement principle offers
superior performance and substantial operational advantages, as
reported in an FRM evaluation for EPA produced by Research Triangle
Institute (Rickman, 1987). Analyzers using this technique can well
provide the needed detection limits, precision, and accuracy and
fulfill other purposes of an FRM, including use as an appropriate
standard of reference for testing and designation of new FEM analyzers.
After reviewing these factors, EPA has determined that a new, automated
FRM for SO2 based on the UVF measurement principle should be
adopted. EPA is proposing to add the new FRM in a new Appendix A-1 to
Part 50.
In association with the proposed new FRM, EPA is also proposing to
update the performance-based requirements for FEM SO2
analyzers currently in 40 CFR Part 53. These requirements were
established in the 1970's, based primarily on the wet-chemical
measurement technology available at that time. Those initial
requirements have become significantly outdated and should be modified
to match current technology, particularly because they would apply to
new FRM analyzers under the proposed new FRM. The better instrumental
performance available with the proposed new UVF reference method
technique allows the performance requirements for SO2 in 40
CFR Part 53 to be made more stringent for both FRM and FEM analyzers
(EPA, 2009c).
2. Proposed new FRM measurement technique
Since the 1970's, a variety of measurement principles have been
successfully used to produce continuous analyzers for SO2,
some of which have qualified for EPA designation as equivalent methods
(found at http://www.epa.gov/ttn/amtic/files/ambient/criteria/reference-equivalent-methods-list.pdf). These include methods based on
ultraviolet fluorescence, flame photometry, differential optical
absorption spectroscopy, coulometric and conductometric techniques, and
second derivative ultraviolet absorption spectrometry. Although some of
these techniques saw considerable utilization in the 1970's, their use
dwindled after the introduction of UVF analyzers because of various
shortcomings such as non-specificity for SO2, susceptibility
to interferences, marginal performance, or operational disadvantages
(e.g. requiring hydrogen gas or wet-chemical reagents). Consequently,
the UVF technique has emerged as the clearly dominant measurement
technique for SO2, providing a majority of the domestic air
monitoring data obtained over the last three decades, and virtually
100% of the current monitoring data (EPA, 2009b). As the proposed new
reference method, the UVF technique would be specified in performance-
based form, with a generic reference measurement principle and
associated calibration procedure in a new Appendix A-1 to 40 CFR Part
50. Associated performance requirements applicable to candidate UVF FRM
analyzers would be specified in 40 CFR Part 53. This form of the FRM is
consistent with that specified for FRMs for CO, O3, and
NO2 in Appendices C, D, and F (respectively) to 40 CFR Part
50.
Reasonable commercial availability of high quality analyzers
utilizing the reference measurement principle that can be offered by
multiple manufacturers, ideally over many years, is an important aspect
of any new reference measurement principle. EPA has designated more
than a dozen UVF analyzers as equivalent to the current reference
method over the last 30 years. Although most of the early model UVF
analyzers are no longer in production, many have been replaced by
redesigned and improved models, and entirely new models continue to
become designated as FEMs. Currently, more than a half-dozen designated
FEM models offered by multiple manufacturers are commercially
available. The widespread use of the method has three important
technical advantages for an FRM: (1) A variety of analyzer models are
available and will likely continue to be available from multiple
manufacturers for many years to come, (2) analyzer manufacturers have
had (and continue to have) a strong marketing incentive to improve,
refine, perfect, and continue to market such analyzers, and (3) the
number of accumulated UVF field monitoring datasets (including related
QC data) provide an extensive, available performance track record that
can be evaluated to assess the performance of the analyzers in actual
monitoring use.
The only other equivalent method measurement technique that has
even a small representation among currently available FEM analyzers is
the differential optical absorption spectrometric method. The open-path
nature of this method (measurement of pollutants in the open air
without a closed measurement cell) is not suitable for many of the
purposes of a reference method. Further, this method is only available
as two product models from two manufacturers, and very few State and
local monitoring agencies are using such analyzers.
The UVF technique is not without some imperfections as a reference
method. Analyzers utilizing the technique are, to a limited degree,
susceptible to interference from aromatic hydrocarbon species and
potentially other compounds at existing levels or levels that may occur
at many monitoring sites. However, analyzer manufacturers have
developed very effective ways to reduce these potential limitations,
including careful selection of wavelengths, optimum optical design, and
sample air scrubbers, such that typical interferences are minimal.
All UVF analyzers that have been designated as SO2 FEMs
have been tested and shown to meet the existing performance
requirements of 40 CFR Part 53. These include required testing for both
positive and negative potential interferents, minimum level of
measurement, zero and span drift, and precision. The results of these
tests have been submitted to EPA and are in the archived FEM
applications for these analyzers. Many newer models substantially
exceed those requirements, with sensitivities down to less than 1 ppb,
and typically commensurate levels of signal noise, precision, and zero
drift (EPA, 2009c). In addition, UVF analyzers can accommodate a wide
range of concentration measurement ranges. They are quite well suited
to measure high, short-term SO2 concentrations near sources,
and they can also be used to measure trace-level concentrations in
clean areas.
For these reasons, EPA has decided to propose a new automated
SO2 FRM based on the UVF measurement technology. EPA is
confident that commercially available UVF instrument models would
provide capability to serve not only current monitoring and FRM
applications but anticipated monitoring and FRM needs well into future
years. EPA solicits comment on the proposal to promulgate an FRM for
SO2 that would be an automated method based on ultraviolet
fluorescence, which would be specified in the form of a reference
measurement principle and calibration procedure, as stated here, and
contained in a new Appendix A-1 to 40 CFR Part 50.
3. Technical description of the proposed UVF FRM
The proposed new reference method is based on automated measurement
of the intensity of the characteristic fluorescence released by
SO2 in an ambient air sample when irradiated by ultraviolet
light. The SO2 fluorescence produced is also in the
ultraviolet range,
[[Page 64848]]
but is measured at a longer wavelength. An analyzer implementing this
measurement principle would include a measurement cell, an ultraviolet
light source of appropriate wavelength, an ultraviolet detector system
with appropriate wavelength sensitivity, and a pump and flow control
system for sampling the ambient air. Generally, the analyzer also
requires a means to reduce concentrations of aromatic hydrocarbons and
possibly other compounds (depending on target wavelengths and other
parameters used) in the air sample to control for potential measurement
interferences. The analyzer is calibrated by referencing the
instrumental fluorescence measurements to SO2 standard
concentrations traceable to a NIST (National Institute of Standards and
Technology) primary standard for SO2. This generic
description of the FRM would be contained in Appendix A-1 to 40 CFR
Part 50 and would be coupled with explicit analyzer performance
requirements specified in Subpart B of 40 CFR Part 53. To qualify as an
FRM, an analyzer model based on this principle would have to be tested
in accordance with test procedures in Subpart B Part 53 and shown to
meet the performance requirements specified in that Subpart. EPA could
then designate the analyzer model as an FRM analyzer, as provided in
Part 53.
4. Implications to air monitoring networks
Under Sec. 53.16, EPA must consider the benefits of a proposed
supersession of an existing reference method, the potential economic
consequences of such action for State and local monitoring agencies,
and any disruption of State and local air quality monitoring programs
that might result from such action. Supersession of an existing
reference method, as described in Sec. 53.16, presumes that the
existing FRM would be deleted from Part 50 and replaced with a new FRM,
and that all equivalent methods based on the old FRM would be
cancelled. In the case of SO2, essentially all current
domestic air monitoring activity is carried out using FEM UVF
analyzers. Cancellation of the FEM designations of all these analyzers
now would be potentially very disruptive to State, local, and other
monitoring networks, even though Sec. 53.16 alludes to a possible
transition period to allow monitoring agencies some period of time to
replace cancelled FEM analyzers.
EPA recognizes that these existing SO2 FEMs are
providing monitoring data that are adequate for the current and the
proposed SO2 NAAQS and for many other purposes, and there
appears to be no need or purpose served by their withdrawal. Therefore,
in this case, EPA proposes instead to retain the existing manual FRM
for SO2 and to promulgate an entirely new automated FRM for
SO2. The new FRM description would be contained in a new
Appendix A-1 to 40 CFR Part 50, and the existing FRM would be re-
codified as Appendix A-2 to 40 CFR Part 50, with both reference methods
coexisting. Following adoption of the new Appendix A-1, new language
proposed for Sec. 53.2(a) and (b) would provide that new FRM and FEM
analyzers for SO2 be designated only with reference to the
proposed new Appendix A-1. At the same time, retention of the existing
SO2 reference method will preclude the need to cancel the
designations of all existing FEMs for SO2.
Under this proposal, no monitoring agencies would be required to
change their SO2 monitoring procedures as a result of the
proposed changes, so it would have no economic costs for implementation
and no disruptive effects on state, local, or tribal air quality
monitoring programs. Further, since UVF FEM analyzers have been in
dominant use for many years, no bias or discontinuity in any aspect of
the monitoring data obtained subsequently would result from the
proposed change in the SO2 reference methodology.
In conjunction with the proposed new FRM, EPA is also proposing to
adopt updated performance requirements in 40 CFR Part 53, applicable to
both FRM and FEM analyzers, consistent with the automated methods and
in anticipation of future NAAQS needs. This would ensure that, going
forward, all new SO2 monitors would have improved
performance. EPA believes that the proposal to retain the existing FRM
while adding the new FRM would provide for a smooth, evolutionary
transition from the older, manual FRM to the new, modern, automated FRM
and FEM technology and the associated better performance requirements,
with no immediate impact to current monitoring activities. For purposes
of comparing SO2 monitoring data to the SO2
NAAQS, the EPA believes that the UVF FEMs are appropriate for continued
use under the current standards and under the option being considered
for a new 1-hour averaged primary SO2 NAAQS. After several
years, at a time when either a new SO2 NAAQS would require
higher monitoring data quality or there would be no further potential
for disruption to monitoring agencies, EPA would plan to withdraw the
older reference method and it's associated FEMs.
5. Proposed revisions to 40 CFR Part 53
Several amendments associated with the proposed new SO2
reference measurement principle are proposed to 40 CFR Part 53. The
most significant of these would update the performance requirements for
both new FRM and new FEM analyzers for SO2, as set forth in
proposed revised Table B-1. Based on typical performance capabilities
available for UVF analyzers, EPA is proposing to reduce the allowable
noise from 5 ppb to 1 ppb, the lower detectable limit from 10 ppb to 2
ppb, and the allowable interference equivalent limits from 20 ppb to 5 ppb for each interferent and from 60 ppb
to 20 ppb for the total of all interferents. Also, EPA proposes to
change the allowable zero drift limits from 20 ppb to
4 ppb, and to delete the specified limits for span drift at
20% of the upper range limit (URL) for SO2 analyzers. Review
of FEM analyzer performance test results has shown that the 20% URL
span limit requirements are unnecessary because drift performance
requirements are adequately covered by the zero drift and 80% URL span
drift limits. EPA proposes to change the lag time allowed from 20 to 2
minutes and change the rise and fall time limits from 15 to 2 minutes.
For precision, EPA proposes to change the form of the precision limit
specifications from ppm to percent (of the URL) for SO2
analyzers and to set the limit at 2 percent for both 20% and 80% of the
URL. Two percent is equivalent to 10 ppb for the standard (500 ppb)
range, which is equivalent to the existing limit value for precision at
20% of the URL, but would be a reduction from 15 ppb to 10 ppb for the
limit value at 80% of the URL. This change in units from ppm (or ppb as
given here) to percent makes the requirement responsive to higher and
lower measurement ranges. Also, a new footnote is proposed to be added
to Table B-1 to clarify how noise tests are to be carried out for
candidate analyzers having an adjustable or automatic time constant
capability.
EPA recognizes that SO2 monitoring needs can vary
widely, from monitoring background levels in pristine areas to
measuring short-term (1-hour) or even very short-term (less than 1-
hour) high-level averages in the vicinity of substantial sources of
SO2. To address the need for more sensitive, lower
measurement ranges for SO2 analyzers, EPA is proposing a
separate set of performance requirements that would apply specifically
to narrower measurement ranges, i.e. ranges extending from zero to
concentrations
[[Page 64849]]
less than 0.5 ppm. These additional requirements are listed in the
proposed revised Table B-1. A candidate analyzer that meets the Table
B-1 requirements for the standard measurement range (0 to 0.5 ppm)
could optionally have one or more narrower ranges included in its FRM
or FEM designation by further testing to show that it meets these
supplemental, narrower-range requirements.
At the other (high) end of the concentration measurement spectrum,
another related change proposed for Sec. 53.20 would allow optional
designation of measurement ranges for SO2 up to 2 ppm rather
than 1 ppm as is now permitted, and designation of these higher ranges
would be applicable to both FRM and FEM analyzers. Such higher ranges
are often needed for measurement of short-interval SO2
averages. Finally, EPA is proposing to clarify in Sec. 53.20 that
optional testing for auxiliary higher or lower measurement ranges (for
all gaseous pollutants) may include tests for only some of the
performance parameters, since the test results for the other
performance parameters carried out for the standard measurement range
would be technically applicable and adequate for the higher and/or
lower ranges as well.
EPA believes that these changes in performance requirements are
appropriate, based on analyzer performance data available from analyzer
manuals and recent FEM applications. EPA solicits comments especially
from UVF instrument users and manufacturers on these proposed changes,
particularly in regard to whether they are reasonable, appropriate, of
significant benefit, and achievable without undue cost. Comments are
also requested on such issues as the trade off between a high
measurement range and the need for adequate resolution at
concentrations near the annual NAAQS, a similar trade off between noise
level and response time (some analyzers allow these parameters to be
adjusted by the operator or may adjust them automatically based on the
rate of change of the concentration level), and whether such
performance parameters should be addressed in more detail in 40 CFR
Part 53. In particular, should SO2 analyzer requirements
address the potential need for faster measurement response time to
permit more accurate monitoring of short-term intervals such as 5-
minute or 10-minute averages, and are the special performance
requirements EPA is proposing for measuring very low levels (trace
levels) of SO2 appropriate and effective?
Another significant change proposed to 40 CFR Part 53 would add
some low and medium level 1-hour comparability tests to the Subpart C
comparability test requirements, as specified in Table C-1. These would
help to ensure that the 1-hour measurement performance of candidate
FEMs are adequate, relative to the FRM. Also, EPA proposes to amend
Table A-1 in Subpart A to reflect the new FRM description in proposed
new Appendix A-1 of 40 CFR Part 50. This table would also be amended to
correct some printing errors in the current table as well as to add new
entries related to the new FRM for lead in PM10 that was
recently promulgated. Other minor changes would be necessary in the
wording of a few sections of Subparts A and B due to the proposed
change in the nature of the SO2 FRM from a manual to an
automated method or to update the language. These changes are reflected
in the proposed regulatory text section of this notice.
EPA proposes additional minor revisions to Tables B-2 and B-3 of
Subpart B. The changes proposed to Table B-2 would update some of the
analytical methods for generation or verification of SO2 and
interferent test concentrations and their associated references.
Similarly, Table B-3 would be updated to add a specific listing for
ultraviolet fluorescent methods and to add a few additional interferent
test species for some other measurement techniques that have been found
from experience to be needed.
B. Network design
1. Background
The basic objectives of an ambient monitoring network, as noted in
40 CFR Part 58 Appendix D, include (1) providing air pollution data to
the general public in a timely manner, (2) supporting compliance with
ambient air quality standards and emissions strategy development, and
(3) providing support for air pollution research. The SO2
network was originally deployed to support implementation of the
SO2 NAAQS established in 1971. Although the SO2
standard was established in 1971, EPA did not establish uniform minimum
monitoring requirements for SO2 monitoring until May 1979.
From the time of the implementation of the 1979 monitoring rule,
through 2008, the SO2 network has steadily decreased in size
from approximately 1496 sites in 1980 to the approximately 488 sites
operating in 2008 (Watkins and Thompson, 2009). The reduction in
network size is due in part to the change in the source sector
contributions to the overall SO2 inventory and the general
decline of ambient SO2 levels over time. In the early
decades of the SO2 network, particularly the 1970s, there
was a wider variety of more ubiquitous SO2 sources in urban
areas, including residential coal and oil furnaces, when compared to
the stationary source, electric generating unit (EGU)-dominated
inventories of today (see below). The situation in the 1970s led to a
network design keyed on population, an appropriate approach at the time
considering the close proximity of sources and people, particularly in
urban, residential settings (Watkins and Thompson, 2009).
An analysis of the approximately 488 monitoring sites comprising
the current (2008) SO2 monitoring network indicates that
just under half (46%) of the sites in the current SO2
network are reported to be for the assessment of concentrations for
general population exposure. As for the present day inventory, the 2005
NEI (http://www.epa.gov/ttn/chief/net/2005inventory.html) indicates
that SO2 emissions from EGUs contribute approximately 70% of
the anthropogenic SO2 emissions in the U.S. However, only
approximately one third (35%) of the network is reported to be
addressing locations of maximum (highest) concentrations, likely linked
to a specific source or group of sources such as EGUs.
The current network supports the reporting of 1-hour data to EPA's
Air Quality System (AQS) database, as required in Sec. 58.12 of 40 CFR
Part 58, since the network utilizes the continuous UVF FEM, which can
provide time-resolved data averaged over periods as short as several
minutes. The routine submittal of hourly data by state, local, and
tribal air monitoring agencies to AQS is suitable for use in comparison
to both of the current primary 24-hour and annual NAAQS. There are a
few monitoring agencies who also report 5-minute data voluntarily to
AQS.
The current network is sited at a variety of spatial scales;
however a majority of the network, just over sixty percent, is sited at
the neighborhood spatial scale\32\ (Watkins and Thompson,
[[Page 64850]]
2009). Although there are 488 SO2 monitors operating in the
network, there are currently no minimum monitoring requirements for
SO2 in 40 CFR part 58 Appendix D, other than the following
three: (1) SO2 must be monitored at National Core (NCore)
monitoring sites (discussed below), (2) the EPA Regional Administrator
must approve the removal of any existing monitors, and (3) any ongoing
SO2 monitoring must have at least one monitor sited to
measure the maximum concentration of SO2 in that area.
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\32\ Spatial scales are defined in 40 CFR Part 58 Appendix D,
Section 1.2, where the scales of representativeness include:
1. Microscale--Defines the concentration in air volumes
associated with area dimensions ranging from several meters up to
about 100 meters.
2. Middle scale--Defines the concentration typical of areas up
to several city blocks in size, with dimensions ranging from about
100 meters to 0.5 kilometers.
3. Neighborhood scale--Defines concentrations within some
extended area of the city that has relatively uniform land use with
dimensions in the 0.5 to 4.0 kilometers range.
4. Urban scale--Defines concentrations within an area of city-
like dimensions, on the order of 4 to 50 kilometers. Within a city,
the geographic placement of sources may result in there being no
single site that can be said to represent air quality on an urban
scale. The neighborhood and urban scales have the potential to
overlap in applications that concern secondarily formed or
homogeneously distributed air pollutants.
5. Regional scale--Defines usually a rural area of reasonably
homogeneous geography without large sources, and extends from tens
to hundreds of kilometers.
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The SO2 monitors that are required as part of the
National Core monitoring network (NCore) were not required solely for
providing direct support of the SO2 NAAQS. The monitoring
rule promulgated in 2006 (71 FR 61236) and codified at 40 CFR Part 58
and its Appendices established the NCore multi-pollutant network
requirement to support integrated air quality management data needs.
Further, NCore is intended to establish long-term sites providing data
for air quality trends analysis, model evaluation, and, for urban
sites, tracking metropolitan air quality statistics. To do this, NCore
sites are required to measure various pollutants, including
SO2, but are not sited to monitor maximum concentrations of
SO2. NCore sites provide data representing concentrations at
the broader neighborhood and urban spatial scales. The data from the
NCore sites will be compared to the NAAQS although, as noted earlier,
NAAQS comparisons are not the primary objective of NCore. The NCore
network, which will be fully implemented by January 1, 2011, will
result in approximately 83 sites, each with an SO2 monitor,
with approximately 60 sites being located in urban areas.
As set out in detail in section II.B of this notice, there is a
causal relationship between short-term SO2 exposure and
respiratory morbidity, with ''short-term'' meaning exposures from 5-10
minutes up to and including 24 hours. This finding is based primarily
on results from controlled human exposure studies of 5-10 minutes as
well as epidemiologic studies using mostly 1-hour daily maximum and 24-
hour average SO2 concentrations. Importantly, the ISA
described the controlled human exposure studies of 5-10 minutes as
being the ``definitive evidence'' for this conclusion (ISA, section
5.2). In addition, when describing epidemiologic studies observing
positive associations between ambient SO2 and respiratory
symptoms, the ISA stated ``that it is possible that these associations
are determined in large part by peak exposures within a 24-hour
period'' (ISA, section 5.2 at p. 5-5). The ISA also stated that the
respiratory effects following 5- to 10-minute SO2 exposures
in controlled human exposure studies provide a basis for a progression
of respiratory morbidity that could result in increased ED visits and
hospital admissions (ISA, section 5.2). Thus, the monitoring network to
support the proposed NAAQS should be focused on identifying the
expected maximum short-term concentrations in any particular area.
The ISA (Section 2.1) indicates that point (i.e., stationary)
sources account for approximately 95% of the total anthropogenic
SO2 emissions in the U.S. According to the 2005 National
Emissions Inventory (http://www.epa.gov/ttn/chief/net/2005inventory.html), electrical generating units (EGUs) emit
approximately 70% of the anthropogenic SO2 emissions in the
U.S. The 2005 NEI indicates that the total anthropogenic emission
inventory of SO2 is approximately 14,742 thousand tons per
year. Of those 14,742 thousand tons per year of emitted SO2,
approximately 85% were emitted by stationary sources that emit 100 or
more tons per year (comprising approximately 1,928 of the 32,988
facilities listed in the 2005 NEI). This information indicates that a
relatively small number (6%) of all SO2 emitting stationary
sources are responsible for a large majority of the total anthropogenic
emissions inventory (85%) in the U.S. Therefore, monitors sited to
reflect locations of expected maximum concentrations should be
primarily oriented towards locations influenced by one or a cluster of
high SO2 emitting sources.
As noted in the key observations of the exposure analysis of the
REA (REA, Section 8.12), there are a variety of factors that influence
overall population exposure to ground-level concentrations in a given
area, including population density and proximity to sources, emissions
density in an area, and source specific emission parameters such as
stack height, among other factors. In general, however, it is expected
that any short-term peaks that may occur in an area are more likely to
occur nearer to a source or sources, or in an area where multiple
sources are significantly contributing to increased ground level
concentrations (an area with high emissions density).\33\ Given that
maximum ground-level concentrations of SO2 are usually
directly traceable to specific sources, or a cluster of sources, the
network design should support implementation of the proposed 1-hour
SO2 NAAQS by targeting maximum ground-level concentrations
in areas of both higher population and higher emissions.
---------------------------------------------------------------------------
\33\ There is inherent variability in where peak ground level
concentrations may occur in space and time from an individual source
or group of sources, due to multiple factors including tons emitted,
stack height, meteorology, among others. These factors are discussed
further in the Monitor Placement and Siting section of this chapter.
---------------------------------------------------------------------------
2. Proposed changes
In conjunction with the proposed 1-hour primary NAAQS and (if EPA
should adopt a standard at the upper end of the range of levels for
which the Agency is soliciting comment) the potential retention of the
current 24-hour NAAQS, we are proposing a number of changes to the
SO2 monitoring network. As just noted, there are currently
minimum monitoring requirements for SO2 only at NCore sites.
The proposal for a new 1-hour NAAQS necessitates the re-introduction of
minimum monitoring requirements. An analysis of the approximately 488
monitoring sites comprising the current (2008) SO2
monitoring network indicates that just under half (~46%) of the sites
in the current SO2 network are reported to be for the
assessment of concentrations for general population exposure. The
current network was not originally deployed to address current short-
term, peak concentrations, such as those locations nearer to stationary
sources or in areas of higher emissions densities, where maximum hourly
and 5- to 10-minute concentrations are likely to occur. The Agency has
data indicating that only about one third of the existing
SO2 network may be source-oriented monitors and/or sited in
locations of expected maximum concentrations (Watkins and Thompson,
2009).
