[Federal Register: May 27, 2010 (Volume 75, Number 102)]
[Rules and Regulations]
[Page 29671-29677]
[DOCID:fr27my10-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2009-0612-200914(a); FRL-9155-3]

Approval and Promulgation of Air Quality Implementation Plans:
Florida; Approval of Section 110(a)(1) Maintenance Plan for the 1997 8-
Hour Ozone Standards for the Jacksonville, Tampa Bay, and Southeast
Florida Areas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve revisions to the
Florida State Implementation Plan (SIP) concerning the maintenance
plans addressing the 1997 8-hour ozone standards for the Jacksonville,
Tampa Bay, and Southeast Florida 1997 8-hour ozone attainment areas in
Florida, hereafter referred to as the ``Jacksonville Area,'' ``Tampa
Bay Area,'' and ``Southeast Florida Area,'' respectively. The
Jacksonville Area is comprised of Duval County; the Tampa Bay Area
comprises Hillsborough and Pinellas Counties; and the Southeast Florida
Area comprises Broward, Dade, and Palm Beach Counties. These
maintenance plans were submitted to EPA on July 2, 2009, by the State
of Florida, through the Florida Department of Environmental Protection
(FDEP), and ensure the continued attainment of the 1997 8-hour ozone
national ambient air quality standards (NAAQS) through the year 2014 in
the Jacksonville, Tampa Bay, and Southeast Florida Areas. EPA is
approving the SIP revisions pursuant to section 110 of the Clean Air
Act (CAA). These maintenance plans meet all the statutory and
regulatory requirements, and are consistent with EPA's guidance. On
March 12, 2008, EPA issued revised ozone standards. On September 16,
2009, EPA announced it would reconsider the 2008 NAAQS for ozone and
proposed a new schedule for designations for the reconsidered
standards. EPA published a proposed rulemaking on January 19, 2010, for
reconsideration of the 2008 NAAQS, and expects to finalize the
reconsidered NAAQS by August 2010. The current action, however, is
being taken to address requirements under the 1997 8-hour ozone
standards. Requirements for the Jacksonville, Tampa Bay, and Southeast
Florida Areas under the 2010 reconsidered ozone standards will be
addressed in the future.

DATES: This rule is effective on July 26, 2010 without further notice,
unless EPA receives relevant adverse comment by June 28, 2010. If EPA
receives such comment, EPA will publish a timely withdrawal in the
Federal Register informing the public that this rule will not take
effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2009-0612, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2009-0612,'' Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. ``EPA-R04-OAR-
2009-0612.'' EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit through http:/
/www.regulations.gov or e-mail, information that you consider to be CBI
or otherwise protected. The http://www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your

name and other contact information in the body of your comment and with
any disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 in http://
www.regulations.gov or in hard copy at the Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. EPA requests that if at all
possible, you contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 a.m. to 4:30
p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Twunjala Bradley, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number
is<PHONE_NUMBER>. Ms. Bradley can also be reached via electronic mail
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Analysis of Florida's Submittals
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background

    In accordance with the CAA, the Jacksonville, Tampa Bay and
Southeast Florida Areas in Florida were designated nonattainment for
the 1-hour ozone NAAQS on November 6, 1991, 56 FR 56694 (effective
January 6, 1992, 60 FR 7124).
    On June 23, 1993, the State of Florida, through the FDEP, submitted
a request to redesignate Duval County in association with the
Jacksonville Area to attainment for the 1-hour ozone standards.
Likewise, Florida submitted redesignation requests for Broward, Dade,
and Palm Beach Counties in association with the Southeast Florida Area
on November 8, 1992, and for Hillsborough and Pinellas Counties in
association with the Tampa Bay Area on February 7, 1995. Included with
these redesignation requests, Florida submitted the required 1-hour
ozone monitoring data and maintenance plans ensuring these areas would
remain in attainment of the 1-hour ozone standards for at least a
period of 10 years (consistent with CAA 175A(a)). The maintenance plans
submitted by Florida followed EPA guidance for maintenance areas,
subject to section 175A of the CAA.
    On January 3, 1995, EPA approved Florida's request to redesignate
the Jacksonville Area (60 FR 41) to attainment for the 1-hour ozone
NAAQS. Likewise, the Southeast Florida and Tampa Bay Areas were
redesignated to attainment on February 24, 1995, and December 7, 1995
(60 FR 10325 and 60 FR 62793), respectively. The maintenance plans for
the Jacksonville, Tampa Bay, and Southeast Florida Areas became
effective on March 6, 1995, February 5, 1996, and April 1995,
respectively. Florida later updated all three maintenance plans, in
accordance with section 175(A)(b), to extend the maintenance plans to
cover additional years such that the entire maintenance period was for
at least 20 years after the initial redesignation of these areas to
attainment.
    On April 30, 2004, EPA designated and classified areas for the 1997
8-hour ozone NAAQS (69 FR 23858), and published the final Phase 1 Rule
for implementation of the 1997 8-hour ozone NAAQS (69 FR 23951) (Phase
1 Rule). The Jacksonville, Tampa Bay, and Southeast Florida Areas were
designated as attainment for the 1997 8-hour ozone standards, effective
June 15, 2004. These attainment areas consequently were required to
submit a 10-year maintenance plan under section 110(a)(1) of the CAA
and the Phase 1 Rule. On May 20, 2005, EPA issued guidance providing
information on how a state might fulfill the maintenance plan
obligation established by the CAA and the Phase 1 Rule (Memorandum from
Lydia N. Wegman to Air Division Directors, Maintenance Plan Guidance
Document for Certain 8-hour Ozone Areas Under Section 110(a)(1) of
Clean Air Act, May 20, 2005--hereafter referred to as the ``Wegman
Memorandum''). On December 22, 2006, the United States Court of Appeals
for the District of Columbia Circuit issued an opinion that vacated
EPA's Phase 1 Rule for the 1997 8-hour Ozone Standard. South Coast Air
Quality Management District. v. EPA, 472 F.3d 882 (D.C. Cir. 2006). The
Court vacated those portions of the Phase 1 Rule that provided for
regulation of the 1997 8-hour ozone nonattainment areas designated
under Subpart 1 in lieu of Subpart 2 (of part D of the CAA), among
other portions. The Court's decision does not alter any requirements
under the Phase 1 Rule for section 110(a)(l) maintenance plans. EPA is
taking action to approve Florida's July 2, 2009, SIP revisions which
satisfy CAA section 110(a)(1) CAA requirements for a plan providing for
maintenance of the 1997 8-hour ozone NAAQS in the Jacksonville, Tampa
Bay and Southeast Florida Areas.

