[Federal Register: August 14, 2008 (Volume 73, Number 158)]
[Rules and Regulations]
[Page 47546-47550]
[DOCID:fr14au08-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-R09-OAR-2008-0555; FRL-8701-7]

Delegation of National Emission Standards for Hazardous Air
Pollutants for Source Categories; State of Arizona, Arizona Department
of Environmental Quality, Pima County Department of Environmental
Quality

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is amending certain regulations to reflect the current
delegation status of national emission standards for hazardous air
pollutants (NESHAP) in Arizona. Several NESHAP were delegated to the
Arizona Department of Environmental Quality on June 4, 2008, and to the
Pima County Department of Environmental Quality on June 16, 2008. The
purpose of this action is to update the listing in the Code of Federal
Regulations.

DATES: This rule is effective on October 14, 2008, without further
notice, unless EPA receives adverse comments by September 15, 2008. If
we receive such comments, we will publish a timely withdrawal in the
Federal Register to notify the public that this direct final rule will
not take effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2008-0555, by one of the following methods:

    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or delivery: Andrew Steckel (AIR-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or e-mail.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send e-mail directly to EPA, your e-mail
address will be automatically captured and included as part of the
public comment. 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.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region
IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Mae Wang, EPA Region IX, (415) 947-
4124<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Background
    A. Delegation of NESHAP
    B. ADEQ Delegations
    C. PDEQ Delegations
II. EPA Action
III. Statutory and Executive Order Reviews

I. Background

A. Delegation of NESHAP

    Section 112(l) of the Clean Air Act, as amended in 1990 (CAA),
authorizes EPA to delegate to state or local air pollution control
agencies the authority to implement and enforce the standards set out
in the Code of Federal Regulations, Title 40 (40 CFR), part 63,
National Emission Standards for Hazardous Air Pollutants for Source
Categories. On November 26, 1993, EPA promulgated regulations, codified
at 40 CFR part 63, Subpart E (hereinafter referred to as ``Subpart
E''), establishing procedures for EPA's approval of state rules or
programs under section 112(l) (see 58 FR 62262). Subpart E was later
amended on September 14, 2000 (see 65 FR 55810).
    Any request for approval under CAA section 112(l) must meet the
approval criteria in 112(l)(5) and Subpart E. To streamline the
approval process for future applications, a state or local agency may
submit a one-time demonstration that it has adequate authorities and
resources to implement and enforce any CAA section 112 standards. If
such demonstration is approved, then the state or local agency would no
longer need to resubmit a demonstration of these same authorities and
resources for every subsequent request for delegation of CAA section
112 standards. However, EPA maintains the authority to withdraw its
approval if the State does not adequately implement or enforce an
approved rule or program.

B. ADEQ Delegations

    On July 17, 1998, EPA published a direct final action delegating to
the Arizona Department of Environmental Quality (ADEQ) several NESHAP
and approving ADEQ's delegation mechanism for future standards (see 63
FR 38478). That action explained the procedure for EPA to grant
delegations to ADEQ by letter, with periodic Federal Register listings
of standards that have been delegated. On April 17, 2008, ADEQ
requested delegation of the following NESHAP contained in 40 CFR part
63:
     Subpart DDDD--NESHAP: Plywood and Composite Wood Products
     Subpart DDDDD--NESHAP for Industrial, Commercial, and
Institutional Boilers and Process Heaters
    On June 4, 2008, EPA granted delegation to ADEQ for these NESHAP,
along with any amendments to previously-delegated NESHAP, as of July 1,
2006. Today's action is serving to notify the public of the June 4,
2008, delegations and to codify these delegations into the Code of
Federal Regulations.

C. PDEQ Delegations

    On June 28, 1999, EPA published a direct final action delegating to
the Pima County Department of Environmental Quality (PDEQ) several
NESHAP and approving PDEQ's delegation mechanism for future standards
(see 64 FR 34560). That action explained the procedure for EPA to grant
delegations to PDEQ by letter, with periodic Federal Register listings
of standards that have been delegated. On May 23, 2008, PDEQ requested
delegation of the following NESHAP contained in 40 CFR part 63:
     Subpart J--NESHAP for Polyvinyl Chloride and Copolymers
Production
     Subpart MM--NESHAP for Chemical Recovery Combustion
Sources at Kraft, Soda, Sulfite, and Stand-Alone Semichemical Pulp
Mills
     Subpart XX--National Emission Standards for Ethylene
Manufacturing Process Units: Heat Exchange Systems and Waste Operations
     Subpart DDDD--NESHAP: Plywood and Composite Wood Products
     Subpart WWWWW--National Emission Standards for Hospital
Ethylene Oxide Sterilizers
     Subpart YYYYY--NESHAP for Area Sources: Electric Arc
Furnace Steelmaking Facilities
     Subpart ZZZZZ--NESHAP for Iron and Steel Foundries Area
Sources
     Subpart BBBBBB--NESHAP for Source Category: Gasoline
Distribution Bulk Terminals, Bulk Plants, and Pipeline Facilities
     Subpart CCCCCC--NESHAP for Source Category: Gasoline
Dispensing Facilities
     Subpart DDDDDD--NESHAP for Polyvinyl Chloride and
Copolymers Production Area Sources
     Subpart EEEEEE--NESHAP for Primary Copper Smelting Area
Sources
     Subpart FFFFFF--NESHAP for Secondary Copper Smelting Area
Sources
     Subpart GGGGGG--NESHAP for Primary Nonferrous Metals Area
Sources--Zinc, Cadmium, and Beryllium
     Subpart HHHHHH--NESHAP: Paint Stripping and Miscellaneous
Surface Coating Operations at Area Sources
     Subpart LLLLLL--NESHAP for Acrylic and Modacrylic Fibers
Production Area Sources
     Subpart MMMMMM--NESHAP for Carbon Black Production Area
Sources
     Subpart NNNNNN--NESHAP for Chemical Manufacturing Area
Sources: Chromium Compounds
     Subpart OOOOOO--NESHAP for Flexible Polyurethane Foam
Production and Fabrication Area Sources
     Subpart PPPPPP--NESHAP for Lead Acid Battery Manufacturing
Area Sources
     Subpart QQQQQQ--NESHAP for Wood Preserving Area Sources