To fully support the proposed SO2 NAAQS, the monitoring
network needs to identify where short-term, peak ground-level
concentrations--i.e. concentrations from 5 minutes to one hour (or
potentially up to 24 hours)--
[[Page 64851]]
may occur. Due to the multiple variables that affect ground level
SO2 concentrations caused by one or more stationary sources,
it is difficult to specify a source specific threshold, algorithm, or
metric by which to require monitoring in a rule such as this. To
achieve this goal, therefore, EPA is proposing a two-pronged network
design to ensure that States perform a sufficient amount of monitoring
of ambient concentrations of SO2 to determine attainment of
the proposed SO2 NAAQS that intends to prevent exposure to
peak concentrations. EPA anticipates this two-pronged network would
require approximately 345 monitors nationwide, providing data for
comparison with both the proposed 1-hour and the 24-hour standard if
retained. The network would be wholly comprised of monitors sited at
locations of expected maximum hourly concentrations. EPA is proposing
that the two prongs of this SO2 network design would be
distributed based on: (1) A Population Weighted Emissions Index (PWEI)
and (2) the state-level contribution to the national, SO2
emissions inventory. EPA notes that although we propose that the
network include a minimum number of required monitors, State, local,
and tribal agencies may conduct additional monitoring above the minimum
requirements. If those additional monitors satisfy all applicable
requirements in 40 CFR Part 58, the data from those monitors would be
comparable to the NAAQS. EPA estimates that one-half to two-thirds of
the monitors in the existing network (excluding any currently operating
NCore sites) may have to be moved in order to be counted towards the
requirement for monitors sited at locations of expected maximum short-
term concentrations of SO2.
We solicit comment on whether the estimated 348 monitors required
by this proposal, distributed based on the two network design
components presented below, are too few, too many, or suitable to
establish a minimum network sufficient to meet the monitoring
objectives noted above, including supporting compliance with the
proposed 1-hour SO2 NAAQS.
We propose that state and, where appropriate, local air monitoring
agencies submit a plan for deploying SO2 monitors in
accordance with the proposed requirements presented below by July 1,
2011. We also propose that the SO2 network being proposed be
physically established no later than January 1, 2013. Considering the
proposed timeline and criteria presented in the network design, we
solicit comment on whether alternative dates would be more appropriate
as deadlines for state and local monitoring agencies to submit a
monitoring plan. We also solicit comments on whether alternative dates
would be more appropriate as deadlines for state and local monitoring
agencies to physically deploy monitors.
a. Population weighted emissions index (PWEI) triggered monitoring
The EPA proposes that the first prong of the ambient SO2
monitoring network account for SO2 exposure by requiring
monitors in locations where population and emissions may lead to higher
potential for population exposure to peak hourly SO2
concentrations. In order to do this, EPA has developed a Population
Weighted Emissions Index (PWEI) that uses population and emissions
inventory data at the CBSA \34\ level to assign required monitoring for
a given CBSA (population and emissions being obvious relevant factors
in prioritizing numbers of required monitors). The PWEI for a
particular CBSA is calculated by multiplying the population (using the
latest Census Bureau estimates) of a CBSA by the total amount of
SO2 emissions in that CBSA. The CBSA emission value is in
tons per year, and is calculated by aggregating the county level
emissions for each county in a CBSA. We then normalize by dividing the
resulting product of CBSA population and CBSA SO2 emissions
by 1,000,000 to provide a PWEI value, the units of which are millions
of people-tons per year. This calculation has been performed for each
CBSA and has been posted in the docket as ``CBSA PWEI Calculation,
2009''. EPA believes that using this PWEI metric to inform where
monitoring is required is more appropriate for the SO2
network design than utilizing a population-only type of approach, so
that we may focus monitoring resources in areas of the country where
people and emission sources are in greater proximity. In addition,
EPA's initial view is that this PWEI concept is appropriate for
SO2 but is not necessarily transferrable to the other
criteria pollutants. From a very broad vantage point, SO2 is
exclusively a primarily emitted pollutant (i.e. unlike PM2.5
and ozone there is no secondary formation of SO2), is almost
exclusively emitted by stationary sources (unlike NO2, CO,
PM2.5, thoracic coarse PM, and ozone), and is a gaseous
pollutant which is somewhat more subject to transport (unlike Pb in the
Total Suspended Particulate (TSP) and PM10 size fractions).
---------------------------------------------------------------------------
\34\ CBSAs are defined by the U.S. Census Bureau, and are
comprised of both Metropolitan Statistical Areas and Micropolitan
Statistical Areas (http://www.census.gov).
---------------------------------------------------------------------------
We propose that the first prong of the SO2 network
design require monitors in CBSAs, according to the following criteria.
For any CBSA with a calculated PWEI value equal to or greater than
1,000,000, a minimum of three SO2 monitors are required
within that CBSA. For any CBSA with a calculated PWEI value equal to or
greater than 10,000, but less than 1,000,000, a minimum of two
SO2 monitors are required within that CBSA. For any CBSA
with a calculated PWEI value equal to or greater than 5,000, but less
than 10,000, a minimum of one SO2 monitor is required within
that CBSA. EPA believes that the monitors required within these
breakpoints provide a reasonable minimum number of monitors in a CBSA
that considers the combination of population and emissions that exist
in a given CBSA. This proposed requirement is based on factors that
will ensure highly populated areas will receive monitoring even if the
emissions in that area are moderate, which is appropriate given the
fact that the greater population creates increased potential for
exposure to those moderate sources. Additionally, this proposed
requirement also ensures that those areas with higher emissions or
emission densities, with moderate or modest populations will receive
monitoring since those increased emissions are likely to have a
significant impact on whatever population may exist nearby.
EPA estimates that these criteria will result in 231 required sites
in 132 CBSAs. We propose that monitors triggered in this first prong of
the network design must be sited in locations of expected maximum 1-
hour concentrations, at the appropriate spatial scale\35\, within the
boundaries of a given CBSA. EPA also proposes that when state or local
agencies make selections for monitoring sites from a pool of similar
candidate site locations, they shall prioritize monitoring where the
maximum expected hourly concentrations occur in relative greater
proximity to populations. EPA believes that states will likely need to
use some form of quantitative analysis, such as
[[Page 64852]]
modeling, data analysis, or saturation studies to aid in determining
where ground-level SO2 maxima may occur in a given CBSA. The
selection of these sites shall be documented in the Annual Monitoring
Network Plan per Sec. 58.10, which includes a requirement for public
inspection or comment, and approval by the EPA Regional Administrator.
---------------------------------------------------------------------------
\35\ Due to the variability in where maximum ground-level
concentrations may occur (discussed in the Monitor Siting and
Placement section of this chapter), the appropriate spatial scales
within which an SO2 monitor might be placed include the
microscale, middle, and neighborhood scales, which are defined in 40
CFR Part 58 Appendix D. [could also refer to the fn above where
these are described]
---------------------------------------------------------------------------
EPA solicits comment on (1) the use of the Population Weighted
Emissions Index (PWEI), (2) the PWEI calculation method, (3) the PWEI
breakpoints that correlate to a number of required monitors, (4) the
requirement that the monitors shall be sited in locations of expected
maximum 1-hour concentration, and (5) that state or local agencies
making selections for monitoring sites from a pool of similar candidate
site locations shall prioritize monitoring where the maximum expected
hourly concentrations occur in relative greater proximity to
populations.
EPA recognizes that CBSA populations and emissions inventories
change over time, suggesting a need for periodic review of the
monitoring network. At the same time, EPA recognizes the advantages of
a stable monitoring network. Therefore, while EPA currently provides
for updates of the NEI every 3 years, EPA believes that the current
network review requirements per Sec. 58.10 which requires an annual
network plan and recurring 5-year assessments provide a suitable
schedule for planning and assessing the monitoring network. Through the
5-year assessments, states will be in a position to review emissions
distributions from updated NEIs to calculate PWEI values for each CBSA
and subsequently assess whether the operational monitoring network
remains appropriate. EPA proposes that the number of sites required to
operate as a result of the PWEI values calculated for each CBSA be
reviewed and revised for each CBSA through the 5-year network
assessment cycle required in Sec. 58.10. EPA solicits comment on
whether such adjustments to the network should be required on a 5-year
cycle that matches the general frequency of network assessments or some
other frequency.
b. State-level emissions triggered monitoring
As the second prong of the SO2 network, we are proposing
to require a monitor or monitors in each state, allocated by state-
level SO2 emissions. In this prong, EPA proposes to
distribute approximately 117 sites, based on the corresponding percent
contribution of each individual state to the national anthropogenic
SO2 emission inventory. This prong of the network design is
intended to allow a portion of the overall required monitors to be
placed where needed, independent of the PWEI, inside or outside of
CBSAs. EPA proposes to require monitors, using state boundaries as the
geographic unit for allocation purposes, in proportion to a state's SO2
emissions, i.e., a state with higher emissions will be required to have
a proportionally higher number of monitors. The proposed percent
contribution of individual states is based on the most recent NEI, with
SO2 emissions being aggregated by state. Each one percent
(after rounding) would correspond to one required monitor. For example,
according to the 2005 NEI, the State of Ohio contributes 8.66% of the
total anthropogenic SO2 inventory, which would correspond to
requiring nine monitors to be distributed within Ohio. Further, EPA
proposes that each state have at least one monitor required as part of
this second prong, even if a particular state contributes less than
0.5% of the total anthropogenic national emissions inventory. As a
result, approximately 117 monitoring sites would be required and
distributed based on state-level SO2 emissions in the most
recent NEI, which in this case, is the 2005 NEI. EPA solicits comment
on the use of state-level emission inventories based on the most recent
NEI to proportionally distribute approximately one third (117 sites) of
the required monitoring network.
According to the most recent NEI, for this proposed second prong,
we estimate the state/percent contribution to the national inventory/
required monitor distribution to be:
Table 5--State-level Emission Triggered Monitors--This Table Shows State
and Territory Level Contributions to the National SO2 Inventory and the
Corresponding Number of Monitors Required for Each State as Proposed in
Prong 2 of the Proposed Network Design
------------------------------------------------------------------------
Percent
contribution to Proposed number
State or Territory the national SO2 of required
inventory monitors
(percent)
------------------------------------------------------------------------
Alabama........................... 4.02 4
Alaska............................ 0.46 1
American Samoa.................... N/A 1
Arizona........................... 0.60 1
Arkansas.......................... 0.77 1
California........................ 1.48 1
Colorado.......................... 0.54 1
Connecticut....................... 0.23 1
Delaware.......................... 0.58 1
District of Columbia.............. 0.03 1
Florida........................... 4.40 4
Georgia........................... 5.07 5
Guam.............................. N/A 1
Hawaii............................ 0.08 1
Idaho............................. 0.16 1
Illinois.......................... 3.51 4
Indiana........................... 7.10 7
Iowa.............................. 1.50 2
Kansas............................ 1.33 1
Kentucky.......................... 3.88 4
Louisiana......................... 2.40 2
Maine............................. 0.25 1
Maryland.......................... 2.58 3
Massachusetts..................... 1.07 1
[[Page 64853]]
Michigan.......................... 3.32 3
Minnesota......................... 1.05 1
Mississippi....................... 0.81 1
Missouri.......................... 2.8 3
Montana........................... 0.26 1
Nebraska.......................... 0.82 1
Nevada............................ 0.49 1
New Hampshire..................... 0.43 1
New Jersey........................ 0.69 1
New Mexico........................ 0.32 1
New York.......................... 2.65 3
North Carolina.................... 4.40 4
North Dakota...................... 1.08 1
Northern Mariana Islands.......... N/A 1
Ohio.............................. 8.66 9
Oklahoma.......................... 1.12 1
Oregon............................ 0.32 1
Pennsylvania...................... 7.96 8
Puerto Rico....................... N/A 1
Rhode Island...................... 0.06 1
South Carolina.................... 2.06 2
South Dakota...................... 0.19 1
Tennessee......................... 2.63 3
Texas............................. 6.34 6
Utah.............................. 0.35 1
Vermont........................... 0.05 1
Virgin Islands.................... N/A 1
Virginia.......................... 2.34 2
Washington........................ 0.45 1
West Virginia..................... 3.63 4
Wisconsin......................... 1.79 2
Wyoming........................... 0.83 1
------------------------------------------------------------------------
EPA proposes siting requirements for this second prong of required
monitors to be the same as those in the first prong: siting in
locations of expected maximum 1-hour concentrations, at the appropriate
spatial scale, within the boundaries of a given state, and prioritizing
the selection of candidate sites where the maximum expected hourly
concentrations occur in greater proximity to populations. This again
would need to be determined case-by-case using quantitative analysis,
such as modeling, data analysis, or saturation studies to aid in
determining where ground-level SO2 maxima may occur in a
given state. We propose that these monitors can be located inside or
outside of CBSA boundaries. However, if a monitor required by the
second prong is placed inside a CBSA that already has a requirement for
monitoring due to the first prong of this network design, that monitor
would not be allowed to count towards satisfying the first prong
requirements. As noted for the first prong of required monitors, the
selection of these sites shall be documented in the Annual Monitoring
Network Plan per Sec. 58.10, which includes a requirement for public
inspection or comment, and approval by the EPA Regional Administrator.
The EPA solicits comment on (1) the use of state-level emission
inventories to proportionally distribute required monitors, (2)
requiring each state to have at least one monitor under this prong of
the network design, and (3) requiring all monitors to be sited in
locations of expected maximum 1-hour concentration inside or outside of
CBSAs.
EPA recognizes that emissions inventories change over time,
suggesting a need for periodic review of the monitoring network. At the
same time, EPA recognizes the advantages of a stable monitoring
network. Therefore, while EPA currently provides for updates of the NEI
every 3 years, EPA believes that the current network review
requirements per Sec. 58.10 which requires an annual network plan and
recurring 5-year assessments provide a suitable schedule for planning
and assessing the monitoring network. Through the 5-year assessments,
states will be in a position to review emissions distributions from
updated NEIs to assess whether the monitoring requirements remain
appropriate. EPA proposes that the number of sites required to operate
as a result of state-level emissions be reviewed and revised for each
state through the 5-year network assessment cycle required Sec. 58.10.
EPA solicits comment on whether such adjustments to the network should
be required on a 5-year cycle that matches the general frequency of
network assessments or some other frequency.
c. Monitor placement and siting
Sites that are to be placed in locations of expected maximum 1-hour
concentrations, will also likely discern 5-minute peaks as well. EPA
expects that in general, these locations will be in proximity to larger
emitting sources (in tons per year) and/or areas of relatively high
emissions densities where multiple sources may be contributing to peak
ground-level concentrations. The variability in where such locations
exist relative to the
[[Page 64854]]
responsible emission source(s) depends on multiple factors including
the tonnage emitted by a source (or group of sources), stack height,
stack diameter, emission exit velocity, emission temperature, terrain,
and meteorology. Depending on these variables, plumes may heavily
fumigate areas immediately downwind of a source, or may never truly
touch down at all, dispersing into ambient air where SO2
concentrations continually decrease with increasing distance away from
the source. This is illustrated in an example where a relatively large
source with a tall stack height may not produce exceedingly high ground
level concentrations anywhere along its plume trajectory while a
smaller source with a relatively short stack may cause relatively
higher ground level concentrations under the same meteorological
conditions at the same location. The primary reason for this
variability is because the peak impacts of sources with higher stacks
will generally be farther downwind and may be more variably located
than is the case for sources with shorter stacks. Further, depending on
meteorology, an emission plume from an individual source may cause
increased ground-level concentrations at any heading, relative to the
parent source, corresponding to the prevailing winds.
When analyzing a particular source, a state may find multiple
locations where peak ground-level concentrations may occur around an
individual source. EPA does not intend for multiple monitors to be
sited around or in proximity to one source. Not siting multiple
monitors around, or in proximity, to one source ensures that more
individual sources or groups of sources will receive attention by the
monitoring network. States always have the discretion to perform
additional monitoring above the minimum requirements to increase
monitoring around a particular source or group of sources.
Due to the variability of how, when, where, and to what degree a
source or group of sources can contribute to peak, ground-level
SO2 concentrations, EPA expects that State and local
monitoring agencies will need to analyze all relevant information,
including available ambient and emissions data, and potentially use air
quality modeling or saturation studies to select appropriate monitoring
site locations. Further, due to the variability in where maximum
ground-level concentrations may occur, the appropriate spatial scales
within which a monitor might be placed include the microscale, middle,
and neighborhood scales, which are defined in 40 CFR Part 58 Appendix
D. EPA believes that states, in evaluating a source (or group of
sources) that contribute to a peak ground-level SO2
concentration that varies with space and time, should identify where
the highest concentrations are expected to occur in developing
candidate site locations. EPA proposes that when state and local
agencies make selections for monitoring sites from candidate site
locations, they shall prioritize monitoring where the maximum expected
hourly concentrations occur in greater proximity to populations. EPA
solicits comment on the role of population exposure in the site
selection process.
d. Monitoring required by the regional administrator
In addition to the two prongs of the proposed SO2
network design, we propose that the Regional Administrator will have
discretion to require monitoring above these minimum requirements under
prongs 1 and 2, as necessary to address situations where the minimum
monitoring requirements are not sufficient to meet monitoring
objectives noted above. EPA recognizes that the minimum required
monitors in the proposed network design under the two prongs described
above are based on indicators that may not provide for all the
monitoring that may be necessary in an area. An example where EPA
envisions requiring an additional monitor might be a case where a
source having modest emissions still has high potential to cause a
violation of the NAAQS in a community or neighborhood. This situation
might occur where a modest SO2 source has, for example, a
low emission stack and/or is in an area where meteorological conditions
cause situations, such as inversions or stagnation, that might lead to
high ground-level concentrations of SO2. In this example,
such a monitor might be needed even though a state is fulfilling its
monitoring requirements under the first and second prongs of the
proposed network design. The purpose of this provision is to monitor in
and provide data for otherwise non-monitored locations that have the
potential to exceed the level of the NAAQS or that are perceived to
have higher exposure risks due to proximity to a source or sources. In
such an example, the Regional Administrators may make use of any
available data including existing model data, existing data analyses,
or screening tools such as AERSCREEN or SCREEN3, to inform a decision
of whether or not a monitor should be required for a given area or
location. Any monitor required through the Regional Administrator and
selected by the state or local agency would be included in the Annual
Monitoring Network Plan per Sec. 58.10, which includes a requirement
for public inspection or comment, and approval by the EPA Regional
Administrator. In any case, EPA encourages state, local, and tribal
monitoring agencies to provide input and information to the appropriate
Regional Administrators in determining whether additional monitors are
needed and the locations of such monitors. We solicit comment on the
proposal to allow Regional Administrators the discretion to require
monitoring above the requirements under prongs 1 and 2 for any area or
location where those monitoring requirements are not sufficient to meet
monitoring objectives.
EPA notes that existing requirements detailed in Sec. 58.14(c)
address certain conditions where existing monitors can be shut down,
with EPA Regional Administrator approval. EPA is not reopening or
otherwise reconsidering this provision. However, this requirement is
noted here so that state or local agency requests to potentially
relocate SO2 monitors to meet the proposed requirements of
prongs 1 or 2 will be considered with the specific provisions of Sec.
58.14(c) in mind.
e. Alternative network design
EPA solicits comments on alternative network designs, including
alternative methods to determine the minimum number of monitors per
state. We are particularly interested in whether a screening approach
for assessing the likelihood of a NAAQS exceedance could be developed
and serve as a basis for determining the number and location of
required monitors.
More specifically, EPA requests comment on whether it should
utilize existing screening tools such as AERSCREEN or SCREEN3, which
use parameters such as effective stack height and emissions levels to
identify facilities with the potential to cause an exceedance of the
proposed standard. For that set of sources, EPA could then require
states to conduct more refined modeling (likely using the American
Meteorological Society (AMS)/EPA Regulatory Model (AERMOD)) to
determine locations where monitoring should be conducted. Any screening
or modeling would likely be carried out by states by using EPA
recommended models and techniques referenced by 40 CFR Part 51,
Appendix W, which provides guidance on air quality modeling. Such
screening or modeling uses facility emission tonnage, stack heights,
stack diameters, emission temperatures, emission velocities, and
accounts for local terrain and meteorology in determining where
[[Page 64855]]
expected maximum hourly concentrations may occur. In using this
approach, EPA would then require states to locate monitors at the point
of maximum concentration around sources identified as likely causing
NAAQS exceedances.
This approach could lead to monitors being required at a
significantly larger number of locations than under the proposed
approach. For example, the NEI shows that 2,407 sources emit 50 tons
per year or more of SO2, while 1,928 sources emit 100 tons
per year or more of SO2. If, for example, the state
screening approach found that a substantial fraction of those 50 or 100
ton per year sources had a significant probability of violating the
NAAQS, states could be required to model, evaluate, and potentially
monitor a corresponding number of sources. EPA also notes that this
alternative approach would not distinctly use population as a factor
for where monitors should be placed. EPA solicits comment on the
resource implications for state and local agencies associated with this
approach.
If EPA selects a standard level near the lower end of the proposed
range, it is likely that a greater number of areas would exceed the
NAAQS, leading to the need for additional monitors. A facility
screening approach, as described above would explicitly account for the
specific parameters of a facility, air quality information, and the
stringency of the standard for determining the number of monitors, in
contrast to the proposed approach. EPA solicits comment on how, in the
absence of a facility screening approach, the number of monitors
required nationwide could be adjusted if EPA finalizes a standard near
the lower end of the proposed range.
C. Data reporting
SO2 UV fluorescence FEMs are continuous gas analyzers,
producing updated data values on the order of every 20 seconds. Data
values are typically aggregated into minute averages and then compiled
into hourly averages for reporting purposes. EPA proposes to retain the
existing requirement that State and local monitoring agencies report
hourly SO2 data to AQS within 90 days of the end of each
calendar quarter. EPA encourages monitoring agencies to voluntarily
report their pre-validated data on an hourly basis to EPA's real time
AIRNow data system.
The definitive evidence for the ISA's conclusion of causal
association between short-term SO2 exposure and respiratory
morbidity is from controlled human exposure studies of 5-10 minutes in
exercising asthmatics (ISA, section 5.2). The REA therefore assessed
exposure and risks associated with 5-minute SO2
concentrations above 5-minute health effect benchmark levels derived
from these controlled human exposure studies. In performing these
analyses, the REA noted that: (1) The majority of the current
SO2 monitoring network reported 1-hour SO2
concentrations (REA section 7.2.3); (2) very few state and local
agencies in the U.S. voluntary reported ambient 5-minute SO2
concentrations, as such reporting is not required (REA, section
10.3.3.2); and (3) the lack of 5-minute monitoring data necessitated
the use of statistically estimated 5-minute SO2
concentrations derived from reported 1-hour SO2 levels (see
REA section 7.2.3) in order to expand the geographic scope of the
exposure and risk analyses. Thus given the demonstrated importance of
5-minute SO2 concentrations, EPA proposes that State and
local agencies shall report to AQS the maximum 5-minute block average
of the twelve 5-minute block averages of SO2 for each hour,
in addition to the existing requirement to report the 1-hour average.
EPA solicits comment on the proposed requirement for state and
local monitoring agencies to report both hourly average and the maximum
5-minute block average out of the twelve 5-minute block averages of
SO2 for each hour. EPA also solicits comment on the
advantages and disadvantages of alternatively requiring state and local
agencies to report all twelve 5-minute SO2 values for each
hour. Having all twelve 5-minute SO2 values for each hour
would provide more detailed information for health research purposes
and provide additional information to help inform the next review of
the SO2 standard. We also solicit comment on alternatively
requiring state and local agencies to report the maximum 5-minute
concentration in an hour based on a moving 5-minute averaging period
rather than time block averaging.
