[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Rules and Regulations]
[Pages 34819-34830]
[FR Doc No: 2012-14102]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R05-OAR-2010-0523; FRL-9683-7]

Approval and Promulgation of Implementation Plans and Designation
of Areas for Air Quality Planning Purposes; Illinois; Redesignation of
the Illinois Portion of the St. Louis, MO-IL Area to Attainment for the
1997 8-hour Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving a request from the State of Illinois to
redesignate the Illinois portion of the St. Louis, MO-IL area to
attainment of the 1997 8-hour ozone National Ambient Air Quality
Standard (NAAQS or standard). The St. Louis area includes Jersey,
Madison, Monroe, and St. Clair Counties in Illinois and St. Louis City
and Franklin, Jefferson, St. Charles, and St. Louis Counties in
Missouri. The Illinois Environmental Protection Agency (IEPA) submitted
this request on May 26, 2010, and supplemented its request on September
16, 2011. EPA proposed to approve this submission on December 22, 2011,
and provided a 30-day review and comment period. On January 20, 2012,
EPA extended the public comment period for an additional 30 days. The
comment period closed on February 22, 2012. EPA received comments
submitted on behalf of Sierra Club. In addition to approving the
redesignation request EPA is taking several other related actions. EPA
is approving, as a revision to the Illinois State Implementation Plan
(SIP), the State's plan for maintaining the 1997 8-hour ozone standard
through 2025 in the area. EPA is approving the 2002 emissions
inventory, submitted by IEPA on June 21, 2006, and supplemented on
September 16, 2011, as meeting the comprehensive emissions inventory
requirement of the Clean Air Act (CAA) for the Illinois portion of the
St. Louis area. Finally, EPA finds adequate and is approving the
State's 2008 and 2025 Motor Vehicle Emission Budgets (MVEBs) for the
Illinois portion of the St. Louis area.

DATES: Effective Date: This rule is effective on June 12, 2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2010-0523. All documents in the docket are listed on
the www.regulations.gov Website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through www.regulations.gov or in hard copy at the
Environmental Protection Agency, Region 5, Air and Radiation Division,
77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. We recommend that you telephone Kathleen D'Agostino,
Environmental Engineer, at<PHONE_NUMBER> before visiting the Region 5
office.

FOR FURTHER INFORMATION CONTACT: Kathleen D'Agostino, Environmental
Engineer, Attainment Planning and Maintenance Section, Air Programs
Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is the background for this rule?
II. What comments did we receive on the proposed rule?
III. What actions is EPA taking?
IV. Statutory and Executive Order Reviews

I. What is the background for this rule?

    On July 18, 1997 (62 FR 38856), EPA promulgated an 8-hour ozone
standard of 0.08 parts per million (ppm). EPA published a final rule
designating and classifying areas under the 1997 8-hour ozone NAAQS on
April 30, 2004 (69 FR 23857). In that rulemaking, the St. Louis area
was designated as nonattainment for the 1997 8-hour ozone standard and
classified as a moderate nonattainment area under subpart 2 of the CAA.
    On May 26, 2010, IEPA requested redesignation of the Illinois
portion of the St. Louis area to attainment of the 1997 8-hour ozone
standard based on ozone data for the period of 2007-2009. On September
16, 2011, IEPA supplemented the original ozone redesignation request,
revising the mobile source emission estimates using EPA's on-road
mobile source emissions model, MOVES, and extending the demonstration
of maintenance of the ozone standard through 2025, with new MVEBs, but
without relying on emission reductions resulting from

implementation of EPA's Clean Air Interstate Rule (CAIR) or Cross-State
Air Pollution Rule (CSAPR).
    On June 9, 2011 (76 FR 33647), EPA issued a final rulemaking
determining that the entire St. Louis, MO-IL area has attained the 1997
8-hour ozone NAAQS based on three years of complete, quality-assured
ozone data for the period of 2008-2010.\1\
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    \1\ Certified ozone data for 2011 demonstrates that the area
continued to attain the 1997 8-hour ozone standard in 2011. EPA
recognizes that the ozone data for 2007-2009 as well as 2010 and
2011 data are impacted by the Clean Air Interstate Rule (CAIR) which
was promulgated in 2005, but remanded to EPA in 2008. The fact that
the data reflect some reductions associated with the remanded and
therefore not permanent CAIR, however, is not an impediment to
redesignation in the circumstances presented here where IEPA's
demonstration and EPA's own modeling demonstrates that the area does
not need reductions associated with the CAIR to attain the 1997
ozone NAAQS.
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    On December 22, 2011 (76 FR 79579), EPA issued a rulemaking action
proposing to approve Illinois' request to redesignate the Illinois
portion of the St. Louis area to attainment of the 1997 8-hour ozone
standard, as well as proposing to approve Illinois' maintenance plan
for the area, Volatile Organic Compound (VOC) and nitrogen oxides
(NOX) MVEBs, and VOC and NOX emissions
inventories. This proposed rulemaking sets forth the basis for
determining that Illinois' redesignation request meets the CAA
requirements for redesignation to attainment for the 1997 8-hour ozone
NAAQS. Air quality monitoring data in the St. Louis area for 2007-2009,
2008-2010, and 2009-2011 show that this area is currently attaining the
1997 8-hour ozone NAAQS.
    The primary background for today's action is contained in EPA's
December 22, 2011, proposal to approve Illinois' redesignation request,
and in EPA's June 9, 2011, final rulemaking determining that the area
has attained the 1997 8-hour ozone NAAQS, based on complete, quality-
assured monitoring data for 2008-2010, and continuing through 2011. In
these rulemakings, we noted that under EPA regulations at 40 CFR 50.10
and 40 CFR part 50, appendix I, the 1997 8-hour ozone standard is
attained when the 3-year average of the annual fourth highest daily
maximum 8-hour average ozone concentrations is less than or equal to
0.08 ppm at all ozone monitoring sites in the area. See 69 FR 23857
(April 30, 2004) for further information. To support the redesignation
of the area to attainment of the NAAQS, the ozone data must be complete
for the three attainment years. The data completeness requirement is
met when the 3-year average of days with valid ambient monitoring data
is greater than 90 percent, and no single year has less than 75 percent
data completeness, as determined in accordance with appendix I of 40
CFR part 50. Under the CAA, EPA may redesignate a nonattainment area to
attainment if sufficient, complete, quality-assured data are available
demonstrating that the area has attained the standard and if the state
meets the other CAA redesignation requirements specified in section
107(d)(E) and section 175A.
    The December 22, 2011, proposed redesignation rulemaking provides a
detailed discussion of how Illinois' ozone redesignation request meets
the CAA requirements for redesignation of the Illinois portion of the
St. Louis area. With the final approval of its VOC and NOX
emissions inventories, Illinois has met all applicable CAA requirements
for redesignation to attainment for the 1997 8-hour ozone NAAQS. Air
quality monitoring in the St. Louis area for 2009-2011 shows that this
area continues to attain the 1997 8-hour ozone NAAQS. Illinois has
demonstrated that attainment of the 1997 8-hour ozone NAAQS will be
maintained through 2025 with or without the implementation of CAIR or
CSAPR. In addition, modeling conducted by EPA during the CSAPR
rulemaking demonstrates that in both 2012 and 2014, even without taking
into account reductions associated solely with CAIR or CSAPR, the
counties in the St. Louis MO-IL nonattainment area will have air
quality that attains the 1997 ozone NAAQS. Finally, Illinois has
adopted 2008 and 2025 MVEBs that are supported by Illinois' ozone
maintenance demonstration and adopted ozone maintenance plan.