     Subpart RRRRRR--NESHAP for Clay Ceramics Manufacturing
Area Sources
     Subpart SSSSSS--NESHAP for Glass Manufacturing Area
Sources
     Subpart TTTTTT--NESHAP for Secondary Nonferrous Metals
Processing Area Sources
    On June 16, 2008, EPA granted delegation to PDEQ for these NESHAP,
along with any amendments to previously-delegated NESHAP, as of
February 1, 2008. Today's action is serving to notify the public of the
June 16, 2008, delegations and to codify these delegations into the
Code of Federal Regulations.

II. EPA Action

    Today's document serves to notify the public of the delegation of
NESHAP to ADEQ on June 4, 2008, and to PDEQ on June 16, 2008. Today's
action will codify these delegations into the Code of Federal
Regulations.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
delegation request that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7412(l); 40 CFR 63.91(b).
Thus, in reviewing state delegation submissions, our role is to approve
state choices, provided that they meet the criteria of the CAA.
Accordingly, this action merely updates the list of approved
delegations in the Code of Federal Regulations 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 Clean Air Act; 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 delegation submission 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 Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by October 14, 2008. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Authority: This action is issued under the authority of Section
112 of the Clean Air Act, as amended, 42 U.S.C. 7412.

    Dated: July 25, 2008.
Amy Zimpfer,
Acting Director, Air Division, Region IX.

0
Title 40, chapter I, part 63 of the Code of Federal Regulations is
amended as follows:

PART 63--[AMENDED]

0
1. The authority citation for part 63 continues to read as follows:

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

Subpart E--Approval of State Programs and Delegation of Federal
Authorities

0
2. Section 63.99 is amended by revising paragraph (a)(3) to read as
follows:

Sec.  63.99  Delegated Federal authorities.

    (a) * * *
    (3) The following table lists the specific part 63 standards that
have been delegated unchanged to the air pollution control agencies in
the State of Arizona. The (X) symbol is used to indicate each category
that has been delegated.

                                Delegation Status for Part 63 Standards--Arizona
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           Subpart                        Description              ADEQ \1\    MCAQD \2\   PDEQ \3\   PCAQCD \4\
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A............................  General Provisions...............          X           X           X           X
F............................  Synthetic Organic Chemical                 X           X           X           X
                                Manufacturing Industry.
G............................  Synthetic Organic Chemical                 X           X           X           X
                                Manufacturing Industry: Process
                                Vents, Storage Vessels, Transfer
                                Operations, and Wastewater.
H............................  Organic Hazardous Air Pollutants:          X           X           X           X
                                Equipment Leaks.