EPA notes the potential resource burden with the proposed
requirement to report 5-minute average values in addition to 1-hour
average values, as is currently required. Accordingly, we solicit
comment on the magnitude and importance of this resource burden,
recognizing that monitoring agencies utilize a variety of automated
data acquisition and management programs, and that the resulting burden
of validating and reporting 5-minute data may vary from a relatively
trivial matter to an issue of greater importance, depending on the
procedures utilized within each agency's data reporting process.
As a part of the larger data quality performance requirements of
the ambient monitoring program, we are proposing data quality
objectives (DQOs) for the proposed SO2 network. The DQOs are
meant to identify measurement uncertainty for a given pollutant method.
We propose a goal for acceptable measurement uncertainty for
SO2 methods to be defined for precision as an upper 90
percent confidence limit for the coefficient of variation (CV) of 15
percent and for bias as an upper 95 percent confidence limit for the
absolute bias of 15 percent. We solicit comment on the proposed DQOs
and on what the acceptable measurement uncertainty should be.
IV. Proposed Appendix T--Interpretation of the Primary NAAQS for Oxides
of Sulfur and Proposed Revisions to the Exceptional Events Rule
The EPA is proposing to add Appendix T, Interpretation of the
Primary National Ambient Air Quality Standards for Oxides of Sulfur, to
40 CFR Part 50 in order to provide data handling procedures for the
proposed SO2 1-hour primary standard. The proposed Sec.
50.11 which sets the averaging period, level, indicator and form of the
NAAQS refers to this Appendix T. The proposed Appendix T would detail
the computations necessary for determining when the proposed 1-hour
primary SO2 NAAQS is met. The proposed Appendix T also would
address data reporting, data completeness considerations, and rounding
conventions.
Two versions of the proposed Appendix T are printed at the end of
this notice. The first applies to a 1-hour primary standard based on
the annual 4th high value form, while the second applies to a 1-hour
primary standard based on the 99th percentile daily value form. (As
explained in section II.F. 3 above, EPA is proposing alternative forms
here based on technical analysis that they are equally effective.) The
discussion here addresses the first of these versions, followed by a
brief description of the differences found in the second version.
For the proposed 1-hour primary standard, EPA is proposing data
handling procedures, a proposed addition of a cross-reference to the
Exceptional Events Rule, a proposed addition to allow the Administrator
discretion to consider otherwise incomplete data to be complete, and a
proposed provision addressing the
[[Page 64856]]
possibility of there being multiple SO2 monitors at one
site.
The EPA is also proposing SO2-specific changes to the
deadlines in 40 CFR 50.14, by which states must flag ambient air data
that they believe have been affected by exceptional events and submit
initial descriptions of those events, and to the deadlines by which
states must submit detailed justifications to support the exclusion of
that data from EPA determinations of attainment or nonattainment with
the NAAQS. The deadlines now contained in 40 CFR 50.14 are generic, and
are not always appropriate for SO2 given the anticipated
schedule for the designations of areas under the proposed
SO2 NAAQS.
A. Background
The general purpose of a data interpretation appendix is to provide
the practical details on how to make a comparison between multi-day and
possibly multi-monitor ambient air concentration data and the level of
the NAAQS, so that determinations of attainment and nonattainment are
as objective as possible. Data interpretation guidelines also provide
criteria for determining whether there are sufficient data to make a
NAAQS level comparison at all.
The regulatory language for the current SO2 NAAQS,
originally adopted in 1977, contains data interpretation instructions
only for the issue of data completeness. This situation contrasts with
the situations for ozone, PM2.5, PM10, and most
recently Pb for which there are detailed data interpretation appendices
in 40 CFR Part 50 addressing issues that can arise in comparing
monitoring data to the NAAQS. EPA has used its experience developing
and applying these other data interpretation appendices to develop the
proposed text for Appendix T.
An exceptional event is defined in 40 CFR 50.1 as an event that
affects air quality, is not reasonably controllable or preventable, is
an event caused by human activity that is unlikely to recur at a
particular location or is a natural event, and is determined by the
Administrator in accordance with 40 CFR 50.14 to be an exceptional
event. Air quality data that is determined, under the procedural steps
and substantive criteria specified in section 50.14, to have been
affected by an exceptional event may be excluded from consideration
when EPA makes a determination that an area is meeting or not meeting
the associated NAAQS. The key procedural deadlines in section 50.14 are
that a State must notify EPA that data have been affected by an event,
i.e., ``flag'' the data in the Air Quality Systems (AQS) database, and
provide an initial description of the event by July 1 of the year after
the data are collected, and that the State must submit the full
justification for exclusion within 3 years after the quarter in which
the data were collected. However, if a regulatory decision based on the
data, for example a designation action, is anticipated, the schedule is
shortened and all information must be submitted to EPA no later than a
year before the decision is to be made. This generic schedule presents
problems when a NAAQS has been recently revised, as discussed below.
B. Interpretation of the primary NAAQS for oxides of sulfur
The purpose of a data interpretation rule for the SO2
NAAQS is to give effect to the form, level, averaging time, and
indicator specified in the proposed regulatory text at 40 CFR 50.11,
anticipating and resolving in advance various future situations that
could occur. The proposed Appendix T provides definitions and
requirements that apply to the proposed 1-hour primary standard for
SO2. The requirements concern how ambient data are to be
reported, what ambient data are to be considered (including the issue
of which of multiple monitors' data sets will be used when more than
one monitor has operated at a site), and the applicability of the
Exceptional Events Rule to the primary SO2 NAAQS.
1. 1-hour primary standard based on the annual 4th high value form
With regard to data completeness for the proposed 1-hour primary
standard, the proposed Appendix follows past EPA practice for other
NAAQS pollutants by requiring that in general at least 75% of the
monitoring data that should have resulted from following the planned
monitoring schedule in a period must be available for the key air
quality statistic from that period to be considered valid. For the
proposed 1-hour primary SO2 NAAQS, the key air quality
statistics are the daily maximum 1-hour concentrations in three
successive years. It is important that sampling within a day encompass
the period when concentrations are likely to be highest and that all
seasons of the year are well represented. Hence, the 75% requirement is
proposed to be applied at the daily and quarterly levels. EPA invites
comment on the proposed completeness requirements.
Recognizing that there may be years with incomplete data, the
proposed text provides that a design value derived from incomplete data
will nevertheless be considered valid in either of two situations.
First, if the design value calculated from at least four days of
monitoring observations in each of these years exceeds the level of the
1-hour primary standard, it would be valid. This situation could arise
if monitoring was intermittent but high SO2 levels were
measured on enough hours and days for the mean of the three annual 4th
highest values to exceed the standard. In this situation, more complete
monitoring could not possibly have indicated that the standard was
actually met.
Second, we are proposing a diagnostic data substitution test which
is intended to identify those cases with incomplete data in which it
nevertheless is very likely, if not virtually certain, that the daily
1-hour design value would have been observed to be below the level of
the NAAQS if monitoring data had been minimally complete.
The diagnostic test would be applied only if there is at least 50%
data capture in each quarter of each year and if the 3-year mean of the
observed annual 4th highest maximum hourly values in the incomplete
data is below the NAAQS level. The test would substitute a high
hypothetical concentration for as much of the missing data as needed to
meet the 100% requirement in each quarter. The value that is
substituted for the missing values is the highest daily maximum 1-hour
observed in the same quarter, looking across all three years under
evaluation. If the resulting 3-year design value is below the NAAQS, it
is highly likely that the design value calculated from complete data
would also have been below the NAAQS, so the original design value
indicating compliance would be considered valid.
It should be noted that one possible outcome of applying the
proposed substitution test is that a year with incomplete data may
nevertheless be determined to not have a valid design value and thus to
be unusable in making 1-hour primary NAAQS compliance determinations
for that 3-year period. EPA invites comment on incorporating the
proposed substitution test into the final rule.
EPA is proposing that the Administrator have general discretion to
use incomplete data to calculate design values that would be treated as
valid for comparison to the NAAQS despite the incompleteness, either at
the request of a state or at her own initiative. Similar provisions
exist already for the PM2.5 and lead NAAQS, and EPA has
recently proposed such provisions to accompany the proposed 1-hour
NO2 and SO2 NAAQS. The Administrator would
[[Page 64857]]
consider monitoring site closures/moves, monitoring diligence, and
nearby concentrations in determining whether to use such data.
2. 1-hour primary standard based on the annual 99th percentile daily
value form
The second version of the proposed Appendix T appearing at the end
of this notice contains proposed interpretation procedures for a 1-hour
primary standard based on the 99th percentile daily value form. The 4th
high daily value form and the 99th percentile daily value form would
yield the same design value in a situation in which every hour and day
of the year has reported monitoring data, since the 99th percentile of
365 daily values is the 4th highest value. However, the two forms
diverge if data completeness is 82% or less, because in that case the
99th percentile value is the 3rd highest (or higher) value, to
compensate for the lack of monitoring data on days when concentrations
could also have been high.
Logically, provisions to address possible data incompleteness under
the 99th percentile daily value form should be somewhat different from
those for the 4th highest form. With a 4th highest form, incompleteness
should not invalidate a design value that exceeds the standard, for
reasons explained above. With the 99th percentile form, however, a
design value exceeding the standard stemming from incomplete data
should not automatically be considered valid, because concentrations on
the unmonitored days could have been relatively low, such that the
actual 99th percentile value for the year could have been lower, and
the design value could have been below the standard. The second
proposed version of Appendix T accordingly has somewhat different
provisions for dealing with data incompleteness. One difference is the
addition of another diagnostic test based on data substitution, which
in some cases can validate a design value based on incomplete data that
exceeds the standard.
The second version of the proposed Appendix T provides a table for
determining which day's maximum 1-hour concentration will be used as
the 99th percentile concentration for the year. The proposed table is
similar to one used now for the 24-hour PM2.5 NAAQS, which
is based on a 98th percentile form, but adjusted to reflect a 99th
percentile form for the 1-hour primary SO2 standard. The
proposed Appendix T also provides instructions for rounding (not
truncating) the average of three annual 99th percentile hourly
concentrations before comparison to the level of the primary NAAQS.
C. Exceptional events information submission schedule
The Exceptional Events Rule at 40 CFR 50.14 contains generic
deadlines for a state to submit to EPA specified information about
exceptional events and associated air pollutant concentration data. A
state must initially notify EPA that data have been affected by an
event by July 1 of the calendar year following the year in which the
event occurred; this is done by flagging the data in AQS and providing
an initial event description. The state must also, after notice and
opportunity for public comment, submit a demonstration to justify any
claim within 3 years after the quarter in which the data were
collected. However, if a regulatory decision based on the data (for
example, a designation action) is anticipated, the schedule to flag
data in AQS and submit complete documentation to EPA for review is
shortened, and all information must be submitted to EPA no later than
one year before the decision is to be made.
These generic deadlines are suitable for the period after initial
designations have been made under a NAAQS, when the decision that may
depend on data exclusion is a redesignation from attainment to
nonattainment or from nonattainment to attainment. However, these
deadlines present problems with respect to initial designations under a
newly revised NAAQS. One problem is that some of the deadlines,
especially the deadlines for flagging some relevant data, may have
already passed by the time the revised NAAQS is promulgated. Until the
level and form of the NAAQS have been promulgated a state does not know
whether the criteria for excluding data (which are tied to the level
and form of the NAAQS) were met on a given day. Another problem is that
it may not be feasible for information on some exceptional events that
may affect final designations to be collected and submitted to EPA at
least one year in advance of the final designation decision. This could
have the unintended consequence of EPA designating an area
nonattainment because of uncontrollable natural or other qualified
exceptional events.
The Exceptional Events Rule at Sec. 50.14(c)(2)(v) indicates
``when EPA sets a NAAQS for a new pollutant, or revises the NAAQS for
an existing pollutant, it may revise or set a new schedule for flagging
data for initial designation of areas for those NAAQS.''
For the specific case of SO2, EPA anticipates that the
signature date for the revised SO2 NAAQS will be June 2,
2010 (a date specified by Consent Decree), that state/tribal
designations recommendations will be due by June 2, 2011, and that
initial designations under the revised NAAQS will be made by June 1,
2012 (since June 2, 2012 would be on a Saturday) and will be based on
air quality data from the years 2008-2010 or 2009-2011 if there is
sufficient data for these data years. (See Section VI below for more
detailed discussion of the designation schedule and what data EPA
intends to use.) Under the current rule, because final designations
would be made by June 1, 2012, all events to be considered during the
designations process would have to be flagged and fully documented by
states one year prior to designations, by June 1, 2011. A state would
not be able to flag and submit documentation regarding events that
occurred between June to December 2011 by one year before designations
are made in June 2012.
EPA is proposing revisions to 40 CFR 50.14 only to change
submission dates for information supporting claimed exceptional events
affecting SO2 data. The proposed rule text at the end of
this notice shows the changes that would apply if a revised
SO2 NAAQS is promulgated by June 2, 2010, and designations
are made two years after such promulgation. For air quality data
collected in 2008, we propose to extend the generic July 1, 2009
deadline for flagging data (and providing a brief initial description
of the event) to October 1, 2010. EPA believes this extension would
provide adequate time for states to review the impact of exceptional
events from 2008 on the revised standard and notify EPA by flagging the
relevant data in AQS. EPA is not proposing to change the foreshortened
deadline of June 1, 2011 for submitting documentation to justify an
SO2-related exceptional event from 2008. We believe the
generic deadline provides adequate time for states to develop and
submit proper documentation.
For data collected in 2009, EPA proposes to extend generic deadline
of July 1, 2010 for flagging data and providing initial event
descriptions to October 1, 2010. EPA is retaining the deadline of June
1, 2011 for states to submit documentation to justify an
SO2-related exceptional event from 2009. EPA plans to assist
the states by providing at the time of signature our assessment of
which monitoring sites and days have exceeded the NAAQS in 2008 and
2009. For data collected in 2010, EPA is proposing a deadline of June
1, 2011 for flagging data and providing initial event descriptions and
[[Page 64858]]
for submitting documentation to justify exclusion of the flagged data.
EPA believes that this deadline provides states with adequate time to
review and identify potential exceptional events that occur in calendar
year 2010, even for those events that might occur late in the year. EPA
believes these deadlines will be feasible because experience suggest
that exceptional events affecting SO2 data are few in number
and easily assessed, so no state is likely to have a large workload.
If a state intends 2011 data to be considered in SO2
designations, 2011 data must be flagged and detailed event
documentation submitted 60 days after the end of the calendar quarter
in which the event occurred or by March 31, 2011, whichever date occurs
first. Again, EPA believes these deadlines will be feasible because
experience suggest that exceptional events affecting SO2
data are few in number and easily assessed, so no state is likely to
have a large workload.
Table 6 summarizes the proposed designation deadlines discussed in
this section and provides designation schedule information from recent,
pending or prior NAAQS revisions for other pollutants. If the
promulgation date for a revised SO2 NAAQS occurs on a
different date than June 1, 2010 (i.e. if the consent decree should be
amended--which EPA does not presently anticipate), EPA will revise the
final SO2 exceptional event flagging and documentation
submission deadlines accordingly, consistent with this proposal, to
provide states with reasonably adequate opportunity to review,
identify, and document exceptional events that may affect an area
designation under a revised NAAQS. EPA invites comment on these
proposed changes in the exceptional event flagging and documentation
submission deadlines for the revised SO2 NAAQS shown in
Table 6.
Table 6--Schedule for Exceptional Event Flagging and Documentation Submission for Data To Be Used in
Designations Decisions for New or Revised NAAQS
----------------------------------------------------------------------------------------------------------------
Air quality data
NAAQS pollutant/ standard/(level)/ collected for Event flagging & initial Detailed documentation
promulgation date calendar year description deadline submission deadline
----------------------------------------------------------------------------------------------------------------
PM2.5/24-Hr Standard (35 [mu]g/m\3\) 2004-2006 October 1, 2007 \a\...... April 15, 2008 \a\.
Promulgated October 17, 2006.
Ozone/8-Hr Standard (0.075 ppm) 2005-2007 June 18, 2009 \a\........ June 18, 2009 \a\.
Promulgated March 12, 2008.
2008 June 18, 2009 \a\........ June 18, 2009 \a\.
2009 60 Days after the end of 60 Days after the end of
the calendar quarter in the calendar quarter in
which the event occurred which the event occurred
or February 5, 2010, or February 5, 2010,
whichever date occurs whichever date occurs
first \b\. first \b\.
NO2/1-Hour Standard (80-100 Ppb, Final 2008 July 1, 2010 \a\......... January 22, 2011 \a\.
Level Tbd).
2009 July 1, 2010 \a\......... January 22, 2011 \a\.
2010 April 1, 2011 \a\........ July 1, 2011 \a\.
SO2/1-Hour Standard (50-100 PPB, Final 2008 October 1, 2010 \b\...... June 1, 2011 \b\.
Level Tbd).
2009 October 1, 2010 \b\...... June 1, 2011 \b\.
2010 June 1, 2011 \b\......... June 1, 2011 \b\.
2011 60 Days after the end of 60 Days after the end of
the calendar quarter in the calendar quarter in
which the event occurred which the event occurred
or March 31, 2011, or March 31, 2011,
whichever date occurs whichever date occurs
first \b\. first \b\.
----------------------------------------------------------------------------------------------------------------
\a\ These dates are unchanged from those published In the original rulemaking, or are being proposed elsewhere
and are shown in this table for informational purposes--the agency is not opening these dates for comment
under this rulemaking.
\b\ Indicates change from general schedule In 40 CFR 50.14.
Note: EPA notes that the table of revised deadlines only applies to data EPA will use to establish the final
initial designations for new or revised NAAQS. The general schedule applies for all other purposes, most
notably, for data used by EPA for redesignations to attainment.
V. Designations for the SO2 NAAQS
After EPA establishes or revises a NAAQS, the CAA directs EPA and
the states to begin taking steps to ensure that the new or revised
NAAQS is met. The first step is to identify areas of the country that
do not meet the new or revised NAAQS. This step is known as the initial
area designations.
Section 107(d)(1)(A) of the CAA provides that, ``By such date as
the Administrator may reasonably require, but not later than 1 year
after promulgation of a new or revised NAAQS for any pollutant under
section 109, the Governor of each state shall * * * submit to the
Administrator a list of all areas (or portions thereof) in the state''
that designates those areas as nonattainment, attainment, or
unclassifiable. The CAA section 107(d)(1)(A)(i) defines an area as
nonattainment if it is violating the NAAQS or if it is contributing to
a violation in a nearby area.
Section 107(d)(1)(B)(i) further provides, ``Upon promulgation or
revision of a NAAQS, the Administrator shall promulgate the
designations of all areas (or portions thereof) * * * as expeditiously
as practicable, but in no case later than 2 years from the date of
promulgation. Such period may be extended for up to one year in the
event the Administrator has insufficient information to promulgate the
designations within 2 years. By no later than 120 days prior to
promulgating designations, EPA is required to notify states of any
intended modifications to their boundaries as EPA may deem necessary.
States then have an opportunity to comment on EPA's intended decisions.
(See section 107(d)(1)(B)(ii).) Whether or not a state provides a
recommendation, EPA must promulgate the designation that the Agency
deems appropriate.
Therefore, following promulgation of any revised SO2
NAAQS in June 2010, EPA must promulgate initial designations by June
2012, or, by June 2013 in the event that the Administrator has
insufficient information to promulgate initial designations within 2
years. Along with the proposal to set a
[[Page 64859]]
new 1-hour primary SO2 NAAQS, elsewhere in this action, EPA
is proposing new SO2 ambient air monitoring network
requirements. As proposed, any new monitors would be deployed no later
than January 1, 2013. Compliance with the proposed 1-hour
SO2 NAAQS would be determined based on 3 years of complete,
quality assured, certified monitoring data. We do not expect newly
sited monitors for the proposed new network to generate sufficient
monitoring data for EPA to use in determining whether areas are in
compliance with the revised SO2 NAAQS by the statutory
deadline for EPA to complete initial designations, even if EPA were to
take an additional third year. Therefore, EPA intends to complete the
designations on a 2-year schedule, by June 2012, based on 3 years of
complete, quality assured, certified air quality monitoring data from
the current monitoring network.
EPA expects to base designations on air quality data from the years
2008-2010 or 2009-2011. Because the new monitoring network requirements
would not apply until January 1, 2013, EPA expects that many
SO2 monitors now operating will continue in operation at
their current locations at least through the end of 2011.\36\ The
SO2 monitors in the current network were generally sited to
measure the highest 24-hour and annual average SO2
concentrations. However, all of the monitors report hourly data. EPA
estimates that around 488 monitors operated in 2008. EPA believes at
least one third of the monitors meet the proposed network design
requirements and therefore would not need to be moved. Additional
monitors may be retained in their current locations if they are
measuring high levels of SO2. If a monitor in the existing
network indicates a violation of the 1-hour SO2 NAAQS, EPA
intends to designate the area nonattainment, regardless of whether or
not the monitor is located such that it could be counted towards
meeting the proposed new network requirements. However, if the monitor
indicates that the monitoring site meets the 1-hour SO2
NAAQS, EPA's decision on the designation of the area would be made on a
case-by-case basis. One possible outcome is that the area may be
designated as unclassifiable because EPA would be unable to determine
whether the area is violating the 1-hour SO2 NAAQS, or
contributing to a violation in a nearby area, because of a lack of a
complete monitoring network meeting the new network requirements.
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\36\ EPA Regional Administrator approval will be required for
any state to discontinue an existing monitoring site, and EPA does
not expect that it will before 2011 approve discontinuation of
monitoring at any site which appears to have a substantial
likelihood of violating the 1-hour NAAQS.
---------------------------------------------------------------------------
Accordingly, state Governors would need to submit their initial
designation recommendations to EPA no later than June 2011. If the
Administrator intends to modify any state recommendation, EPA would
notify the state's Governor no later than February 2012, 120 days prior
to promulgating the final designations. States would then have an
opportunity to comment on EPA's tentative decisions before EPA
promulgates the final designations in June 2012.
While CAA section 107 specifically addresses states, EPA intends to
follow the same process for tribes to the extent practicable, pursuant
to section 301(d) of the CAA regarding tribal authority, and the Tribal
Authority Rule (63 FR 7254; February 12, 1998). Pursuant to the Tribal
Authority Rule, Tribes are not subject to the schedule requirements
that apply to states. However, EPA intends to promulgate designations
for Tribal land as well as state land according to the schedule
mandated for state land, so EPA encourages Tribes that wish to provide
input on EPA's designations to provide this input on the schedule
mandated for states.
VI. Clean Air Act Implementation Requirements
This section of the preamble discusses the Clean Air Act (CAA)
requirements that states and emissions sources would need to address
when implementing new or revised SO2 NAAQS based on the
structure outlined in the CAA and existing rules.\37\ The EPA believes
that there are sufficient guidance documents and regulations currently
in place to fully implement the proposed revision to the SO2
NAAQS.\38\ However, EPA may provide additional guidance in the future,
as necessary, to assist states and emissions sources to comply with the
CAA provisions for implementing a new or revised SO2 NAAQS.
---------------------------------------------------------------------------
\37\ Since EPA is proposing to take comments on retaining the
current 24-hr standards without revision if the 1-hr standard is set
at 100-150 ppb, the discussion in this section relates to
implementation of the proposed 1-hour standard and the possible
retention or revocation of the current 24-hr standard.
\38\ See SO2 Guideline Document, Office of Air
Quality Planning and Standards, Research Triangle Park, NC 27711,
EPA-452/R-94-008, February 1994.
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The CAA assigns important roles to EPA, states and tribal
governments to achieve the NAAQS. States have the primary
responsibility for developing and implementing state implementation
plans (SIPs) that contain state measures necessary to achieve the air
quality standards in each area once EPA has established the NAAQS. EPA
provides assistance to states and tribes by providing technical tools,
assistance, and guidance, including information on the potential
control measures that may assist in helping areas attain the standards.