II. What comments did we receive on the proposed rule?

    EPA initially provided a 30-day comment period for the December 22,
2011, proposed rule. On January 20, 2012, EPA extended the comment
period for an additional 30 days. During the comment period, we
received comments from one individual representing the Sierra Club.
These comments are summarized and addressed below.
    Comment 1: The commenter contends that it is inappropriate to
redesignate the Illinois portion of the St. Louis nonattainment area to
attainment of the 1997 8-hour ozone standard when EPA intends to
designate the St. Louis area as nonattainment under the 2008 8-hour
ozone standard, yet the EPA is illegally delaying the implementation of
the 2008 8-hour ozone standard.
    Response 1: On May 21, 2012 EPA published its designations for the
2008 standard. 77 FR 30088, 30116. EPA designated the St. Louis-St.
Charles-Farmington, MO-IL area as nonattainment, with a classification
of marginal. The area's status with respect to the 2008 standard,
however, does not affect or prevent redesignation of the area to
attainment for the 1997 standard. The 1997 standard currently remains
in effect, and thus EPA continues to evaluate the area's designation
status with respect to that standard. Until the 1997 8-hour ozone
standard is revoked, it remains in effect and independent of the 2008
8-hour ozone standard, and EPA continues to evaluate and act upon
states' requests for redesignation with respect to the 1997 standard.
    EPA has in the past continued to redesignate areas under existing
standards even after the adoption of new standards for the same
pollutant. After adopting the 1997 8-hour ozone standard, EPA continued
to redesignate areas for the 1-hour ozone standard until that standard
was revoked. See, for example, Cincinnati, Ohio redesignation, 70 FR
35946 (June 21, 2005). Subsequent to the adoption of the 2008 8-hour
ozone standard, EPA has continued to redesignate for the 1997 8-hour
ozone standard those areas attaining that ozone standard and otherwise
meeting redesignation requirements. See, for example, Detroit, Michigan
redesignation, 74 FR 30950 (June 29, 2009); Clearfield and Indiana
Counties, Pennsylvania redesignation, 74 FR 11674 (March 19, 2009);
Kewaunee County, Wisconsin redesignation 73 FR 29436 (May 21, 2008),
and Door and Manitowoc Counties, Wisconsin redesignation, 75 FR 39635
(July 12, 2010).
    Comment 2: The commenter states that the Jerseyville, Nilwood,
Maryville, Wood River, and East St. Louis ozone monitors all show
upward trends in the annual fourth highest daily maximum 8-hour ozone
concentrations over the 2009-2011 three year period.
    Response 2: The CAA sets forth the criteria for redesignating a
nonattainment area to attainment. Section 107(d)(3)(E) provides for
approval of a redesignation request if, among other things, the
Administrator determines that the area has attained the applicable
NAAQS. A determination that an area has attained the standard is based
on a review of monitored air quality data that meet regulatory quality-
assurance requirements for the specific purpose of comparison to the
NAAQS. See 40 CFR part 50.10 and appendix I and 40 CFR part 58. A
determination of attainment for ozone is

based on a 3-year average of data, and does not consider monitoring
data trends or statistical analyses as criteria for determining
attainment in evaluating a redesignation request. As discussed in
detail in the proposed rule, the St. Louis area has monitored
attainment of the 1997 8-hour ozone standard. See 76 FR 79582-79583
(December 22, 2011).
    Furthermore, EPA considers data collected over a 3-year period for
determining attainment, but not for statistically determining a
``trend.'' It is expected that there will be year-to-year variations in
ozone concentrations due to meteorological influences. A review of
annual fourth highest daily maximum 8-hour ozone concentrations and
design values over a longer time period, from 2001 (designations under
the 1997 8-hour ozone standard was based on air quality monitoring data
from 2001-2003) through 2011, shows an overall downward trend at each
of the monitors. Moreover, in its maintenance demonstration the State
has shown that the 1997 8-hour ozone standard can be maintained in the
area through 2025.
    Comment 3 General: The commenter contends that, to demonstrate that
the observed improvement in ozone air quality is due to the
implementation of permanent air quality controls, EPA has relied on
several emission control programs that are not permanent and
enforceable. The commenter sets out several specific points to support
this contention, which are discussed below in 3a-3d.
    Response 3 General: It is not necessary for every change in
emissions between the nonattainment year and the attainment year to be
permanent and enforceable. Rather, the improvement in air quality
necessary for the area to attain the relevant NAAQS must be reasonably
attributable to permanent and enforceable reductions in emissions. As
discussed in the proposed rule at 76 FR 79586-79588 (December 22,
2011), Illinois and upwind areas have implemented a number of permanent
and enforceable regulatory control measures which have reduced
emissions and resulted in a corresponding improvement in air quality.
    Comment 3a: The commenter contends that EPA cannot rely on the
implementation of CSAPR, which has been stayed by court order. The
commenter objects to EPA claims that IEPA has met its obligation under
section 110(a)(2)(D), in part, via emission control programs
established through CSAPR, and also objects to inclusion of CSAPR as a
potential contingency measure in Illinois' ozone maintenance plan. In
addition, EPA credits Illinois with NOX emission reduction
in upwind areas that are projected to result from the implementation of
CSAPR. Since CSAPR was stayed by the United States Court of Appeals for
the District of Columbia Circuit on December 30, 2011, CSAPR is not
enforceable. In addition, CSAPR cannot be assumed to be permanent
because EPA cannot conclude that CSAPR will survive the litigation
challenge to be subsequently decided by the court. Further, any attempt
by EPA to claim it will replace CSAPR is of no moment because courts
have repeatedly told EPA that it cannot use the promise of future
action to meet current emission control requirements. See, e.g., Sierra
Club v. EPA, 356 F.3d 296, 298 (DC Cir. 2004).
    Response 3a: Illinois has not relied on CSAPR to demonstrate that
attainment was due to permanent and enforceable emissions reductions or
to demonstrate that it will maintain the standard. While we did note in
the proposal that emissions reductions resulting from the
implementation of CSAPR would aid in maintenance of the standard, that
statement did not provide the basis for our action. Further, contrary
to the commenter's assertion, EPA did not credit Illinois with
NOX emissions reductions from the implementation of CSAPR,
nor did the State take credit for any such emissions reductions when
demonstrating maintenance.
    In addition, modeling performed by EPA during the CSAPR rulemaking
process also demonstrates that the counties in the St. Louis MO-IL
ozone nonattainment area will have ozone levels below the 1997 8-hour
standard in both 2012 and 2014 without emission reductions from CSAPR
or CAIR, with the highest average value for any monitor in the area
projected to be 79.6 ppb. See ``Air Quality Modeling Final Rule
Technical Support Document,'' App. B, B-10, B-11, and B-18, which can
be found at http://www.epa.gov/crossstaterule/pdfs/AQModeling.pdf.
Ozone modeling performed by the Lake Michigan Air Directors Consortium
also concludes that the St. Louis area will be able to maintain the
ozone standard throughout the maintenance period without considering
emission reductions from implementation of the CAIR or CSAPR.\2\
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    \2\ The Lake Michigan Air Directors Consortium modeling was
conducted prior to EPA's promulgation of CSAPR. The subsequent
modeling conducted by EPA during the CSAPR rulemaking provides a
more detailed analysis of the impact upwind state emissions would,
in the absence of CAIR, have on downwind areas projected to have
difficulty attaining or maintaining the standard.
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    Although Illinois did list the ``Clean Air Transport Rule, after
promulgation by USEPA'' as a possible contingency measure in the
maintenance plan, this measure is only one of many that may be selected
should the contingency plan be triggered. EPA has concluded, in its
consideration of the maintenance plan contingency measures, that there
are other contingency measures sufficient to satisfy the requirements
of 175A, without consideration of CSAPR.
    The commenter also claims that EPA relies, in part, on emission
control programs established through CSAPR to determine that IEPA has
met its obligation under section 110(a)(2)(D). Section 110(a)(2)(D) of
the CAA requires that SIPs contain measures to prevent sources in a
state from significantly contributing to air quality problems in
another state. While EPA noted in the proposed rule that programs such
as the NOX SIP Call, CAIR, and CSAPR were established to
address transport of air pollutants, we also clearly stated that the
section 110(a)(2)(D) requirements for a state are not linked with a
particular nonattainment area's designation and classification.
Further, EPA concludes that the requirements linked with a particular
nonattainment area's designation and classification are the relevant
measures to evaluate in reviewing a redesignation request. Therefore,
because the section 110(a)(2)(D) requirements apply to a state
regardless of the designation of any one particular area in the state,
EPA further concludes that these requirements should not be construed
to be applicable requirements for purposes of redesignation. EPA is not
taking any action, in this rulemaking, to determine whether the State
of Illinois has satisfied the requirements of 110(a)(2)(D) with respect
to the 1997 ozone NAAQS.
    Comment 3b: The commenter asserts that EPA erred in concluding that
emission reductions resulting from regulations developed in response to
the NOX SIP Call are permanent and enforceable. The
commenter asserts that the NOX SIP Call cannot satisfy a
requirement that requires reductions to be permanent and enforceable
because this program has been replaced and therefore effectively no
longer exists. The commenter also asserts that because the
NOX SIP Call is a cap-and-trade program no actual reductions
are required from the emission sources in the St. Louis nonattainment
area. The commenter argues that to the extent any reductions were once
required, they could have happened only in areas downwind that have
little to no impact on the St. Louis area nonattainment.

