[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Proposed Rules]
[Pages 47259-47264]
[FR Doc No: 2013-18843]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2013-0088; FRL-9841-6]

Approval and Promulgation of Implementation Plans; Washington:
Thurston County Second 10-Year PM10 Limited Maintenance Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The EPA is proposing to approve a limited maintenance plan
submitted by the State of Washington on July 1, 2013, for the Thurston
County maintenance area (Thurston County) for particulate matter with
an aerodynamic diameter less than or equal to a nominal

10 micrometers (PM10). The EPA is also proposing to approve
both local and state regulatory updates related to this maintenance
plan.

DATES: Comments must be received on or before September 4, 2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2013-0088, by any of the following methods:
    A. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    B. Mail: Jeff Hunt, EPA Region 10, Office of Air, Waste and Toxics
(AWT-107), 1200 Sixth Avenue, Suite 900, Seattle WA, 98101
    C. Email<EMAIL_ADDRESS>    D. Hand Delivery: EPA Region 10 Mailroom, 9th Floor, 1200 Sixth
Avenue, Suite 900, Seattle WA, 98101. Attention: Jeff Hunt, Office of
Air, Waste and Toxics, AWT-107. Such deliveries are only accepted
during normal hours of operation, and special arrangements should be
made for deliveries of boxed information
    Instructions: Direct your comments to Docket ID No. EPA-R10-OAR-
2013-0088. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information the
disclosure of which is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
www.regulations.gov or email. The www.regulations.gov Web site is an
``anonymous access'' system, which means the EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to the EPA without
going through www.regulations.gov your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, the EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD-ROM you submit. If the EPA cannot read your comment due
to technical difficulties and cannot contact you for clarification, the
EPA may not be able to consider your comment. Electronic files should
avoid the use of special characters, any form of encryption, and be
free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
the disclosure of which 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 in
www.regulations.gov or in hard copy during normal business hours at the
Office of Air, Waste and Toxics, EPA Region 10, 1200 Sixth Avenue,
Seattle WA, 98101.

FOR FURTHER INFORMATION CONTACT: Jeff Hunt at<PHONE_NUMBER>,
<EMAIL_ADDRESS>or by using the above EPA, Region 10 address.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we'',
``us'' or ``our'' are used, it is intended to refer to the EPA.

Table of Contents

I. This Action
II. Background
III. Public and Stakeholder Involvement in Rulemaking Process
IV. The Limited Maintenance Plan Option for PM10 Areas
    A. Requirements for the Limited Maintenance Plan Option
    B. Conformity under the Limited Maintenance Plan Option
V. Review of the State's Submittal
    A. Has the State demonstrated that Thurston County qualifies for
the limited maintenance plan option?
    B. Does the State have an approved attainment emissions
inventory?
    C. Does the limited maintenance plan include an assurance of
continued operation of an appropriate EPA-Approved air quality
monitoring network, in accordance with 40 CFR Part 58?
    D. Does the plan meet the Clean Air Act requirements for
contingency provisions?
    E. Has the State met conformity requirements?
VI. Revisions to the Washington SIP
VII. Proposed Action
VIII. Statutory and Executive Order Reviews

I. This Action

    The EPA is proposing to approve the limited maintenance plan
submitted by the State of Washington (the State) on July 1, 2013, for
Thurston County, including approval of a monitoring system modification
for the area. The limited maintenance plan also includes Washington
State Department of Ecology (Ecology) regulatory changes that
strengthen the control measures contained in the State Implementation
Plan (SIP) since our last approval on January 15, 1993 (58 FR 4578). In
addition to the state regulatory changes, the EPA is proposing to
approve corresponding local regulations adopted by the Olympic Region
Clean Air Agency (ORCAA) because they have direct implementation
authority in Thurston County. Lastly, the EPA is proposing to remove
Chapter 173-433-170 Washington Administrative Code (WAC) Retail Sales
Fee from the SIP because this provision was not a control measure
relied on for attainment or a required element of the SIP. The EPA has
determined that removal of this provision will not interfere with
continued attainment and maintenance of the standard. Similarly, the
EPA is proposing to remove Chapter 173-433-200 WAC Regulatory Actions
and Penalties from the SIP incorporated by reference in 40 CFR 52.2470.
The EPA reviews and approves state submissions to ensure they provide
adequate enforcement authority. However, regulations describing agency
enforcement authority are not incorporated into the SIP to avoid
potential conflict with the EPA's independent authorities. Likewise,
the EPA has reviewed and is proposing approval of ORCAA Rule 8.1.6
Penalties as having adequate enforcement authority, but will not
incorporate this section by reference into the SIP codified in 40 CFR
52.2470.