I............................  Organic Hazardous Air Pollutants:          X           X           X           X
                                Certain Processes Subject to the
                                Negotiated Regulation for
                                Equipment Leaks.
J............................  Polyvinyl Chloride and Copolymers          X           X           X   ..........
                                Production.
L............................  Coke Oven Batteries..............          X           X           X           X
M............................  Perchloroethylene Dry Cleaning...          X           X           X           X
N............................  Hard and Decorative Chromium               X           X           X           X
                                Electroplating and Chromium
                                Anodizing Tanks.
O............................  Ethylene Oxide Sterilization               X           X           X           X
                                Facilities.
Q............................  Industrial Process Cooling Towers          X           X           X           X
R............................  Gasoline Distribution Facilities.          X           X           X           X
S............................  Pulp and Paper...................          X           X           X   ..........
T............................  Halogenated Solvent Cleaning.....          X           X           X           X
U............................  Group I Polymers and Resins......          X           X           X           X
W............................  Epoxy Resins Production and Non-           X           X           X           X
                                Nylon Polyamides Production.
X............................  Secondary Lead Smelting..........          X           X           X           X
AA...........................  Phosphoric Acid Manufacturing              X           X           X   ..........
                                Plants.
BB...........................  Phosphate Fertilizers Production           X           X           X   ..........
                                Plants.
CC...........................  Petroleum Refineries.............          X           X           X           X
DD...........................  Off-Site Waste and Recovery                X           X           X           X
                                Operations.
EE...........................  Magnetic Tape Manufacturing                X           X           X           X
                                Operations.
GG...........................  Aerospace Manufacturing and                X           X           X           X
                                Rework Facilities.
HH...........................  Oil and Natural Gas Production             X           X           X   ..........
                                Facilities.
JJ...........................  Wood Furniture Manufacturing               X           X           X           X
                                Operations.
KK...........................  Printing and Publishing Industry.          X           X           X           X
LL...........................  Primary Aluminum Reduction Plants          X   ..........          X   ..........
MM...........................  Chemical Recovery Combustion               X           X           X   ..........
                                Sources at Kraft, Soda, Sulfite,
                                and Stand-Alone Semichemical
                                Pulp Mills.
OO...........................  Tanks--Level 1...................          X           X           X           X
PP...........................  Containers.......................          X           X           X           X
QQ...........................  Surface Impoundments.............          X           X           X           X
RR...........................  Individual Drain Systems.........          X           X           X           X
SS...........................  Closed Vent Systems, Control               X           X           X   ..........
                                Devices, Recovery Devices and
                                Routing to a Fuel Gas System or
                                a Process.
TT...........................  Equipment Leaks--Control Level 1.          X           X           X   ..........
UU...........................  Equipment Leaks--Control Level 2.          X           X           X   ..........
VV...........................  Oil-Water Separators and Organic-          X           X           X           X
                                Water Separators.
WW...........................  Storage Vessels (Tanks)--Control           X           X           X   ..........
                                Level 2.
XX...........................  Ethylene Manufacturing Process             X           X           X   ..........
                                Units: Heat Exchange Systems and
                                Waste Operations.
YY...........................  Generic MACT Standards...........          X           X           X   ..........
CCC..........................  Steel Pickling...................          X           X           X   ..........
DDD..........................  Mineral Wool Production..........          X           X           X   ..........
EEE..........................  Hazardous Waste Combustors.......          X           X           X   ..........
GGG..........................  Pharmaceuticals Production.......          X           X           X   ..........
HHH..........................  Natural Gas Transmission and               X           X           X   ..........
                                Storage Facilities.
III..........................  Flexible Polyurethane Foam                 X           X           X   ..........
                                Production.
JJJ..........................  Group IV Polymers and Resins.....          X           X           X           X
LLL..........................  Portland Cement Manufacturing              X           X           X   ..........
                                Industry.
MMM..........................  Pesticide Active Ingredient                X           X           X   ..........
                                Production.
NNN..........................  Wool Fiberglass Manufacturing....          X           X           X   ..........
OOO..........................  Manufacture of Amino/Phenolic              X           X           X   ..........
                                Resins.
PPP..........................  Polyether Polyols Production.....          X           X           X   ..........
QQQ..........................  Primary Copper Smelting..........          X           X           X   ..........
RRR..........................  Secondary Aluminum Production....          X           X           X   ..........
TTT..........................  Primary Lead Smelting............          X           X           X   ..........
UUU..........................  Petroleum Refineries: Catalytic            X           X           X   ..........
                                Cracking, Catalytic Reforming,
                                and Sulfur Recovery Units.
VVV..........................  Publicly Owned Treatment Works...          X           X           X   ..........
XXX..........................  Ferroalloys Production...........          X           X           X   ..........
AAAA.........................  Municipal Solid Waste Landfills..          X           X           X   ..........
CCCC.........................  Manufacturing of Nutritional               X           X           X   ..........
                                Yeast.
DDDD.........................  Plywood and Composite Wood                 X   ..........          X   ..........
                                Products.
EEEE.........................  Organic Liquids Distribution (non-         X           X           X   ..........
                                gasoline).
FFFF.........................  Miscellaneous Organic Chemical             X           X           X   ..........
                                Manufacturing.
GGGG.........................  Solvent Extraction for Vegetable           X           X           X   ..........
                                Oil Production.
HHHH.........................  Wet-Formed Fiberglass Mat                  X           X           X   ..........
                                Production.
IIII.........................  Surface Coating of Automobiles             X           X   ..........  ..........
                                and Light-Duty Trucks.
JJJJ.........................  Paper and Other Web Coating......          X           X           X   ..........
KKKK.........................  Surface Coating of Metal Cans....          X           X           X   ..........
MMMM.........................  Miscellaneous Metal Parts and              X           X           X   ..........
                                Products.
NNNN.........................  Large Appliances.................          X           X           X   ..........
OOOO.........................  Printing, Coating, and Dyeing of           X           X           X   ..........
                                Fabrics and Other Textiles.