Finally the commenter asserts that the DC Circuit Court of Appeals
recently held that EPA cannot use cap-and-trade programs to satisfy an
area-specific statutory mandate. See NRDC v. EPA, 571 F.3d 1245, 1257
(DC Cir. 2009).
    Response 3b: EPA disagrees with the commenter's position that
emission reductions associated with the NOX SIP Call cannot
be considered to be permanent and enforceable. The commenter's first
argument--that the reductions are not permanent and enforceable because
the NOX SIP Call has been replaced--is based on a
misunderstanding of the relationship between CAIR and the
NOX SIP Call. While the CAIR ozone-season trading program
replaced the ozone-season NOX trading program developed in
the NOX SIP Call (70 FR 25290), nothing in CAIR relieved
states of their NOX SIP Call obligations. In fact, in the
preamble to CAIR, EPA emphasized that the states and certain units
covered by the NOX SIP Call but not CAIR must still satisfy
the requirements of the NOX SIP Call. EPA provided guidance
regarding how such states could meet these obligations.\3\ In no way
did EPA suggest states could disregard their NOX SIP Call
obligations. (70 FR 25290). For NOX SIP Call states, the
CAIR NOX ozone season program provides a way to continue to
meet the NOX SIP Call obligations for electric generating
units (EGUs) and large non-electric generating units (nonEGUs). In
addition, the anti-backsliding provisions of 40 CFR 51.905(f)
specifically provide that the provisions of the NOX SIP
Call, including the statewide NOX emission budgets, continue
to apply. In sum, the requirements of the NOX SIP Call
remain in force. They are permanent and enforceable as are state
regulations developed to implement the requirements of the
NOX SIP Call.
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    \3\ EPA guidance regarding the NOX SIP Call
transition to CAIR can be found at http://www.epa.gov/airmarkets/progsregs/cair/faq-10.html. EPA guidance regarding the
NOX SIP Call transition for CSAPR can be found at http://www.epa.gov/crossstaterule/faqs.html.
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    EPA also disagrees with the commenter's second argument--that the
reductions associated with the NOX SIP Call cannot be
considered permanent and enforceable because the NOX SIP
Call is a trading program. There is no support for the commenter's
argument that EPA must ignore all reductions achieved by the
NOX SIP Call simply because the mechanism used to achieve
the reductions is an emissions trading program. As a general matter,
trading programs establish mandatory caps on emissions and permanently
reduce the total emissions allowed by sources subject to the programs.
The emission caps and associated controls are enforced through the
associated SIP rules or Federal Implementation Plans (FIPs). Any
purchase of allowances and increase in emissions by a utility
necessitates a corresponding sale of allowances and reduction in
emissions by another utility. Given the regional nature of ozone, the
emission reductions will have an air quality benefit that will
compensate, at least in part, for the impact of any emission increase.
    In addition, the case cited by the commenter, NRDC v. EPA, 571 F.3d
1245 (DC Cir. 2009), does not support the commenter's position. That
case addressed EPA's determination that the nonattainment Reasonably
Available Control Technology (RACT) requirement was satisfied by the
NOX SIP Call trading program. The court held that because
EPA had not demonstrated that the trading program would result in
sufficient reductions within a nonattainment area, its determination
that the program satisfied RACT (a nonattainment area requirement) was
not supported. Id. 1256-58. The court explicitly noted that EPA might
be able to reinstate the provision providing that compliance with the
NOX SIP Call satisfies NOX RACT for EGUs for
particular nonattainment areas if, upon conducting a technical
analysis, it could demonstrate that the NOX SIP Call results
in greater emissions reductions in a nonattainment area than would be
achieved if RACT-level controls were installed in that area. Id. at
1258. In this case, EPA's comparison of emissions in 2002 and 2008 in
this rulemaking necessarily looked only at changes in emissions ``in
the nonattainment area.'' As such, the commenter's reliance on NRDC v.
EPA is misplaced.
    Comment 3c: The commenter contends that the Illinois State rules
are not permanent and enforceable. The commenter asserts that Illinois'
consumer products and Architectural and Industrial Maintenance Coatings
(AIM) rules are not permanent and enforceable components of the
Illinois SIP. The commenter contends that these rules have only been
adopted by the State, and that EPA has not yet approved them into the
Illinois SIP. The commenter claims that, until they are approved by EPA
and incorporated into the SIP, they cannot be relied upon for the
purposes of redesignation to attainment of the standard. The commenter
claims that for EPA to rely on these rules for the redesignation, it
must approve them into the SIP in conjunction with the redesignation.
    Response 3c: It is not necessary for every change in emissions
between the nonattainment year and the attainment year to be permanent
and enforceable. Rather, the improvement in air quality necessary for
the area to attain must be reasonably attributable to permanent and
enforceable reductions in emissions. As discussed in the proposed rule
at 76 FR 79586-79588 (December 22, 2011), Illinois and upwind areas
have implemented a number of permanent and enforceable regulatory
control measures which have reduced emissions and resulted in a
corresponding improvement in air quality sufficient to demonstrate
attainment and maintenance. Even if EPA does not finalize action on the
Illinois consumer products and AIM rules before completing action on
the redesignation, these emissions reductions are not necessary to
demonstrate that the improvement in air quality is reasonably
attributable to permanent and enforceable reductions in emissions. It
should be noted, however, that EPA proposed to approve the Illinois
consumer products and AIM rules on October 27, 2011, at 76 FR 66663.
EPA received no comments on the proposal and we are currently in the
process of finalizing action on the rules.
    Comment 3d: The commenter asserts that the use of 2008 air quality
data is inappropriate to demonstrate that the attainment of the 1997 8-
hour ozone standard is due to the implementation of permanent and
enforceable emission reductions. EPA documented the changes in
emissions between 2002 and 2008 to demonstrate that the observed ozone
air quality improvement is due to permanent and enforceable emissions
reduction during this period. The commenter claims that this is
unacceptable for a number of reasons.
    First, the commenter asserts that EPA has done nothing to connect
the emissions and air quality impacts, and EPA has not conducted
analyses to prove that emission reductions between 2002 and 2008 have
led to reduced ozone concentrations and attainment of the 1997 8-hour
ozone standard.
    Second, the commenter argues that using a single attainment year,
2008, is arbitrary because the impact of cap-and-trade emission control
programs, such as the NOX SIP Call and CSAPR, can cause
emissions to vary over time as sources buy, sell, and trade emission
allowances.
    Third, the commenter claims that the choice of 2008 is further
problematic because 2008 was the beginning of a large economic
recession. The commenter contends that this resulted in decreased
electricity demand, decreased automobile, truck and shipping traffic,
and decreased factory

production. The commenter objects to EPA's conclusion that monitored
changes in ozone levels between 2002 and 2008 were due to the
implementation of permanent and enforceable emission controls rather
than to changes in meteorology, economic conditions, or temporary or
voluntary (not enforceable) emissions reductions. The commenter
contends that EPA has not provided an analysis showing that the
recession was not the cause of the 2002-2008 emission reduction and
observed air quality improvement.
    Finally, the commenter claims that EPA has not shown that the 2008
emissions inventory reflects permanent and enforceable emission
reductions occurring between 2002 and 2008, and states that the 2008
emissions inventory appears to be the ``actual'' or the ``projected''
emissions from an unidentified group of sources. The commenter argues
that there is a significant difference between what sources actually
emit and what sources are allowed to emit, and that the IEPA and EPA
have incorrectly assumed allowable emissions are equal to actual
emissions.
    Response 3d: EPA's conclusion here is fully supported by the facts
and applicable legal criteria. EPA's longstanding practice and policy
\4\ provides for states to demonstrate permanent and enforceable
emissions reductions by comparing nonattainment area emissions
occurring during the nonattainment period (represented by emissions
during one of the years during the 3-year nonattainment period on which
the area's nonattainment designated was based,\5\ in this case 2002)
with emissions in the area during the attainment period (represented by
emissions during one of the 3 attainment years, in this case 2008,
which is included in the 3-year period, 2007-2009, that the State used
to show attainment with 1997 8-hour ozone standard). A determination
that an area has attained the 1997 8-hour ozone standard is based on an
objective review of air quality data in accordance with 40 CFR 50.10
and part 50, appendix I, based on 3 complete, consecutive calendar
years of quality-assured air quality monitoring data. In the State's
redesignation request, Illinois considered data for the 2007-2009 time
period to demonstrate attainment. In EPA's determination of attainment
and proposed approval of the redesignation request, EPA considered data
for the 2008-2010 time period, which was the most recent quality-
assured, certified data available. See 76 FR 33647 (June 9, 2011), 76
FR 79582-79583 (December 22, 2011). In this final rulemaking, EPA is
also considering continued attainment based on complete, quality-
assured certified data for 2009-2011. Therefore, selecting 2008 as a
representative attainment year, and comparing emissions for this year
to those for a representative year during the nonattainment period,
2002, is an appropriate and long-established approach that demonstrates
the occurrence of emission reductions in the area between the years of
nonattainment and attainment. These reductions therefore, can be seen
to account for the observed air quality improvement.
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    \4\ See September 4, 1992 memorandom from John Calcagni entitled
``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' pp. 4 and 8-9.
    \5\ The nonattainment designation of the St. Louis area for the
1997 8-hour ozone standard was based on 2001-2003 ozone data.
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    With respect to the commenter's assertion that EPA has conducted no
analyses to prove that emission reductions between 2002 and 2008 led to
reduced ozone concentrations, as noted above, comparing emissions for a
representative nonattainment year to emissions for a representative
attainment year is consistent with longstanding practice and EPA policy
for making such a demonstration. The CAA does not specifically require
the use of modeling in making any such demonstration and it has not
been the general practice to do so.
    EPA disagrees with the commenter's contention that using a single
attainment year is arbitrary due to year-to-year variations in
emissions levels resulting from cap-and-trade programs. As a general
matter, trading programs establish mandatory caps on emissions and
permanently reduce the total emissions allowed by sources subject to
the programs. The emission caps and associated controls are enforced
through the associated SIP rules or FIPs. Any purchase of allowances
and increase in emissions by a utility necessitates a corresponding
sale of allowances and reduction in emissions by another utility. Given
the regional nature of ozone, the emission reduction will have an air
quality benefit that will compensate, at least in part, for the impact
of any emission increase.
    With respect to NOX SIP Call reductions within the St.
Louis area, there is no evidence of significant temporal variation in
emissions levels. In fact, actual emissions from NOX SIP
Call sources in the St. Louis area have not varied much from year-to-
year over the 2003-2011 time period. The largest emitters in the St.
Louis area that are covered by the NOX SIP Call are
operating near full capacity. Even if all of the large EGUs and large
nonEGUs begin emitting at full capacity, emissions would not increase
significantly. Further, these sources do not have the type of emissions
controls that can simply be ``shut off.''
    While the commenter expressed concerns that an economic downturn
was responsible for the improvement in air quality, the commenter has
made no demonstration that the reduction in emissions and observed
improvement in air quality is due to an economic recession, changes in
meteorology, or temporary or voluntary emissions reductions. Also, as
noted previously, the CAA does not require modeling to make any such
demonstration.
    Finally, longstanding practice and EPA policy support the use of
actual emissions when demonstrating permanent and enforceable emissions
reductions. Actual emissions are more reflective of emissions that in
reality contribute to monitored ozone concentrations. Sources seldom,
if ever, emit at maximum allowable levels and assuming that all sources
operate at maximum capacity at the same time would grossly overestimate
emissions levels. For this reason EPA believes actual emissions are the
appropriate emissions to consider when comparing nonattainment year
emissions with attainment year emissions.
    Comment 4: The commenter claims that EPA has not conducted an
adequate analysis of the effect that redesignation to attainment will
have on attainment and maintenance of other NAAQS under section 110(l)
of the CAA. The commenter asserts that EPA has failed to conduct an
adequate analysis of the ozone redesignation impacts with respect to
the 1997 annual fine particulate (PM2.5) NAAQS, the 2006 24-
hour PM2.5 NAAQS, the 1-hour NOX (NO2)
NAAQS, the 1-hour sulfur dioxide (SO2) NAAQS, and the 2008
8-hour ozone NAAQS.
    Response 4: Section 110(l) provides in part: ``The Administrator
shall not approve a revision of a plan if the revision would interfere
with any applicable requirement concerning attainment and reasonable
further progress * * *, or any other applicable requirement of this
chapter.'' As a general matter, EPA must and does consider section
110(l) requirements for every SIP revision, including whether the
revision would ``interfere with'' any applicable requirement. See,
e.g., 70 FR 53, 57 (January 3, 2005); 70 FR 17029, 17033 (April 4,
2005); 70 FR 28429, 28431 (May 18, 2005); and 70 FR 58119, 58134
(October 5, 2005). The Illinois