Under section 110 of the CAA, 42 U.S.C. 7410, and related
provisions, states are directed to submit, for EPA approval, SIPs that
provide for the attainment and maintenance of such standards through
control programs directed at sources of SO2 emissions. If a
state fails to adopt and implement the required SIPs by the time
periods provided in the CAA, EPA has the responsibility under the CAA
to adopt a federal implementation plan (FIP) to assure that areas
attain the NAAQS in an expeditious manner. The states, in conjunction
with EPA, also administer the prevention of significant deterioration
(PSD) program for SO2. See sections 160-169 of the CAA, 42
U.S.C. 7470-7479. In addition, federal programs provide for nationwide
reductions in emissions of SO2 and other air pollutants
under Title II of the Act, 42 U.S.C. 7521-7574. These programs involve
limits on the sulfur content of the fuel used by automobiles, trucks,
buses, motorcycles, non-road engines and equipment, marine vessels and
locomotives. EPA is also in the process of establishing limits on the
sulfur content of the fuel used by ocean going vessels. Emissions
reductions for SO2 are also obtained from implementation of
the new source performance standards (NSPS) for stationary sources
under sections 111 and 129 of the CAA, 42 U.S.C. 7411 and 7429; and the
national emission standards for hazardous air pollutants (NESHAP) for
stationary sources under section 112 of the CAA, 42 U.S.C. 7412.
A. How this rule applies to tribes
CAA section 301(d) authorizes EPA to treat eligible Indian tribes
in the same manner as states (TAS) under the CAA and requires EPA to
promulgate regulations specifying the provisions of the statute for
which such treatment is appropriate. EPA has promulgated these
regulations--known as the Tribal Authority Rule or TAR--at 40 CFR Part
49. See 63 FR 7254 (February 12, 1998). The TAR establishes the process
for Indian tribes to seek TAS eligibility and sets forth the CAA
functions for which TAS will be available. Under the TAR, eligible
tribes may seek approval for all CAA and regulatory purposes other than
a small number of functions enumerated at section 49.4. Implementation
plans
[[Page 64860]]
under section 110 are included within the scope of CAA functions for
which eligible tribes may obtain approval. Section 110(o) also
specifically describes tribal roles in submitting implementation plans.
Eligible Indian tribes may thus submit implementation plans covering
their reservations and other areas under their jurisdiction.
The CAA and TAR do not, however, direct tribes to apply for TAS or
implement any CAA program. In promulgating the TAR EPA explicitly
determined that it was not appropriate to treat tribes similarly to
states for purposes of, among other things, specific plan submittal and
implementation deadlines for NAAQS-related requirements. 40 CFR
49.4(a). In addition, where tribes do seek approval of CAA programs,
including section 110 implementation plans, the TAR provides
flexibility and allows them to submit partial program elements, so long
as such elements are reasonably severable--i.e., ``not integrally
related to program elements that are not included in the plan
submittal, and are consistent with applicable statutory and regulatory
requirements''. 40 CFR 49.7.
To date, very few tribes have sought TAS for purposes of section
110 implementation plans. However, some tribes may be interested in
pursuing such plans to implement today's proposed standard, once it is
promulgated. In several sections of this preamble, EPA describes the
various roles and requirements states will address in implementing
today's proposed standard. Such references to states generally include
eligible Indian tribes to the extent consistent with the flexibility
provided to tribes under the TAR. Where tribes do not seek TAS for
section 110 implementation plans, EPA under its discretionary authority
will promulgate FIPs as ``necessary or appropriate to protect air
quality.'' 40 CFR 49.11(a). EPA also notes that some tribes operate air
quality monitoring networks in their areas. For such monitors to be
used to measure attainment with the proposed revised primary NAAQS for
SO2, the criteria and procedures identified in this proposed
rule would apply.
B. Attainment dates
The latest date by which an area is required to attain the
SO2 NAAQS is determined from the effective date of the
nonattainment designation for the affected area. For areas designated
nonattainment for the revised SO2 NAAQS, SIPs must provide
for attainment of the NAAQS as expeditiously as practicable, but no
later than 5 years from the effective date of the nonattainment
designation for the area. See section 192(a) of the CAA. The EPA will
determine whether an area has demonstrated attainment of the
SO2 NAAQS by evaluating air quality monitoring data
consistent with the form of the NAAQS for SO2, if revised,
which will be codified at 40 CFR part 50, Appendix T.
1. Attaining the NAAQS
In order for an area to be redesignated as attainment, it must meet
five conditions provided under section 107(d)(3)(E) of the CAA. This
section requires that:
EPA must have determined that the area has met the
SO2 NAAQS;
EPA has fully approved the state's implementation plan;
The improvement in air quality in the affected area is due
to permanent and enforceable reductions in emissions;
EPA has fully approved a maintenance plan for the area;
and
The state(s) containing the area have met all applicable
requirements under section 110 and part D.
2. Consequences of failing to attain by the statutory attainment date
Any SO2 nonattainment area that fails to attain by its
statutory attainment date would be subject to the requirements of
sections 179(c) and (d) of the CAA. EPA is required to make a finding
of failure to attain no later than 6 months after the specified
attainment date and publish a notice in the Federal Register. The state
would then need to submit an implementation plan revision no later than
one year following the effective date of the Federal Register notice
making the determination of the area's failure to attain. This
submission must demonstrate that the standard will be attained as
expeditiously as practicable, but no later than 5 years from the
effective date of EPA's finding that the area failed to attain. In
addition, section 179(d)(2) provides that the SIP revision must include
any specific additional measures as may be reasonably prescribed by
EPA, including ``all measures that can be feasibly implemented in the
area in light of technological achievability, costs, and any nonair
quality and other air quality-related health and environmental
impacts.''
C. Section 110(a)(1) and (2) NAAQS infrastructure requirements
Section 110(a)(2) of the CAA directs all states to develop and
maintain a solid air quality management infrastructure, including
enforceable emission limitations, an ambient monitoring program, an
enforcement program, air quality modeling capabilities, and adequate
personnel, resources, and legal authority. Section 110(a)(2)(D) also
requires state plans to prohibit emissions from within the state which
contribute significantly to nonattainment or maintenance areas in any
other state, or which interfere with programs under part C of the CAA
to prevent significant deterioration of air quality or to achieve
reasonable progress toward the national visibility goal for Federal
class I areas (national parks and wilderness areas).
Under sections 110(a)(1) and (2) of the CAA, all states are
directed to submit SIPs to EPA which demonstrate that basic program
elements have been addressed within 3 years of the promulgation of any
new or revised NAAQS. Subsections (A) through (M) of section 110(a)(2)
set forth the elements that a state's program must contain in the
SIP.\39\ The list of section 110(a)(2) NAAQS implementation
requirements are the following:
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\39\ Two elements identified in section 110(a)(2) are not listed
below because, as EPA interprets the CAA, SIPs incorporating any
necessary local nonattainment area controls would not be due within
3 years, but rather are due at the time the nonattainment area
planning requirements are due. These elements are: (1) Emission
limits and other control measures, section 110(a)(2)(A), and (2)
Provisions for meeting part D, section 110(a)(2)(I), which requires
areas designated as nonattainment to meet the applicable
nonattainment planning requirements of part D, title I of the CAA.
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Ambient air quality monitoring/data system: Section
110(a)(2)(B) requires SIPs to provide for setting up and operating
ambient air quality monitors, collecting and analyzing data and making
these data available to EPA upon request.
Program for enforcement of control measures: Section
110(a)(2)(C) requires SIPs to include a program providing for
enforcement of SIP measures and the regulation and permitting of new/
modified sources.
Interstate transport: Section 110(a)(2)(D) requires SIPs
to include provisions prohibiting any source or other type of emissions
activity in the state from contributing significantly to nonattainment
or interfering with maintenance of the NAAQS in another state, or from
interfering with measures required to prevent significant deterioration
of air quality or to protect visibility.
Adequate resources: Section 110(a)(2)(E) directs states to
provide assurances of adequate funding, personnel and legal authority
to implement their SIPs.
Stationary source monitoring system: Section 110(a)(2)(F)
directs
[[Page 64861]]
states to establish a system to monitor emissions from stationary
sources and to submit periodic emissions reports to EPA.
Emergency power: Section 110(a)(2)(G) directs states to
include contingency plans, and adequate authority to implement them,
for emergency episodes in their SIPs.
Provisions for SIP revision due to NAAQS changes or
findings of inadequacies: Section 110(a)(2)(H) directs states to
provide for revisions of their SIPs in response to changes in the
NAAQS, availability of improved methods for attaining the NAAQS, or in
response to an EPA finding that the SIP is inadequate.
Consultation with local and Federal government officials:
Section 110(a)(2)(J) directs states to meet applicable local and
Federal government consultation requirements when developing SIPs and
reviewing preconstruction permits.
Public notification of NAAQS exceedances: Section
110(a)(2)(J) directs states to adopt measures to notify the public of
instances or areas in which a NAAQS is exceeded.
PSD and visibility protection: Section 110(a)(2)(J) also
directs states to adopt emissions limitations, and such other measures,
as may be necessary to prevent significant deterioration of air quality
in attainment areas and protect visibility in Federal Class I areas in
accordance with the requirements of CAA Title I, part C.
Air quality modeling/data: Section 110(a)(2)(K) requires
that SIPs provide for performing air quality modeling for predicting
effects on air quality of emissions of any NAAQS pollutant and
submission of data to EPA upon request.
Permitting fees: Section 110(a)(2)(L) requires the SIP to
include requirements for each major stationary source to pay permitting
fees to cover the cost of reviewing, approving, implementing and
enforcing a permit.
Consultation/participation by affected local government:
Section 110(a)(2)(M) directs states to provide for consultation and
participation by local political subdivisions affected by the SIP.
D. Attainment planning requirements
1. SO2 nonattainment area SIP requirements
Any state containing an area designated as nonattainment with
respect to the SO2 NAAQS would need to develop for
submission to EPA a SIP meeting the requirements of part D, Title I, of
the CAA, providing for attainment by the applicable statutory
attainment date. See sections 191(a) and 192(a) of the CAA. As
indicated in section 191(a), all components of the SO2 part
D SIP must be submitted within 18 months of the effective date of an
area's designation as nonattainment.
Section 172 of the CAA addresses the general requirements for areas
designated as nonattainment. Section 172(c) directs states with
nonattainment areas to submit a SIP which contains an attainment
demonstration showing that the affected area will attain the standard
by the applicable statutory attainment date. The SIP must show that the
area will attain the standard as expeditiously as practicable, and must
``provide for the implementation of all Reasonably Available Control
Measures (RACM) as expeditiously as practicable (including such
reductions in emissions from existing sources in the area as may be
obtained through the adoption, at a minimum, of Reasonably Available
Control Technology (RACT)).''
SIPs required under Part D of the CAA must also provide for
reasonable further progress (RFP). See section 172(c)(2) of the CAA.
The CAA defines RFP as ``such annual incremental reductions in
emissions of the relevant air pollution as are required by part D, or
may reasonably be required by the Administrator for the purpose of
ensuring attainment of the applicable NAAQS by the applicable
attainment date.'' See section 171 of the CAA. Historically, for some
pollutants, RFP has been met by showing annual incremental emission
reductions sufficient to maintain generally linear progress toward
attainment by the applicable attainment date.
All SO2 nonattainment area SIPs must include contingency
measures which must be implemented in the event that an area fails to
meet RFP or fails to attain the standards by its attainment date. See
section 172(c)(9) of the CAA. These contingency measures must be fully
adopted rules or control measures that take effect without further
action by the state or the Administrator. The EPA interprets this
requirement to mean that the contingency measures must be implemented
with only minimal further action by the state or the affected sources
with no additional rulemaking actions such as public hearings or
legislative review.
Emission inventories are also critical for the efforts of state,
local, and federal agencies to attain and maintain the NAAQS that EPA
has established for criteria pollutants including SO2.
Section 191(a) in conjunction with section 172(c) requires that areas
designated as nonattainment for SO2 submit an emission
inventory to EPA no later than 18 months after designation as
nonattainment. In the case of SO2, sections 191(a) and
172(c) also direct states to submit periodic emission inventories for
nonattainment areas. The periodic inventory must include emissions of
SO2 for point, nonpoint, mobile, and area sources.
2. New source review and prevention of significant deterioration
requirements
The Prevention of Significant Deterioration (PSD) and nonattainment
New Source Review (NSR) programs contained in parts C and D of Title I
of the CAA govern preconstruction review of any new or modified major
stationary sources of air pollutants regulated under the CAA as well as
any precursors to the formation of that pollutant when identified for
regulation by the Administrator.\40\ The EPA rules addressing these
programs can be found at 40 CFR 51.165, 51.166, 52.21, 52.24, and Part
51, appendix S.
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\40\ The terms ``major'' and ``minor'' define the size of a
stationary source, for applicability purposes, in terms of an annual
emissions rate (tons per year, tpy) for a pollutant. Generally, a
minor source is any source that is not ``major.'' ``Major'' is
defined by the applicable regulations--PSD or nonattainment NSR.
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The PSD program applies when a major source located in an area that
is designated as attainment or unclassifiable for any criteria
pollutant is constructed or undergoes a major modification.\41\ The
nonattainment NSR program applies on a pollutant-specific basis when a
major source constructs or modifies in an area that is designated as
nonattainment for that pollutant. The minor NSR program addresses major
and minor sources that undergo construction or modification activities
that do not qualify as major, and it applies, as necessary to assure
attainment, regardless of the designation of the area in which a source
is located.
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\41\ In addition, the PSD program applies to non-criteria
pollutants subject to regulation under the Act, except those
pollutants regulated under section 112 and pollutants subject to
regulation only under section 211(o).
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PSD permit requirements are effective on the promulgation date of a
new or revised standard. SIPs that address the PSD requirements related
to attainment areas are due no later than 3 years after the
promulgation of a revised NAAQS for SO2. The PSD
requirements include but are not limited to the following:
Installation of Best Available Control Technology (BACT);
Air quality monitoring and modeling analyses to ensure
that a project's emissions will not cause or contribute to a violation
of any NAAQS
[[Page 64862]]
or maximum allowable pollutant increase (PSD increment);
Notification of Federal Land Manager of nearby Class I
areas; and public comment on the permit.
If EPA establishes a 1-hour NAAQS for SO2, the owner or
operator of any major stationary source or major modification locating
in an attainment or unclassifiable area for SO2 will be
required, as a prerequisite for a PSD permit, to demonstrate that the
emissions increases from the new or modified source will not cause or
contribute to a violation of the that new NAAQS. The EPA does not
anticipate that this will pose a technical problem, since the modeling
capability and SO2 emissions input data already exist.
Depending on the final form of the 1-hour NAAQS, it may be necessary to
make adjustments to the AERMOD modeling system to accommodate the form
of the standard; however, EPA anticipates that any such adjustments can
be readily accomplished in coordination with the promulgation of any
new NAAQS for SO2 in time to enable states to implement such
standard via the PSD program. The analyses for the 1-hour NAAQS will be
in addition to the existing demonstration of compliance for the annual
and 24-hour SO2 NAAQS, which will continue to be required
unless EPA revokes these standards in conjunction with its promulgation
of a new 1-hour NAAQS for SO2.
The owner or operator of a new or modified source will still be
required to demonstrate compliance with the annual and 24-hour
SO2 increments, even if their counterpart NAAQS are revoked.
The annual and 24-hour increments are established in the CAA and will
need to remain in the PSD regulations because EPA does not interpret
the Clean Air Act to authorize EPA to remove them. It appears necessary
for Congress to amend the Act to make appropriate changes to the
statutory SO2 increments, perhaps similar to the way the Act
was amended to accommodate PM10 increments in lieu of the
statutory TSP increments. If we establish a new 1-hour SO2
NAAQS, EPA will consider the need to adopt new 1-hour SO2
increments.
In association with the requirement to demonstrate compliance with
the NAAQS and increments, the owner or operator of a new or modified
source must submit for review and approval a source impact analysis and
an air quality analysis. The source impact analysis, primarily a
modeling analysis, must demonstrate that allowable emissions increases
from the proposed source or modification, in conjunction with emissions
from other existing sources will not cause or contribute to either a
NAAQS or increment violation. The air quality analysis must assess the
ambient air quality in the area that the proposed source or
modification would affect.
For the air quality analysis, the owner or operator must submit in
its permit application air quality monitoring data that shall have been
gathered over a period of one year and is representative of air quality
in the area of the proposed project. If existing data representative of
the area of the proposed project is not available, new data may need to
be collected by the owner or operator of the source or modification.
Where data is already available, it might be necessary to evaluate the
location of the monitoring sites from which the SO2 data
were collected in comparison to any new siting requirements associated
with the 1-hour NAAQS. If existing sites are inappropriate for
providing the necessary representative data, then new monitoring data
will need to be collected by the owner or operator of the proposed
project.
Historically, EPA has allowed the use of several screening tools to
help facilitate the implementation of the new source review program by
reducing the permit applicant's burden, and streamlining the permitting
process for de minimis circumstances. These screening tools include a
significant emissions rate (SER), significant impact levels (SILs), and
a significant monitoring concentration (SMC). The SER, as defined in
tons per year for each regulated pollutant, is used to determine
whether any proposed source or modification will emit sufficient
amounts of a particular pollutant to require the review of that
pollutant under the NSR permit program. EPA will consider whether to
evaluate the existing significant emissions rate (SER) for
SO2 to see if it would change substantially based on the
NAAQS levels for the 1-hour averaging period. Historically, we have
defined a de minimis pollutant impact as one that results in a modeled
ambient impact of less than approximately 4% of the short-term NAAQS.
The current SER for SO2 (40 tpy) is based on the impact on
the 24-hour SO2 NAAQS. See, 45 FR 52676, 52707 (August 7,
1980). We have typically used the most sensitive averaging period to
calculate the SER, and we may want to evaluate the new 1-hour period
for SO2 because it is likely to represent most sensitive
averaging period for SO2.
The SIL, expressed as an ambient pollutant concentration ([mu]g/
m\3\), is used to determine whether the impact of a particular
pollutant is significant enough to warrant a complete air quality
impact analysis for any applicable NAAQS and increments. EPA has
promulgated regulations under 40 CFR 51.165(b) which include SILs for
SO2 to determine whether a source's impact would be
considered to cause or contribute to a NAAQS violation for either the
3-hour, 24-hour or annual averaging periods. These SILs were originally
developed in 1978 to limit the application of air quality dispersion
models to a downwind distance of no more than 50 kilometers or to
``insignificant levels.'' See, 43 FR 26398, June 19, 1978. Through
guidance, EPA has also allowed the use of SILs to determine whether or
not it is necessary for a source to carry out a comprehensive source
impact analysis and to determine the extent of the impact area in which
the analysis will be carried out. The existing SILs for SO2
were not developed on the basis of specific SO2 NAAQS
levels, so if the existing NAAQS are not being revised, there is
probably no need to revise the existing SILs. Even if we decide to
revoke any of the existing NAAQS, the corresponding SIL should still be
useful for increment assessment. A SIL for the 1-hour averaging period
does not exist, and would need to be developed for use with modeling
for 1-hour SO2 NAAQS and increments (if and when developed).
Finally, the SMC, also measured as an ambient pollutant
concentration ([mu]g/m\3\), is used to determine whether it may be
appropriate to exempt a proposed project from the requirement to
collect ambient monitoring data for a particular pollutant as part of a
complete permit application. EPA first defined SMCs for regulated
pollutants under the PSD program in 1980. See, 45 FR 52676, 52709-10
(August 7, 1980). The existing SMC for SO2, based on a 24-
hour averaging period, may need to be re-evaluated to consider the
effect of basing the SMC on the 1-hour averaging period, especially in
light of the fact that we may revoke the NAAQS for the 24-hour
averaging period. Third, even if the 1-hour averaging period does not
indicate the need for a revised SMC for SO2, the fact that
the original SMC for SO2 is based on 1980 monitoring data
(Lowest Detectable Level, correction factor of ``5''), could be a basis
for revising the existing value. More up-to-date monitoring data and
statistical analyses of monitoring accuracy may yield a different--
possibly lower--correction factor today. A new 1-hour NAAQS would not
necessarily cause this result, but may provide a ``window
[[Page 64863]]
of opportunity'' to re-evaluate the SMC for SO2. See
sections II.E.2 and II.F.2 above.
As a means of reducing the permit applicant's burden, and to
streamline permitting, permit authorities use screening tools referred
to as significant impact levels (SILs) and a significant monitoring
concentration (SMC). EPA issued unofficial SO2 SILs for the
3-hour (secondary standard), 24-hour and annual averaging periods.
These SILs were developed in 1978 to limit the application of air
quality dispersion models to a downwind distance of no more than 50
kilometers or to ``insignificant levels.'' See, 43 FR 263--, 26398,
(June 19, 1978). These values were not developed on the basis of
specific SO2 NAAQS levels, so if the existing NAAQS are not
being revised, there is probably no need to revise the existing SILs.
Even if we decide to revoke any of the existing NAAQS, the
corresponding SIL should still be useful for increment assessment. A
SIL for the 1-hour averaging period does not exist, and would need to
be developed for use with modeling for the 1-hour SO2 NAAQS
and increments (if and when developed).
States which have areas designated as nonattainment for the
SO2 NAAQS are directed to submit, as a part of the SIP due
18 months after an area is designated as nonattainment, provisions
requiring permits for the construction and operation of new or modified
stationary sources anywhere in the nonattainment area. Prior to
adoption of the SIP revision addressing major source nonattainment NSR
for SO2 nonattainment areas, the requirements of 40 CFR part
51, appendix S will apply. Nonattainment NSR requirements include but
are not limited to:
Installation of Lowest Achievable Emissions Rate (LAER)
control technology;
Offsetting new emissions with creditable emissions
reductions;
A certification that all major sources owned and operated
in the state by the same owner are in compliance with all applicable
requirements under the CAA;
An alternative siting analysis demonstrating that the
benefits of a proposed source significantly outweigh the environmental
and social costs imposed as a result of its location, construction, or
modification; and
Public comment on the permit.
Minor NSR programs must meet the statutory requirements in section
110(a)(2)(C) of the CAA which requires ``* * * regulation of the
modification and construction of any stationary source * * * as
necessary to assure that the [NAAQS] are achieved.'' These programs
must be established in each state within 3 years of the promulgation of
a new or revised NAAQS.
3. General conformity
Section 176(c) of the CAA requires that all federal actions conform
to an applicable implementation plan developed pursuant to section 110
and part D of the CAA. The EPA rules developed under section 176(c)
prescribe the criteria and procedures for demonstrating and assuring
conformity of federal actions to a SIP. Each federal agency must
determine that any actions covered by the general conformity rule
conform to the applicable SIP before the action is taken. The criteria
and procedures for conformity apply only in nonattainment areas and
those areas redesignated attainment since 1990 (``maintenance areas'')
with respect to the criteria pollutants under the CAA \42\: carbon
monoxide (CO), lead (Pb), nitrogen dioxide (NO2), ozone
(O3), particulate matter (PM2.5 and PM10), and
sulfur dioxide (SO2). The general conformity rules apply one
year following the effective date of designations for any new or
revised NAAQS.\43\
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\42\ Criteria pollutants are those pollutants for which EPA has
established a NAAQS under section 109 of the CAA.
\43\ Transportation conformity is required under CAA section
176(c) (42 U.S.C. 7506(c) to ensure that federally supported highway
and transit project activities are consistent with (``conform to'')
the purpose of the SIP. Transportation conformity applies to areas
that are designated nonattainment, and those areas redesignated to
attainment after 1990 (``maintenance areas'' with plans developed
under CAA section 175A) for transportation-related criteria
pollutants. Due to the relatively small amounts of sulfur in
gasoline and on-road diesel fuel, transportation conformity does not
apply to the SO2 NAAQS. 40 CFR 93.102(b)(1).
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The general conformity determination examines the impacts of direct
and indirect emissions related to federal actions. The general
conformity rule provides several options to satisfy air quality
criteria, such as modeling or offsets, and requires the federal action
to also meet any applicable SIP requirements and emissions milestones.
The general conformity rule also requires that notices of draft and
final general conformity determinations be provided directly to air
quality regulatory agencies and to the public by publication in a local
newspaper.