PPPP.........................  Surface Coating of Plastic Parts           X           X   ..........  ..........
                                and Products.
QQQQ.........................  Wood Building Products...........          X           X           X   ..........
RRRR.........................  Surface Coating of Metal                   X           X           X   ..........
                                Furniture.
SSSS.........................  Surface Coating of Metal Coil....          X           X           X   ..........
TTTT.........................  Leather Finishing Operations.....          X           X           X   ..........
UUUU.........................  Cellulose Products Manufacturing.          X           X           X   ..........
VVVV.........................  Boat Manufacturing...............          X           X           X   ..........
WWWW.........................  Reinforced Plastics Composites             X           X           X   ..........
                                Production.
XXXX.........................  Tire Manufacturing...............          X           X           X   ..........
YYYY.........................  Stationary Combustion Turbines...          X           X           X   ..........
ZZZZ.........................  Stationary Reciprocating Internal          X           X   ..........  ..........
                                Combustion Engines.
AAAAA........................  Lime Manufacturing Plants........          X           X           X   ..........
BBBBB........................  Semiconductor Manufacturing......          X           X           X   ..........
CCCCC........................  Coke Oven: Pushing, Quenching and          X           X           X   ..........
                                Battery Stacks.
DDDDD........................  Industrial, Commercial, and                X   ..........  ..........  ..........
                                Institutional Boiler and Process
                                Heaters.
EEEEE........................  Iron and Steel Foundries.........          X           X           X   ..........
FFFFF........................  Integrated Iron and Steel........          X           X           X   ..........
GGGGG........................  Site Remediation.................          X           X           X   ..........
HHHHH........................  Miscellaneous Coating                      X           X           X   ..........
                                Manufacturing.
IIIII........................  Mercury Emissions from Mercury             X           X           X   ..........
                                Cell Chlor-Alkali Plants.
JJJJJ........................  Brick and Structural Clay                  X           X           X   ..........
                                Products Manufacturing.
KKKKK........................  Clay Ceramics Manufacturing......          X           X           X   ..........
LLLLL........................  Asphalt Roofing and Processing...          X           X           X   ..........
MMMMM........................  Flexible Polyurethane Foam                 X           X           X   ..........
                                Fabrication Operation.
NNNNN........................  Hydrochloric Acid Production.....          X           X           X   ..........
PPPPP........................  Engine Test Cells/Stands.........          X           X           X   ..........
QQQQQ........................  Friction Products Manufacturing..          X           X           X   ..........
RRRRR........................  Taconite Iron Ore Processing.....          X           X           X   ..........
SSSSS........................  Refractory Products Manufacturing          X           X           X   ..........
TTTTT........................  Primary Magnesium Refining.......          X           X           X   ..........
WWWWW........................  Hospital Ethylene Oxide            ..........  ..........          X   ..........
                                Sterilizers.
YYYYY........................  Area Sources: Electric Arc         ..........  ..........          X   ..........
                                Furnace Steelmaking Facilities.
ZZZZZ........................  Iron and Steel Foundries Area      ..........  ..........          X   ..........
                                Sources.
BBBBBB.......................  Gasoline Distribution Bulk         ..........  ..........          X   ..........
                                Terminals, Bulk Plants, and
                                Pipeline Facilities.
CCCCCC.......................  Gasoline Dispensing Facilities...  ..........  ..........          X   ..........
DDDDDD.......................  Polyvinyl Chloride and Copolymers  ..........  ..........          X   ..........
                                Production Area Sources.
EEEEEE.......................  Primary Copper Smelting Area       ..........  ..........          X   ..........
                                Sources.
FFFFFF.......................  Secondary Copper Smelting Area     ..........  ..........          X   ..........
                                Sources.
GGGGGG.......................  Primary Nonferrous Metals Area     ..........  ..........          X   ..........
                                Sources--Zinc, Cadmium, and
                                Beryllium.
HHHHHH.......................  Paint Stripping and Miscellaneous  ..........  ..........          X   ..........
                                Surface Coating Operations at
                                Area Sources.
LLLLLL.......................  Acrylic and Modacrylic Fibers      ..........  ..........          X   ..........
                                Production Area Sources.
MMMMMM.......................  Carbon Black Production Area       ..........  ..........          X   ..........
                                Sources.
NNNNNN.......................  Chemical Manufacturing Area        ..........  ..........          X   ..........
                                Sources: Chromium Compounds.
OOOOOO.......................  Flexible Polyurethane Foam         ..........  ..........          X   ..........
                                Production and Fabrication Area
                                Sources.
PPPPPP.......................  Lead Acid Battery Manufacturing    ..........  ..........          X   ..........
                                Area Sources.
QQQQQQ.......................  Wood Preserving Area Sources.....  ..........  ..........          X   ..........
RRRRRR.......................  Clay Ceramics Manufacturing Area   ..........  ..........          X   ..........
                                Sources.
SSSSSS.......................  Glass Manufacturing Area Sources.  ..........  ..........          X   ..........
TTTTTT.......................  Secondary Nonferrous Metals        ..........  ..........          X   ..........
                                Processing Area Sources.
----------------------------------------------------------------------------------------------------------------
\1\ Arizona Department of Environmental Quality.
\2\ Maricopa County Air Quality Department.
\3\ Pima County Department of Environmental Quality.
\4\ Pinal County Air Quality Control District.