redesignation request and maintenance plan for the 1997 8-hour ozone
standard neither revises nor removes any existing emissions limit for
any NAAQS, nor does it alter any existing control requirements. On that
basis, EPA concludes that the redesignation will not interfere with
attainment or maintenance of any of these air quality standards. The
commenter does not provide any information in its comment to indicate
that approval of this redesignation would have any impact on the area's
ability to comply with the 1997 annual PM2.5 NAAQS, the 2006
24-hour PM2.5 NAAQS, the 1-hour NO2 NAAQS, the 1-
hour SO2 NAAQS, or the 2008 8-hour ozone NAAQS. In fact, the
maintenance plan provided with the State's submission demonstrates a
decline in ozone precursor emissions over the timeframe of the initial
maintenance period. As a result, the redesignation does not relax any
existing rules or limits, nor will the redesignation alter the status
quo air quality.\6\ The commenter has not explained why the
redesignation might interfere with attainment of any standard or with
satisfaction of any other requirement, and EPA finds no basis under
section 110(l) for EPA to disapprove the SIP revision at issue or to
disapprove the requested redesignation.
---------------------------------------------------------------------------

    \6\ EPA notes that the St. Louis area does not have violating
monitors for the 1997 annual PM2.5 NAAQS, 2006 24-hour
PM2.5 NAAQS, or the 1-hour NOX NAAQS, and that
this area has not been designated nonattainment for 2006 24-hour
PM2.5 NAAQS, the 1-hour NOX NAAQS, or the 1-
hour SO2 NAAQS.
---------------------------------------------------------------------------

    Comment 5a: The commenter asserts that the 2002 emissions inventory
that EPA is proposing to approve as meeting the emission inventory
requirement of section 182(a)(1) of the CAA is inadequate and EPA
cannot approve this emissions inventory. The commenter notes that the
emissions inventory is 10 years old. In addition, the commenter states
that portions of the emissions inventory were estimated, as opposed to
being actual emissions, and claims that EPA has not included a
``comprehensive'' emissions inventory in the docket, EPA has only
included a summary of the emissions inventory. The commenter asserts
that EPA must place a comprehensive emissions inventory, which includes
information for each point source, in the docket to allow the public to
review the inventory and comment on it.
    Response 5a: Illinois developed a 2002 comprehensive inventory to
meet the requirement of section 182(a)(1) of the CAA in accordance with
EPA's November 18, 2002, policy memorandum from Lydia N. Wegman
entitled ``2002 Base Year Emission Inventory SIP Planning: 8-hr Ozone,
PM2.5 and Regional Haze Programs,'' and EPA's policy Phase 2
ozone implementation rule published on November 29, 2005 (70 FR 71612,
71664). EPA notes that Illinois submitted the 2002 inventory on June
21, 2006, and at that time, 2002 was the most current emissions
inventory available for the nonattainment area.
    The commenter observes that portions of the emissions inventory
were estimated. This is entirely consistent with accepted EPA
procedures for emissions inventory development procedures. It is common
practice, and consistent with EPA emissions inventory guidance, for
states to estimate emissions for any given year using related activity
factors or to project emissions based on information from prior years
and associated activity growth factors. See ``Emissions Inventory
Guidance for Implementation of Ozone and Particulate Matter National
Ambient Air Quality Standards (NAAQS) and Regional Haze Regulations,''
dated August 2005. For mobile sources, it is standard and accepted
practice for states to estimate emissions using an EPA- approved
emissions model coupled with the output of a transportation model,
which provides traffic levels by roadway and activity type. The
commenter provided no information or specific details that show that
the 2002 inventory was inaccurate.
    With respect to the commenter's concern regarding the availability
of the emissions inventory submittal in the docket, we acknowledge that
the inventory was unintentionally omitted from the electronic docket at
www.regulations.gov. However, the document was available to the public
in hard copy at the EPA Region 5 office, and had the commenter
contacted the Region, the inventory could have been provided. The
inventory has since been added to the electronic docket.
    While we believe the 2002 inventory submitted by the State meets
the inventory requirements of both section 182(a)(1) and section
172(c)(3) of the CAA, EPA notes that the State also submitted a
comprehensive 2008 emissions inventory to serve as the attainment year
inventory as part of the maintenance plan. EPA's longstanding view, as
set forth in the September 4, 1992 memorandom from John Calcagni
entitled ``Procedures for Processing Requests to Redesignate Areas to
Attainment'' (Calcagni memorandum) is that the ``requirements for an
emission inventory [under section 172(c) or 182(a)(1)] will be
satisfied by the inventory requirements of the maintenance plan.'' See
Calcagni memorandum at 6.
    When preparing the comprehensive 2008 emissions inventory, Illinois
compiled point source information from the 2008 annual emissions
reports submitted to IEPA by sources and EPA's Clean Air Markets
Division database for electric utilities. Area source emissions were
calculated using the most recently available methodologies and
emissions factors from EPA along with activity data (population,
employment, fuel use, etc.) specific to 2008. Non-road mobile source
emissions were calculated using EPA's NONROAD emissions model. In
addition, emissions estimates were calculated for commercial marine
vessels, aircraft, and railroads, three non-road categories not
included in the NONROAD model. On-road mobile source emissions were
calculated using EPA's MOVES emissions model with 2008 Vehicle Miles
Traveled (VMT) data provided by Illinois Department of Transportation
(IDOT).
    Therefore, in actuality, the State has more than satisfied the CAA
inventory requirements by its submittal of two inventories that meet
the applicable emissions inventory requirement.
    Comment 5b: The commenter asserts that emissions calculations for
on-road mobile sources fail to consider the use of gasoline containing
up to 15 volume percent ethanol (E15).
    Response 5b: In 2010 and 2011, EPA granted partial waivers for use
of E15 in model year (MY) 2001 and newer light-duty motor vehicles (75
FR 68094 and 76 FR 4662). As discussed in the waiver decisions, there
may be some small emission impacts from the use of E15. E15 is expected
to cause a small immediate emissions increase in NOX
emissions. However, due to its lower volatility than the E10 currently
in-use, its use is also expected to result in lower evaporative
emissions. Other possible emissions impacts may be from the misfueling
of E15 in vehicles or engines for which its use is not approved, i.e.,
MY2000 and older motor vehicles, heavy-duty engines and vehicles,
motorcycles and all nonroad engines, vehicles, and equipment. EPA has
promulgated a separate rule dealing specifically with the mitigation of
misfueling to reduce the potential emissions impacts from misfueling
(76 FR 44406).
    However, the E15 partial waivers do not require that E15 be made or
sold and it is unclear if and to what extent E15 may even be used in
Illinois. Even if E15 is introduced into commerce in Illinois,
considering the likely small and