II. Analysis of Florida's Submittals

    On July 2, 2009, the State of Florida, through the FDEP, submitted
SIP revisions containing the 1997 8-hour ozone maintenance plans for
the Jacksonville, Tampa Bay and Southeast Florida Areas as required by
section 110(a)(1) of the CAA and the provisions of EPA's Phase 1 Rule
(see 40 CFR 51.905(a)(4)). The purpose of these plans is to ensure
continued attainment and maintenance of the 1997 8-hour ozone NAAQS in
these Areas until 2018.
    As required, these plans provide for continued attainment and
maintenance of the 1997 8-hour ozone NAAQS in the Jacksonville, Tampa
Bay and Southeast Florida Areas for at least 10 years from the
effective date of these areas' designation as attainment for the 1997
8-hour ozone NAAQS. These plans also include components illustrating
how each area will continue attainment of the 1997 8-hour ozone NAAQS,
and provide contingency measures. Each of the section 110(a)(1) plan
components is discussed below for each area.
    (a) Attainment Inventory. In order to demonstrate maintenance in
the aforementioned areas, Florida developed comprehensive inventories
of volatile organic compounds (VOC) and nitrogen oxide (NOX)
emissions from area, stationary, on-road mobile, and non-road mobile
sources using 2002 as the base year. The year 2002 is an appropriate
year for Florida to base attainment level emissions because states may
select any one of the three years on which the 1997 8-hour attainment
designation was based (2001, 2002, and 2003). The State's submittal

contains the detailed inventory data and summaries by source category
for each area. Using the 2002 inventory (as a base year) reflects one
of the years used for calculating the air quality design values on
which the 1997 8-hour ozone designation decisions were based.
    A further practical reason for selecting 2002 as the base year
emission inventory is that Section 110(a)(2)(B) of the CAA and the
Consolidated Emissions Reporting Rule (67 FR 39602, June 10, 2002)
requires states to submit emissions inventories for all criteria
pollutants and their precursors every three years, on a schedule that
includes the emissions year 2002. The due date for the 2002 emissions
inventory is established in the rule as June 2004. In accordance with
these requirements, Florida compiles a statewide emissions inventory
for point sources on an annual basis. On-road mobile emissions of VOC
and NOX were estimated using MOBILE6 motor vehicle emissions
factor computer model. Non-road mobile emissions data were derived
using the U.S. EPA's NONROAD 2002 model.
    In projecting data for the maintenance year 2014 emissions
inventories, Florida used several methods to project data from the base
year 2002 to the years 2009 and 2018; and the interim years 2005, 2008,
2011 and 2014. These projected inventories were developed using EPA-
approved technologies and methodologies including the Visibility
Improvement State and Tribal Association of the Southeast (VISTAS)
methodology. Point source inventories were developed through VISTAS
using the Integrated Planning Model (IPM) for electrical generating
units (EGU) sources and updated growth and control data for non-EGU
sources. EPA's Emissions Growth Analysis System model was used to
derive area source emissions data. Non-road mobile projections were
derived from the NONROAD model.
    The following tables provide VOC and NOX emissions data
for the 2002 base attainment year inventories, as well as projected
detailed source category VOC and NOX emission inventory data
for 2009 and 2018. To further support these maintenance demonstrations,
interim projections for VOC and NOX emission inventory data
beginning in the year 2005 through the year 2018 are also provided for
each area. The requirement for these maintenance plans is an end year
of 2014, but Florida has chosen to provide projections through 2018
also in support of these maintenance demonstrations. The Phase 1 Rule
provides that the 10-year maintenance period begin as of the effective
date of designation for the 1997 8-hour NAAQS for the area. The
designations were effective in 2004 so the maintenance period must end
no earlier than 2014. Florida has opted to provide additional
supporting information through the year 2018.

                                                 Table 1--2002 VOC and NOX Base Year Emissions Inventory
                                                                       [Tons/day]
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                                                             Southeast Florida                                    Tampa Bay                 Jacksonville
                                         ---------------------------------------------------------------------------------------------------------------
                                           Miami-Dade      Broward     Palm Beach       Total     Hillsborough    Pinellas        Total         Duval
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                                                                           VOC
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Point Source............................          4.68          4.28          1.44         10.40          5.19          2.81          8.00          5.61
Area Source.............................        132.08         96.74         73.77        302.60         72.34         61.20        133.54         59.53
On-Road.................................        131.07        107.43         80.69        319.19         81.76         61.47        143.23         64.13
Non Road................................         52.79         37.39         55.74        145.92         29.39         22.97         52.36         25.39
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................        320.63        245.54        211.64        778.11        188.67        148.45        337.13        154.65
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                                                                           NOX
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Point Source............................         40.23         58.76         25.33        124.32        151.02         25.64        176.66        115.47
Area Source.............................          7.41          5.08          3.53         16.02          4.39         15.63         20.02          6.10
On-Road.................................        144.95        120.19         91.31        356.46         92.88         62.63        155.51         72.68
Non Road................................         57.42         54.79         39.62        151.82         86.98         18.41        105.39         43.34
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................        250.01        238.82        159.79        648.62        335.26        122.31        457.57        237.60
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                                                 Table 2--2009 Projected VOC and NOX Emissions Inventory
                                                                       [Tons/day]
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                                                             Southeast Florida                                    Tampa Bay                 Jacksonville
                                         ---------------------------------------------------------------------------------------------------------------
                                           Miami-Dade      Broward     Palm Beach       Total     Hillsborough    Pinellas        Total         Duval
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                                                                           VOC
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Point Source............................          3.74          3.95          1.19          8.87          5.12          2.49          7.61          5.62
Area Source.............................        140.57        103.37         77.41        321.35         77.18         65.88        143.06         62.55
On-Road.................................         77.98         66.24         50.31        194.53         50.22         37.64         87.86         39.26
Non Road................................         41.55         27.40         39.46        108.41         22.47         17.58         40.05         18.23
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................        263.84        200.95        168.36        633.16        154.98        123.59        278.57        125.67
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                                                                           NOX
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Point Source............................         24.75         18.39          7.31         50.45         16.62          5.03         21.65         21.43
Area Source.............................          7.36          5.05          3.53         15.95          4.46         12.68         17.13          6.43
On-Road.................................         93.47         79.81         61.32        234.60         61.62         41.79        103.41         47.94