E. Transition from the existing SO2 NAAQS to a revised SO2 NAAQS
As stated in section II.F.5 of this notice, in addition to
proposing a short-term 1-hour SO2 NAAQS, EPA is proposing to
revoke the current annual and 24-hour standards, (annual 0.03 ppm and
24-hour 0.14 ppm). Specifically, EPA is proposing that the level for
the 1-hour standard for SO2 be a range between 50-100 ppb,
and is taking comment on setting the level of the standard up to 150
ppb. If the Administrator sets the 1-hour standard at 100 ppb or lower,
EPA is proposing to revoke the current 24-hour standard. If the
Administrator sets the level of the 1-hour standard between a range of
100-150 ppb, then EPA would retain the current 24-hour standard.
If EPA revises the SO2 NAAQS and revokes either the
current annual or 24-hour standard, EPA would need to promulgate
adequate anti-backsliding provisions. The CAA establishes anti-
backsliding requirements where EPA relaxes a NAAQS. Here, if EPA were
to replace the annual and/or 24-hour standard with a short term 1-hour
standard, EPA would need to address the section 172(e) anti-backsliding
provision of the CAA and determine whether it applies on its face or by
analogy, and what provisions would be appropriate to provide for
transition to the new standard. States would need to insure that the
health protection provided under the existing SO2 NAAQS
continues to be achieved as well as maintained as states begin to
implement a revised NAAQS. This means that states would be directed to
continue implementing attainment and maintenance SIPs associated with
the existing SO2 NAAQS until such time as they are subsumed
by any new planning and control requirements associated with a revised
NAAQS.
Whether or not section 172(e) directly applies to EPA's final
action on the SO2 NAAQS, EPA has previously looked to other
provisions of the CAA to determine how to address anti-backsliding. The
CAA contains a number of provisions that indicate Congress's intent to
not allow provisions from implementation plans to be altered or removed
if the plan revision would jeopardize the air quality protection being
provided by the existing plan when EPA revises a NAAQS to make it more
stringent. For example, section 110(l) provides that EPA may not
approve a SIP revision if it interferes with any applicable requirement
concerning attainment and RFP, or any other applicable requirement
under the CAA. In addition, section 193 of the CAA prohibits the
modification of a control, or a control requirement, in effect or
required to be adopted as of November 15, 1990 (i.e., prior to the
promulgation of the Clean Air Act Amendments of 1990), unless such a
modification would
[[Page 64864]]
ensure equivalent or greater emissions reductions. Further, section
172(e) of the CAA specifies that if EPA revises a NAAQS to make it less
stringent than a previous NAAQS, control obligations that apply in
nonattainment area SIPs may not be relaxed, and adopting those controls
that have not yet been adopted as needed may not be avoided. The intent
of Congress, concerning the aforementioned sections of the CAA, was
confirmed in a recent DC Circuit Court opinion on the Phase I ozone
implementation rule. See South Coast Air Quality Management Dist. v.
EPA, 472 F.3d 882 (DC Cir. 2006).
To ensure that the antibacksliding provisions and principles of
section 172(e) are met and applied if EPA revokes the current
standards, EPA is proposing that the current SO2 NAAQS would
remain in effect for one year following the effective date of the
initial designations under section 107(d)(1) for the revised
SO2 NAAQS before the current NAAQS are revoked in most
attainment areas. However, any existing SIP provisions under CAA
sections 110, 191 and 192 associated with the existing annual and 24-
hour SO2 NAAQS would remain in effect, including all
currently implemented planning and emissions control obligations,
including both those in the state's SIP and that have been promulgated
by EPA in FIPs. This would ensure that both the new nonattainment NSR
requirements and the general conformity requirements for a revised
standard are in place so that there will be no gap in the public health
protections provided by these two programs. It will also insure that
all nonattainment areas under the current NAAQS and all areas for which
SIP calls have been issued would continue to be protected by currently
required control measures.
EPA is also proposing that the existing NAAQS remain in place for
any current nonattainment area, or any area for which a state has not
fulfilled the requirements of a SIP call, until the affected area
submits, and EPA approves, a SIP with an attainment demonstration which
fully addresses the attainment requirements of the revised
SO2 NAAQS. This, in combination with the CAA mechanisms
provided in sections 110(l), 193, and 172(e) will help to ensure that
continued progress is made toward timely attainment of the
SO2 NAAQS. Also, in light of the nature of the proposed
revision of the SO2 NAAQS, the lack of classifications (and
mandatory controls associated with such classifications pursuant to the
CAA), and the small number of current nonattainment areas, and areas
subject to SIP calls, EPA believes (subject to consideration of public
comment) that retaining the current standard for a limited period of
time until attainment SIPs are approved for the new standard in current
nonattainment areas and SIP call areas, and one year after designations
in other areas, will adequately serve the anti-backsliding requirements
and goals of the CAA.\44\
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\44\ The areas that are currently designated as nonattainment
for the pre-existing SO2 primary NAAQS are Hayden, AZ;
Armstrong, PA; Laurel, MT; Piti, GU; and Tanguisson, GU. The areas
that are designated nonattainment for both the primary and the
secondary standards are East Helena, MT, Salt Lake Co, MT, Toole Co,
UT, and Warren Co, NJ. (See http://www.epa.gov/oar/oaqps/greenbk/lnc.html). The Billings/Laurel, MT, area is the only area currently
subject to a SIP call.
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VII. Communication of Public Health Information
Information on the public health implications of ambient
concentrations of criteria pollutants is currently made available
primarily through EPA's Air Quality Index (AQI) program. The current
Air Quality Index has been in use since its inception in 1999 (64 FR
42530). It provides accurate, timely, and easily understandable
information about daily levels of pollution (40 CFR 58.50). The AQI
establishes a nationally uniform system of indexing pollution levels
for NO2, carbon monoxide, ozone, particulate matter and
sulfur dioxide. The AQI converts pollutant concentrations in a
community's air to a number on a scale from 0 to 500. Reported AQI
values enable the public to know whether air pollution levels in a
particular location are characterized as good (0-50), moderate (51-
100), unhealthy for sensitive groups (101-150), unhealthy (151-200),
very unhealthy (201-300), or hazardous (300-500). The AQI index value
of 100 typically corresponds to the level of the short-term primary
NAAQS for each pollutant. An AQI value greater than 100 means that a
pollutant is in one of the unhealthy categories (i.e., unhealthy for
sensitive groups, unhealthy, very unhealthy, or hazardous) on a given
day; an AQI value at or below 100 means that a pollutant concentration
is in one of the satisfactory categories (i.e., moderate or good).
Decisions about the pollutant concentrations at which to set the
various AQI breakpoints, that delineate the various AQI categories,
draw directly from the underlying health information that supports the
review of the primary NAAQS.
The Agency recognizes the importance of revising the AQI in a
timely manner to be consistent with any revisions to the primary NAAQS.
Therefore EPA proposes to finalize conforming changes to the AQI, in
connection with the Agency's final decision on the SO2 NAAQS
if revisions to the primary standard are promulgated. If EPA
promulgates a short-term primary SO2 NAAQS, conforming
changes would include setting the 100 level of the AQI at the same
level as the revised primary SO2 NAAQS. Conforming changes
also would include setting the other AQI breakpoints at the lower end
of the AQI scale (i.e., AQI values of 50 and 150). EPA does not propose
to change breakpoints at the higher end of the AQI scale (from 200 to
500), which would apply to state contingency plans or the Significant
Harm Level (40 CFR 51.16), because the information from this review
does not inform decisions about breakpoints at those higher levels.
With regard to an AQI value of 50, the breakpoint between the good
and moderate categories, historically this value is set at the level of
the annual NAAQS, if there is one, or one-half the level of the short-
term NAAQS in the absence of an annual NAAQS (63 FR 67823, Dec. 12,
1998). Taking into consideration this practice, EPA is proposing to set
the AQI value of 50 to be between 25 and 50 ppb SO2, 1-hour
average. EPA anticipates that figures towards the lower end of this
range would be appropriate if the standard is set towards the lower end
of the range for the proposed standard (e.g. 50 ppb), while figures
towards the higher end of the range would be more appropriate for
standards set at the higher end of the range (e.g., 100 ppb). If the
short-term standard is set at a level above 100 ppb, and (contrary to
the proposal) the annual standard is not revoked, then consideration
could be given to setting an AQI value of 50 at the level of the annual
standard, or 30 ppb. EPA solicits comments on this range for an AQI of
50, and the appropriate basis for selecting an AQI of 50 both within
this range and, in light of EPA's solicitation of comment on 1-hour
standard levels above 100 ppb, above this range.
With regard to an AQI value of 150, the breakpoint between the
unhealthy for sensitive groups and unhealthy categories, historically
values between the short-term standard and an AQI value of 500 are set
at levels that are approximately equidistant between the AQI values of
100 and 500 unless there is health evidence that suggests a specific
level would be appropriate (63 FR 67829, Dec. 12, 1998). For an AQI
value of 150, the range of 175 to 200 ppb SO2, 1-hour
average, represents the midpoint between the proposed range for the
short-term standard and the level
[[Page 64865]]
of an AQI value of 200 (300 ppb SO2, 1-hour average).
VIII Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under section 3(f)(1) of Executive Order 12866 (58 FR 51735,
October 4, 1993), this action is an ``economically significant
regulatory action'' because it is likely to have an annual effect on
the economy of $100 million or more. Accordingly, EPA submitted this
action to the Office of Management and Budget (OMB) for review under EO
12866 and any changes made in response to OMB recommendations have been
documented in the docket for this action. In addition, EPA prepared a
Regulatory Impact Analysis (RIA) of the potential costs and benefits
associated with this action. However, the CAA and judicial decisions
make clear that the economic and technical feasibility of attaining the
national ambient standards cannot be considered in setting or revising
NAAQS, although such factors may be considered in the development of
State implementation plans to implement the standards. Accordingly,
although an RIA has been prepared, the results of the RIA have not been
considered by EPA in developing this proposed rule.
B. Paperwork Reduction Act
The information collection requirements in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document prepared by EPA for these
proposed revisions to part 58 has been assigned EPA ICR number 2370.01
The information collected under 40 CFR part 53 (e.g., test results,
monitoring records, instruction manual, and other associated
information) is needed to determine whether a candidate method intended
for use in determining attainment of the NAAQS in 40 CFR part 50 will
meet the design, performance, and/or comparability requirements for
designation as a Federal reference method (FRM) or Federal equivalent
method (FEM). We do not expect the number of FRM or FEM determinations
to increase over the number that is currently used to estimate burden
associated with SO2 FRM/FEM determinations provided in the
current ICR for 40 CFR part 53 (EPA ICR numbers 2370.01). As such, no
change in the burden estimate for 40 CFR part 53 has been made as part
of this rulemaking.
The information collected and reported under 40 CFR part 58 is
needed to determine compliance with the NAAQS, to characterize air
quality and associated health impacts, to develop emissions control
strategies, and to measure progress for the air pollution program. The
proposed amendments would revise the technical requirements for
SO2 monitoring sites, require the siting and operation of
additional SO2 ambient air monitors, and the reporting of
the collected ambient SO2 monitoring data to EPA's Air
Quality System (AQS). The annual average reporting burden for the
collection under 40 CFR part 58 (averaged over the first 3 years of
this ICR) is $13,863,950. Burden is defined at 5 CFR 1320.3(b). State,
local, and tribal entities are eligible for State assistance grants
provided by the Federal government under the CAA which can be used for
monitors and related activities.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.
To comment on the Agency's need for this information, the accuracy
of the provided burden estimates, and any suggested methods for
minimizing respondent burden, EPA has established a public docket for
this rule, which includes this ICR, under Docket ID number EPA-HQ-OAR-
2007-0352. Submit any comments related to the ICR to EPA and OMB. See
ADDRESSES section at the beginning of this notice for where to submit
comments to EPA. Send comments to OMB at the Office of Information and
Regulatory Affairs, Office of Management and Budget, 725 17th Street,
NW, Washington, DC 20503, Attention: Desk Office for EPA. Since OMB is
required to make a decision concerning the ICR between 30 and 60 days
after December 8, 2009, a comment to OMB is best assured of having its
full effect if OMB receives it by January 7, 2010. The final rule will
respond to any OMB or public comments on the information collection
requirements contained in this proposal.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of this rule on small
entities, small entity is defined as: (1) A small business that is a
small industrial entity as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201; (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.
After considering the economic impacts of this proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This
proposed rule will not impose any requirements on small entities.
Rather, this rule establishes national standards for allowable
concentrations of SO2 in ambient air as required by section
109 of the CAA. American Trucking Ass'ns v. EPA, 175 F. 3d 1027, 1044-
45 (DC Cir. 1999) (NAAQS do not have significant impacts upon small
entities because NAAQS themselves impose no regulations upon small
entities). Similarly, the proposed amendments to 40 CFR Part 58 address
the requirements for States to collect information and report
compliance with the NAAQS and will not impose any requirements on small
entities. We continue to be interested in the potential impacts of the
proposed rule on small entities and welcome comments on issues related
to such impacts.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Unless otherwise prohibited by law,
under section 202 of the UMRA, EPA generally must prepare a written
statement, including a cost-benefit analysis, for proposed and final
rules with ``Federal mandates'' that may result in expenditures to
State, local, and tribal governments, in the aggregate, or to the
private sector, of $100 million or more in any one year. Before
promulgating an EPA rule for which a written statement is required
under section 202, section 205 of the UMRA generally requires EPA to
identify and consider a reasonable number of
[[Page 64866]]
regulatory alternatives and to adopt the least costly, most cost-
effective or least burdensome alternative that achieves the objectives
of the rule. The provisions of section 205 do not apply when they are
inconsistent with applicable law. Moreover, section 205 allows EPA to
adopt an alternative other than the least costly, most cost-effective
or least burdensome alternative if the Administrator publishes with the
final rule an explanation why that alternative was not adopted. Before
EPA establishes any regulatory requirements that may significantly or
uniquely affect small governments, including tribal governments, it
must have developed under section 203 of the UMRA a small government
agency plan. The plan must provide for notifying potentially affected
small governments, enabling officials of affected small governments to
have meaningful and timely input in the development of EPA regulatory
proposals with significant Federal intergovernmental mandates, and
informing, educating, and advising small governments on compliance with
the regulatory requirements.
This action is not subject to the requirements of sections 202 and
205 of the UMRA. EPA has determined that this proposed rule does not
contain a Federal mandate that may result in expenditures of $100
million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any one year. The revisions to the
SO2 NAAQS impose no enforceable duty on any State, local or
Tribal governments or the private sector. The expected costs associated
with the monitoring requirements are described in EPA's ICR document,
but those costs are not expected to exceed $100 million in the
aggregate for any year. Furthermore, as indicated previously, in
setting a NAAQS, EPA cannot consider the economic or technological
feasibility of attaining ambient air quality standards. Because the CAA
prohibits EPA from considering the types of estimates and assessments
described in section 202 when setting the NAAQS, the UMRA does not
require EPA to prepare a written statement under section 202 for the
revisions to the SO2 NAAQS.
With regard to implementation guidance, the CAA imposes the
obligation for States to submit SIPs to implement the SO2
NAAQS. In this proposed rule, EPA is merely providing an interpretation
of those requirements. However, even if this rule did establish an
independent obligation for States to submit SIPs, it is questionable
whether an obligation to submit a SIP revision would constitute a
Federal mandate in any case. The obligation for a State to submit a SIP
that arises out of section 110 and section 191 of the CAA is not
legally enforceable by a court of law, and at most is a condition for
continued receipt of highway funds. Therefore, it is possible to view
an action requiring such a submittal as not creating any enforceable
duty within the meaning of U.S.C. 658 for purposes of the UMRA. Even if
it did, the duty could be viewed as falling within the exception for a
condition of Federal assistance under U.S.C. 658.
EPA has determined that this proposed rule contains no regulatory
requirements that might significantly or uniquely affect small
governments because it imposes no enforceable duty on any small
governments. Therefore, this rule is not subject to the requirements of
section 203 of the UMRA.
E. Executive Order 13132: Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255; August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
This proposed rule does not have federalism implications. It will
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. The rule does not alter the
relationship between the Federal government and the States regarding
the establishment and implementation of air quality improvement
programs as codified in the CAA. Under section 109 of the CAA, EPA is
mandated to establish NAAQS; however, CAA section 116 preserves the
rights of States to establish more stringent requirements if deemed
necessary by a State. Furthermore, this rule does not impact CAA
section 107 which establishes that the States have primary
responsibility for implementation of the NAAQS. Finally, as noted in
section E (above) on UMRA, this rule does not impose significant costs
on State, local, or tribal governments or the private sector. Thus,
Executive Order 13132 does not apply to this rule.
However, EPA recognizes that States will have a substantial
interest in this rule and any corresponding revisions to associated air
quality surveillance requirements, 40 CFR part 58. Therefore, in the
spirit of Executive Order 13132, and consistent with EPA policy to
promote communications between EPA and State and local governments, EPA
specifically solicits comment on this proposed rule from State and
local officials.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This proposed rule does not
have tribal implications, as specified in Executive Order 13175. It
does not have a substantial direct effect on one or more Indian tribes,
on the relationship between the Federal government and Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and tribes. The rule does not alter the relationship
between the Federal government and tribes as established in the CAA and
the TAR. Under section 109 of the CAA, EPA is mandated to establish
NAAQS; however, this rule does not infringe existing tribal authorities
to regulate air quality under their own programs or under programs
submitted to EPA for approval. Furthermore, this rule does not affect
the flexibility afforded to tribes in seeking to implement CAA programs
consistent with the TAR, nor does it impose any new obligation on
tribes to adopt or implement any NAAQS. Finally, as noted in section E
(above) on UMRA, this rule does not impose significant costs on tribal
governments. Thus, Executive Order 13175 does not apply to this rule.
However, EPA recognizes that tribes may be interested in this rule and
any corresponding revisions to associated air quality surveillance
requirements. Therefore, in the spirit of Executive Order 13175, and
consistent with EPA policy to promote communications between EPA and
tribes, EPA specifically solicits additional comment on this proposed
rule from tribal officials.
[[Page 64867]]
G. Executive Order 13045: Protection of Children From Environmental
Health & Safety Risks
This action is subject to Executive Order (62 FR 19885, April 23,
1997) because it is an economically significant regulatory action as
defined by Executive Order 12866, and we believe that the environmental
health risk addressed by this action has a disproportionate effect on
children. The proposed rule will establish uniform national ambient air
quality standards for SO2; these standards are designed to
protect public health with an adequate margin of safety, as required by
CAA section 109. The protection offered by these standards may be
especially important for asthmatics, including asthmatic children,
because respiratory effects in asthmatics are among the most sensitive
health endpoints for SO2 exposure. Because asthmatic
children are considered a sensitive population, we have evaluated the
potential health effects of exposure to SO2 pollution among
asthmatic children. These effects and the size of the population
affected are discussed in chapters 3 and 4 of the ISA; chapters 3, 4,
7, 8, 9 of the REA, and sections II.A through II.E of this preamble.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution or Use
This rule is not a ``significant energy action'' as defined in
Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355; May 22, 2001) because it is not likely to have a significant
adverse effect on the supply, distribution, or use of energy. The
purpose of this rule is to establish revised NAAQS for SO2.
The rule does not prescribe specific control strategies by which these
ambient standards will be met. Such strategies will be developed by
States on a case-by-case basis, and EPA cannot predict whether the
control options selected by States will include regulations on energy
suppliers, distributors, or users. Thus, EPA concludes that this rule
is not likely to have any adverse energy effects.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 27)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
This proposed rulemaking involves technical standards with regard
to ambient monitoring of SO2. The use of this voluntary
consensus standard would be impractical because the analysis method
does not provide for the method detection limits necessary to
adequately characterize ambient SO2 concentrations for the
purpose of determining compliance with the proposed revisions to the
SO2 NAAQS.
EPA welcomes comments on this aspect of the proposed rule, and
specifically invites the public to identify potentially applicable
voluntary consensus standards and to explain why such standards should
be used in the regulation.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629; Feb. 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health effects on
any population, including any minority or low-income population. The
proposed rule will establish uniform national standards for
SO2 in ambient air. EPA solicits comment on environmental
justice issues related to the proposed revision of the SO2
NAAQS.
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Samet JM. (2009). Letter to EPA Administrator Lisa P. Jackson: Clean
Air Scientific Advisory Committee's (CASAC) Review of EPA's Risk and
Exposure Assessment to Support the Review of the SO2
Primary National Ambient Air Quality Standards: Second Draft. EPA-
CASAC-09-007, May 18, 2009. Sulfur Dioxide Review Docket. Docket ID
No. EPA-HQ-OAR-2007-0352-0035. Available at www.regulations.gov.
Schildcrout JS, Sheppard L, Lumley T, Slaughter JC, Koenig JQ,
Shapiro GG. (2006). Ambient air pollution and asthma exacerbations
in children: an eight-city analysis. Am J Epidemiol. 164:505-517.
Schwartz J, Dockery DW, Neas LM, Wypij D, Ware JH, Spengler JD,
Koutrakis P, Speizer FE, Ferris BG, Jr. (1994). Acute effects of
summer air pollution on respiratory symptom reporting in
[[Page 64869]]
children. Am J Respir Crit Care Med. 150:1234-1242.
Schwartz J. (1995). Short term fluctuations in air pollution and
hospital admissions of the elderly for respiratory disease. Thorax.
50:531-538.
Schwartz J. (1996). Air pollution and hospital admissions for
respiratory disease. Epidemiology. 7:20-28.
Sheppard D, Saisho A, Nadel JA, Boushey HA. (1981). Exercise
increases sulfur dioxide- induced bronchoconstriction in asthmatic
subjects. Am Rev Respir Dis. 123:486-491.
Sheppard reanalysis (2003). Ambient Air Pollution and Nonelderly
Asthma Hospital Admissions in Seattle, Washington, 1987-1994. In:
Revised Analyses of Time-Series Studies of Air Pollution and Health.
Special report. Boston, MA: Health Effects Institute; pp. 227-230.
Smith E. (1993). Subject Data Supplied by the Researchers for the
Recent Controlled Human Studies Analyzed in the Staff Paper
Supplement and Accompanying Memorandum. Memorandum to Docket No. A-
84-25, Item IV-B-5.
Thompson R. (2009). Sulfur Dioxide Descriptive Statistics Tables.
Office of Air Quality Planning and Standards, U.S. Environmental
Protection Agency, Research Triangle Park, NC. Sulfur Dioxide Review
Docket. Docket ID No. EPA-HQ-OAR-2007-0352-0036. Available at
www.regulations.gov.
Thompson R and Stewart MJ. (2009). Air Quality Statistics for Cities
Referenced in Key U.S. and Canadian Hospital Admission and Emergency
Department Visits for All Respiratory Causes and Asthma. Office of
Air Quality Planning and Standards, U.S. Environmental Protection
Agency, Research Triangle Park, NC. Sulfur Dioxide Review Docket.
Docket ID No. EPA-HQ-OAR-2007-0352-0018. Available at
www.regulations.gov.
Tolbert PE, Klein M, Peel JL, Sarnat SE, Sarnat JA. (2007).
Multipollutant modeling issues in a study of ambient air quality and
emergency department visits in Atlanta. J Expos Sci Environ
Epidemiol. 17:S29-S35
Trenga CA, Koenig JQ, Williams PV. (1999). Sulphur dioxide
sensitivity and plasma antioxidants in adult subjects with asthma.
Occup Environ Med. 56:544-547.
Watkins and Thompson. (2009). SO2 Network Review and
Background; OAQPS; Office of Air Quality Planning and Standards,
U.S. Environmental Protection Agency, Research Triangle Park, NC.
Sulfur Dioxide NAAQS Review Docket. (OAR-2005-0352). Sulfur Dioxide
Review Docket. Docket ID No. EPA-HQ-OAR-2007-0352-0037. Available at
www.regulations.gov.