II. Background

    The EPA identified a portion of Thurston County as a ``Group I''
area of concern due to measured violations of the newly promulgated 24-
hour PM10 National Ambient Air Quality Standard (NAAQS) on
August 7, 1987 (52 FR 29383). Ecology and ORCAA worked with the
communities of Lacey, Olympia, and Tumwater to develop a plan for
attainment of the PM10 NAAQS. The plan was focused on wood
smoke reduction and was submitted in November 1988. On November 15,
1990, the Clean Air Act (CAA) Amendments under section 107(d)(4)(B),
designated the Thurston County Group I area as nonattainment for
PM10 by operation of law. The EPA published a Federal
Register notice announcing all areas designated nonattainment for
PM10 on March 15, 1991 (56 FR 11101). In order to address
the additional moderate area requirements imposed by the 1990 CAA
Amendments, Ecology submitted a supplement to the attainment plan in
November 1991. EPA took final action to approve the entire plan on July
27, 1993 (58 FR 40056).
    The control measures contained in the Thurston County plan rapidly
brought the area into attainment by 1991 and

formed the foundation of the wood smoke reduction program still in use
today. As PM10 levels in the area steadily declined, the EPA
redesignated the Thurston County nonattainment area to a maintenance
area on October 4, 2000 (65 FR 59128). In addition to approving
Ecology's redesignation request for the area, the EPA also approved a
maintenance plan to ensure continued compliance with the
PM10 NAAQS for ten years. The purpose of the current limited
maintenance plan is to fulfill the second 10-year planning requirement
of Clean Air Act section 175A (b) to ensure compliance through 2020.

III. Public and Stakeholder Involvement in Rulemaking Process

    Section 110(a)(2) of the Clean Air Act requires that each SIP
revision offer a reasonable opportunity for notice and public hearing.
This must occur prior to the revision being submitted by the State to
the EPA. The State provided notice and an opportunity for public
comment beginning April 22, 2013, with no comments received. Under the
requirements of 40 CFR 51.102(a), the State also offered an opportunity
for a public hearing; however no requests were received. This SIP
revision was submitted by the Governor's designee and was received by
the EPA on July 1, 2013. The EPA evaluated Ecology's submittal and
determined that the State met the requirements for reasonable notice
and public hearing under section 110(a)(2).

IV. The Limited Maintenance Plan Option for PM10 Areas

A. Requirements for the Limited Maintenance Plan Option

    On August 9, 2001, the EPA issued guidance on streamlined
maintenance plan provisions for certain moderate PM10
nonattainment areas (Memo from Lydia Wegman, Director, Air Quality
Standards and Strategies Division, entitled ``Limited Maintenance Plan
Option for Moderate PM10 Nonattainment Areas'' (limited
maintenance plan option memo). The limited maintenance plan option memo
contains a statistical demonstration that areas meeting certain air
quality criteria will, with a high degree of probability, maintain the
standard ten years into the future. Thus, the EPA provided the
maintenance demonstration for areas meeting the criteria outlined in
the memo. It follows that future year emission inventories for these
areas, and some of the standard analyses to determine transportation
conformity with the SIP, are no longer necessary.
    To qualify for the limited maintenance plan option the State must
demonstrate the area meets the criteria described below. First, the
area should have attained the PM10 NAAQS. Second, the most
recent five years of air quality data at all monitors in the area,
called the 24-hour average design value, should be at or below 98
[mu]g/m\3\. Third, the State should expect only limited growth in on-
road motor vehicle PM10 emissions (including fugitive dust)
and should have passed a motor vehicle regional emissions analysis
test. Lastly, the memo identifies core provisions that must be included
in all limited maintenance plans. These provisions include an
attainment year emissions inventory, assurance of continued operation
of an EPA-approved air quality monitoring network, and contingency
provisions.