Non Road................................         52.07         49.55         34.11        135.72         80.40         15.38         95.78         39.13
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................        177.64        152.80        106.27        436.72        163.10         74.88        237.98        114.93
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                                                 Table 3--2018 Projected VOC and NOX Emissions Inventory
                                                                       [Tons/day]
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                                                             Southeast Florida                                    Tampa Bay                 Jacksonville
                                         ---------------------------------------------------------------------------------------------------------------
                                           Miami-Dade      Broward     Palm Beach       Total     Hillsborough    Pinellas        Total         Duval
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                                                                           VOC
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Point Source............................          4.64          4.95          1.54         11.13          6.39          3.29          9.68          6.63
Area Source.............................        168.91        124.81         90.22         33.94         90.21         79.95        170.16         73.89
On-Road.................................         49.76         43.85         33.54        127.15         33.14         24.81         57.94         25.85
Non Road................................         41.61         27.56         36.15        105.32         21.17         16.02         37.19         17.08
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................        264.92        201.16        161.45        627.52        150.90        124.07        274.97        123.45
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                                                                           NOX
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Point Source............................         28.52         16.93          9.64         55.08         18.25          6.96         25.22         22.20
Area Source.............................          7.84          5.39          3.78          17.0          5.03         13.86         18.90          6.89
On-Road.................................         42.41         37.74         29.17        109.31         28.81         19.84         48.64         22.42
Non Road................................         40.34         39.56         21.90        101.80         67.67          9.86         77.52         31.13
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................        119.11         99.62         64.48        283.21        119.76         50.52        170.28         82.65
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                                               Table 4--Projections of Anthropogenic VOC and NOX Emissions
                                                                       [Tons/day]
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                                                             Southeast Florida                                    Tampa Bay                 Jacksonville
                  Year                   ---------------------------------------------------------------------------------------------------------------
                                           Miami-Dade      Broward     Palm Beach       Total     Hillsborough    Pinellas        Total         Duval
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                                                                           VOC
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2002....................................        320.63        245.84        211.64        778.11        188.67        148.45        337.13        154.65
2005....................................        296.29        226.61        193.09        715.99        174.24        137.80        312.03        142.23
2008....................................        271.96        207.37        174.55        653.87        159.80        127.14        286.94        129.81
2009*...................................        263.84        200.95        168.36        633.16        154.98        123.59        278.57        125.67
2011....................................        264.08        201.00        166.83        631.91        154.08        123.70        277.77        125.17
2014....................................        264.44        201.07        164.52        630.04        152.71        123.85        276.57        124.44
2018*...................................        264.92        201.16        161.45        627.52        150.90        124.07        274.97        123.45
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                                                                           NOX
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2002....................................        250.01        238.82        159.79        648.62        335.26        122.31        457.57        237.60
2005....................................        219.00        201.95        136.85        557.81        261.48        101.98        363.46        185.03
2008....................................        187.98        165.09        113.92        466.99        187.70         81.66        269.35        132.45
2009*...................................        177.64        152.80        106.27        436.72        163.10         74.88        237.98        114.93
2011....................................        164.64        140.98         96.99        402.61        153.47         69.47        222.94        107.75
2014....................................        145.13        123.25         83.06        351.44        139.02         61.35        200.37         97.00
2018*...................................        119.11         99.62         64.48        283.21        119.76         50.52        170.28         82.65
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* More detailed information regarding the source category emissions for these projections is provided in Tables 2 and 3 in this rulemaking.

    As shown in Table 4 above, the Jacksonville, Tampa Bay, and
Southeast Florida Areas projected to decrease total VOC and
NOX emissions from the base year of 2002 to the maintenance
year of 2014. This VOC and NOX emission decrease
demonstrates continued attainment/maintenance of the 1997 8-hour ozone
standards for ten years from 2004 as required by the CAA and Phase 1
Rule. Furthermore, total VOC and NOX emissions are projected
to steadily decrease from the base year of 2002 through 2018.
    As shown in the tables above, Florida has demonstrated that the
future year emissions will be less than the 2002 base attainment year's
emissions for the

1997 8-hour ozone NAAQS for the Jacksonville, Tampa Bay and Southeast
Florida Areas. The attainment inventories submitted by Florida for
these areas are consistent with the criteria as discussed in the Wegman
Memorandum. EPA finds that the future emission levels for the projected
years 2005, 2008, 2009, 2011, 2014 and 2018, are expected to be less
than the attainment level emissions in 2002. In the event that a future
8-hour ozone monitoring reading in one of these areas is found to
violate the 1997 ozone standards, the contingency plan section of each
area's maintenance plan includes measures that will be promptly
implemented to ensure that the Area returns to maintenance of the 1997
ozone standards. Please see section (d) Contingency Plan, below, for
additional information related to the contingency measures in each of
the maintenance plans.
    (b) Maintenance Demonstration. The primary purpose of a maintenance
plan is to demonstrate how an area will continue to remain in
attainment with the 1997 8-hour ozone standards for the 10-year period
following the effective date of designation as unclassifiable/
attainment. The required end projection year for all three maintenance
areas is 2014; however, Florida has opted to provide additional
supporting information through the year 2018. As discussed in section
(a) Attainment Inventory above, Florida identified the level of ozone-
forming emissions that were consistent with attainment of the NAAQS for
ozone in 2002. Florida projected VOC and NOX emissions for
2009 and 2018, as well as provided interim projection emissions
inventories for VOC and NOX emissions for the years 2005,
2008, 2011 and 2014 in the Jacksonville, Tampa Bay and Southeast
Florida Areas. EPA finds that the future emissions levels in these
years are expected to be below the emissions levels in 2002 in the
Jacksonville, Tampa Bay, and Southeast Florida Areas.
    Florida's SIP revision for the maintenance plans for the
Jacksonville, Tampa Bay, and Southeast Florida Areas also relies on a
combination of several air quality measures that will provide for
additional 8-hour ozone emissions reductions in these areas. These
measures include the implementation of the following, among others: (1)
Heavy Duty 2007 Engine Standards, (2) Tier 2 Tailpipe Program, (3)
Large Spark Ignition and Recreational Vehicle Rule, (4) Nonroad Diesel
Rule, (5) Industrial Boiler/Process Heater/RICE maximum available
control technology (MACT), (6) Petroleum Refinery Initiative, (7) VOC
2-, 4-, 7-, and 10-year MACT Standards, (8) Combustion Turbine MACT,
and (9) consent decrees from Tampa Electric, Virginia Electric and
Power Company and Gulf Power Crist. These Florida attainment areas are
also benefiting from the following reductions that are occurring in
other states in the Southeast: (1) North Carolina Clean Smokestacks
Act, (2) Atlanta/Northern Kentucky/Birmingham 1-hour SIPs, (3)
NOX Reasonably Available Control Technology (RACT) in 8-hour
nonattainment area SIP, and (4) implementation of NOX SIP
Call Phase 1 in southeastern states. Moreover, despite the legal status
of the Clean Air Interstate Rule (CAIR) as remanded, many facilities
have already installed or are continuing with plans to install emission
controls that may benefit the Jacksonville, Tampa Bay, and Southeast
Florida Areas.
    There are no sources subject to CAIR or the NOX SIP Call
in the Jacksonville, Tampa Bay, and Southeast Florida Areas. Hence, the
recent remand of CAIR does not affect the maintenance inventories or
maintenance demonstrations in any way. Moreover, these areas were in
attainment prior to implementation of these rules. As a result, any
contribution to the reduction in the background ozone levels from these
rules would be in addition to the projected decreases within the
maintenance planning areas. These rules, even though the submittal
takes no credit for emissions reductions from them, would be expected
to reduce transported NOX and ozone from outside the
nonattainment area, thereby providing a further, unquantified
improvement in these areas' air quality.
    (c) Ambient Air Quality Monitoring. The table below shows design
values \1\ for the Jacksonville, Tampa Bay, and Southeast Florida
Areas. The ambient ozone monitoring data were collected at sites that
were selected with assistance from EPA and are considered
representative of the areas of highest concentration. Florida will
continue to depend on local air pollution control agencies in the
Jacksonville, Tampa Bay, and Southeast Florida Areas to conduct ambient
air quality monitoring programs for ozone in their respective areas.
All monitoring programs will continue in accordance with applicable EPA
monitoring requirements contained in 40 CFR part 58.
---------------------------------------------------------------------------