Wilson AM, Wake CP, Kelly T, Salloway JC. (2005). Air pollution,
weather, and respiratory emergency room visits in two northern New
England cities: An ecological time-series study. Environ Res.
97:312-321.
Winterton DL, Kaufman J, Keener CV, Quigley S, Farin FM, Williams
PV, Koenig JQ. (2001). Genetic polymorphisms as biomarkers of
sensitivity to inhaled sulfur dioxide in subjects with asthma. Ann
Allergy Asthma Immunol. 86:232-238.
List of Subjects
40 CFR Part 50
Environmental protection, Air pollution control, Carbon monoxide,
Lead, Nitrogen dioxide, Ozone, Particulate matter, Sulfur oxides.
40 CFR Part 53
Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.
40 CFR Part 58
Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.
Dated: November 16, 2009.
Lisa P. Jackson,
Administrator.
For the reasons stated in the preamble, title 40, chapter I of the
Code of Federal Regulations is proposed to be amended as follows:
PART 50--NATIONAL PRIMARY AND SECONDARY AMBIENT AIR QUALITY
STANDARDS
1. The authority citation for part 50 continues to read as follows:
Authority: 42 U.S.C. 7401, et seq.
2. Section 50.4 is amended by adding paragraph (e) to read as
follows:
Sec. 50.4 National primary ambient air quality standards for sulfur
oxides (sulfur dioxide).
* * * * *
(e) The standards set forth in this section will remain applicable
to all areas notwithstanding the promulgation of SO2
national ambient air quality standards (NAAQS) in Sec. 50.17. The
SO2 NAAQS set forth in this section will no longer apply to
an area one year after the effective date of the designation of that
area, pursuant to section 107 of the Clean Air Act, for the
SO2 NAAQS set forth in Sec. 50.17; except that for areas
designated nonattainment for the SO2 NAAQS set forth in this
section as of the effective date of Sec. 50.17, and areas not meeting
the requirements of a SIP call with respect to requirements for the
SO2 NAAQS set forth in this section, the SO2
NAAQS set forth in this section will apply until that area submits,
pursuant to section 191 of the Clean Air Act, and EPA approves, an
implementation plan providing for attainment of the SO2
NAAQS set forth in Sec. 50.17.
3. Section 50.14 is amended by revising paragraph (c)(2)(vi) to
read as follows:
Sec. 50.14 Treatment of air quality monitoring data influenced by
exceptional events.
* * * * *
(c) * * *
(2) * * *
(vi) When EPA sets a NAAQS for a new pollutant or revises the NAAQS
for an existing pollutant, it may revise or set a new schedule for
flagging exceptional event data, providing initial data descriptions
and providing detailed data documentation in AQS for the initial
designations of areas for those NAAQS. Table 1 provides the schedule
for submission of flags with initial descriptions in AQS and detailed
documentation. These schedules shall apply for those data which will or
may influence the initial designation of areas for those NAAQS. EPA
anticipates revising Table 1 as necessary to accommodate revised data
submission schedules for new or revised NAAQS.
Table 1--Schedule or Exceptional Event Flagging and Documentation Submission for Data To Be Used in Designations
Decisions for New or Revised NAAQS
----------------------------------------------------------------------------------------------------------------
Air quality data
NAAQS pollutant/ standard/(level)/ collected for Event flagging and initial Detailed documentation
promulgation date calendar year description deadline submission deadline
----------------------------------------------------------------------------------------------------------------
PM2.5/24-Hr Standard (35 [mu]g/m\3\) 2004-2006 October 1, 2007 \a\....... April 15, 2008 \a\.
Promulgated October 17, 2006.
Ozone/8-Hr Standard (0.075 ppm) 2005-2007 June 18, 2009 \a\......... June 18, 2009 \a\.
Promulgated March 12, 2008.
2008 June 18, 2009 \a\......... June 18, 2009 \a\.
[[Page 64870]]
2009 60 Days after the end of 60 Days after the end of
the calendar quarter in the calendar quarter in
which the event occurred which the event occurred
or February 5, 2010, or February 5, 2010,
whichever date occurs whichever date occurs
first \b\. first \b\.
NO2/1-Hour Standard (80-100 PPB, final 2008 July 1, 2010 \a\.......... January 22, 2011 \a\.
level TBD).
2009 July 1, 2010 \a\.......... January 22, 2011 \a\.
2010 April 1, 2011 \a\......... July 1, 2011 \ a\.
SO2/1-Hour Standard (50-100 PPB, final 2008 October 1, 2010 \b\....... June 1, 2011 \b\.
level TBD).
2009 October 1, 2010 \b\....... June 1, 2011 \b\.
2010 June 1, 2011 \b\.......... June 1, 2011 \b\.
2011 60 Days after the end of 60 Days after the end of
the calendar quarter in the calendar quarter in
which the event occurred which the event occurred
or March 31, 2011, or March 31, 2011,
whichever date occurs whichever date occurs
first \b\. first \b\.
----------------------------------------------------------------------------------------------------------------
\a\ These dates are unchanged from those published in the original rulemaking, or are being proposed elsewhere
and are shown in this table for informational purposes--the Agency is not opening these dates for comment
under this rulemaking.
\b\ Indicates change from general schedule in 40 CFR 50.14.
Note: EPA notes that the table of revised deadlines only applies to data EPA will use to establish the final
initial designations for new or revised NAAQS. The general schedule applies for all other purposes, most
notably, for data used by EPA for redesignations to attainment.
* * * * *
4. A new 50.17 is added to read as follows:
Sec. 50.17 National primary ambient air quality standards for sulfur
oxides (sulfur dioxide).
(a) The level of the national primary 1-hour annual ambient air
quality standard for oxides of sulfur is (50-100) parts per billion
(ppb, which is 1 part in 1,000,000,000), measured in the ambient air as
sulfur dioxide (SO2).
(b) The 1-hour primary standard is met when the three-year average
of the annual (99th percentile)(fourth highest) of the daily maximum 1-
hour average concentrations is less than or equal to (50-100) ppb, as
determined in accordance with Appendix T of this part.
5. Add Appendix A-1 to Part 50 to read as follows:
Appendix A-1 to Part 50--Reference Measurement Principle and
Calibration Procedure for the Measurement of Sulfur Dioxide in the
Atmosphere (Ultraviolet Fluorescence Method)
1.0 Applicability.
1.1 This ultraviolet fluorescence (UVF) method provides a
measurement of the concentration of sulfur dioxide (SO2)
in ambient air for determining compliance with the national primary
and secondary ambient air quality standards for sulfur oxides
(sulfur dioxide) as specified in Sec. 50.4 and Sec. 50.5 of this
chapter. The method is applicable to the measurement of ambient
SO2 concentrations using continuous (real-time) sampling.
Additional quality assurance procedures and guidance are provided in
part 58, appendix A, of this chapter and in Reference 3.
2.0 Principle.
2.1 This reference method is based on automated measurement of
the intensity of the characteristic fluorescence released by
SO2 in an ambient air sample contained in a measurement
cell of an analyzer when the air sample is irradiated by ultraviolet
(UV) light passed through the cell. The fluorescent light released
by the SO2 is also in the ultraviolet region, but at
longer wavelengths than the excitation light. Typically, optimum
instrumental measurement of SO2 concentrations is
obtained with an excitation wavelength in a band between
approximately 190 to 230 nm, and measurement of the SO2
fluorescence in a broad band around 320 nm, but these wavelengths
are not necessarily constraints of this reference method. Generally,
the measurement system (analyzer) also requires means to reduce the
effects of aromatic hydrocarbon species, and possibly other
compounds, in the air sample to control measurement interferences
from these compounds, which may be present in the ambient air.
References 1 and 2 describe UVF method.
2.2. The measurement system is calibrated by referencing the
instrumental fluorescence measurements to SO2 standard
concentrations traceable to a National Institute of Science and
Technology (NIST) primary standard for SO2 (see
Calibration Procedure below).
2.3. An analyzer implementing this measurement principle is
shown schematically in Figure 1. Designs should include a
measurement cell, a UV light source of appropriate wavelength, a UV
detector system with appropriate wave length sensitivity, a pump and
flow control system for sampling the ambient air and moving it into
the measurement cell, sample air conditioning components as
necessary to minimize measurement interferences, suitable control
and measurement processing capability, and other apparatus as may be
necessary. The analyzer must be designed to provide accurate,
repeatable, and continuous measurements of SO2
concentrations in ambient air, with measurement performance as
specified in subpart B of part 53 of this chapter.
2.4. Sampling considerations: The use of a particle filter on
the sample inlet line of a UVF SO2 analyzer is required
to prevent interference, malfunction, or damage due to particles in
the sampled air.
3.0 Interferences.
3.1 The effects of the principal potential interferences may
need to be mitigated to meet the interference equivalent
requirements of part 53 of this chapter. Poly-nuclear aromatic (PNA)
hydrocarbons such as xylene and naphthalene can fluoresce and act as
strong positive interferences. These gases can be removed by using a
permeation type scrubber (hydrocarbon ``kicker''). Nitrogen oxide
(NO) in high concentrations can also fluoresce and cause positive
interference. Optical filtering can be employed to improve the
rejection of interference from high NO. Ozone can absorb UV light
given off by the SO2 molecule and cause a measurement
offset. This effect can be reduced by minimizing the measurement
path length between the area where SO2 fluorescence
occurs and the photomultiplier tube detector (e.g. <5 cm). A
hydrocarbon scrubber, optical filter and appropriate distancing of
the measurement path length may be required method components to
reduce interference.
4.0 Calibration Procedure. Atmospheres containing accurately
known concentrations of sulfur dioxide are prepared using a
compressed gas transfer standard diluted with accurately metered
clean air flow rates.
4.1 Apparatus: Figure 2 shows a typical generic system suitable
for diluting a SO2 gas cylinder concentration standard
with clean air through a mixing chamber to produce the desired
calibration concentration standards.
[[Page 64871]]
A valve may be used to conveniently divert the SO2 from
the sampling manifold to provide clean zero air at the output
manifold for zero adjustment. The system may be made up using common
laboratory components, or it may be a commercially manufactured
system. In either case, the principle components are as follows:
4.1.1 Air and standard gas flow controllers, capable of
maintaining constant gas flow rates to within 2
percent.
4.1.2 Air and standard gas flow meters, capable of measuring and
monitoring air or N2 (standard gas) flow rates to within
2 percent and properly calibrated to a NIST-traceable
standard.
4.1.3 Mixing chamber, of an inert material such as glass and of
proper design to provide thorough mixing of pollutant gas and
diluent air streams.
4.1.4 Sampling manifold, constructed of glass,
polytetrafluoroethylene (PTFE TeflonTM), or other
suitably inert material and of sufficient diameter to insure a
minimum pressure drop at the analyzer connection, with a vent
designed to insure a minimum over-pressure (relative to ambient air
pressure) at the analyzer connection and to prevent ambient air from
entering the manifold.
4.1.5 Standard gas pressure regulator, of clean stainless steel
with a stainless steel diaphragm, suitable for use with a high
pressure SO2 gas cylinder.
4.1.6 Reagents.
4.1.6.1 SO2 gas transfer standard, in N2,
with the concentration traceable to a NIST Standard Reference
Material (SRM) such as SRM 1693a (50 [mu]mole/mole) or SRM 1694a
(100 [mu]mole/mole) Since UVF analyzers may be sensitive to
O2-to-N2 ratios, it is important that the
SO2 standard concentration be sufficiently high (50 to
100 ppm) such that the O2 content in the diluent air is
not significantly changed by the added standard gas.
4.1.6.2 Clean zero air, free of contaminants that could cause a
detectable response or a change in sensitivity of the analyzer.
Since ultraviolet fluorescence analyzers may be sensitive to
aromatic hydrocarbons and O2-to-N2 ratios, it
is important that the clean zero air contains less than 0.1 ppm
aromatic hydrocarbons and O2 and N2
percentages approximately the same as in ambient air. A procedure
for generating zero air is given in reference 1.
4.2 Procedure
4.2.1 Obtain a suitable calibration apparatus, such as the one
shown schematically in Figure 1, and verify that all materials in
contact with the pollutant are of glass, Teflon\TM\, or other
suitably inert material and completely clean.
4.2.2 Purge the SO2 standard gas lines and pressure
regulator to remove any residual air.
4.2.3 Ensure that there are no leaks in the system and that the
flow measuring devices are properly and accurately calibrated under
the conditions of use against a reliable volume or flow rate
standard such as a soap-bubble meter or a wet-test meter traceable
to a NIST standard. All volumetric flow rates should be corrected to
the same reference temperature and pressure by using the formula
below:
[GRAPHIC] [TIFF OMITTED] TP08DE09.004
Where:
Fc = corrected flow rate (L/min at 25[deg] C and 760 mm Hg),
Fm = measured flow rate, (at temperature, Tm and
pressure, Pm),
Pm = measured pressure in mm Hg, (absolute), and
Tm = measured temperature in degrees Celsius.
4.2.4 Allow the SO2 analyzer under calibration to
sample zero air until a stable response is obtained, then make the
proper zero adjustment.
4.2.5 Adjust the airflow to provide an SO2
concentration of approximately 80 percent of the upper measurement
range limit of the SO2 instrument and verify that the
total air flow of the calibration system exceeds the demand of all
analyzers sampling from the output manifold (with the excess
vented).
4.2.6 Calculate the actual SO2 calibration
concentration standard as:
[GRAPHIC] [TIFF OMITTED] TP08DE09.005
Where:
C = the concentration of the SO2 gas standard
Fp = the flow rate of SO2 gas standard
Ft = the total air flow rate of pollutant and diluent
gases
4.2.7 When the analyzer response has stabilized, adjust the
SO2 span control to obtain the desired response
equivalent to the calculated standard concentration. If substantial
adjustment of the span control is needed, it may be necessary to re-
check the zero and span adjustments by repeating steps 4.2.4 through
4.2.7 until no further adjustments are needed.
4.2.8 Adjust the flow rate(s) to provide several other
SO2 calibration concentrations over the analyzer's
measurement range. At least five different concentrations evenly
spaced throughout the analyzer's range are suggested.
4.2.9 Plot the analyzer response (vertical or Y-axis) versus
SO2 concentration (horizontal or X-axis). Compute the
linear regression slope and intercept and plot the regression line
to verify that no point deviates from this line by more than 2
percent of the maximum concentration tested.
Note: Additional information on calibration and pollutant
standards is provided in Section 12 of Reference 3.
5.0 Frequency of calibration.
The frequency of calibration, as well as the number of points
necessary to establish the calibration curve and the frequency of
other performance checking will vary by analyzer; however, the
minimum frequency, acceptance criteria, and subsequent actions are
specified in Reference 3, Appendix D: Measurement Quality Objectives
and Validation Template for SO2 (page 9 of 30). The
user's quality control program should provide guidelines for initial
establishment of these variables and for subsequent alteration as
operational experience is accumulated. Manufacturers of analyzers
should include in their instruction/operation manuals information
and guidance as to these variables and on other matters of
operation, calibration, routine maintenance, and quality control.
6.0 References for SO2 Method.
1. H. Okabe, P.L. Splitstone, and J.J. Ball, ``Ambient and Source
SO2 Detector Based on a Fluorescence Method'', Journal of
the Air Control Pollution Association, vol. 23, p. 514-516 (1973).
2. F.P. Schwarz, H. Okabe, and J.K. Whittaker, ``Fluorescence
Detection of Sulfur Dioxide in Air at the Parts per Billion Level,''
Analytical Chemistry, vol. 46, pp. 1024-1028 (1974).
3. QA Handbook for Air Pollution Measurement Systems--Volume II.
Ambient Air Quality Monitoring Programs. U. S. EPA. EPA-454/B-08-003
(2008). (Available at http://www.epa.gov/ttn/amtic/qabook.html.)
[[Page 64872]]
[GRAPHIC] [TIFF OMITTED] TP08DE09.006
[GRAPHIC] [TIFF OMITTED] TP08DE09.007
[[Page 64873]]
6. Appendix A to Part 50 is redesignated as Appendix A-2 to Part
50.
7. Appendix T to Part 50 is added to read as follows:
Option 1 for Appendix T to Part 50
Appendix T to Part 50--Interpretation of the Primary National Ambient
Air Quality Standards for Oxides of Sulfur (Sulfur Dioxide) [1-hour
primary standard based on the 4th highest daily maximum value form]
1. General.
(a) This appendix explains the data handling conventions and
computations necessary for determining when the primary national
ambient air quality standards for Oxides of Sulfur as measured by
Sulfur Dioxide (``SO2 NAAQS'') specified in Sec. 50.4
are met. Sulfur Dioxide (SO2) is measured in the ambient
air by a Federal reference method (FRM) based on appendix A to this
part or by a Federal equivalent method (FEM) designated in
accordance with part 53 of this chapter. Data handling and
computation procedures to be used in making comparisons between
reported SO2 concentrations and the levels of the
SO2 NAAQS are specified in the following sections.
(b) Decisions to exclude, retain, or make adjustments to the
data affected by exceptional events, including natural events, are
made according to the requirements and process deadlines specified
in Sec. Sec. 50.1, 50.14 and 51.930 of this chapter.
(c) The terms used in this appendix are defined as follows:
Annual 4th highest daily maximum 1-hour value refers to the 4th
highest daily 1-hour maximum value at a site in a particular year.
Daily maximum 1-hour values for SO2 refers to the
maximum 1-hour SO2 concentration values measured from
midnight to midnight (local standard time) that are used in NAAQS
computations.
Design values are the metrics (i.e., statistics) that are
compared to the NAAQS levels to determine compliance, calculated as
specified in section 5 of this appendix. The design value for the
primary NAAQS is the 3-year average of annual 4th highest daily
maximum 1-hour values for a monitoring site (referred to as the ``1-
hour primary standard design value'').
Quarter refers to a calendar quarter.
Year refers to a calendar year.
2. Requirements for Data Used for Comparisons With the
SO2 NAAQS and Data Reporting Considerations.
(a) All valid FRM/FEM SO2 hourly data required to be
submitted to EPA's Air Quality System (AQS), or otherwise available
to EPA, meeting the requirements of part 58 of this chapter
including appendices A, C, and E shall be used in design value
calculations. Multi-hour average concentration values collected by
wet chemistry methods shall not be used.
(b) When two or more SO2 monitors are operated at a
site, the state may in advance designate one of them as the primary
monitor. If the state has not made this designation in advance, the
Administrator will make the designation, either in advance or
retrospectively. Design values will be developed using only the data
from the primary monitor, if this results in a valid design value.
If data from the primary monitor do not allow the development of a
valid design value, data solely from the other monitor(s) will be
used in turn to develop a valid design value, if this results in a
valid design value. If there are three or more monitors, the order
for such comparison of the other monitors will be determined by the
Administrator. The Administrator may combine data from different
monitors in different years for the purpose of developing a valid 1-
hour primary standard design value, if a valid design value cannot
be developed solely with the data from a single monitor. However,
data from two or more monitors in the same year at the same site
will not be combined in an attempt to meet data completeness
requirements, except if one monitor has physically replaced another
instrument permanently, in which case the two instruments will be
considered to be the same monitor, or if the state has switched the
designation of the primary monitor from one instrument to another
during the year.
(c) Hourly SO2 measurement data shall be reported to
AQS in units of parts per billion (ppb), to at most one place after
the decimal, with additional digits to the right being truncated
with no further rounding.
3. Comparisons with the 1-hour Primary SO2 NAAQS.
(a) The 1-hour primary SO2 NAAQS is met at a site
when the valid 1-hour primary standard design value is less than or
equal to [50-150] parts per billion (ppb).
(b) An SO2 1-hour primary standard design value is
valid if it encompasses three consecutive calendar years of complete
data. A year meets data completeness requirements when all 4
quarters are complete. A quarter is complete when at least 75
percent of the sampling days for each quarter have complete data. A
sampling day has complete data if 75 percent of the hourly
concentration values are reported.
(c) In the case of one, two, or three years that do not meet the
completeness requirements of section 3(b) of this appendix and thus
would normally not be usable for the calculation of a valid 3-year
1-hour primary standard design value, the 3-year 1-hour primary
standard design value shall nevertheless be considered valid if
either of the following conditions is true:
(i) If there are at least four days in each of the 3 years that
have at least one reported hourly value, and the resulting 3-year 1-
hour primary standard design value exceeds the 1-hour primary NAAQS.
In this situation, more complete data capture could not possibly
have resulted in a design value below the 1-hour primary NAAQS:
(ii)(A) A 1-hour primary standard design value that is below the
level of the NAAQS can be validated if the substitution test in
section 3(c)(ii)(B) results in a ``test design value'' that is below
the level of the NAAQS. The test substitutes actual ``high''
reported daily maximum 1-hour values from the same site at about the
same time of the year (specifically, in the calendar quarter) for
unknown hourly values that were not successfully measured. Note that
the test is merely diagnostic in nature, intended to confirm that
there is a very high likelihood that the original design value (the
one with less than 75 percent data capture of hours by day and of
days by quarter) reflects the true under-NAAQS-level status for that
3-year period; the result of this data substitution test (the ``test
design value,'' as defined in section 3(c)(ii)(B)) is not considered
the actual design value. For this test, substitution is permitted
only if there are at least 200 days across the three matching
quarters of the three years under consideration (which is about 75
percent of all possible daily values in those three quarters) for
which 75 percent of the hours in the day have reported
concentrations. However, maximum 1-hour values from days with less
than 75 percent of the hours reported shall also be considered in
identifying the high value to be used for substitution.
(B) The substitution test is as follows: Data substitution will
be performed in all quarter periods that have less than 75 percent
data capture but at least 50 percent data capture; if any quarter
has less than 50 percent data capture, then this substitution test
cannot be used. Identify for each quarter (e.g., January-March) the
highest reported daily maximum 1-hour value for that quarter,
looking across those three months of all three years under
consideration. All daily maximum 1-hour values from all days in the
quarter period shall be considered when identifying this highest
value, including days with less than 75 percent data capture. If
after substituting the highest reported daily maximum 1-hour value
for a quarter for as much of the missing daily data in the matching
deficient quarter(s) as is needed to make them 100 percent complete,
the procedure in section 5 yields a recalculated 3-year 1-hour
standard ``test design value'' below the level of the standard, then
the 1-hour primary standard design value is deemed to have passed
the diagnostic test and is valid, and the level of the standard is
deemed to have been met in that 3-year period. As noted in section
3(c)(i), in such a case, the 3-year design value based on the data
actually reported, not the ``test design value,'' shall be used as
the valid design value.
(d) A 1-hour primary standard design value based on data that do
not meet the completeness criteria stated in 3(b) and also do not
satisfy section 3(c), may also be considered valid with the approval
of, or at the initiative of, the Administrator, who may consider
factors such as monitoring site closures/moves, monitoring
diligence, the consistency and levels of the valid concentration
measurements that are available, and nearby concentrations in
determining whether to use such data.
(e) The procedures for calculating the 1-hour primary standard
design values are given in section 5 of this appendix.
4. Rounding Conventions for the 1-hour Primary SO2
NAAQS.
(a) Hourly SO2 measurement data shall be reported to
AQS in units of parts per billion (ppb), to at most one place after
the decimal, with additional digits to the right being truncated
with no further rounding.
[[Page 64874]]
(b) Daily maximum 1-hour values, including the annual 4th
highest of those daily values, are not rounded.
(c) The 1-hour primary standard design value is calculated
pursuant to section 5 and then rounded to the nearest whole number
or 1 ppb (decimals 0.5 and greater are rounded up to the nearest
whole number, and any decimal lower than 0.5 is rounded down to the
nearest whole number).
5. Calculation Procedures for the 1-hour Primary SO2
NAAQS.
(a) When the data for a particular site and year meet the data
completeness requirements in section 3(b), or if one of the
conditions of section 3(c) is met, or if the Administrator exercises
the discretionary authority in section 3(d), calculation of the 4th
highest daily 1-hour maximum is accomplished as follows.
(i) For each year, select from each day the highest hourly
value. All daily maximum 1-hour values from all days in the quarter
period shall be considered at this step, including days with less
than 75 percent data capture.