B. Conformity Under the Limited Maintenance Plan Option

    The transportation conformity rule and the general conformity rule
(40 CFR parts 51 and 93) apply to nonattainment areas and maintenance
areas covered by an approved maintenance plan. Under either conformity
rule, an acceptable method of demonstrating a Federal action conforms
to the applicable SIP is to demonstrate that expected emissions from
the planned action are consistent with the emissions budget for the
area.
    While qualification for the limited maintenance plan option does
not exempt an area from the need to affirm conformity, conformity may
be demonstrated without submitting an emissions budget. Under the
limited maintenance plan option, emissions budgets are treated as
essentially not constraining for the length of the maintenance period
because it is unreasonable to expect that the qualifying areas would
experience so much growth in that period that a violation of the
PM10 NAAQS would result. For transportation conformity
purposes, the EPA would conclude that emissions in these areas need not
be capped for the maintenance period and therefore a regional emissions
analysis would not be required. Similarly, Federal actions subject to
the general conformity rule could be considered to satisfy the ``budget
test'' specified in 40 CFR 93.158 (a)(5)(i)(A) for the same reasons
that the budgets are essentially considered to be unlimited.

V. Review of the State's Submittal

A. Has the State demonstrated that Thurston County qualifies for the
limited maintenance plan option?

    As discussed above, the limited maintenance plan option memo
outlines the requirements for an area to qualify. First, the area
should be attaining the NAAQS. Thurston County has been attaining the
NAAQS since 1991. EPA formally redesignated the area from nonattainment
to attainment, making it a maintenance area effective December 4, 2000
(65 FR 59128).
    Second, the average design value for the past five years of
monitoring data must be at or below the critical design value of 98
[mu]g/m\3\ for the 24-hour PM10 NAAQS. The critical design
value is a margin of safety in which an area has a one in ten
probability of exceeding the NAAQS. Using the most recently available
Federal Reference Method (FRM) monitoring data for the years 2001-2005,
the State's analysis demonstrated that Thurston County's average design
value was 60 [mu]g/m\3\, well below the 98 [mu]g/m\3\ threshold. An FRM
monitor is one that has been approved by the EPA under 40 CFR part 58
to measure compliance with the NAAQS. As discussed later in this
proposal, Ecology and ORCAA also calculated average design values using
more recent non-FRM nephelometer data for the period 2008 to 2012. This
more recent monitoring data shows that PM10 levels continued
to decline with an average design value of 45 [mu]g/m\3\. The EPA
reviewed the data provided by Ecology and ORCAA and finds that Thurston
County meets the design value criteria outlined in the limited
maintenance plan option memo.
    Third, the area must meet the motor vehicle regional emissions
analysis test described in attachment B of the limited maintenance plan
option memo. Ecology submitted an analysis showing that growth in on-
road mobile PM10 emissions sources was minimal and would not
threaten the assumption of maintenance that underlies the limited
maintenance plan policy. Using the EPA's methodology, Ecology
calculated a regional emissions analysis margin of safety of 62 [mu]g/
m\3\, easily meeting the threshold of 98 [mu]g/m\3\. The EPA reviewed
the calculations in the State's limited maintenance plan submittal and
concurs with this conclusion.
    Lastly, the limited maintenance plan option memo requires all
controls relied on to demonstrate attainment remain in place for the
area to qualify. The controls on wood smoke reduction, Chapter 173-433
WAC Solid Fuel Burning Device Standards, were

approved by the EPA into the SIP on January 15, 1993 (58 FR 4578). As
discussed later in this proposal, Ecology made updates to Chapter 173-
433 WAC strengthening the control measures since the EPA's last
approval. The EPA reviewed these changes and confirmed that the
underlying control measures remain in place, thus qualifying for the
limited maintenance plan option.
    As described above, Thurston County meets the qualification
criteria set forth in the limited maintenance plan option memo. Under
the limited maintenance plan option, the State will be expected to
determine on an annual basis that the criteria are still being met. If
the State determines that the limited maintenance plan criteria are not
being met, it should take action to reduce PM10
concentrations enough to requalify. One possible approach the State
could take is to implement contingency measures. Section V. I. provides
a description of contingency provisions submitted as part of the
limited maintenance plan submittal. To insure this requirement is met,
Ecology commits to reporting to the EPA on continued qualification for
the limited maintenance plan option in the annual monitoring network
report.