    \1\ The air quality design value at a monitoring site is defined
as that concentration that when reduced to the level of the standard
ensures that the site meets the standard. For a concentration-based
standard, the air quality design value is simply the standard-
related test statistic. Thus, for the primary and secondary 1997 8-
hour ozone standards, the 3-year average annual fourth-highest daily
maximum 8-hour average ozone concentration is also the air quality
design value for the site. 40 CFR part 50, Appendix I, Section 3.
---------------------------------------------------------------------------

    Even though 2002 is established as the base year, the actual year
each of these areas monitored attainment for the 1997 8-hour NAAQS
occurred prior to 2002. The Southeast Florida Area has not had a
monitor design value exceed the 1997 8-hour NAAQS since the 1970s. For
the Tampa Bay Area, the most recent year of a monitored 8-hour design
value exceedance of the 1997 NAAQS was 2000. For the Jacksonville Area,
the most recent year of a monitored NAAQS exceedance was 1989.

                                   Table 5--Maximum 8-Hour Ozone Design Values
                                                      [Ppm]
----------------------------------------------------------------------------------------------------------------
                 Year                        Jacksonville              Tampa Bay            Southeast Florida
----------------------------------------------------------------------------------------------------------------
2001-2003............................                    0.070                    0.080                    0.071
2002-2004............................                    0.070                    0.078                    0.068
2003-2005............................                    0.073                    0.078                    0.067
2004-2006............................                    0.076                    0.079                    0.068
2005-2007............................                    0.077                    0.080                    0.074
2006-2008............................                    0.075                    0.081                    0.074
2007-2009............................                    0.070                    0.078                    0.069
----------------------------------------------------------------------------------------------------------------

    Based on Table 5 above, the maximum design values identified
demonstrate attainment with the 1997 8-hour ozone NAAQS. Further, these
design values indicate that these maintenance areas are expected to
continue attainment of the 1997 8-hour ozone NAAQS. The attainment
level for the 1997 8-hour ozone standards is 0.080 parts per million
(ppm), effectively 0.084 ppm with the rounding convention. However, in
the event a design value for one of the Jacksonville, Tampa Bay and
Southeast Florida Areas' monitors exceeds the 1997 8-hour ozone
standards, one or more contingency measures included in Florida's
maintenance plans for the Jacksonville, Tampa Bay and Southeast Florida
Areas would be promptly implemented in accordance with the contingency
plan, as discussed below.
    (d) Contingency Plan. In accordance with 40 CFR 51.905(a)(4)(ii)
and the Wegman Memorandum, the section 110(a)(1) maintenance plans
include contingency provisions to promptly correct a violation of the
1997 ozone NAAQS that may occur. The indicators for triggering
contingency measures for the Jacksonville, Tampa Bay, and Southeast
Florida Areas are based on updates to the emission inventories. The
State of Florida has established two triggers to activate contingency
measures including: (1) violation of the 1997 8-hour ozone standards at
any monitor and (2) a five percent or more increase in ozone precursor
emissions for the emissions inventory update (for VOC or
NOX) above the 2002 emissions inventory and the ozone design
value for the update year is greater than or equal to 0.081 ppm. In the
maintenance plans for the Jacksonville, Tampa Bay and Southeast Florida
Areas, if contingency measures are triggered, Florida is committed to
implement the measures as expeditiously as practicable, including
adopting one or more contingency measures within 18-months of the
trigger and implementing the measures within twenty-four months of the
triggering event. The contingency measures include: (1) Reinstate
nonattainment new source review; (2) mandate less volatile gasoline
\2\; (3) provide additional or revise existing VOC or NOX
RACT Rules; (4) expand VOC or NOX control strategies to
other counties affecting the maintenance area; (5) expand control
strategies to new control technique guideline categories; (6) implement
mobile source transportation control measures; and/or (7) other
measures deemed appropriate by the FDEP at the time as a result of
efficient and cost-effective emissions reduction.
---------------------------------------------------------------------------

    \2\ States are generally preempted from prescribing low
volatility fuel requirements that are different from those
prescribed by EPA under CAA section 211(c)(4). Therefore, EPA notes
that consideration of the preemption provisions of 211(c)(4)(A) of
the CAA would be required and that this contingency could only be
implemented after such time that EPA grants a waiver to allow the
mandate of a low volatility fuel, under CAA section 211(c)(4)(C).
See ``Guidance on use of opt-in to RFG and low RVP requirements in
ozone SIPs'' at http://www.epa.gov/otaq/regs/fuels/rvpguide.pdf and
the ``Boutique fuels list under Section 1541(b) of the Energy Policy
Act'' at http://www.epa.gov/EPA-AIR/2006/December/Day-28/a22313.htm.
---------------------------------------------------------------------------

    These contingency measures and schedules for implementation satisfy
EPA's long-standing guidance on the requirements of section 110(a)(1)
of continued attainment. Continued attainment of the 1997 8-hour ozone
NAAQS in the Jacksonville, Tampa Bay and Southeast Florida Areas will
depend, in part, on the air quality measures discussed previously (see
section II). In addition, Florida along with the assistance of local
air pollution control agencies and local metropolitan planning
organizations commit to verify the 1997 8-hour ozone status in each
maintenance plan through periodic ozone precursor emission inventory
updates. Emission inventory updates will be completed by 18 months
following the end of the inventory year to verify continued attainment
of the 1997 8-hour ozone standards.