offsetting direction of the emission impacts, the limited set of motor
vehicles approved for its use, and the measures required to mitigate
misfueling, EPA believes that any potential emission impacts of E15
will be less than the maintenance plan safety margin by which Illinois
shows maintenance.
    Comment 6: The commenter contends that EPA cannot approve the ozone
redesignation because Illinois' VOC RACT rules have not been approved
in conjunction with the approval of the ozone redesignation. The
commenter pointed to EPA's statement in the proposed approval of the
redesignation that it would take action on Illinois' VOC RACT rules in
a separate rulemaking. The commenter states that approval ``in a
separate rule'' is not approval ``in conjunction'' with rulemaking on a
redesignation, and that this would be a departure from EPA's previous
practice of approving needed SIP revisions in the same final rule as a
redesignation. The commenter also points to the Sixth Circuit Court of
Appeals decision in Wall v. EPA, in which the Court stated that ``the
EPA abused its discretion when it determined that it could redesignate
the Cincinnati metropolitan area as achieving attainment before Ohio
had fully adopted all RACT rules of Part D, Subpart 2 of the CAA.''
Wall v. EPA, 265 F.3d 426,442 (6th Cir. 2001). The commenter claims
that RACT measures must be contained in SIPs submitted with respect to
redesignation requests.
    Response 6: EPA disagrees with the commenter's position that VOC
RACT rules must be approved in the same final rule as the
redesignation. The commenter's contention is without basis in either
the law or common sense. EPA acknowledged in its proposed redesignation
at 76 FR 79585, that approval of IEPA's VOC RACT submittal is a
prerequisite for approval of the redesignation of the Illinois portion
of the St. Louis area to attainment of the 1997 8-hour ozone standard.
This simply requires that EPA approve the VOC RACT rules on or before
finalizing approval of the redesignation. EPA approved the Illinois VOC
RACT submittal on March 23, 2012 (77 FR 16940). Therefore, this
prerequisite to redesignation has been met.
    Comment 7: The commenter contends that EPA cannot approve the
State's ozone redesignation request because the State and EPA have not
satisfied all part D requirements. The specific points of contention
raised by the commenter are discussed separately below.
    Comment 7a: The commenter disagrees with EPA's conclusion that an
area can be redesignated to attainment of a NAAQS regardless of the
status of the State's SIP relative to the requirements of section
110(a)(2) of the CAA. The commenter argues that EPA's position does not
make sense given that the State's infrastructure SIP will apply to the
``former'' nonattainment area once it is redesignated to attainment. To
the commenter, it is clear that Congress wanted to ensure that there is
a valid infrastructure SIP in place to protect areas that are being
redesignated to attainment.
    Response 7a: EPA stands by its position that section 110 elements
that are not connected with nonattainment plan submissions and not
linked with an area's attainment status are not applicable requirements
for purposes of redesignation. A state remains subject to these
requirements after an area is redesignated to attainment. We conclude
that only the section 110 and part D requirements which are linked with
a particular area's designation and classification are the relevant
measures which we may consider in evaluating a redesignation request.
This approach is consistent with EPA's existing policy on applicability
of conformity and oxygenated fuels requirements for redesignation
purposes, as well as with section 184 ozone transport requirements. See
Reading, Pennsylvania, proposed and final rulemakings (61 FR 53174-
53176, October 10, 1996), (62 FR 24826, May 7, 1997); Cleveland-Akron-
Lorain, Ohio, final rulemaking (61 FR 20458, May 7, 1996); and Tampa,
Florida, final rulemaking (60 FR 62748, December 7, 1995). See also the
discussion on this issue in the Cincinnati, Ohio ozone redesignation
(65 FR 37890, June 19, 2000), and in the Pittsburgh, Pennsylvania ozone
redesignation (66 FR 50399, October 19, 2001), and in the St. Louis 1-
hour ozone redesignation 68 FR 25418, 25426-27 (May 12, 2003). Both the
6th and 7th Circuits have agreed that the CAA provides EPA with leeway
to determine what is an ``applicable requirement'' for purposes of
redesignation. Sierra Club v. EPA, 375 F.3d 537 (7th Cir. 2004). See
Wall v. EPA, 265 F.3d 426 (6th Cir. 2001), upholding EPA's
interpretation of ``applicable requirements'' with respect to
conformity.
    In any event, on July 13, 2011, EPA approved elements of the
Illinois submittal to meet the infrastructure requirements of sections
110(a)(1) and (2) of the CAA for the 1997 8-hour ozone standard. See 76
FR 41075. Specifically, EPA approved the following infrastructure
elements: emission limits and other control measures, ambient air
quality monitoring and data system, enforcement of SIP measures,
interstate and international pollution abatement, adequate resources,
stationary source monitoring system, emergency power, future SIP
revisions, consultation with government officials, public notification,
air quality modeling and data, permitting fees, and consultation and
participation by affected local entities. Also note that Federally
promulgated Prevention of Significant Deterioration (PSD) rules are in
place in Illinois. For all these reasons, EPA concludes that the SIP
elements applicable for purposes of redesignation have been approved by
EPA.
    Comment 7b: The commenter contends that EPA cannot redesignate the
Illinois portion of the St. Louis nonattainment area to attainment of
the 1997 8-hour ozone standard because section 172(c) of the CAA
requires SIPs to include a Reasonable Further Progress (RFP) plan, an
ozone attainment demonstration, contingency measures, nonattainment New
Source Review (NSR) rules, and Reasonably Available Control Measures
(RACM)/RACT rules and EPA has not approved these items into the SIP for
the Illinois portion of the St. Louis ozone nonattainment area. The
commenter disagrees with EPA's conclusions that these CAA requirements
are no longer applicable to an area after it has achieved attainment of
the NAAQS. In addition, the commenter disagrees with EPA's conclusion
that, for an ozone nonattainment area, the CAA section 172(c)(3) SIP
requirement for a comprehensive, accurate, and current emissions
inventory is superseded by the section 182(a)(1) emission inventory
requirement. Therefore, the commenter believes that the EPA has not
adequately addressed this SIP requirement when it concludes that
Illinois has met all SIP requirements applicable to the Illinois
portion of the St. Louis ozone nonattainment area for purposes of
redesignation to attainment of the 1997 8-hour ozone standard.
    Response 7b: Under EPA's Clean Data regulation, 40 CFR 51.918 (1997
8-hour ozone), an EPA rulemaking determination that an area is
attaining the relevant standard suspends the area's obligations to
submit an attainment demonstration, RACM, RFP, contingency measures,
and other planning requirements related to attainment for as long as
the area continues to attain. See 70 FR 71702 (November 29, 2005). This
regulation, which embodies EPA's interpretation under its ``Clean Data
Policy,'' has been

upheld by the DC Circuit. NRDC v. EPA, 571 F.3d 1245 (DC Cir. 2009).\7\
---------------------------------------------------------------------------

    \7\ See also Sierra Club v. EPA, 99 F. 3d 1551 (10th Cir. 1996);
Sierra Club v. EPA, 375 F.3d 537 (7th Cir. 2004); and Our Children's
Earth Foundation v. EPA, No. 04-73032 (9th Cir. June 28, 2005)
(memorandum opinion).
---------------------------------------------------------------------------

    Because EPA determined that the St. Louis area has attained the
1997 8-hour ozone standard (see 76 FR 33647, June 9, 2011) and because
the area continues to meet that standard, the State is not currently
obligated to submit an attainment demonstration, RACM, RFP, contingency
measures, and other planning requirements related to attainment.
    In addition, in the context of redesignations, EPA has interpreted
requirements related to attainment as not applicable for purposes of
redesignation. For example, in the General Preamble for implementation
of Title 1 of the CAA 1990 amendments EPA stated that:

[t]he section 172(c)(9) requirements are directed at ensuring RFP
and attainment by the applicable date. These requirements no longer
apply when an area has attained the standard and is eligible for
redesignation. Furthermore, section 175A for maintenance plans * * *
provides specific requirements for contingency measures that
effectively supersede the requirements of section 172(c)(9) for
these areas. ``General Preamble for the Interpretation of Title I of
the Clean Air Act Amendments of 1990,'' (General Preamble) 57 FR
13498, 13564 (April 16, 1992).