B. Does the State have an approved attainment emissions inventory?

    Pursuant to the limited maintenance plan option memo, the State's
approved attainment plan should include an emissions inventory which
can be used to demonstrate attainment of the NAAQS. The inventory
should represent emissions during the same five-year period associated
with air quality data used to determine whether the area meets the
applicability requirements of the limited maintenance plan option.
    Ecology's Thurston County limited maintenance plan submittal
includes an emissions inventory based on Ecology's 2005 Triennial
Emissions Inventory and the 2008 National Emissions Inventory. These
base years represent the most recent emissions inventory data available
and are consistent with the data used to determine applicability of the
limited maintenance plan option (i.e., having no violations of the
PM10 NAAQS). The emissions inventory focused on four
significant source categories chosen based on a review of the original
maintenance plan. These source categories, in order of relative impact,
are wood burning, construction dust, road dust, and vehicle exhaust and
tire wear. Since the Thurston County area is primarily residential and
governmental, other source categories, including industrial sources,
are insignificant. This data supports Ecology's conclusion that the
control measures contained in the original attainment plan will
continue to protect and maintain the PM10 NAAQS.

C. Does the limited maintenance plan include an assurance of continued
operation of an appropriate EPA-Approved air quality monitoring
network, in accordance with 40 CFR Part 58?

    PM10 monitoring was established in the Thurston County
area in 1985, with many changes to the monitoring technology and
requirements since. Beginning in 1990, Ecology and ORCAA collocated a
nephelometer with the existing PM10 FRM monitor. A
nephelometer is an instrument that is widely used to calculate
particulate matter concentrations based on light scatter measurements.
While not an EPA-approved FRM monitoring method, Ecology and ORCAA
found that the nephelometer and the PM10 FRM monitor were
highly correlated. Because of this high level of correlation between
the monitors, as part of the 2007 annual network monitoring report
under 40 CFR part 58, Ecology requested replacing the FRM monitor with
the nephelometer so that resources could be redirected to more pressing
environmental issues such as ensuring that areas of concern in the
State were in compliance with the recently revised fine particulate
matter (PM2.5) NAAQS, which is defined as particulate matter
with an aerodynamic diameter less than or equal to a nominal 2.5
micrometers. The EPA approved this request on November 16, 2007. A full
description of the correlation data is included in the limited
maintenance plan submittal. The EPA is proposing to approve this
monitoring system modification, using nephelometer data to represent
PM10 concentrations, under 40 CFR 58.14(c) for the second
10-year maintenance plan period because this modification is a
reproducible approach to representing air quality in the Thurston
County maintenance area, and the area continues to meet all applicable
Appendix D requirements evaluated as part of the annual network
approval process. As detailed in the limited maintenance plan, ORCAA
will calculate the PM10 design value estimate annually from
nephelometer data through 2020 to confirm the area continues to meet
the PM10 NAAQS. ORCAA also makes a commitment to continue
operation of a nephelometer in the Thurston County maintenance area
through the 2020, the end of the maintenance period, to determine
PM10 levels. In the unlikely event that after exceptional
events are discounted, the second highest PM10 concentration
in a calendar year based on nephelometer monitoring exceeds the LMP
threshold of 98 [mu]g/m\3\, Ecology, ORCAA, and EPA will discuss
reestablishment of FRM monitoring as part of the annual network
monitoring report process.