III. Final Action

    Pursuant to section 110 of the CAA, EPA is approving the
maintenance plans addressing the 1997 8-hour ozone standards in the
Jacksonville, Tampa Bay, and Southeast Florida Areas in Florida,
submitted by FDEP on July 2, 2009. These maintenance plans ensure
continued attainment of the 1997 8-hour ozone NAAQS through the
maintenance year 2014. Further, Florida has provided additional
information to indicate maintenance in these areas through 2018. EPA
has evaluated Florida's submittals and has determined that it meets the
applicable requirements of the CAA and EPA regulations, and is
consistent with EPA policy.
    EPA is publishing this rule without prior proposal because the
Agency views this as a non-controversial amendment and anticipates no
adverse comments. However, in the proposed rules section of this
Federal Register publication, EPA is publishing a separate document
that will serve as the proposal to approve the SIP revision should
adverse comment be filed. This rule will be effective on July 26, 2010
without further notice unless the Agency receives adverse comment by
June 28, 2010. If EPA receives such comments, then EPA will publish a
document withdrawing the final rule and informing the public that the
rule will not take effect. All public comments received will then be
addressed in a subsequent final rule based on the proposed rule. EPA
will not institute a second comment period on this action. Any parties
interested in commenting must do so at this time. If no such comments
are received, the public is advised this rule will be effective on July
26, 2010 and no further action will be taken on the proposed rule.

IV. Statutory and Executive Order Reviews

    Under the CAA, 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, 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 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 CAA; and

     Does 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 July 26, 2010. 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. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. 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, Intergovernmental
relations, Incorporation by reference, Ozone, Nitrogen dioxides,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: May 11, 2010.
Beverly H. Banister,
Acting Regional Administrator, Region 4.

0
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.

Subpart K--Florida

0
2. Section 52.520(e) is amended by adding new entries at the end of the
table for the ``110(a)(1) Maintenance Plan for the Southeast Florida
Area'', ``110(a)(1) Maintenance Plan for the Tampa Area'', and
``110(a)(1) Maintenance Plan for the Jacksonville, Florida Area'' to
read as follows:

Sec.  52.520  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Florida Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                    State effective                        Federal Register
            Provision                    date          EPA approval date        notice            Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
110(a)(1) Maintenance Plan for    July 2, 2009......  July 26, 2010.....  [Insert citation    110(a)(1)
 the Southeast Florida Area.                                               of publication].    maintenance plan
                                                                                for 1997 8-hour
                                                                                ozone NAAQS.
110(a)(1) Maintenance Plan for    July 2, 2009......  July 26, 2010,....  [Insert citation    110(a)(1)
 the Tampa, Florida Area.                                                  of publication].    maintenance plan
                                                                                for 1997 8-hour
                                                                                ozone NAAQS.
110(a)(1) Maintenance Plan for    July 2, 2009......  July 26, 2010.....  [Insert citation    110(a)(1)
 the Jacksonville, Florida Area.                                           of publication].    maintenance plan
                                                                                for 1997 8-hour
                                                                                ozone NAAQS.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-12660 Filed 5-26-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42755-42756]
[FR Doc No: 2018-18251]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Office of Commercial Space Transportation: Notice of Availability
of the Final Programmatic Environmental Assessment and Finding of No
Significant Impact/Record of Decision for Front Range Airport Launch
Site Operator License, Spaceport Colorado

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of availability.

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SUMMARY: In accordance with the National Environmental Policy Act of
1969, as amended (NEPA), Council on Environmental Quality NEPA
implementing regulations, and Federal Aviation Administration (FAA)
Order 1050.1F, Environmental Impacts: Policies and Procedures, the FAA
is announcing the availability of the Final Programmatic Environmental
Assessment and Finding of No Significant Impact/Record of Decision for
Front Range Airport Launch Site

Operator License, Spaceport Colorado (Final PEA and FONSI/ROD).

FOR FURTHER INFORMATION CONTACT: Stacey Zee, Environmental Protection
Specialist, Federal Aviation Administration, 800 Independence Avenue
SW, Suite 325, Washington, DC 20591; phone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION: The Board of County Commissioners (the BOCC)
of Adams County, Colorado proposes to operate a commercial space launch
site, called ``Spaceport Colorado,'' at the Front Range Airport (FTG),
in Watkins, Colorado. This would require the FAA to issue a launch site
operator license to the BOCC. FTG is a 3,200-acre general aviation
airport located in the northeast quadrant of the Denver metropolitan
area, approximately 5 miles southeast of the Denver International
Airport in Adams County, Colorado. Under the Proposed Action, the FAA
would issue a launch site operator license to the BOCC, which would
authorize the BOCC to offer Spaceport Colorado to commercial launch
providers to conduct launch operations of horizontal take-off and
horizontal landing reusable launch vehicles (RLVs). The FAA would also
conditionally approve FTG's modified Airport Layout Plan (ALP) showing
the launch site boundary. The Proposed Action does not include the
approval of any launches. Any future application for a launch license
would be subject to a separate environmental review, as explained in
the Final PEA.
    The Final PEA evaluated the potential environmental impacts of the
Proposed Action and the No Action Alternative. Under the No Action
Alternative, the FAA would not issue a launch site operator license to
the BOCC for the operation of Spaceport Colorado, FTG would not be
available to potential RLV launch operators, and there would be no need
for conditional approval of the FTG ALP.
    The FAA published a Draft PEA for public comment on April 18, 2018.
In response to preliminary comments received on the Draft PEA, the FAA
extended the comment period from May 25, 2018 to June 15, 2018. As a
result of the comments received, the FAA made minor revisions to the
PEA and developed three new appendices. Appendix I provides a summary
of the comments received and FAA's responses. Appendix J provides a
copy of correspondence with Congressional representatives and the FAA.
Appendix K includes copies of the comments received from the public.
The FAA has posted the Final PEA and FONSI/ROD on the FAA Office of
Commercial Space Transportation website: https://www.faa.gov/about/office_org/headquarters_offices/ast/environmental/nepa_docs/review/documents_progress/front_range/.