* * * * *
[FR Doc. E8-18748 Filed 8-13-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70187-70190]
[FR Doc No: 2011-29110]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65689; File No. SR-Phlx-2011-142]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Modify
its Co-Location Fee Schedule Regarding Low Latency Network Connections

November 4, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 31, 2011, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify the Exchange Fee Schedule, Section
X(b) entitled ``Co-Location Services'' to establish a program for
offering low latency network connections and to establish the initial
fees for such connections. The Exchange also proposes administrative
modifications to the Exchange Fee Schedule, Section X(b).
    The text of the proposed rule change is available at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings, at the Exchange's
principal office, on the Commission's Web site at http://www.sec.gov,
and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements

concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
Low Latency Network Connection Option
    The purpose of the proposed rule change is to modify the Exchange
Fee Schedule, Section X(b) entitled ``Co-Location Services'' to offer
new options for low latency network telecommunication connections and
to establish the initial fees for such connections. As its initial
offering, the Exchange proposes to offer point-to-point
telecommunication connectivity from the co-location facility to select
major financial trading and co-location venues in the New York and New
Jersey metropolitan areas, Toronto, and Chicago.
Background
    Currently the Exchange provides a cross connect from a client's
cabinet to its requested telecommunication carrier's cabinet (known as
a ``telco cross connect''). Through the enhanced point-to-point
connectivity service, clients will now have the option to receive low
latency network connectivity from the Exchange's data center to the
client's chosen venue(s), in addition to the telco cross connect. These
connections can be utilized to send market data to and receive orders
from the chosen venues.
    The enhanced point-to-point connectivity provides the Exchange's
co-location customers the opportunity to obtain low latency network
connectivity with greater ease than is currently the case, and at a
competitive price. Currently, co-location customers obtain similar
services by negotiating fees, obtaining service level agreements, and
executing service agreements directly with approved telecommunication
carriers. A co-located customer is currently charged a monthly
negotiated fee by the telecommunications carrier in addition to a cross
connection fee by the Exchange. There are currently 16 approved
telecommunication carriers with equipment in the Exchange's data
center, with additional carriers added at the request of a client. In
order to provide the new connectivity option described in this proposed
rule change, the Exchange established a low-latency minimum
standard,\3\ approached those telecommunications carriers with low
latency connections to select major financial trading and co-location
venues in the New York and New Jersey metropolitan areas, Toronto, and
Chicago that met the low-latency minimum standard,\4\ and invited them
to agree to discounted rates. In effect, the Exchange is obtaining
wholesale rates from the carriers and then charging a markup to
compensate it for its efforts to negotiate and establish the
arrangement and integrate the connectivity into the Exchange co-
location connectivity offering, as well as administrative costs
associated with establishing and maintaining each new connection. Of
the 16 approved telecommunication carriers with equipment in the
Exchange's data center, one carrier has, to date, agreed to offer
connections under the program and others are in negotiations with the
Exchange; additional carriers are eligible to join the program upon
meeting the same terms and conditions.
---------------------------------------------------------------------------

    \3\ The low-latency minimum standard is less than or equal to
0.41 milliseconds for New York/New Jersey routes, less than or equal
to 10.1 milliseconds for Toronto routes, and less than or equal to
17 milliseconds for Chicago routes. This standard will change as the
technology improves and the latency is further reduced.
    \4\ The Exchange selected these locations because of the high
numbers of member firms and/or liquidity venues located there.
---------------------------------------------------------------------------

    Under the program, co-located customers will have the opportunity
to request these new low latency network telecommunication connections
through the same process used to request a new co-located cabinet and
other co-location services, with no need for direct fee negotiations or
new service agreements with telecommunication carriers. The co-located
customer will choose the connection destination,\5\ but the elimination
of direct negotiations and separate service agreements with the
telecommunications provider for these services will allow them to
obtain a similar service at a competitive price and with greater ease
of implementation. In addition, the proposed low latency network
connectivity fees include cross connections and eliminate a separate
fee for that service.
---------------------------------------------------------------------------

    \5\ As additional providers join the program, customers will
also have the opportunity to choose from among these providers.
---------------------------------------------------------------------------