D. Does the plan meet the Clean Air Act requirements for contingency
provisions?

    Clean Air Act section 175A states that a maintenance plan must
include contingency provisions, as necessary, to ensure prompt
correction of any violation of the NAAQS which may occur after
redesignation of the area to attainment. The EPA is proposing approval
of ORCAA Rule 8.1.4(e) into the SIP. This regulation was passed in
conjunction with the 1997 maintenance plan submission and prohibits the
use of uncertified woodstoves in the Thurston County maintenance area
for the sole purpose of meeting Clean Air Act requirements for
contingency measures. The EPA reviewed ORCAA Rule 8.1.4(e) and
determined that it meets the contingency measure requirements. The
contingency measure will be triggered if a violation of the
PM10 standard occurs at the Thurston County maintenance area
monitor based on nephelometer and/or FRM monitoring. A violation of the
PM10 standard will be determined by the procedures outlined
in 40 CFR Part 50, Appendix K--Interpretation of the NAAQS for
Particulate Matter.

E. Has the State met conformity requirements?

(1) Transportation Conformity
    Under the limited maintenance plan option, emissions budgets are
treated as essentially not constraining for the maintenance period
because it is unreasonable to expect that qualifying areas would
experience so much growth in that period that a NAAQS violation would
result. While areas with maintenance plans approved under the limited
maintenance plan option are not subject to the budget test, the areas
remain subject to the other transportation conformity requirements of
40 CFR part 93, subpart A. Thus, the metropolitan planning organization
(MPO) in the area or the State must document and ensure that:
    (a) Transportation plans and projects provide for timely
implementation of SIP transportation control measures (TCMs) in
accordance with 40 CFR 93.113;
    (b) Transportation plans and projects comply with the fiscal
constraint element as set forth in 40 CFR 93.108;

    (c) The MPO's interagency consultation procedures meet the
applicable requirements of 40 CFR 93.105;
    (d) Conformity of transportation plans is determined no less
frequently than every three years, and conformity of plan amendments
and transportation projects is demonstrated in accordance with the
timing requirements specified in 40 CFR 93.104;
    (e) The latest planning assumptions and emissions model are used as
set forth in 40 CFR 93.110 and 40 CFR 93.111;
    (f) Projects do not cause or contribute to any new localized carbon
monoxide or particulate matter violations, in accordance with
procedures specified in 40 CFR 93.123; and
    (g) Project sponsors and/or operators provide written commitments
as specified in 40 CFR 93.125.
    Upon approval of the Thurston County limited maintenance plan, the
area is exempt from performing a regional emissions analysis, but must
meet project-level conformity analyses as well as the transportation
conformity criteria mentioned above.
(2) General Conformity
    For Federal actions required to address the specific requirements
of the general conformity rule, one set of requirements applies
particularly to ensuring that emissions from the action will not cause
or contribute to new violations of the NAAQS, exacerbate current
violations, or delay timely attainment. One way that this requirement
can be met is to demonstrate that ``the total of direct and indirect
emissions from the action (or portion thereof) is determined and
documented by the state agency primarily responsible for the applicable
SIP to result in a level of emissions which, together with all other
emissions in the nonattainment area, would not exceed the emissions
budgets specified in the applicable SIP'' (40 CFR 93.158(a)(5)(i)(A)).
    The decision about whether to include specific allocations of
allowable emissions increases to sources is one made by the state air
quality agencies. These emissions budgets are different than those used
in transportation conformity. Emissions budgets in transportation
conformity are required to limit and restrain emissions. Emissions
budgets in general conformity allow increases in emissions up to
specified levels. The State has not chosen to include specific
emissions allocations for Federal projects that would be subject to the
provisions of general conformity.