     Issued in Washington, DC on: August 16, 2018.
Daniel Murray,
Manager, Space Transportation Development Division.
[FR Doc. 2018-18251 Filed 8-22-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 1, 2010 (Volume 75, Number 39)]
[Notices]
[Page 9197-9198]
[DOCID:fr01mr10-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 1

February 18, 2010.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP10-383-000.
    Applicants: CenterPoint Energy Gas Transmission Co.
    Description: CenterPoint Energy Gas Transmission Co submits Ninth
Revised Sheet No. 1 et al. to FERC Gas Tariff, Sixth Revised Volume No.
1.
    Filed Date: 02/16/2010.
    Accession Number: 20100217-0223.
    Comment Date: 5 p.m. Eastern Time on Monday, March 1, 2010.

    Docket Numbers: RP10-384-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Columbia Gas Transmission, LLC submits petition for

a limited waiver of FSS Rate Schedule Section 4(d) of Columbia's FERC
Gas Tariff, Third Revised Volume 1.
    Filed Date: 02/17/2010.
    Accession Number: 20100217-0235.
    Comment Date: 5 p.m. Eastern Time on Tuesday, February 23, 2010.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-4151 Filed 2-26-10; 8:45 am]
BILLING CODE 6717-01-P


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 		     WASHINGTON, D.C. 20460

 ADVANCE \d61 			ICE OF PREVENTION,

OFFICE OF PESTICIDES AND TOXIC SUBSTANCES

MEMORANDUM

DATE:
        February 13, 2009

SUBJECT:	Summary of Ecotoxicity Data for Capsaicin Registration Review

				EPA Reg. #:

 				Reg. review Case #:  4018

				Chemical Class: Biochemical

PC Code : 070701

CAS Number:  404-86-4

FROM:		Miachel Rexrode, Ph.D, Senior Biologist        /S/

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

TO:			Chris Pfeifer, Regulatory Action Leader     /S/

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

ACTION REQUESTED

The following is a preliminary ecotoxicity assessment for capsaicin in
support of the Registration Review Work Plan.

RECOMMENDATIONS AND CONCLUSIONS

Executive Summary

Based on the available information for capsaicin, the Agency does not
foresee the need for additional ecotoxicity data for a new risk
assessment.  All Tier I ecotoxicity data requirements per 40 CFR
158.2060 have been waived. The non-toxic mode of action of this
compound, and biodegradability (low to no persistence) should minimize
the risks to all non-target organisms, including threatened and
endangered species. The Agency has reviewed available data (mammalian
toxicology) and found that capsaicin is practically nontoxic to
mammalian species as noted from acute inhalation, dermal, and dietary
routes of exposure. This data also suggests that capsaicin should be
practically nontoxic to all terrestrial wildlife. Since it is difficult
to assess risk of capsaicin exposure to aquatic organisms, the Agency is
requiring restrictive product label statements to minimize potential
exposure and reduce risk. However, capsaicin has a non toxic mode of
action, low use rate, and is not persistent in the aquatic environment.
This exposure scenario suggest low risk to aquatic organisms.

I. Background

Capsaicin (8-methyl-n-vanillyl-6-non) and related capsaicinoids are the
ingredients that produce the “hotness" in certain species of peppers
in the Genus Capsicum. The U.S. Department of Agriculture first
registered a product containing these actives in 1962, as a dog-attack
repellent (Reregistration Eligibility Document for Capsaicin, Case 4018,
U.S. Environmental Protection Agency, June 1992, Page 3). Currently, the
capsaicin registration has been extended as an animal repellent against
birds, voles, deer, rabbits, and tree squirrels, and for use as an
insect toxicant and repellent. Capsaicin products are also used indoors
in crack and crevice, on carpets and upholstered furniture, and outdoors
on fruit and vegetable crops, grains, ornamental plants and shrubs,
flowers, lawns, gardens and garbage bags. Because capsaicin is a
naturally-occurring substance which exhibits a non-toxic mode of action
in humans, in 1991, EPA reclassified this compound as a biochemical
pesticide.

Red peppers have long been used as a food without any known adverse
health effects to man. In the absence of known toxicological concerns
from the ingestion of capsaicin and related capsaicinoids, the Agency
does not believe a tolerance for capsaicin is needed to protect the
public health. Therefore, EPA has exempted capsaicin from the
requirement of a tolerance for residues in or on fruits, vegetables, and
grains (EPA, 1992).

II. Toxicity Profile

 NON-TARGET ORGANISMS

The basic data requirements for a biochemical pesticide consist of acute
ecological effects (Tier I) studies. Environmental fate and additional
ecological toxicity studies are required only if adverse effects are
observed in these acute studies. Regarding capsaicin, the EPA has waived
Tier I studies (Table 1.0) because of the following rationale that was
presented in the RED (EPA, 1992):

1) Capsaicin is a strong, fast-acting irritant when consumed or exposed
to the skin. Since, this compound is used to repel birds and mammals;
the Agency assumes that earlier studies are correct and that terrestrial
organisms avoid excessive and prolonged exposure to capsaicin, thus
minimizing risk to these organisms.

2) Since it is difficult to assess risk of capsaicin exposure to aquatic
organisms, the Agency is requiring restrictive product label statements
to minimize potential exposure and reduce risk to aquatic ecosystems.

Table 1.0 Waiver Request for Ecotoxicity  Studies on Capsaicin

Study Type/OPPTS Guideline

LD50/LC50/Results

Classification	MRID

Avian Acute Oral/OPPTS 850.2100	Waiver

Acceptable	47192005

Avian Dietary/OPPTS 850.2200

Waiver

Acceptable	47192005

Freshwater Fish LC50/OPPTS 850.1075

Waiver	Acceptable	47192005

Freshwater Invertebrate/OPPTS 850.1010

Waiver	Acceptable	47192005

Non-target Plants/OPPTS 850.4000 	Waiver 	Acceptable	47192005

Non-target Insects

Waiver	Acceptable	47192005

Mammalian Tier I Toxicity (MRIDs  47192002 thru 47192011)

The summary (Table 2.0) of the most sensitive toxicity values (acute)
for mammals shows that capsaicin is a Toxicity Category IV compound. The
acute oral and acute dermal toxicity suggest that this compound is
practically non-toxic to mammals with LD50 > 5000 mg/kg. The low
exposure expected from capsaicin should not result in acute inhalation
toxicity or primary eye irritation. The results of these studies suggest
that capsaicin should not cause any acute adverse effects to mammalian
or terrestrial wildlife.