See also Calcagni memorandum at 6 (``The requirements for reasonable
further progress and other measures needed for attainment will not
apply for redesignations because they only have meaning for areas not
attaining the standard.'').
    With respect to the RACT requirement, EPA approved the Illinois VOC
RACT submittal on March 23, 2012 (77 FR 16940), and granted Illinois a
waiver from the requirement to submit RACT rules under section 182(f)
of the CAA on February 22, 2011 (76 FR 9655).
    With respect to emissions inventories, by meeting the section
182(a)(1) emission inventory requirement, the State has also met the
section 172(c)(3) requirement for a comprehensive, accurate, and
current emissions inventory. Further, redesignation policy states that
emissions inventory requirements of section 172(c) of the CAA are
satisfied by the inventory requirements of the maintenance plan. See
the Calcagni memorandum at 6.
    With respect to the nonattainment NSR requirement, the issue is
moot because EPA has approved the Illinois nonattainment NSR SIP.
Nonetheless, since PSD requirements will apply after redesignation,
areas being redesignated need not comply with the requirement that a
part D NSR program be approved prior to redesignation, provided that
the area demonstrates maintenance of the NAAQS without a part D NSR
program. A more detailed rationale for this view is described in a
memorandum from Mary Nichols, Assistant Administrator for Air and
Radiation, dated October 14, 1994, entitled, ``Part D New Source Review
Requirements for Areas Requesting Redesignation to Attainment''
(Nichols memorandum). Illinois has demonstrated that the St. Louis area
will be able to maintain the 1997 8-hour ozone standard without a part
D NSR program in effect; therefore, the State need not have a fully
approved part D NSR program prior to approval of the redesignation
request. This issue is discussed in greater detail below in response to
Comment 7d. Upon redesignation, the PSD program will apply. See
Greenbaum v. EPA, 370 F.3d 527, 536 (6th Cir. 2004) (``It would make
little sense for [part D NSR] to be included in the post-attainment
SIP, as the Clean Air Act * * * explicitly states that attainment area
SIPs must include a PSD program.'')
    Comment 7c: With further regard to contingency measure requirements
of the CAA, the commenter contends that EPA is incorrect to conclude
that contingency measures are inapplicable once an area reaches
attainment of the NAAQS. The commenter asserts that contingency
measures must be in place so that, if an area monitor shows a violation
of the NAAQS in the future, that violation of the NAAQS is quickly
addressed, minimizing the number of people that will be harmed by air
quality levels above the NAAQS.
    Response 7c: As set forth in detail in Response 7b, the
nonattainment area contingency measure requirements of section
172(c)(9) are directed at ensuring RFP and attainment by the applicable
date. These nonattainment area requirements no longer apply after an
area has attained the standard and the area has been redesignated to
attainment. Under section 175A of the CAA, maintenance plans must
contain contingency provisions, ``as deemed necessary by the
Administrator,'' and it is these contingency measures that apply to the
area after redesignation to attainment. Illinois included such
provisions in its maintenance plan which EPA is approving in this
action.
    Comment 7d: The commenter, although acknowledging that EPA has
certified that it has approved Illinois' nonattainment NSR rules, takes
issue with EPA's related conclusion that an area being redesignated to
attainment of a NAAQS need not have fully approved part D NSR rules,
since PSD requirements of the CAA would apply after redesignation to
attainment. The commenter contends that this EPA conclusion was
explicitly rejected by the Court in Greenbaum v. EPA, 370 F.3d 527, 534
(6th Cir. 2004). The commenter asserts that without an approved NSR
program, there can be no redesignation to attainment of the NAAQS. The
commenter believes that this is true, because if a redesignated area
violates the NAAQS in the future, all provisions that are contained in
the state's nonattainment SIP, including NSR rules, would need to
become applicable again.
    Response 7d: Part D NSR would not be retained in the SIP as a
section 175A(d) contingency measure. As clearly stated in the Nichols
memorandum, ``EPA believes it is reasonable to interpret `measure,' as
used in section 175A(d), not to include part D NSR.'' Congress used the
undefined term ``measure'' differently in different provisions of the
CAA, which indicates that the term is susceptible to more than one
interpretation and that EPA has the discretion to interpret it in a
reasonable manner in the context of section 175A. See Greenbaum v.
United States EPA, 370 F. 3d 527, 535-38 (6th Cir. 2004). (Court
``find[s] persuasive the EPA's argument that the very nature of the NSR
permit program supports its interpretation that it is not intended to
be a contingency measure pursuant to section 175A(d).'') It is
reasonable to interpret ``measure'' to exclude part D NSR in this
context because PSD, a program that is the corollary of part D NSR for
attainment areas, goes into effect in lieu of part D NSR upon
redesignation. PSD requires that new sources demonstrate that emissions
from their construction and operation will not cause or contribute to a
violation of any NAAQS or PSD increment. The State has demonstrated
that the area will be able to maintain the standard without part D NSR
in effect, and the State's PSD program will become effective in the
area upon redesignation to attainment. See the rationale set forth at
length in the Nichols Memorandum. See also the discussions of why full
approval and retention of NSR is not required in redesignation actions
in the following redesignation rulemakings: 60 FR 12459, 12467-12468
(March 7, 1995) (Redesignation of Detroit, MI); 61 FR 20458, 20469-
20470 (May 7, 1996) (Cleveland-Akron-Lorrain, OH); 66 FR 53665, 53669
(October 23, 2001)

(Louisville, KY); 61 FR 31831, 31836-31837 (June 21, 1996) (Grand
Rapids, MI). Contrary to the commenter's assertion, the Greenbaum court
declined to reach the issue of whether full approval of a part D NSR
program is required prior to redesignation. See Greenbaum, 370 F. 3d at
534-35.
    Comment 8: The commenter generally asserts that Illinois lacks a
fully approved maintenance plan complying with the requirements of
section 175A of the CAA. The commenter's specific arguments supporting
this assertion follow.
    Comment 8a(1): The commenter asserts that the contingency measures
contained in Illinois' maintenance plan do not provide for prompt
correction of violations of the 1997 8-hour ozone standard. The
commenter believes that neither the ``Level I'' nor the ``Level II''
response occurs on a prompt schedule as required by section 175A of the
CAA, and that several of the potential contingency measures are
inappropriate, inadequate, or unacceptably vague. The commenter notes
that after the determination of a Level I trigger \8\ event, Illinois
has committed to adopt needed emission control measures within 18
months and has committed to implement the adopted emission control
measures within 24 months after adoption. The commenter also notes that
after the determination of a Level II trigger \9\ event, the
maintenance plan contains no specific emission control commitments, but
that Illinois will work with Missouri to conduct a study to determine
the causes of the ozone standard violation and the emission control
measures necessary to mitigate the air quality problem, with
implementation of adopted emission controls to occur within 18 months
of the determination of the Level II event. The commenter contends that
the implementation schedules for the Level I and II triggers are
unacceptably long and not in keeping with the prompt response timing
required by section 175A of the CAA.
---------------------------------------------------------------------------

    \8\ A Level I response is triggered in the event that: (1) The
annual fourth highest daily maximum 8-hour ozone concentration at
any monitoring site in the St. Louis area exceeds 84 parts per
billion (ppb) in any year; or, (2) VOC or NOX emissions
increase more than 5 percent above the levels contained in the
attainment year (2008) emissions inventory for the Illinois portion
of the St. Louis ozone nonattainment area.
    \9\ A Level II response is triggered in the event that a
violation of the 1997 8-hour ozone standard is monitored at any
monitoring site in the St. Louis area.
---------------------------------------------------------------------------