VI. Revisions to the Washington SIP

    As previously discussed, the EPA approved the wood smoke control
measures contained in Chapter 173-433 WAC Solid Fuel Burning Device
Standards on January 15, 1993, based on state regulatory provisions in
effect as of October 18, 1990 (58 FR 4578). Ecology subsequently
revised Chapter 173-433 WAC to strengthen the control measures with
changes such as adding one of the nation's most stringent state
woodstove certification standards and by moving towards a two-stage
burn ban system to encourage adoption of the cleaner burning
woodstoves. These changes to Chapter 173-433 WAC were effective on
April 20, 1991 and March 6, 1993, but were not submitted for adoption
into the SIP at that time. A redline strikeout copy of the regulatory
changes along with the EPA's analysis is included in the docket for
this action. Based on our review, the EPA is proposing to approve
Ecology's 1991 and 1993 regulatory updates. In addition, Ecology
requested that the EPA remove from the approved SIP Chapter 173-433-170
WAC Retail Sales Fee (state effective January 3, 1989) because this
provision is not a control measure or a required element of the SIP.
After reviewing the original Thurston County attainment plan, the EPA
agrees that this provision was not a control measure relied upon for
attainment and removal of Chapter 173-433-170 from the SIP will not
interfere with continued attainment or maintenance of the NAAQS.
Similarly, the EPA erred in including Chapter 173-433-200 WAC
Regulatory Actions and Penalties in the SIP incorporated by reference
in 40 CFR 52.2470. The EPA reviews and approves state submissions to
ensure they provide adequate enforcement authority. However,
regulations describing agency enforcement authority are not
incorporated into the SIP to avoid potential conflict with the EPA's
independent authorities. Therefore, we will remove Chapter 173-433-200
WAC from 40 CFR 52.2470.
    While the provisions of Chapter 173-433 WAC Solid Fuel Burning
Device Standards apply statewide per Chapter 173-433-020 WAC, Ecology
requested that the EPA approve portions of ORCAA Rule 8.1 Wood Heating
and ORCAA Rule 6.2 Outdoor Burning because ORCAA has direct
implementation authority in Thurston County. The EPA reviewed these
regulations to ensure they are as stringent as the existing control
measures, with a full copy of the EPA's analysis included in the docket
for this action. It is important to note that the ORCAA control
measures, particularly burn ban trigger levels, focus on the more
stringent and environmentally relevant 24-hour PM2.5 NAAQS.
Ecology and ORCAA provided an analysis of PM10 and
PM2.5 data collected by collocated FRM monitors at the
Thurston County monitoring site. ORCAA found that the two pollutants
were correlated and one could be determined from the other with a high
degree of accuracy within the range of observations. The 24-hour
PM2.5 NAAQS revised in 2006 has a protection level of 35
[mu]g/m\3\ compared to the 1987 PM10 24-hour NAAQS of 150
[mu]g/m\3\. Based on the monitoring data from Thurston County, ORCAA
found that in the critical winter season the majority of
PM10 is PM2.5. The statistical relationship
between the two PM parameters indicates PM2.5 levels would
need to exceed 139 [mu]g/m\3\ before the PM10 NAAQS is
exceeded. The EPA concurs that Thurston County would violate the 24-
hour PM2.5 NAAQS well before it exceeded the PM10
NAAQS. By setting burn ban trigger levels to protect the 35 [mu]g/m\3\
24-hour PM2.5 NAAQS, ORCAA is simultaneously protecting the
150 [mu]g/m\3\ 24-hour PM10 NAAQS. Finally, ORCAA Rule
8.1.4(e) provides a local clean air agency rule for implementing the
contingency measure which would prohibit the use of uncertified wood
stoves. The EPA reviewed the ORCAA regulations and determined that they
strengthen the SIP and meet the CAA requirements. As discussed above
with respect to enforcement authorities, the EPA reviewed and proposes
approval of ORCAA Rule 8.1.6 Penalties but will not incorporate this
provision by reference in 40 CFR 52.2470.

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                                                                State or local
             Agency                      Citation                  Title          effective date     Submitted
----------------------------------------------------------------------------------------------------------------
Ecology........................  173-433-030............  Definitions...........        04/20/91        07/01/13