Table 2.0.  Mammalian Toxicological Data for Capsaicin

Data Requirement	LD50	Toxicity Category	MRIDs

Acute Oral Toxicity

OPPTS 870.1100	>5000 mg/kg	IV	47192008

Acute Dermal Toxicity

OPPTS 870.1200	>5000 mg/kg	IV	47192003

Acute Inhalation Toxicity

OPPTS 870.1300	Low exposure based on anticipated low rate of product
release.	IV	47192004

Primary Eye Irritation

OPPTS 870.2400	No corneal opacity, iritis, or positive conjunctival
irritation; max average score 4.0 at 1 hour after instillation.	IV
47192009

Primary Dermal Irritation

OPPTS 870.2500	Primary irritation index was 0.2 – slightly irritating
IV	47192010

Dermal Sensitization

OPPTS 870.2600	Not a dermal sensitizer	-	47192004

Classification:  Acceptable; no additional data are required.

Endangered Species

The unique characteristics of capsaicin, its non-toxic mode of action,
low use volumes, and biodegradability (low to no persistence) should
minimize the risks to threatened and endangered species. The Agency has
calculated the potential risk to terrestrial species by relying on
Individual Effects Model Version 1.1 that predicts the chance of
individual effect at about 1 in 294,000. Based on the mammalian toxicity
data that has been submitted on the active ingredients, there should not
be toxic risk to endangered/ threatened species from exposure to the end
use product. Capsaicin should present a No Adverse Affects (NAA) to
terrestrial threatened or endangered species, if used in accordance with
approved labeling.

Table 3.0.  Individual Effects Chance Model Version 1.1 for Predicting
the Chance of Individual Effects of Capsaicin to Terrestrial Endangered
Species

IEC V1.1 - Individual Effect Chance Model Version 1.1

Predictor of chance of individual effect using probit dose-response
curve slope and median lethal estimate

Enter LC50 or LD50	5000

Enter desired threshold 	0.1

Enter slope of dose-response	4.5	Is this a default slope estimate? Yes
or No

z score result	-4.5	 z is the standard normal deviate

Probability associated with z	3.40E-06	Uses Excel NORMDIST function to
estimate P with lower reporting limit of 1.0 E-16

Chance of individual effect,                  ~1 in .  .  .	2.94E+05
Calculated as 1/P

Since it is difficult to assess risk of capsaicin exposure to aquatic
organisms, the Agency is requiring restrictive product label statements
to minimize potential exposure and reduce risk to aquatic ecosystems.
However, capsaicin’s non-toxic mode of action, low use volumes, and
biodegradability (low to no persistence) presents little exposure risk
to endangered aquatic species. Capsaicin should present a No Adverse
Affects (NAA) to aquatic threatened or endangered species, if used in
accordance with approved labeling.

Ecological Effects Summary

No risk assessment was performed for capsaicin. However, the Agency has
reviewed the available toxicity data and found that this compound is
practically nontoxic to terrestrial non-target species as noted from
acute inhalation, dermal, and dietary routes of exposure

should not cause adverse effects relative to potential exposure to
nontarget wildlife, aquatic species, or endangered/threatened species.

III. References

1. Registration Eligibility Decision (RED) Capsaicin, Case 4018;
U.S.Environmental Protection Agency, Office of Prevention, Pesticides,
and Toxic Substances, Office of Pesticide Programs, U.S. Government
Printing Office: Washington, D.C., 1992.


[Federal Register Volume 86, Number 156 (Tuesday, August 17, 2021)]
[Rules and Regulations]
[Pages 45888-45892]
[FR Doc No: 2021-17450]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0164; FRL-8678-01-OCSPP]

C10-C18-Alkyl Dimethyl Amine Oxides (ADAOs); Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of C10-C18-Alkyl dimethyl amine oxides
herein referred to as ADAOs when used as inert ingredients
(surfactants/foaming agents) in antimicrobial pesticide formulations
applied to food-contact surfaces in public eating places, dairy-
processing equipment, food-processing equipment and utensils, limited
to not more than 1,350 parts per million (ppm) at the end-use
concentration in pesticide formulations. Technology Sciences Group Inc.
on behalf of Mason Chemical Company submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
amendment to an existing requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of ADAOs when used in accordance with this exemption.

DATES: This regulation is effective August 17, 2021. Objections and
requests for hearings must be received on or before October 18, 2021,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0164, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0164 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
October 18, 2021. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0164, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of March 22, 2021 (86 FR 15162) (FRL-10021-
44), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11435) by
Technology Sciences Group Inc., 1150 18th Street NW, Suite 1000,
Washington, DC 20036, on behalf of Mason Chemical Company, 9075 Centre
Point Dr., Suite 400, West Chester, OH 45069. The petition requested
that 40 CFR 180.940(a) be amended by establishing an exemption from the
requirement of a tolerance for residues of ADAOs when used as inert
ingredients used as surfactants and foaming agents in antimicrobial
pesticide formulations applied to food-contact surfaces in public
eating places, dairy-processing equipment, food-processing equipment
and utensils. That document referenced a summary of the petition
prepared by Technology Sciences Group Inc. on behalf of the Mason
Chemical Company, the petitioner, which is available in the docket at
http://www.regulations.gov.

There were no comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
limited the maximum concentration of ADAOs to not more than 1,350 ppm
at the end-use concentration in pesticide formulations. This limitation
is based on the Agency's risk assessment, which can be found at http://www.regulations.gov in document ``C10-C18-Alkyldimethylamine oxides;
Human Health Risk Assessment and Ecological Effects Assessment to
Support Proposed Exemption from the Requirement of a Tolerance When
Used as Inert Ingredients in Pesticide Formulations'' in docket ID
number EPA-HQ-OPP-2021-0164.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue.''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a tolerance is not necessary to ensure that there is a
reasonable certainty that no harm will result from aggregate exposure
to the inert ingredient, an exemption from the requirement of a
tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for ADAOs, including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with ADAOs follows.
    On October 7, 2009, EPA published in the Federal Register a final
rule establishing an exemption from the requirement of a tolerance for
residues of ADAOs when used as an inert ingredient in pesticide
formulations applied to raw agricultural commodities pre- and post-
harvest. See 74 FR 51474 (FRL-8437-3). That document contains a summary
of the toxicological profile, toxicological points of departure/levels
of concern, certain assumptions for exposure assessment, and the
Agency's determination regarding the children's safety factor, which
have not changed except as described below.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by ADAOs as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in Unit IV.A of
the final rule published in the Federal Register of October 7, 2009 (74
FR 51474) (FRL-8437-3).