    The Exchange is making the low latency network telecommunication
connections available as a convenience to customers and notes that
receipt of these connections is completely voluntary. Customers retain
the option of contracting directly with telecommunication providers,
including either the provider(s) that participate in the program, the
current providers in the data center who have not yet agreed to
participate, or any new carrier that is approved to install equipment
in the Exchange's data center.
Low Latency Pricing Structure
    The Exchange proposes: (1) A one-time fee of $1,165 for the
installation of 100 MB of telecommunication connectivity to select New
York and New Jersey metropolitan area financial trading and co-location
venues, which includes fiber telecommunication cross connects within
the NASDAQ OMX data center, along with a per-month connectivity fee of
$1,650; (2) a one-time fee of $2,150 for the installation of 1G of
telecommunication connectivity to select New York and New Jersey
metropolitan area financial trading and co-location venues, which
includes fiber telecommunication cross connects within the NASDAQ OMX
data center, along with a per-month connectivity fee of $2,150; (3) a
one-time fee of $5,000 for the installation of 10G of telecommunication
connectivity to select New York and New Jersey metropolitan area
financial trading and co-location venues, which includes fiber
telecommunication cross connects within the NASDAQ OMX data center,
along with a per-month connectivity fee of $5,000; (4) a one-time fee
of $5,150 for the installation of 100 MB of telecommunication
connectivity to select Toronto area financial trading and co-location
venues, which includes fiber telecommunication cross connects within
the NASDAQ OMX data center, along with a per-month connectivity fee of
$4,350; (5) a one-time fee of $8,200 for the installation of 1G of
telecommunication connectivity to select Toronto area financial trading
and co-location venues, which includes fiber telecommunication cross
connects within the NASDAQ OMX data center, along with a per-month
connectivity fee of $10,450; (6) a one-time fee of $15,150 for the
installation of 10G of telecommunication connectivity to select Toronto
area financial trading and co-location venues, which includes fiber
telecommunication cross connects within the NASDAQ OMX data center,
along with a per-month connectivity fee of $32,400; (7) a one-time fee
of $4,850 for the installation of 100 MB of telecommunication
connectivity to select Chicago area financial trading and co-location
venues, which includes fiber

telecommunication cross connects within the NASDAQ OMX data center,
along with a per-month connectivity fee of $8,350; (8) a one-time fee
of $5,900 for the installation of 1G of telecommunication connectivity
to select Chicago area financial trading and co-location venues, which
includes fiber telecommunication cross connects within the NASDAQ OMX
data center, along with a per-month connectivity fee of $16,400; and
(9) a one-time fee of $12,050 for the installation of 10G of
telecommunication connectivity to select Chicago area financial trading
and co-location venues, which includes fiber telecommunication cross
connects within the NASDAQ OMX data center, along with a per-month
connectivity fee of $39,750.
    The fees are based on anticipated bandwidth necessary for the
connections and distances to these select venues. Furthermore, the
Exchange believes the fees are reasonable as they are similar and
competitive with fees charged for similar services by other
entities.\6\
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    \6\ See http://www.cmegroup.com/globex/files/CMEGlobexConnectionAgrmt.pdf; http://nysetechnologies.nyx.com/global-connectivity/sfti-americas/sfti-ip-americas; http://nysetechnologies.nyx.com/sites/technologies.nyx.com/files/SFTI_Americas_Market_Connectivity.pdf; http://nysetechnologies.nyx.com/global-connectivity/sfti-americas.
---------------------------------------------------------------------------

Elimination of Obsolete Rule Language Concerning Waiver of Fees
    The Exchange also proposes to eliminate references to certain fee
waivers that expired July 31, 2011.\7\ Since the fee waivers expired,
such language is no longer necessary.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 64629 (June 8,
2011), 76 FR 34798 (June 14, 2011) (SR-Phlx-2011-77); and Securities
Exchange Act Release No. 64842 (July 8, 2011), 76 FR 41536 (July 14,
2011) (SR-Phlx-2011-97).
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \8\ in general, and Sections 6(b)(4) and (b)(5) of the
Act \9\ in particular, in that it provides for the equitable allocation
of reasonable dues, fees and other charges among members and issuers
and other persons using any facility or system which the Exchange
operates or controls, and is designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in general
to protect investors and the public interest. The proposal is designed
to provide a method of connectivity between the Exchange's co-location
facility and various remote locations. Currently, market participants
obtain such connections by negotiating directly with telecommunication
providers. Through its efforts to negotiate standard wholesale rates
with providers, the Exchange seeks to offer market participants an
opportunity to obtain the same connectivity service at a potentially
lower cost and with greater ease of implementation. The Exchange
believes that this change will be unambiguously beneficial to market
participants, who will retain all current options for obtaining
connectivity through direct negotiations with telecommunications
providers, while also receiving a new option for obtaining the service
through the Exchange's program.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The proposed fees for the service cover the costs charged to the
Exchange by telecommunication provider(s). The fees charged to the
Exchange are based on anticipated bandwidth necessary for the
connections and distances to the available locations covered by the
service (New York/New Jersey, Chicago, and Toronto). The proposed fees
also include a markup to allow the Exchange to cover its administrative
costs and to earn a profit on its provision of the service. The
Exchange believes that it is reasonable to use fees assessed on this
basis as a means to recoup the Exchange's share of the costs associated
with the proposed low latency network telecommunication connections,
provide a convenience for the customers, and to the extent the costs
are covered, provide the Exchange a profit. The Exchange further
believes that the proposed fees are reasonable in light of the costs
associated with the service and the fees charged by other trading
venues for comparable services.\10\
---------------------------------------------------------------------------

    \10\ See supra n. 6.
---------------------------------------------------------------------------