Ecology........................  173-433-100............  Emission performance          03/06/93        07/01/13
                                                           standards.
Ecology........................  173-433-110............  Opacity standards.....        03/06/93        07/01/13
Ecology........................  173-433-120............  Prohibited fuel types.        04/20/91        07/01/13
Ecology........................  173-433-140............  Impaired air quality          04/20/91        07/01/13
                                                           criteria.
Ecology........................  173-433-150............  Curtailment...........        04/20/91        07/01/13
ORCAA..........................  6.2.3 (only as it        No residential or land        02/04/12        07/01/13
                                  applies to the cities    clearing burning.
                                  of Olympia, Lacey, and
                                  Tumwater).
ORCAA..........................  6.2.6..................  Curtailment...........        03/18/11        07/01/13
ORCAA..........................  6.2.7..................  Recreational Burning..        03/18/11        07/01/13
ORCAA..........................  8.1.1..................  Definitions...........        05/22/10        07/01/13
ORCAA..........................  8.1.2 (b) and (c)......  General emission              05/22/10        07/01/13
                                                           standards.
ORCAA..........................  8.1.3..................  Prohibited fuel types.        05/22/10        07/01/13
ORCAA..........................  8.1.4..................  Curtailment...........        05/22/10        07/01/13
ORCAA..........................  8.1.5..................  Exceptions............        05/22/10        07/01/13
ORCAA..........................  8.1.6..................  Penalties.............        05/22/10        07/01/13
ORCAA..........................  8.1.7..................  Sale and installation         05/22/10        07/01/13
                                                           of uncertified
                                                           woodstoves.
ORCAA..........................  8.1.8..................  Disposal of                   05/22/10        07/01/13
                                                           uncertified
                                                           woodstoves.
----------------------------------------------------------------------------------------------------------------

VII. Proposed Action

    The EPA is proposing to approve the second 10-year limited
maintenance plan for Thurston County submitted by Washington State. The
state's submittal also included a request to approve state regulatory
updates to the original control measures included in Chapter 173-433
WAC as well as corresponding local ORCAA regulations. The EPA is
proposing to approve these regulatory changes as well as corrections to
the EPA's January 1993 approval because these changes strengthen the
SIP.

VIII. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is 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);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is 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.);
     Does 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);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to the 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
     does not provide the 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 it will not impose substantial direct costs on tribal
governments or preempt tribal law. The SIP is not approved to apply in
Indian country located in the State, except for non-trust land within
the exterior boundaries of the Puyallup Indian Reservation, also known
as the 1873 Survey Area. Under the Puyallup Tribe of Indians Settlement
Act of 1989, 25 U.S.C. 1773, Congress explicitly provided state and
local agencies in Washington authority over activities on non-trust
lands within the 1873 Survey Area and the EPA is therefore approving
this SIP on such lands.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter, and Reporting and recordkeeping
requirements.

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

    Dated: July 22, 2013.
Dennis J. McLerran,
Regional Administrator, Region 10.
[FR Doc. 2013-18843 Filed 8-2-13; 8:45 am]
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[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60837-60838]
[FR Doc No: 2021-24068]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-E-2023]

Determination of Regulatory Review Period for Purposes of Patent
Extension; RECARBRIO

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for RECARBRIO and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by January 3, 2022.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 3, 2022. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 3, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-E-2023 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; RECARBRIO.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit

both copies to the Dockets Management Staff. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with Sec.  10.20 (21 CFR 10.20) and other applicable
disclosure law. For more information about FDA's posting of comments to
public dockets, see 80 FR 56469, September 18, 2015, or access the
information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, RECARBRIO.
RECARBRIO is a combination of cilastatin, imipenem, and relebactam
indicated in patients 18 years of age and older who have limited or no
alternative treatment options for the treatment of the following
infections caused by susceptible gram-negative bacteria: Complicated
urinary tract infections, including pyelonephritis, and complicated
intra-abdominal infections. Approval of these indications is based on
limited clinical safety and efficacy data for RECARBRIO. Subsequent to
this approval, the USPTO received a patent term restoration application
for RECARBRIO (U.S. Patent No. 8,487,093) from Merck Sharp & Dohme
Corp., and the USPTO requested FDA's assistance in determining the
patent's eligibility for patent term restoration. In a letter dated
January 4, 2021, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of RECARBRIO
represented the first permitted commercial marketing or use of
relebactam, one of the three active ingredients in the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
RECARBRIO is 3,200 days. Of this time, 2,957 days occurred during the
testing phase of the regulatory review period, while 243 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
October 13, 2010. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
October 13, 2010.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: November 16,
2018. FDA has verified the applicant's claim that the new drug
application (NDA) for RECARBRIO (NDA 212819) was initially submitted on
November 16, 2018.
    3. The date the application was approved: July 16, 2019. FDA has
verified the applicant's claim that NDA 212819 was approved on July 16,
2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,218 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24068 Filed 11-3-21; 8:45 am]
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