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to ADAOs, EPA considered exposure under the proposed exemption
from the requirement of a tolerance. To assess dietary exposures from
ADAOs in food, the Agency calculated the Daily Dietary Dose (DDD) and
the Estimated Daily Intake (EDI) using U.S. Food and Drug
Administration (FDA) Food Contact Surface Sanitizing Solution Dietary
Exposure Assessment Model. EPA's assessment used FDA's default
assumptions for the amount of residual solution or quantity of solution
remaining on the treated surface without rinsing with potable water (1
mg/cm\2\); surface area of the treated surface which comes into contact
with food (4,000 cm\2\); and the pesticide

migration fraction (100%). EPA used an application rate of ADAOs of
1,350 ppm, which was provided by the petitioner. EPA also derived
exposure amounts for population subgroups by accounting for body
weights and adjusting for relative food consumption using data from the
National Health and Nutrition Examination Survey (NHANES) (specifically
the 2003-2008 survey data).
    ADAOs are currently exempt from the requirements of a tolerance
under 40 CFR 180.910 for use as inert ingredients in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest limited to 15% by weight in pesticide
formulations and use as a surfactant. One of the ADAO chemicals in the
group, alkyl (C10-16) dimethyl amine oxide, is also approved as an
antibacterial agent in dishwashing detergent for residential use.
Potential dietary exposures from these uses were included in the
overall dietary exposure.
    2. Dietary exposure from drinking water. The proposed use of ADAOs
will not result in measurable levels in surface water or ground water
and therefore will not contribute to dietary exposure.
    As stated above, ADAOs are approved for pre- and post-harvest uses
and for use in dishwashing detergent. Dietary exposures from drinking
water due to these uses are included in the overall dietary exposure.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    Indoor residential exposure may occur from use of ADAOs as inert
ingredients in antimicrobial pesticide products applied to food contact
surfaces. Indoor and outdoor residential exposure may also occur as a
result of current approved uses of ADAOs in pesticide formulations for
pre- and post-harvest application and in dishwashing detergent. ADAOs
are also used in soap and hair products. The Agency's assessment of
residential exposure combines exposure from all of the aforementioned
uses. A summary of certain other assumptions for exposure assessment of
ADAOs is discussed in Unit IV.C. of the final rule published in the
Federal Register of October 7, 2009 (74 FR 51474) (FRL-8437-3).
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) and (c)(2)(B) of FFDCA requires that,
when considering whether to establish, modify, or revoke a tolerance or
exemption, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.''
    EPA has not found ADAOs to share a common mechanism of toxicity
with any other substances, and ADAOs do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
action, therefore, EPA has assumed that ADAOs do not have a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) and (c)(2)(B) of FFDCA provides that EPA shall
apply an additional tenfold (10X) margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA Safety Factor
(SF). In applying this provision, EPA either retains the default value
of 10X, or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor. EPA has
determined that reliable data show the safety of infants and children
would be adequately protected if the FQPA SF were reduced to 1X. The
rationale for the Agency's determination regarding the children's
safety factor is discussed in unit IV.D of the final rule published in
the Federal Register of October 7, 2009 (74 FR 51474) (FRL-8437-3).

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
ADAOs are not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described for
chronic exposure, EPA has concluded that chronic exposure to ADAOs from
food and water will utilize 91% of the cPAD for children 1 to 2 years
old, the population group receiving the greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    ADAOs are currently used as an inert ingredient in pesticide
products that are registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to ADAOs.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 171 and 101 for
the U.S. population and children 1 to 2 years old, respectively.
Because EPA's level of concern for ADAOs is MOEs of 100 or below, these
MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    ADAOs are currently used as inert ingredients in pesticide products
that are registered for uses that could result in intermediate-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
intermediate-term residential exposures to ADAOs.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 322 and 104 for the U.S. population and children 1 to
2 years old, respectively. Because EPA's level of concern for ADAOs are
MOEs

of 100 or below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to ADAOs.
    6. Determination of safety. Taking into consideration all available
information on ADAOs, EPA has determined that there is a reasonable
certainty that no harm to the general population or any population
subgroup, including infants and children, will result from aggregate
exposure to residues of ADAOs. Therefore, the establishment of an
exemption from the requirement of a tolerance under 40 CFR 180.940(a)
for residues of ADAOs when used as inert ingredients in antimicrobial
pesticide formulations applied to food-contact surfaces in public
eating places, dairy-processing equipment, food-processing equipment,
and utensils limited to not more than 1,350 ppm at the end-use
concentration in pesticide formulations, is safe under FFDCA section
408.

V. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
ADAOs in or on any food commodities. EPA is establishing limitations on
the amount of ADAOs that may be used in pesticide formulations applied
to food-contact surfaces in public eating places, dairy-processing
equipment, food-processing equipment, and utensils. These limitations
will be enforced through the pesticide registration process under the
Federal Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7
U.S.C. 136 et seq. EPA will not register any pesticide formulation for
food use that exceeds 1350 ppm of ADAOs in the end-use concentration in
pesticide formulations.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for C10-C18-Alkyl dimethyl amine
oxides (CAS Reg. Nos. 1643-20-5, 2571-88-2, 2605-79-0, 3332-27-2,
61788-90-7, 68955-55-5, 70592-80-2, 7128-91-8, 85408-48-6, and 85408-
49-7) when used as inert ingredients (surfactants/foaming agents) in
antimicrobial pesticide formulations applied to food-contact surfaces
in public eating places, dairy-processing equipment, food-processing
equipment and utensils limited to not more than 1,350 ppm at the end-
use concentration in pesticide formulations.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule 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. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 10, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.940, in paragraph (a), amend table 180.940(a) by adding
in alphabetical order an entry for the inert ingredient ``C10-C18-Alkyl
dimethyl amine oxides'' to read as follows:

Sec.  180.940   Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).

* * * * *
    (a) * * *

                            Table 180.940(a)
------------------------------------------------------------------------
       Inert ingredients             CAS reg. No.            Limits
------------------------------------------------------------------------

                              * * * * * * *
C10-C18-Alkyl dimethyl amine    1643-20-5, 2571-88-2,   When ready for
 oxides.                         2605-79-0, 3332-27-2,   use, the end-
                                 61788-90-7, 68955-55-   use
                                 5, 70592-80-2, 7128-    concentration
                                 91-8, 85408-48-6, and   is not to
                                 85408-49-7.             exceed 1,350
                                                         ppm.

                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-17450 Filed 8-16-21; 8:45 am]
BILLING CODE 6560-50-P