(ii) For each year, order these daily values and take the 4th
highest.
(iii) The 1-hour primary standard design value for a site is
mean of the three annual 4th highest values, rounded according to
the conventions in section 4.
Option 2 for Appendix T to Part 50
Appendix T to Part 50--Interpretation of the Primary National Ambient
Air Quality Standards for Oxides of Sulfur (Sulfur Dioxide) [1-hour
primary standard based on the 99th percentile form]
1. General.
(a) This appendix explains the data handling conventions and
computations necessary for determining when the primary national
ambient air quality standards for Oxides of Sulfur as measured by
Sulfur Dioxide (``SO2 NAAQS'') specified in Sec. 50.4
are met. Sulfur Dioxide (SO2) is measured in the ambient
air by a Federal reference method (FRM) based on appendix A to this
part or by a Federal equivalent method (FEM) designated in
accordance with part 53 of this chapter. Data handling and
computation procedures to be used in making comparisons between
reported SO2 concentrations and the levels of the
SO2 NAAQS are specified in the following sections.
(b) Decisions to exclude, retain, or make adjustments to the
data affected by exceptional events, including natural events, are
made according to the requirements and process deadlines specified
in Sec. Sec. 50.1, 50.14 and 51.930 of this chapter.
(c) The terms used in this appendix are defined as follows:
Daily maximum 1-hour values for SO2 refers to the
maximum 1-hour SO2 concentration values measured from
midnight to midnight (local standard time) that are used in NAAQS
computations.
Design values are the metrics (i.e., statistics) that are
compared to the NAAQS levels to determine compliance, calculated as
specified in section 5 of this appendix. The design value for the
primary 1-hour NAAQS is the 3-year average of annual 99th percentile
daily maximum 1-hour values for a monitoring site (referred to as
the ``1-hour primary standard design value'').
99th percentile daily maximum 1-hour value is the value below
which nominally 99 percent of all daily maximum 1-hour concentration
values fall, using the ranking and selection method specified in
section 5 of this appendix.
Quarter refers to a calendar quarter.
Year refers to a calendar year.
2. Requirements for Data Used for Comparisons With the
SO2 NAAQS and Data Reporting Considerations.
(a) All valid FRM/FEM SO2 hourly data required to be
submitted to EPA's Air Quality System (AQS), or otherwise available
to EPA, meeting the requirements of part 58 of this chapter
including appendices A, C, and E shall be used in design value
calculations. Multi-hour average concentration values collected by
wet chemistry methods shall not be used.
(b) When two or more SO2 monitors are operated at a
site, the state may in advance designate one of them as the primary
monitor. If the state has not made this designation, the
Administrator will make the designation, either in advance or
retrospectively. Design values will be developed using only the data
from the primary monitor, if this results in a valid design value.
If data from the primary monitor do not allow the development of a
valid design value, data solely from the other monitor(s) will be
used in turn to develop a valid design value, if this results in a
valid design value. If there are three or more monitors, the order
for such comparison of the other monitors will be determined by the
Administrator. The Administrator may combine data from different
monitors in different years for the purpose of developing a valid 1-
hour primary standard design value, if a valid design value cannot
be developed solely with the data from a single monitor. However,
data from two or more monitors in the same year at the same site
will not be combined in an attempt to meet data completeness
requirements, except if one monitor has physically replaced another
instrument permanently, in which case the two instruments will be
considered to be the same monitor, or if the state has switched the
designation of the primary monitor from one instrument to another
during the year.
(c) Hourly SO2 measurement data shall be reported to
AQS in units of parts per billion (ppb), to at most one place after
the decimal, with additional digits to the right being truncated
with no further rounding.
3. Comparisons with the 1-hour Primary SO2 NAAQS.
(a) The 1-hour primary SO2 NAAQS is met at a site
when the valid 1-hour primary standard design value is less than or
equal to [50-150] parts per billion (ppb).
(b) An SO2 1-hour primary standard design value is
valid if it encompasses three consecutive calendar years of complete
data. A year meets data completeness requirements when all 4
quarters are complete. A quarter is complete when at least 75
percent of the sampling days for each quarter have complete data. A
sampling day has complete data if 75 percent of the hourly
concentration values are reported.
(c) In the case of one, two, or three years that do not meet the
completeness requirements of section 3(b) of this appendix and thus
would normally not be useable for the calculation of a valid 3-year
1-hour primary standard design value, the 3-year 1-hour primary
standard design value shall nevertheless be considered valid if one
of the following conditions is true.
(i) At least 75 percent of the days in each quarter of each of
three consecutive years have at least one reported hourly value, and
the design value calculated according to the procedures specified in
section 5 is above the level of the primary 1-hour standard.
(ii) (A) A 1-hour primary standard design value that is below
the level of the NAAQS can be validated if the substitution test in
section 3(c)(ii)(B) results in a ``test design value'' that is below
the level of the NAAQS. The test substitutes actual ``high''
reported daily maximum 1-hour values from the same site at about the
same time of the year (specifically, in the same calendar quarter)
for unknown values that were not successfully measured. Note that
the test is merely diagnostic in nature, intended to confirm that
there is a very high likelihood that the original design value (the
one with less than 75 percent data capture of hours by day and of
days by quarter) reflects the true under-NAAQS-level status for that
3-year period; the result of this data substitution test (the ``test
design value'', as defined in section 3(c)(ii)(B)) is not considered
the actual design value. For this test, substitution is permitted
only if there are at least 200 days across the three matching
quarters of the three years under consideration (which is about 75
percent of all possible daily values in those three quarters) for
which 75 percent of the hours in the day have reported
concentrations. However, maximum 1-hour values from days with less
than 75 percent of the hours reported shall also be considered in
identifying the high value to be used for substitution.
(B) The substitution test is as follows: Data substitution will
be performed in all quarter periods that have less than 75 percent
data capture but at least 50 percent data capture; if any quarter
has less than 50 percent data capture then this substitution test
cannot be used. Identify for each quarter (e.g., January-March) the
highest reported daily maximum 1-hour value for that quarter,
looking across those three months of all three years under
consideration. All daily maximum 1-hour values from all days in the
quarter period shall be considered when identifying this highest
value, including days with less than 75 percent data capture. If
after substituting the highest reported daily maximum 1-hour value
for a quarter for as much of the missing daily data in the matching
deficient quarter(s) as is needed to make them 100 percent complete,
the procedure in section 5 yields a recalculated 3-year 1-hour
standard ``test design value'' below the level of the standard, then
the 1-hour primary standard design value is deemed to have passed
the diagnostic test and is valid, and the level of
[[Page 64875]]
the standard is deemed to have been met in that 3-year period. As
noted in section 3(c)(i), in such a case, the 3-year design value
based on the data actually reported, not the ``test design value'',
shall be used as the valid design value.
(iii) (A) A 1-hour primary standard design value that is above
the level of the NAAQS can be validated if the substitution test in
section 3(c)(iii)(B) results in a ``test design value'' that is
above the level of the NAAQS. The test substitutes actual ``low''
reported daily maximum 1-hour values from the same site at about the
same time of the year (specifically, in the same three months of the
calendar) for unknown hourly values that were not successfully
measured. Note that the test is merely diagnostic in nature,
intended to confirm that there is a very high likelihood that the
original design value (the one with less than 75 percent data
capture of hours by day and of days by quarter) reflects the true
above-NAAQS-level status for that 3-year period; the result of this
data substitution test (the ``test design value'', as defined in
section 3(c)(iii)(B)) is not considered the actual design value. For
this test, substitution is permitted only if there are a minimum
number of available daily data points from which to identify the low
quarter-specific daily maximum 1-hour values, specifically if there
are at least 200 days across the three matching quarters of the
three years under consideration (which is about 75 percent of all
possible daily values in those three quarters) for which 75 percent
of the hours in the day have reported concentrations. Only days with
at least 75 percent of the hours reported shall be considered in
identifying the low value to be used for substitution.
(B) The substitution test is as follows: Data substitution will
be performed in all quarter periods that have less than 75 percent
data capture. Identify for each quarter (e.g., January-March) the
lowest reported daily maximum 1-hour value for that quarter, looking
across those three months of all three years under consideration.
All daily maximum 1-hour values from all days with at least 75
percent capture in the quarter period shall be considered when
identifying this lowest value. If after substituting the lowest
reported daily maximum 1-hour value for a quarter for as much of the
missing daily data in the matching deficient quarter(s) as is needed
to make them 75 percent complete, the procedure in section 5 yields
a recalculated 3-year 1-hour standard ``test design value'' above
the level of the standard, then the 1-hour primary standard design
value is deemed to have passed the diagnostic test and is valid, and
the level of the standard is deemed to have been exceeded in that 3-
year period. As noted in section 3(c)(i), in such a case, the 3-year
design value based on the data actually reported, not the ``test
design value'', shall be used as the valid design value.
(d) A 1-hour primary standard design value based on data that do
not meet the completeness criteria stated in 3(b) and also do not
satisfy section 3(c), may also be considered valid with the approval
of, or at the initiative of, the Administrator, who may consider
factors such as monitoring site closures/moves, monitoring
diligence, the consistency and levels of the valid concentration
measurements that are available, and nearby concentrations in
determining whether to use such data.
(e) The procedures for calculating the 1-hour primary standard
design values are given in section 5 of this appendix.
4. Rounding Conventions for the 1-hour Primary SO2
NAAQS.
(a) Hourly SO2 measurement data shall be reported to
AQS in units of parts per billion (ppb), to at most one place after
the decimal, with additional digits to the right being truncated
with no further rounding.
(b) Daily maximum 1-hour values and therefore the annual 4th
highest of those daily values are not rounded.
(c) The 1-hour primary standard design value is calculated
pursuant to section 5 and then rounded to the nearest whole number
or 1 ppb (decimals 0.5 and greater are rounded up to the nearest
whole number, and any decimal lower than 0.5 is rounded down to the
nearest whole number).
5. Calculation Procedures for the 1-hour Primary SO2
NAAQS.
(a) Procedure for identifying annual 99th percentile values.
When the data for a particular site and year meet the data
completeness requirements in section 3(b), or if one of the
conditions of section 3(c) is met, or if the Administrator exercises
the discretionary authority in section 3(d), identification of
annual 99th percentile value is accomplished as follows.
(i) The annual 99th percentile value for a year is the higher of
the two values resulting from the following two procedures.
(1) Procedure 1. For the year, determine the number of days with
at least 75 percent of the hourly values reported.
(A) For the year, from only the days with at least 75 percent of
the hourly values reported, select from each day the maximum hourly
value.
(B) Sort all these daily maximum hourly values from a particular
site and year by descending value. (For example: (x[1], x[2], x[3],
* * *, x[n]). In this case, x[1] is the largest number and x[n] is
the smallest value.) The 99th percentile is determined from this
sorted series of daily values which is ordered from the highest to
the lowest number. Using the left column of Table 1, determine the
appropriate range (i.e., row) for the annual number of days with
valid data for year y (cny). The corresponding ``n''
value in the right column identifies the rank of the annual 99th
percentile value in the descending sorted list of daily site values
for year y. Thus, P0.99, y = the nth largest value.
(2) Procedure 2. For the year, determine the number of days with
at least one hourly value reported.
(A) For the year, from all the days with at least one hourly
value reported, select from each day the maximum hourly value.
(B) Sort all these daily maximum values from a particular site
and year by descending value. (For example: (x[1], x[2], x[3], * *
*, x[n]). In this case, x[1] is the largest number and x[n] is the
smallest value.) The 99th percentile is determined from this sorted
series of daily values which is ordered from the highest to the
lowest number. Using the left column of Table 1, determine the
appropriate range (i.e., row) for the annual number of days with
valid data for year y (cny). The corresponding ``n''
value in the right column identifies the rank of the annual 99th
percentile value in the descending sorted list of daily site values
for year y. Thus, P0.99, y = the nth largest value.
(b) The 1-hour primary standard design value for a site is mean
of the three annual 99th percentile values, rounded according to the
conventions in section 4.
Table 1
------------------------------------------------------------------------
P0.99, y is the nth maximum value
Annual number of days with valid data of the year, where n is the
for year ``y'' (cny) listed number
------------------------------------------------------------------------
1-100................................ 1
101-200.............................. 2
201-300.............................. 3
301-366.............................. 4
------------------------------------------------------------------------
PART 53--AMBIENT AIR MONITORING REFERENCE AND EQUIVALENT METHODS
8. The authority citation for part 53 continues to read as follows:
Authority: Sec. 301(a) of the Clean Air Act (42 U.S.C. sec.
1857g(a)), as amended by sec. 15(c)(2) of Public Law 91-604, 84
Stat. 1713, unless otherwise noted.
Subpart A--[Amended]
9. Section 53.2 is amended by revising paragraphs (a)(1) and (b) to
read as follows:
Sec. 53.2. General requirements for a reference method determination.
* * * * *
(a) Manual methods--(1) Sulfur dioxide (SO2) and Lead. For
measuring SO2 and lead, Appendixes A-2 and G of part 50 of
this chapter specify unique manual FRM for measuring those pollutants.
After [effective date of Appendix A-1], a new FRM for SO2
must be an automated method that utilizes the measurement principle and
calibration procedure specified in Appendix A-1 to part 50 of this
chapter and must meet applicable requirements of this part, as
specified in paragraph (b) of this section. Except as provided in Sec.
53.16, other manual methods for lead will not be considered for a
reference method determination under this part.
* * * * *
(b) Automated methods. An automated FRM for measuring
SO2, CO, O3, or NO2 must utilize the
measurement principle and calibration procedure specified in the
appropriate appendix to part 50 of this chapter (appendix A-1 only for
SO2 methods) and must have been shown in accordance with
this part to meet the
[[Page 64876]]
requirements specified in this subpart A and subpart B of this part.
10. Section 53.8 is amended by revising paragraph (c) to read as
follows:
Sec. 53.8 Designation of reference and equivalent methods.
* * * * *
(c) The Administrator will maintain a current list of methods
designated as FRM or FEM in accordance with this part and will send a
copy of the list to any person or group upon request. A copy of the
list will be available via the Internet and may be available from other
sources.
11. Table A-1 to Subpart A is revised to read as follows:
Table A-1 to Subpart A of Part 53--Summary of Applicable Requirements for Reference and Equivalent Methods for Air Monitoring of Criteria Pollutants
--------------------------------------------------------------------------------------------------------------------------------------------------------
Applicable subparts of part 53
Pollutant Reference or Manual or automated Applicable part 50 appendix -----------------------------------------------------------
equivalent A B C D E F
--------------------------------------------------------------------------------------------------------------------------------------------------------
SO2............... Reference........... Manual.............. A-2
Automated........... A-1 [check] [check]
Equivalent.......... Manual.............. A-1 [check] ........ [check]
Automated........... A-1 [check] [check] [check]
CO................ Reference........... Automated........... C [check] [check]
Equivalent.......... Manual.............. C [check] ........ [check]
Automated........... C [check] [check] [check]
O3................ Reference........... Automated........... D [check] [check]
Equivalent.......... Manual.............. D [check] ........ [check]
Automated........... D [check] [check] [check]
NO2............... Reference........... Automated........... F [check] [check]
Equivalent.......... Manual.............. F [check] ........ [check]
Automated........... F [check] [check] [check]
Pb................ Reference........... Manual.............. G
Equivalent.......... Manual.............. G [check] ........ [check]
Automated........... G [check] ........ [check]
PM10-Pb........... Reference........... Manual.............. Q
Equivalent.......... Manual.............. Q [check] ........ [check]
Automated........... Q [check] ........ [check]
PM10.............. Reference........... Manual.............. J [check] ........ ........ [check] ........ ........
Equivalent.......... Manual.............. J [check] ........ [check] [check] ........ ........
Automated........... J [check] ........ [check] [check] ........ ........
PM2.5............. Reference........... Manual.............. L [check] ........ ........ ........ [check] ........
Equivalent Class I.. Manual.............. L [check] ........ [check] ........ [check] ........
Equivalent Class II. Manual.............. L \1\ [check] ........ [check] ........ [check] [check]
\2\ 1 2
Equivalent Class III Automated........... L \1\ [check] ........ [check] ........ [check] [check]
\1\
PM10 2.5.......... Reference........... Manual.............. L, O [check] ........ ........ ........ [check] ........
Equivalent Class I.. Manual.............. L, O [check] ........ [check] ........ [check] ........
Equivalent Class II. Manual.............. L, O [check] ........ [check] ........ [check] [check]
\2\ 1 2
Equivalent Class III Automated........... L \1\, O \1\ [check] ........ [check] ........ [check] [check]
\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Some requirements may apply, based on the nature of each particular candidate method, as determined by the Administrator.
\2\ Alternative Class III requirements may be substituted.
Subpart B--[Amended]
12. Section 53.20 is amended as follows:
A. By revising paragraph (b).
B. In paragraph (c), by revising Table B-1.
The revisions read as follows:
Sec. 53.20 General provisions.
* * * * *
(b) For a candidate method having more than one selectable
measurement range, one range must be that specified in table B-1
(standard range for SO2), and a test analyzer representative
of the method must pass the tests required by this subpart while
operated in that range. The tests may be repeated for one or more
broader ranges (i.e., ones extending to higher concentrations) than the
range specified in table B-1, provided that the range does not extend
to concentrations more than four times the upper range limit specified
in table B-1. For broader ranges, only the tests for range
(calibration), noise at 80% of the upper range limit, and lag, rise and
fall time are required to be repeated. The tests may be repeated for
one or more narrower ranges (ones extending to lower concentrations)
than that specified in table B-1. For SO2 methods, table B-1
specifies special performance requirements for narrower (lower) ranges.
For methods other than SO2, only the tests for range
(calibration), noise at 0% of the measurement range, and lower
detectable limit are required to be repeated. If the tests are
conducted or passed only for the specified range (standard range for
SO2), any FRM or FEM method determination with respect to
the method will be limited to that range. If the tests are passed for
both the specified range and one or more broader ranges, any such
determination will include the additional range(s) as well as the
specified range, provided that the tests required by subpart C of this
part (if applicable) are met for the broader range(s). If the tests are
passed for both the specified range and one or more narrower ranges,
any FRM or FEM method determination for the method will include the
narrower range(s) as well as the specified range. Appropriate test data
shall be submitted for each range sought to be included in a FRM or FEM
method determination under this paragraph (b).
(c) * * *
[[Page 64877]]
Table B-1--Performance Specifications for Automated Methods
--------------------------------------------------------------------------------------------------------------------------------------------------------
SO2
----------------------------
Performance parameter Units \1\ Lower O3 CO NO2 Definitions and test
Std. range \3\ range \2\ procedures
\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Range........................... ppm................... 0-0.5 <0.5 0-0.5 0-50 0-0.5 Sec. 53.23(a).
2. Noise........................... ppm................... 0.001 0.0005 0.005 50 0.005 Sec. 53.23(b).
3. Lower detectable limit.......... ppm................... 0.002 0.001 0.010 1.0 0.010 Sec. 53.23(c).
4. Interference equivalent
Each interferent............... ppm................... 0.005 minus>0.00 minus>0.02 minus>1.0 minus>0.02
5
Total, all interferents........ ppm................... 0.020 0.020 0.06 1.5 0.04 Sec. 53.23(d).
5. Zero drift, 12 and 24 hour...... ppm................... 0.004 minus>0.00 minus>0.02 minus>1.0 minus>0.02
2
7. Span drift, 24 hour:
20% of upper range limit....... Percent............... .............. .......... 20.0 minus>10.0 minus>20.0
80% of upper range limit....... Percent............... 5.0 minus>5.0 minus>5.0 minus>2.5 minus>5.0
8. Lag time........................ Minutes............... 2 2 20 10 20 Sec. 53.23(e).
9. Rise time....................... Minutes............... 2 2 15 5 15 Sec. 53.23(e).
10. Fall time...................... Minutes............... 2 2 15 5 15 Sec. 53.23(e).
11. Precision:
20% of upper range limit....... ppm................... .............. .......... 0.010 0.5 0.020 Sec. 53.23(e).
Percent............... 2 2 .......... ........... .......... Sec. 53.23(e).
80% of upper range limit....... ppm................... .............. .......... 0.010 0.5 0.030 Sec. 53.23(e).
Percent............... 2 2 .......... ........... .......... Sec. 53.23(e).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ To convert from parts per million (ppm) to [mu]g/m\3\ at 25 [deg]C and 760 mm Hg, multiply by M/0.02447, where M is the molecular weight of the gas.
Percent means percent of the upper range limit.
\2\ Tests for interference equivalent and lag time do not need to be repeated for any lower SO2 range provided the test for the standard range shows
that the lower range specification is met for each of these test parameters.
\3\ For candidate analyzers having automatic or adaptive time constants or smoothing filters, describe their functional nature, and describe and conduct
suitable tests to demonstrate their function aspects and verify that performances for calibration, noise, lag, rise, fall times, and precision are
within specifications under all applicable conditions. For candidate analyzers with operator-selectable time constants or smoothing filters, conduct
calibration, noise, lag, rise, fall times, and precision tests at the highest and lowest settings that are to be included in the FRM or FEM
designation.
* * * * *
13. Section 53.21 is amended by revising paragraph (a) to read as
follows:
Sec. 53.21 Test conditions.
(a) Set-up and start-up of the test analyzer shall be in strict
accordance with the operating instructions specified in the manual
referred to in Sec. 53.4(b)(3). Allow adequate warm-up or
stabilization time as indicated in the operating instructions before
beginning the tests. The test procedures assume that the test analyzer
has an analog measurement signal output that is connected to a suitable
strip chart recorder of the servo, null-balance type. This recorder
shall have a chart width of a least 25 centimeters, chart speeds up to
10 cm per hour, a response time of 1 second or less, a deadband of not
more than 0.25 percent of full scale, and capability either of reading
measurements at least 5 percent below zero or of offsetting the zero by
at least 5 percent. If the test analyzer does not have an analog signal
output, or if other types of measurement data output are used, an
alternative measurement data recording device (or devices) may be used
for the tests, provided it is reasonably suited to the nature and
purposes of the tests and an analog representation of the analyzer
measurements for each test can be plotted or otherwise generated that
is reasonably similar to the analog measurement recordings that would
be produced by a conventional chart recorder.
* * * * *
14. Section 53.22(d) is amended by revising Table B-2 to read as
follows:
Sec. 53.22 Generation of test atmospheres.
* * * * *
(d) * * *
Table B-2--Test Atmospheres
------------------------------------------------------------------------
Test gas Generation Verification
------------------------------------------------------------------------
Ammonia....................... Permeation device. Indophenol method,
Similar to system reference 3.
described in
references 1 and 2.
Carbon dioxide................ Cylinder of zero Use NIST-certified
air or nitrogen standards whenever
containing CO2 as possible. If NIST
required to obtain standards are not
the concentration available, obtain
specified in table 2 standards from
B-3. independent
sources which
agree within 2
percent, or obtain
one standard and
submit it to an
independent
laboratory for
analysis, which
must agree within
2 percent of the
supplier's nominal
analysis.
Carbon monoxide............... Cylinder of zero Use a FRM CO
air or nitrogen analyzer as
containing CO as described in
required to obtain reference 8.
the concentration
specified in table
B-3.
Ethane........................ Cylinder of zero Gas chromatography,
air or nitrogen ASTM D2820,
containing ethane reference 10. Use
as required to NIST-traceable
obtain the gaseous methane or
concentration propane standards
specified in table for calibration.
B-3.
Ethylene...................... Cylinder of pre- Do.
purified nitrogen
containing
ethylene as
required to obtain
the concentration
specified in table
B-3.
[[Page 64878]]
Hydrogen chloride............. Cylinder \1\ of pre- Collect samples in
purified nitrogen bubbler containing
containing distilled water
approximately 100 and analyze by the
ppm of gaseous mercuric
HCL. Dilute with thiocyante method,
zero air to ASTM (D612), p.
concentration 29, reference 4.
specified in table
B-3.
Hydrogen sulfide.............. Permeation device Tentative method of
system described analysis for H2S
in references 1 content of the
and 2. atmosphere, p.