    The proposed co-location services are entirely voluntary and
available to all members, with uniform fees charged to all market
participants that opt to obtain connectivity through the Exchange.
Moreover, market participants may choose to obtain services through the
Exchange, or may choose to negotiate their own connectivity with 16
different providers. Accordingly, the Exchange's proposed fees are non-
discriminatory, and equitably allocated to market participants that
choose to avail themselves of the Exchange's services, rather than
obtaining comparable services directly.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. First, competition between the
Exchange and competing trading venues will be enhanced by allowing the
Exchange to offer its market participants connectivity to its data
center at a potentially lower price, and with greater ease. As noted
above, NYSE already offers comparable services, at comparable fees, to
its market participants. Accordingly, the proposal will allow the
Exchange to enhance its competitive standing vis-[agrave]-vis other
trading venues. Conversely, any delay in the effectiveness of the
proposed rule change would burden competition by preventing the
Exchange from mounting a response to a primary competitor. Second,
competition among market participants will be supported by allowing
small and large participants to pay a lower price for data center
connectivity.
    The Exchange believes that the proposed rule change will likewise
enhance competition among telecommunications providers that seek to
offer connections between market participants and the Exchange's data
center. As discussed above, the Exchange does not discriminate among
telecommunication providers, but rather allows providers to access the
data center upon request of a market participant. As a result, 16
providers are currently connected. Likewise, the Exchange does not
discriminate among providers with respect to eligibility to offer
connectivity through the Exchange under the service proposed in this
filing, provided the latency, destinations, and fees offered by the
provider are consistent with the minimum standards established by the
Exchange. Thus, telecommunications providers can choose to participate
in the program, or can choose to service market participants
exclusively through direct negotiations with customers. The Exchange's
approach is consistent with its own economic incentives to facilitate
as many market participants as possible in connecting to its market.
Burdening competition among telecommunications providers would be
antithetical to the Exchange's own competitive interests, since
impaired competition would make it more expensive and more difficult
for market participants to send order flow to the Exchange.
    The Exchange expects that the result of the proposal will be a
reduction in

fees charged to market participants, the very essence of competition.
To the extent that fees under the program are less expensive than the
rates currently paid by many market participants, the welfare of these
market participants will increase, and other telecommunications
providers will be incentivized to lower their own rates. This will, in
turn, facilitate the introduction of greater volumes of order flow to
the Exchange.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2011-142 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2011-142. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2011-142 and should be
submitted on or before December 1, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-29110 Filed 11-9-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 215 (Tuesday, November 6, 2018)]
[Rules and Regulations]
[Pages 55491-55495]
[FR Doc No: 2018-24265]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0538; FRL-9982-75]

Fludioxonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes revised tolerances for residues of
fludioxonil in or on beet, sugar, roots at 4.0 parts per million.
Syngenta Crop Protection, LLC requested this tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 6, 2018. Objections and
requests for hearings must be received on or before January 7, 2019,
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-2017-0538, 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>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, 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 protected].

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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing 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, 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-2017-0538 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
January 7, 2019. 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-2017-0538, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of December 15, 2017 (82 FR 59604) (FRL-
9970-50), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F8592) by Syngenta Crop Protection, LLC, 410 Swing Road, Greensboro,
NC 27409. The petition requested that the existing tolerance in 40 CFR
180.516 for residues of the fungicide fludioxonil, 4-(2, 2-difluoro-
1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, in or on beet, sugar,
roots be amended to 5.0 parts per million (ppm). That document
referenced a summary of the petition prepared by Syngenta Crop
Protection, LLC, the registrant, which is available in the docket,
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
determined that the tolerance be set at 4.0 ppm, which is less than the
tolerance level of 5.0 ppm proposed by the petitioner. The reason for
this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 fludioxonil including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fludioxonil follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
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.
    In all species tested, the effects in the fludioxonil database are
indicative of toxicity to the liver, kidney, and hematopoietic system
(dogs only). There were also decreased body weights and clinical signs
throughout the database. Fludioxonil was non-toxic through the dermal
route and there was no evidence of immunotoxicity when tested up to the
limit dose. Fludioxonil was not mutagenic in the tests for gene
mutations. There was no quantitative or qualitative evidence of
increased susceptibility following in utero exposure to rats and
rabbits or following pre-/postnatal exposure to rats.
    In a rat developmental toxicity study, fludioxonil caused an
increase in fetal incidence and litter incidence of both dilated renal
pelvis and ureter at the limit dose (1000 mg/kg/day). These effects are
known to occur spontaneously in the rat, in addition to being transient
and reversible, which is consistent with the fludioxonil hazard
database (not seen in offspring in the two-generation reproductive
study). Maternal toxicity occurred at the same dose and manifested as
body-weight decrements. Fludioxonil was not developmentally toxic in
rabbits. In the two-generation reproduction study, parental and
offspring effects occurred at the same dose and consisted of decreased
body weights in parental and offspring animals, as well as increased
clinical signs in parental animals.
    Fludioxonil was classified as a Group D carcinogen (not
classifiable as to human carcinogenicity); therefore, there is no need
for a quantitative cancer risk assessment.
    Specific information on the studies received and the nature of the
adverse effects caused by fludioxonil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Fludioxonil. ``Human Health Risk
Assessment for the Proposed New Post

Harvest Use on Sugar Beets.'' at pg. 11 in docket ID number EPA-HQ-OPP-
2017-0538.