    Response 8a(1): The commenter overlooks the provisions of the CAA
applicable to contingency measures. Section 175(A(d) provides that
``[e]ach plan revision submitted under this section shall contain such
contingency provisions as the Administrator deems necessary to assure
that the state will promptly correct any violation of the standard
which occurs after the redesignation of the area as an attainment
area.'' (emphasis added). Thus Congress gave EPA discretion to evaluate
and determine the contingency measures EPA ``deems necessary'' to
assure that the state will promptly correct any subsequent violation.
EPA has long exercised this discretion in its rulemakings on section
175A contingency measures in redesignation maintenance plans, allowing
as contingency measures commitments to adopt and implement in lieu of
fully adopted contingency measures, and finding that implementation
within 18 months of a violation complies with the requirements of
section 175A. See recent redesignations, e.g. Indianapolis, IN
PM2.5 annual standard (76 FR 59512), Lake and Porter
Counties, IN 8-hour ozone standard (75 FR 12090), and Northwest Indiana
PM2.5 annual standard (76 FR 59600). Section 175A does not
establish any deadlines for implementation of contingency measures
after redesignation to attainment. It also provides far more latitude
than does section 172(c)(9), which applies to a different set of
contingency measures applicable to nonattainment areas. Section
172(c)(9) contingency measures must ``take effect * * * without further
action by the State or [EPA].'' By contrast, section 175A confers upon
EPA the discretion to determine what constitutes adequate assurance,
and thus permits EPA to take into account the need of a state to
assess, adopt and implement contingency measures if and when a
violation occurs after an area's redesignation to attainment.
Therefore, in accordance with the discretion accorded it by statute,
EPA may allow reasonable time for states to analyze data and address
the causes and appropriate means of remedying a violation. In assessing
what ``promptly'' means in this context, EPA also may take into account
time for adopting and implementation of the appropriate measure. In the
case of the St. Louis area, EPA reasonably concluded that, 18 months
constitutes a timeline consistent with prompt correction of a potential
monitored violation. This timeframe also conforms with EPA's many prior
rulemakings on acceptable schedules for implementing section 175A
contingency measures as noted above.
    Comment 8a(2): The commenter contends that several of Illinois'
contingency measures, ``NOX RACT'' and ``Broader geographic
applicability of existing measures,'' are too vague. The commenter
asserts that the vagueness of these contingency measures provides no
evidence that the maintenance plan will provide enough emission
controls to correct ozone standard violations.
    Response 8a(2): As discussed above in response to Comment 8a (1),
the CAA does not specify the requisite nature, scope, specificity, or
number of contingency measures to be included in a maintenance plan
under section 175A. It is for EPA to determine whether the State has
given adequate assurance that it can promptly correct a violation.
Illinois has submitted contingency measures that EPA deems adequate.
They have committed to remedy a future violation, and have included
measures to address potential violations from a range of sources and a
timeline for promptly completing adoption and implementation. The State
has identified measures that are sufficiently specific but which allow
for latitude in potential scope. This will enable the State to address
a range of potential sources and differing degrees and types of
violations. EPA believes that the contingency measures set forth in the
submittal, combined with the State's commitment to an expeditious
timeline and process for implementation, provide assurance that the
State will promptly correct a future potential violation. Given the
uncertainty as to timing, degree and nature of any future violation,
EPA believes that the contingency measures set forth adequately balance
the need for flexibility in the scope and type of measure to be
implemented with the need for expeditious state action.
    Comment 8a(3): The commenter contends that several of the potential
contingency emission control measures are inappropriate or inadequate.
The commenter states that several of the contingency emission control
measures, including the Tier 2 vehicle emission standards, low sulfur
fuel standards, heavy duty diesel standards, and low sulfur diesel
standards are Federal emission control measures that EPA is already
implementing. The commenter contends that EPA cannot both credit these
emission control measures with existing emission reductions and allow
IEPA to include them as potential contingency measures in the ozone
maintenance plan. The commenter states that this approach would amount
to double counting the effects of these emission control measures.
    Response 8a(3): As discussed above in response to Comment 8a(2),
the CAA

does not specify the requisite nature, scope, specificity, or number of
contingency measures to be included in a maintenance plan under section
175A. EPA has considered that the maintenance plan includes adequate
state contingency measures, and that these are sufficient for the
purpose of maintenance. EPA considers that the state measures
themselves constitute adequate contingency measures, and that the
Federal measures included also bolster maintenance to the extent that
they provide reductions that were not counted in the maintenance plan's
demonstration as explained below.
    EPA also disagrees with the commenter's contention that EPA is
double counting emissions reductions. The fact that some emissions
reductions may have already been realized by a control measure does not
prevent the control measure from resulting in greater reductions in
future years. Further, as stated in the proposed rule (76 FR 79591),
``[t]o qualify as a contingency measure, emissions reductions from that
measure must not be factored into the emissions projections used in the
maintenance plan.'' This prevents possible double counting of emissions
reductions during the maintenance period. Should the contingency plan
be triggered, the state would be required to choose a contingency
measure that meets this criterion. Any control measure listed in the
contingency plan that fails to meet this criterion would not be
considered to be an eligible contingency measure at that time and the
state would be required to choose one that does.
    Comment 8b: The commenter asserts that EPA, in assessing the
adequacy of Illinois' ozone maintenance demonstration, has credited the
state with NOX emission reductions in upwind areas that are
the products of the NOX SIP call and CSAPR. These rules
develop cap-and-trade programs that the commenter argues cannot satisfy
the maintenance plan requirement. In addition, CSAPR has been stayed by
the Court and may not be relied upon to provide NOX emission
reductions.
    Response 8b: As discussed in Response 3b, EPA disagrees with the
commenter's position that emission reductions associated with the
NOX SIP Call cannot be considered to be permanent and
enforceable simply because they result from an emissions trading
program. In addition, as discussed in Response 3a, Illinois has not
relied on CSAPR to demonstrate attainment or maintenance of the
standard.
    Comment 8c: The commenter contends that Illinois' maintenance plan
fails to consider additional emissions expected to occur from the
Prairie State electrical power plant, which is currently under
construction. This power plant is expected to commence operation during
the ozone maintenance period. This power plant is expected to be a
major source of NOX emissions. The commenter asserts that
EPA cannot presume that, because the Prairie State power plant has
obtained a PSD source permit, it will not cause or contribute to a
violation of the 1997 8-hour ozone standard. EPA must review the PSD
record and include the relevant portions in the administrative record
for this ozone redesignation rulemaking.
    Response 8c: Neither the CAA nor EPA redesignation policy requires
that EPA review and take into consideration construction permits as a
criterion for redesignation. Consistent with EPA's redesignation policy
as articulated in the September 4, 1992, Calcagni memorandum, the State
demonstrated maintenance of the standard by showing that future
emissions in the area will not exceed the level of emissions in the
attainment inventory for the area. The Prairie State power plant under
construction is located in Washington County, which is not part of the
St. Louis area. Thus emissions from this facility do not factor into
the attainment or maintenance inventories for the area. EPA, in its
proposed redesignation and elsewhere in our responses to comments in
this final rule, has addressed and considered issues pertaining to the
potential impact of emissions from outside the St. Louis area on the
area's maintenance of the 1997 ozone standard.
    Finally, under title I, part C of the CAA, the PSD preconstruction
permit program requires an air quality analysis to demonstrate that
emissions from construction or operation of a proposed major stationary
source or major modification will not cause or contribute to a
violation of any applicable NAAQS or PSD increment. CAA section
165(a)(3); see also 40 CFR 51.166(k) (providing that the owner or
operator of a proposed source or modification ``shall demonstrate that
allowable emissions increases from the proposed source or modification,
in conjunction with all other applicable emissions increases or
reduction * * * would not cause or contribute to air pollution in
violation of'' any NAAQS or PSD increment). Therefore, the effect of
the emissions from a proposed source on the maintenance of the NAAQS is
addressed through the PSD permitting program before the facility is
authorized to build and operate. Neither the CAA nor EPA policy require
EPA to include the record from an independent PSD proceeding in the
record for a redesignation action or to reopen permitting issues as
part of a redesignation action. In addition, the commenter has not
provided data indicating that the Prairie State plant will cause or
contribute to a NAAQS or increment violation in the St. Louis area.
    Comment 9: The commenter asserts that EPA has not accounted for the
effects of weather in its modeling. The commenter notes that EPA's
analysis of Illinois' ozone redesignation request is devoid of weather-
adjusted considerations of ambient ozone levels. For this reason, this
commenter believes that EPA cannot approve Illinois' ozone
redesignation request. In addition, the commenter believes that EPA has
erred in not considering the impacts that climate change will have on
future ozone formation during the maintenance period.
    Response 9: A determination that an area has attained the 1997 8-
hour ozone standard is based on a review of monitored air quality data
that meets regulatory requirements for purposes of comparison to the
NAAQS, and it is not derived from modeling. An area is considered to be
in attainment of the 1997 8-hour ozone standard if the 3-year average
of the fourth highest daily maximum 8-hour average ozone concentrations
measured at each monitor within an area over each year does not exceed
0.084 ppm. Three years of air quality data are used to allow for year-
to-year variations in meteorology. As discussed in detail in the
proposed rule, the St. Louis area is monitoring attainment of the 1997
8-hour ozone standard. See 76 FR 79582-79583 (December 22, 2011).
    In addition, a maintenance demonstration need not be based on
modeling. See Wall v. EPA, 265 F.3d 426 (6th Cir. 2001), Sierra Club v.
EPA, 375 F. 3d 537 (7th Cir. 2004). See also 66 FR 53094, 53099-53100
(October 19, 2001), and 68 FR 25413, 25430-25432 (May 12, 2003). EPA
policy and longstanding practice allows states to demonstrate
maintenance by preparing an attainment emissions inventory
corresponding to the period during which the area monitored attainment
and to project maintenance by showing that future emissions are
projected to remain below this level for the next ten years. See
Calcagni memorandum. Holding emissions at or below the level of
attainment is adequate to reasonably assure continued maintenance of
the standard. See 65 FR 37879, 37888 (June

19, 2000). Since the St. Louis action is not based on modeling, EPA
concludes that weather related impacts, including climate change, on
modeling are not relevant. Impacts of weather on monitored data are
accounted for by the three years of data used for the attainment
determination.