426, reference 5.
Methane....................... Cylinder of zero Gas chromatography
air containing ASTM D2820,
methane as reference 10. Use
required to obtain NIST-traceable
the concentration methane standards
specified in table for calibration.
B-3.
Nitric oxide.................. Cylinder\1\ of pre- Gas phase titration
purified nitrogen as described in
containing reference 6,
approximately 100 section 7.1.
ppm NO. Dilute
with zero air to
required
concentration.
Nitrogen dioxide.............. 1. Gas phase 1. Use an FRM NO2
titration as analyzer
described in calibrated with a
reference 6. gravimetrically
2. Permeation calibrated
device, similar to permeation device.
system described 2. Use an FRM NO2
in reference 6. analyzer
calibrated by gas-
phase titration as
described in
reference 6.
Ozone......................... Calibrated ozone Use an FEM ozone
generator as analyzer
described in calibrated as
reference 9. described in
reference 9.
Sulfur dioxide................ 1. Permeation Use an SO2 FRM or
device as FEM analyzer as
described in described in
references 1 and 2. reference 7.
2. Dynamic dilution
of a cylinder
containing
approximately 100
ppm SO2 as
described in
reference 7.
Water......................... Pass zero air Measure relative
through distilled humidity by means
water at a fixed of a dew-point
known temperature indicator,
between 20 [deg] calibrated
and 30 [deg]C such electrolytic or
that the air piezo electric
stream becomes hygrometer, or wet/
saturated. Dilute dry bulb
with zero air to thermometer.
concentration
specified in table
B-3.
Xylene........................ Cylinder of pre- Use NIST-certified
purified nitrogen standards whenever
containing 100 ppm possible. If NIST
xylene. Dilute standards are not
with zero air to available, obtain
concentration 2 standards from
specified in table independent
B-3. sources which
agree within 2
percent, or obtain
one standard and
submit it to an
independent
laboratory for
analysis, which
must agree within
2 percent of the
supplier's nominal
analysis.
Zero air...................... 1. Ambient air
purified by
appropriate
scrubbers or other
devices such that
it is free of
contaminants
likely to cause a
detectable
response on the
analyzer.
2. Cylinder of
compressed zero
air certified by
the supplier or an
independent
laboratory to be
free of
contaminants
likely to cause a
detectable
response on the
analyzer.
------------------------------------------------------------------------
\1\ Use stainless steel pressure regulator dedicated to the pollutant
measured.
Reference 1. O'Keefe, A. E., and Ortaman, G. C. ``Primary Standards for
Trace Gas Analysis,'' Anal. Chem. 38, 760 (1966).
Reference 2. Scaringelli, F. P., A. E. Rosenberg, E*, and Bell, J. P.,
``Primary Standards for Trace Gas Analysis.'' Anal. Chem. 42, 871
(1970).
Reference 3. ``Tentative Method of Analysis for Ammonia in the
Atmosphere (Indophenol Method)'', Health Lab Sciences, vol. 10, No. 2,
115-118, April 1973.
Reference 4. 1973 Annual Book of ASTM Standards, American Society for
Testing and Materials, 1916 Race St., Philadelphia, PA.
Reference 5. Methods for Air Sampling and Analysis, Intersociety
Committee, 1972, American Public Health Association, 1015.
Reference 6. 40 CFR 50 Appendix F, ``Measurement Principle and
Calibration Principle for the Measurement of Nitrogen Dioxide in the
Atmosphere (Gas Phase Chemiluminescence).''
Reference 7. 40 CFR 50 Appendix A-1, ``Measurement Principle and
Calibration Procedure for the Measurement of Sulfur Dioxide in the
Atmosphere (Ultraviolet Fluorescence).''
Reference 8. 40 CFR 50 Appendix C, ``Measurement Principle and
Calibration Procedure for the Measurement of Carbon Monoxide in the
Atmosphere'' (Non-Dispersive Infrared Photometry)''.
Reference 9. 40 CFR 50 Appendix D, ``Measurement Principle and
Calibration Procedure for the Measurement of Ozone in the
Atmosphere''.
Reference 10. ``Standard Test Method for C, through C5 Hydrocarbons in
the Atmosphere by Gas Chromatography'', D 2820, 1987 Annual Book of
Aston Standards, vol 11.03, American Society for Testing and
Materials, 1916 Race St., Philadelphia, PA 19103.
* * * * *
15. Section 53.23(d) is amended by revising Table B-3 to read as
follows:
Sec. 53.23 Test procedures.
* * * * *
(d) * * *
Table B-3--Interferent Test Concentration,\1\ Parts Per Million
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Hydro- Hydro- Carbon
Pollutant Analyzer type chloric Ammo- gen Sulfur Nitrogen Nitric Carbon Ethy- Ozone M- Water vapor mon- Meth- Ethane Naph-
acid nia sulfide dioxide dioxide oxide dioxide lene xylene oxide ane thalene
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
SO2..................... Ultraviolet fluorescence.. ....... ....... \5\ 0.1 \4\ 0.5 0.5 ....... ....... 0.5 0.2 20,000 ....... ....... ....... \6\
0.14 0.05
SO2..................... Flame photometric......... ....... ....... 0.01 \4\ ........ ....... 750 ....... ....... ....... \3\ 20,000 50 ....... ....... .......
0.14
SO2..................... Gas chromatography........ ....... ....... 0.1 \4\ ........ ....... 750 ....... ....... ....... \3\ 20,000 50 ....... ....... .......
0.14
SO2..................... Spectrophotometric-wet 0.2 0.1 0.1 \4\ 0.5 ....... 750 ....... 0.5 ....... ........... ....... ....... ....... .......
chemical (pararosanaline). 0.14
SO2..................... Electrochemical........... 0.2 0.1 0.1 \4\ 0.5 0.5 ....... 0.2 0.5 ....... \3\ 20,000 ....... ....... ....... .......
0.14
SO2..................... Conductivity.............. 0.2 0.1 ....... \4\ 0.5 ....... 750 ....... ....... ....... ........... ....... ....... ....... .......
0.14
SO2..................... Spectrophotometric-gas ....... ....... ....... \4\ 0.5 ....... ....... ....... 0.5 0.2 ........... ....... ....... ....... .......
phase, including DOAS. 0.14
O3...................... Chemiluminescent.......... ....... ....... \3\ 0.1 ....... ........ ....... 750 ....... \4\ ....... \3\ 20,000 ....... ....... ....... .......
0.08
O3...................... Electrochemical........... ....... \3\ 0.1 ....... 0.5 0.5 ....... ....... ....... \4\ ....... ........... ....... ....... ....... .......
0.08
[[Page 64879]]
O3...................... Spectrophotometric-wet ....... \3\ 0.1 ....... 0.5 0.5 \3\ 0.5 ....... ....... \4\ ....... ........... ....... ....... ....... .......
chemical (potassium 0.08
iodide).
O3...................... Spectrophotometric-gas ....... ....... ....... 0.5 0.5 0.5 ....... ....... \4\ 0.02 20,000 ....... ....... ....... .......
phase, including 0.08
ultraviolet absorption
and DOAS).
CO...................... Infrared.................. ....... ....... ....... ....... ........ ....... 750 ....... ....... ....... 20,000 \4\ 10 ....... ....... .......
CO...................... Gas chromatography with ....... ....... ....... ....... ........ ....... ....... ....... ....... ....... 20,000 \4\ 10 ....... 0.5 .......
flame ionization detector.
CO...................... Electrochemical........... ....... ....... ....... ....... ........ 0.5 ....... 0.2 ....... ....... 20,000 \4\ 10 ....... ....... .......
CO...................... Catalytic combustion- ....... 0.1 ....... ....... ........ ....... 750 0.2 ....... ....... 20,000 \4\ 10 5.0 0.5 .......
thermal detection.
CO...................... IR fluorescence........... ....... ....... ....... ....... ........ ....... 750 ....... ....... ....... 20,000 \4\ 10 ....... 0.5 .......
CO...................... Mercury replacement-UV ....... ....... ....... ....... ........ ....... ....... 0.2 ....... ....... ........... \4\ 10 ....... 0.5 .......
photometric.
NO2..................... Chemiluminescent.......... ....... \3\ 0.1 ....... 0.5 \4\ 0.1 0.5 ....... ....... ....... ....... 20,000 ....... ....... ....... .......
NO2..................... Spectrophotometric-wet ....... ....... ....... 0.5 \4\ 0.1 0.5 750 ....... 0.5 ....... ........... ....... ....... ....... .......
chemical (azo-dye
reaction).
NO2..................... Electrochemical........... 0.2 \3\ 0.1 ....... 0.5 \4\ 0.1 0.5 750 ....... 0.5 ....... 20,000 50 ....... ....... .......
NO2..................... Spectrophotometric-gas ....... \3\ 0.1 ....... 0.5 \4\ 0.1 0.5 ....... ....... 0.5 ....... 20,000 50 ....... ....... .......
phase.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Concentrations of interferent listed must be prepared and controlled to 10 percent of the stated value.
\2\ Analyzer types not listed will be considered by the Administrator as special cases.
\3\ Do not mix with the pollutant.
\4\ Concentration of pollutant used for test. These pollutant concentrations must be prepared to 10 percent of the stated value.
\5\ If candidate method utilizes an elevated-temperature scrubber for removal of aromatic hydrocarbons, perform this interference test.
\6\ If naphthalene test concentration cannot be accurately quantified, remove the scrubber, use a test concentration that causes a full scale response, reattach the scrubber, and evaluate
response for interference.
* * * * *
Subpart C--[Amended]
16. Section 53.32 is amended by revising paragraph (e)(2) to read
as follows:
Sec. 53.32 Test procedures for methods for SO2, CO, O3, and NO2.
* * * * *
(e) * * *
(2) For a candidate method having more than one selectable range,
one range must be that specified in table B-1 of subpart B of this
part, and a test analyzer representative of the method must pass the
tests required by this subpart while operated on that range. The tests
may be repeated for one or more broader ranges (i.e., ones extending to
higher concentrations) than the one specified in table B-1 of subpart B
of this part, provided that such a range does not extend to
concentrations more than four times the upper range limit specified in
table B-1 of subpart B of this part and that the test analyzer has
passed the tests required by subpart B of this part (if applicable) for
the broader range. If the tests required by this subpart are conducted
or passed only for the range specified in table B-1 of subpart B of
this part, any equivalent method determination with respect to the
method will be limited to that range. If the tests are passed for both
the specified range and a broader range (or ranges), any such
determination will include the broader range(s) as well as the
specified range. Appropriate test data shall be submitted for each
range sought to be included in such a determination.
* * * * *
17. Table C-1 to Subpart C is revised to read as follows:
Table C-1 to Subpart C of Part 53--Test Concentration Ranges, Number of Measurements Required, and Maximum Discrepancy Specifications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Simultaneous measurements required Maximum
---------------------------------------------------- discrepancy
Pollutant Concentration range, parts per 1-hour 24-hour specification,
million (ppm) ---------------------------------------------------- parts per
First set Second set First set Second set million
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ozone.......................................... Low 0.06 to 0.10................. 5 6 ........... ........... 0.02
Med. 0.15 to 0.25................ 5 6 ........... ........... 0.03
High 0.35 to 0.46................ 4 6 ........... ........... 0.04
---------------------------------------------------------------------
Total......................... 14 18 ........... ........... ................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carbon monoxide................................ Low 7 to 11...................... 5 6 ........... ........... 1.5
Med. 20 to 30.................... 5 6 ........... ........... 2.0
High 25 to 45.................... 4 6 ........... ........... 3.0
---------------------------------------------------------------------
Total......................... 14 18 ........... ........... ................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sulfur dioxide................................. Low 0.02 to 0.05................. 5 6 3 3 0.02
Med. 0.10 to 0.15................ 5 6 2 3 0.03
High 0.30 to 0.50................ 4 6 2 2 0.04
---------------------------------------------------------------------
Total......................... 14 18 7 8 ................
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 64880]]
Nitrogen dioxide............................... Low 0.02 to 0.08................. ........... ........... 3 3 0.02
Med. 0.10 to 0.20................ ........... ........... 2 2 0.02
High 0.25 to 0.35................ ........... ........... 2 2 0.03
---------------------------------------------------------------------
Total......................... ........... ........... 7 8 ................
--------------------------------------------------------------------------------------------------------------------------------------------------------
PART 58--AMBIENT AIR QUALITY SURVEILLANCE
18. The authority citation for part 58 continues to read as
follows:
Authority: 42 U.S.C. 7403, 7410, 7601(a), 7611, and 7619.
Subpart B--[Amended]
19. Section 58.10 is amended by adding paragraph (a)(6) to read as
follows:
Sec. 58.10 Annual monitoring network plan and periodic network
assessment.
(a) * * *
(6) A plan for establishing SO2 monitoring sites in
accordance with the requirements of appendix D to this part shall be
submitted to the EPA Regional Administrator by July 1, 2011 as part of
the annual network plan required in paragraph (a)(1) of this section.
The plan shall provide for all required SO2 monitoring sites
to be operational by January 1, 2013.
* * * * *
20. Section 58.12 is amended by adding paragraph (g) to read as
follows:
Sec. 58.12 Operating schedules.
* * * * *
(g) For continuous SO2 analyzers, the maximum 5-minute
block average concentration of the twelve 5-minute blocks in the hour
must be collected except as noted in Sec. 58.12(a).
21. Section 58.13 is amended by adding paragraph (d) to read as
follows:
Sec. 58.13 Monitoring network completion.
* * * * *
(d) The network of SO2 monitors must be physically
established no later than January 1, 2013, and at that time, must be
operating under all of the requirements of this part, including the
requirements of appendices A, C, D, and E to this part.
22. Section 58.16 is amended by adding paragraph (g) to read as
follows:
Sec. 58.16 Data submittal and archiving requirements.
* * * * *
(g) Any State, or where applicable, local agency operating an
SO2 monitor shall report the maximum 5-minute SO2
block average of the twelve 5-minute block averages in each hour, in
addition to the hourly SO2 average.
23. Appendix A to Part 58 is amended by adding paragraph 2.3.1.6 to
read as follows:
Appendix A to Part 58--Quality Assurance Requirements for SLAMS, SPMs
and PSD Air Monitoring
* * * * *
2.3.1.6 Measurement Uncertainty for SO2. The goal for
acceptable measurement uncertainty for precision is defined as an
upper 90 percent confidence limit for the coefficient of variation
(CV) of 15 percent and for bias as an upper 95 percent confidence
limit for the absolute bias of 15 percent.
* * * * *
24. Appendix C to Part 58 is amended by adding paragraph 2.1.2 to
read as follows:
Appendix C to Part 58--Ambient Air Quality Monitoring Methodology
* * * * *
2.1.2 Any SO2 FRM or FEM used for making NAAQS
decisions, as prescribed in 40 CFR Part 50 Appendix A-1, must be
capable of providing 1-hour averaged and 5-minute averaged
concentration data.
* * * * *
25. Appendix D to Part 58 is amended by revising paragraph 4.4 to
read as follows:
Appendix D to Part 58--Network Design Criteria for Ambient Air Quality
Monitoring
* * * * *
4.4 Sulfur Dioxide (SO2) Design Criteria.
4.4.1 General Requirements. State and, where appropriate, local
agencies must operate a minimum number of required SO2
monitoring sites as described below.
4.4.2 Requirement for Monitoring by the Population Weighted
Emissions Index. (a) The population weighted emissions index (PWEI)
shall be calculated by states for each CBSA they contain or share
with another state or states for use in the implementation of or
adjustment to the SO2 monitoring network. The PWEI shall
be calculated by multiplying the population of each CBSA, using the
most current census data, by the total amount of SO2 in
tons per year emitted within the CBSA area, using an aggregate of
the most recent county level emissions data available in the
National Emissions Inventory for each county in each CBSA. The
resulting product shall be divided by one million, providing a PWEI
value, the units of which are million persons-tons per year. For any
CBSA with a calculated PWEI value equal to or greater than
1,000,000, a minimum of three SO2 monitors are required
within that CBSA. For any CBSA with a calculated PWEI value equal to
or greater than 10,000, but less than 1,000,000, a minimum of two
SO2 monitors are required within that CBSA. For any CBSA
with a calculated PWEI value equal to or greater than 5,000, but
less than 10,000, a minimum of one SO2 monitor is
required within that CBSA.
(1) The SO2 monitoring site(s) required as a result
of the PWEI in each CBSA shall be sited by states through a process
of identifying locations within the boundaries of that CBSA where
maximum ground-level 1-hour SO2 concentrations occur due
to emissions that originate inside and/or outside of that CBSA.
Where a state or local air monitoring agency identifies multiple
acceptable candidate sites where maximum hourly SO2
concentrations are expected to occur, the monitoring agency shall
select the location with the greater population exposure. Where one
CBSA is required to have more than one SO2 monitor, the
monitoring sites shall not be oriented to measure maximum hourly
concentrations from the same SO2 source or group of
sources, but shall monitor a different source or group of sources.
Any PWEI-triggered monitors shall not count toward satisfying any
required monitors resulting from the state emissions triggered
requirements described below.
(2) The number of SO2 monitors operated as a result
of the PWEI shall be reviewed and adjusted as needed as a part of
the 5-year network assessment cycle required in Sec. 58.10 of this
part.
(b) [Reserved]
4.4.3 Requirement for State Emission Triggered SO2
Monitoring. (a) Each State shall operate a minimum number of
monitors based on that state's contribution of SO2
emissions to the national, anthropogenic SO2 inventory as
identified in the most recent
[[Page 64881]]
National Emissions Inventory. Each state shall operate one monitor
for each percent that it contributes to the NEI. The percent
contribution shall be rounded to the nearest whole integer value.
Every state shall operate a minimum of one monitor under this
requirement.
(1) Each state emission triggered SO2 monitoring
station shall be sited by states through a process of identifying
locations within the boundaries of that state where maximum ground-
level 1-hour SO2 concentrations occur due to
SO2 source emissions originate inside or outside the
state. Where a state has CBSAs with PWEI-triggered monitoring, the
PWEI-triggered monitors shall not count toward the emission-
triggered monitors. State emission-triggered monitors shall not be
sited to measure maximum hourly concentrations from the same
SO2 source or group of sources as another SO2
monitor, but shall measure maximum hourly concentrations resulting
from a different source or group of sources.
(2) The number of SO2 monitors operated as a result
of state-level emissions shall be reviewed and adjusted as needed as
a part of the 5-year network assessment cycle required in Sec.
58.10 of this part.
(b) [Reserved]
4.4.4 Regional Administrator Required Monitoring. The Regional
Administrator may require additional SO2 monitoring
stations above the minimum number of monitors required in 4.4.2 and
4.4.3 of this appendix, where the minimum monitoring requirements
are not sufficient to meet monitoring objectives. The Regional
Administrator may require, at his/her discretion, additional
monitors in situations where an area has the potential to have
concentrations that may violate or contribute to the violation of
the NAAQS and the area is not monitored under the minimum monitoring
provisions described above. The Regional Administrator and the
responsible State or local air monitoring agency shall work together
to design and/or maintain the most appropriate SO2
network to provide sufficient data to meet monitoring objectives.
4.4.5 SO2 Monitoring Spatial Scales. (a) The
appropriate spatial scales for SO2 SLAMS monitors are the
microscale, middle, neighborhood, and possibly urban scales.
Monitors sited at the microscale, middle, and neighborhood scales
are suitable for determining maximum hourly concentrations for
SO2 and can be used for compliance actions. Monitors
sited at urban scales are useful for identifying SO2
transport, trends, and, if sited upwind of local sources, background
concentrations.
(1) Microscale--This scale would typify areas in close proximity
to SO2 point and area sources. Emissions from stationary
point and area sources, and non-road sources may, under certain
plume conditions, result in high ground level concentrations at the
microscale. The microscale typically represents an area impacted by
the plume with dimensions extending up to approximately 100 meters.
(2) Middle scale--This scale generally represents air quality
levels in areas up to several city blocks in size with dimensions on
the order of approximately 100 meters to 500 meters. The middle
scale may include locations of expected maximum short-term
concentrations due to proximity to major SO2 point, area,
and/or non-road sources.
(3) Neighborhood scale--The neighborhood scale would
characterize air quality conditions throughout some relatively
uniform land use areas with dimensions in the 0.5 to 4.0 kilometer
range. Emissions from stationary point and area sources may, under
certain plume conditions, result in high SO2
concentrations at the neighborhood scale. Where a neighborhood site
is located away from immediate SO2 sources, the site may
be useful in representing typical air quality values for a larger
residential area, and therefore suitable for population exposure and
trends analyses.
(4) Urban scale--Measurements in this scale would be used to
estimate concentrations over large portions of an urban area with
dimensions from 4 to 50 kilometers. Such measurements would be
useful for assessing trends in area-wide air quality, and hence, the
effectiveness of large scale air pollution control strategies. Urban
scale sites may also support other monitoring objectives of the
SO2 monitoring network such as identifying trends, and
when monitors are sited upwind of local sources, background
concentrations.
(b) [Reserved]
4.4.6 NCore Monitoring. SO2 measurements are included
within the NCore multipollutant site requirements as described in
paragraph (3)(b) of this appendix. NCore-based SO2
measurements are primarily used to characterize SO2
trends and assist in understanding SO2 transport across
representative areas in urban or rural locations and are also used
for comparison with the SO2 NAAQS.
* * * * *
26. Appendix G to Part 58 is amended as by revising Table 2 to read
as follows:
Appendix G to Part 58--Uniform Air Quality Index (AQI) and Daily
Reporting
* * * * *
Table 2--Breakpoints for the AQI
--------------------------------------------------------------------------------------------------------------------------------------------------------
These breakpoints Equal these AQIs
--------------------------------------------------------------------------------------------------------------------------------------------------------
PM10
O3 (ppm) 8-hour O3 (ppm) 1- PM2.5 ([mu]g/ CO (ppm) SO2 (ppm) 1-hour NO2 (ppm) 1-hour AQI Category
hour 1 ([mu]g/m3) m3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.000-0.059................ .......... 0.0-15.4 0-54 0.0-4.4 0-(0.025-0.050) 0-(0.040-0.053) 0-50 Good.
0.060-0.075................ .......... 15.5-40.4 55-154 4.5-9.4 (0.026-0.051)-(0. (0.041-0.054)-(0. 51-100 Moderate.
050-0.100) 080-0.100)
0.076-0.095................ 0.125-0.16 40.5-65.4 155-254 9.5-12.4 (0.051-0.101)-(.1 (0.081-0.101)-(0. 101-150 Unhealthy for Sensitive Groups.
4 75-.200) 360-0.370)
0.096-0.115................ 0.165-0.20 \3\ 65.5- 255-354 12.5-15. (0.176-0.201)-(.3 (0.361-0.371)-0.6 151-200 Unhealthy.
4 150.4 4 04) 4
0.116-0.374................ 0.205-0.40 \3\ 150.5- 355-424 15.5-30. 0.305-0.604 0.65-1.24 201-300 Very Unhealthy.
4 250.4 4
(2)........................ 0.405-0.50 \3\ 250.5- 425-504 30.5-40. 0.605-0.804 1.25-1.64 301-400 .................................
4 350.4 4
(2)........................ 0.505-0.60 \3\ 350.5- 505-604 40.5-50. 0.805-1.004 1.65-2.04 401-500 Hazardous.
4 500.4 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Areas are generally required to report the AQI based on 8-hour ozone values. However, there are a small number of areas where an AQI based on 1-hour
ozone values would be more precautionary. In these cases, in addition to calculating the 8-hour ozone index value, the 1-hour ozone index value may be
calculated, and the maximum of the two values reported.
\2\ 8-hour O3 values do not define higher AQI values (>= 301). AQI values of 301 or greater are calculated with 1-hour O3 concentrations.
\3\ If a different SHL for PM2.5 is promulgated, these numbers will change accordingly.
* * * * *
[FR Doc. E9-28058 Filed 12-7-09; 8:45 am]
BILLING CODE 6560-50-P