III. What actions is EPA taking?

    EPA is approving a request from the State of Illinois to
redesignate the Illinois portion of the St. Louis, MO-IL area to
attainment of the 1997 8-hour ozone standard. EPA is also taking
several other related actions. EPA is approving, as a revision to the
Illinois SIP, the State's plan for maintaining the 1997 8-hour ozone
standard through 2025 in the area. EPA is approving the 2002 emissions
inventory as meeting the comprehensive emissions inventory requirement
of the CAA for the Illinois portion of the St. Louis area. Finally, EPA
finds adequate and is approving the State's 2008 and 2025 MVEBs for the
Illinois portion of the St. Louis area.
    In accordance with 5 U.S.C. 553(d), EPA finds there is good cause
for these actions to become effective immediately upon publication.
This is because a delayed effective date is unnecessary due to the
nature of a redesignation to attainment, which relieves the area from
certain CAA requirements that would otherwise apply to it. The
immediate effective date for this action is authorized under both 5
U.S.C. 553(d)(1), which provides that rulemaking actions may become
effective less than 30 days after publication if the rule ``grants or
recognizes an exemption or relieves a restriction,'' and section
553(d)(3) which allows an effective date less than 30 days after
publication ``as otherwise provided by the agency for good cause found
and published with the rule.'' The purpose of the 30 day waiting period
prescribed in section 553(d) is to give affected parties a reasonable
time to adjust their behavior and prepare before the final rule takes
effect. Today's rule, however, does not create any new regulatory
requirements such that affected parties would need time to prepare
before the rule takes effect. Rather, today's rule relieves the state
of planning requirements for this 8-hour ozone nonattainment area. For
these reasons, EPA finds good cause under 5 U.S.C. 553(d)(3) for these
actions to become effective on the date of publication of these
actions.

IV. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to attainment and the
accompanying approval of a maintenance plan under section 107(d)(3)(E)
are actions that affect the status of a geographical area and do not
impose any additional regulatory requirements on sources beyond those
imposed by state law. A redesignation to attainment does not in and of
itself create any new requirements, but rather results in the
applicability of requirements contained in the CAA for areas that have
been redesignated to attainment. Moreover, the Administrator is
required to approve a SIP submission that complies with the provisions
of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40
CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to
approve state choices, provided that they meet the criteria of the CAA.
These actions do not impose additional requirements beyond those
imposed by state law and the CAA. For that reason, these actions:
     Are not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Do not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not an economically significant regulatory action
based on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 13, 2012. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Volatile organic compounds.

    Dated: May 30, 2012.
Susan Hedman,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

0
2. Section 52.726 is amended by adding paragraphs (ll) and (mm) to read
as follows:

Sec.  52.726  Control strategy: Ozone.

* * * * *

    (ll) Approval--On May 26, 2010, and September 16, 2011, Illinois
submitted a request to redesignate the Illinois portion of the St.
Louis, MO-IL area to attainment of the 1997 8-hour ozone standard. The
St. Louis area includes Jersey, Madison, Monroe, and St. Clair Counties
in Illinois and St. Louis City and Franklin, Jefferson, St. Charles and
St. Louis Counties in Missouri. As part of the redesignation request,
the State submitted a plan for maintaining the 1997 8-hour ozone
standard through 2025 in the area as required by section 175A of the
Clean Air Act. Part of the section 175A maintenance plan includes a
contingency plan. The ozone maintenance plan establishes 2008 motor
vehicle emissions budgets for the Illinois portion of the St. Louis
area of 17.27 tpd for volatile organic compounds (VOC) and 52.57 tpd
for nitrogen oxides (NOX). In addition the maintenance plan
establishes 2025 motor vehicle emissions budgets for the Illinois
portion of the St. Louis area of 5.68 tpd for VOC and 15.22 tpd for
NOX.
    (mm) Emissions inventories for the 1997 8-hour ozone standard--
    (1) Approval--Illinois' 2002 emissions inventory satisfies the
emissions inventory requirements of section 182(a)(1) of the Clean Air
Act for the Illinois portion of the St. Louis, MO-IL area under the
1997 8-hour ozone standard.
    (2) [Reserved]

PART 81--[AMENDED]

0
3. The authority citation for part 81 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

0
4. Section 81.314 is amended by revising the entry for St. Louis, MO-IL
in the table entitled ``Illinois-Ozone (8-Hour Standard)'' to read as
follows:

Sec.  81.314  Illinois.

* * * * *

                                                            Illinois--Ozone (8-Hour Standard)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Designation \a\                                         Classification
             Designated area             ---------------------------------------------------------------------------------------------------------------
                                            Date \1\                      Type                      Date \1\                      Type
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
St. Louis, MO-IL:
    Jersey County.......................    6/12/2012  Attainment...............................
    Madison County......................    6/12/2012  Attainment...............................
    Monroe County.......................    6/12/2012  Attainment...............................
    St. Clair County....................    6/12/2012  Attainment...............................

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is June 15, 2004, unless otherwise noted.

* * * * *
[FR Doc. 2012-14102 Filed 6-11-12; 8:45 am]
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[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Rules and Regulations]
[Pages 54007-54010]
[FR Doc No: 2018-23412]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. FDA-2018-N-3772]

Medical Devices; Ear, Nose, and Throat Devices; Classification of
the Active Implantable Bone Conduction Hearing System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the active implantable bone conduction hearing system into class II
(special controls). The special controls that apply to the device type
are identified in this order and will be part of the codified language
for the active implantable bone conduction hearing system's
classification. We are taking this action because we have determined
that classifying the device into class II (special controls) will
provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective October 26, 2018. The classification was
applicable on July 20, 2018.

FOR FURTHER INFORMATION CONTACT: Oldooz Hazrati, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2455, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the active implantable bone
conduction hearing system as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application to market a substantially equivalent
device (see 21 U.S.C. 360c(i), defining ``substantial equivalence'').
Instead, sponsors can use the less-burdensome 510(k) process, when
necessary, to market their device.

II. De Novo Classification

    On February 16, 2017, MED-EL Elektromedizinische Geraete GmbH
submitted a request for De Novo classification of the BONEBRIDGE. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on July 20, 2018, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 874.3340. We have named
the generic type of device active implantable bone conduction hearing
system, and it is identified as a prescription device consisting of an
implanted transducer, implanted electronics components, and an audio
processor. The active implantable bone conduction hearing system is
intended to compensate for conductive or mixed hearing losses by
conveying amplified acoustic signals to the cochlea via mechanical
vibrations on the skull bone.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

  Table 1--Active Implantable Bone Conduction Hearing System Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Dural erosion or compression resulting   Labeling.
 from failure to confirm adequate
 thickness and consistency of bone and
 related anatomy.
Surgical complications leading to:
     Bleeding/hematoma.........
     Seizures..................
     Cerebrospinal fluid (CSF)
     leak.
     Implant damage or           Clinical performance testing
     migration leading to revision/       and Labeling.
     explantation.
Device software failure................  Software verification,
                                          validation, and hazard
                                          analysis.
Implant failure due to:
      Fatigue..................
      Damage/breakage..........
     Loss of hermeticity.......  Clinical performance testing
                                          and Non-clinical performance
                                          testing.
Device failure to compensate for         Clinical performance testing
 hearing loss.                            and Non-clinical performance
                                          testing.
Interference with other devices........  Electromagnetic compatibility
                                          testing, Wireless coexistence
                                          testing, Electrical safety
                                          testing, and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation and
                                          Labeling.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, active implantable bone conduction
hearing systems are for prescription use only. Prescription devices are
exempt from the requirement for adequate directions for use for the
layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1))
and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met
(referring to 21 U.S.C. 352(f)(1)).

III. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 820, regarding quality system regulation,
have been approved under OMB control number 0910-0073; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 874

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
874 is amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

0
1. The authority citation for part 874 is revised to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  874.3340 to subpart D to read as follows:

Sec.  874.3340  Active implantable bone conduction hearing system.

    (a) Identification. An active implantable bone conduction hearing
system is a prescription device consisting of an implanted transducer,
implanted electronics components, and an audio processor. The active
implantable bone conduction hearing system is intended to compensate
for conductive or mixed hearing losses by conveying amplified acoustic
signals to the cochlea via mechanical vibrations on the skull bone.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical performance testing must characterize any adverse
events observed during implantation and clinical use, and must also
demonstrate that the device performs as intended under anticipated
conditions of use.
    (2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use,
including the following:
    (i) Performance data must validate force output in a clinically
relevant model.
    (ii) Impact testing in a clinically relevant anatomic model must be
performed.
    (iii) Mechanical integrity testing must be performed.
    (iv) Reliability testing consistent with expected device life must
be performed.
    (3) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (5) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
    (6) Performance data must demonstrate the wireless compatibility,
electromagnetic compatibility, and electrical safety of the device.
    (7) Software verification, validation, and hazard analysis must be
performed.

    (8) Labeling must include:
    (i) A summary of clinical testing conducted with the device that
includes a summary of device-related complications and adverse events;
    (ii) Instructions for use;
    (iii) A surgical guide for implantation, which includes
instructions for imaging to assess bone dimensions;
    (iv) A shelf life, for device components provided sterile;
    (v) A patient identification card; and
    (vi) A patient user manual.

    Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23412 Filed 10-25-18; 8:45 am]
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