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.
    A summary of the toxicological endpoints for fludioxonil used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of April 14, 2015 (80 FR 48743) (FRL-
9931-06).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fludioxonil, EPA considered exposure under the petitioned-
for tolerance as well as all existing fludioxonil tolerances in 40 CFR
180.516. EPA assessed dietary exposures from fludioxonil in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
fludioxonil; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
As to residue levels in food, EPA an unrefined chronic dietary exposure
and risk assessment was conducted assuming 100% percent crop treated
(PCT) and tolerance-level residues for all food commodities. The
Processing Factor Focus (PFFG) default processing factors were used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
classified fludioxonil as a group D carcinogen, i.e., not classifiable
as to human carcinogenicity. Therefore, a dietary exposure assessment
for the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
    EPA did not use anticipated residue and/or PCT information in the
dietary assessment for fludioxonil. Tolerance level residues and/or
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fludioxonil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fludioxonil. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM) and the Variable Volume Water Model (VVWM) along with the
Pesticide Root Zone Model Ground Water (PRZM GW) were used, the
estimated drinking water concentrations (EDWCs) of fludioxonil for
chronic exposures for non-cancer assessments are estimated to be 17.7
parts per billion (ppb) for surface water and 48.34 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 48.34 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Fludioxonil is currently registered for the following uses that
could result in residential exposures: Parks, golf courses, athletic
fields, residential lawns, ornamentals, and greenhouses. EPA assessed
residential exposure based on the following: The residential exposure
for use in the adult aggregate assessment reflects inhalation exposures
from handler exposure to applying paints with airless sprayers. The
residential exposure for use in the children 1 to <2 years old
aggregate assessment reflects incidental oral exposures (hand-to-mouth)
from post-application exposure to outdoor treated turf.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, 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 fludioxonil to share a common mechanism of
toxicity with any other substances, and fludioxonil does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fludioxonil does 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/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) 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 Food Quality Protection Act
Safety Factor (FQPA 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.
    2. Prenatal and postnatal sensitivity. There was no quantitative or
qualitative evidence of increased susceptibility following in utero
exposure to rats and rabbits or following pre-/postnatal exposure. In a
rat developmental toxicity study, fludioxonil caused an increase in
fetal incidence and litter incidence of dilated renal pelvis at the
limit dose (1,000 mg/kg/day). Maternal toxicity occurred at the same
dose and manifested as body weight decrements. Fludioxonil was not
developmentally toxic in rabbits. In the 2-generation reproduction
study, parental and offspring effects occurred at the same dose and
consisted of decreased body weights in parental and offspring animals,
as well as increased clinical signs in parental animals.
    3. Conclusion. 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. That decision is based on the following
findings:
    i. The toxicity database for fludioxonil is complete.
    ii. There is low concern that fludioxonil is a neurotoxic chemical.
The only potential indicator of neurotoxicity for fludioxonil was
convulsions in mice following handling in the mouse carcinogenicity
study at the mid- and high-doses. There was no supportive
neuropathology, the effect was not seen at similar doses in a second
mouse carcinogenicity study, there were no other signs of potential
neurotoxicity observed in the database, and selected endpoints are
protective of the effect seen in mice. Therefore, there is no residual
uncertainty concerning neurotoxicity and no need to retain the FQPA 10X
safety factor.
    iii. There is no evidence that fludioxonil results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to fludioxonil in drinking water. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to fludioxonil in drinking water. EPA
used similarly conservative assumptions to assess postapplication
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by fludioxonil.

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,
fludioxonil is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fludioxonil from food and water will utilize 51% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
fludioxonil is not expected.
    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).
    Fludioxonil is currently 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 fludioxonil.
    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 15,000 for adults
and 4,600 for children 1-2 years old. Because EPA's level of concern
for fludioxonil is a MOE 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).
    Intermediate- and long-term aggregate risk assessments were not
performed because there are no registered or proposed uses of
fludioxonil that result in intermediate- or long-term residential
exposures.
    5. Aggregate cancer risk for U.S. population. Based on the
discussion contained in Unit III.A., fludioxonil is not expected to
pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fludioxonil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology high-performance liquid
chromatography/ultraviolet (HPLC/UV) methods (Methods AG-597 and AG-
597B) are available for enforcing tolerances for fludioxonil on plant
commodities. An adequate liquid chromatography, tandem mass
spectrometry (LC-MS/MS) method (Analytical Method GRM025.03A) is
available for enforcing tolerances for residues of fludioxonil in or on
livestock commodities.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is

different from a Codex MRL; however, FFDCA section 408(b)(4) requires
that EPA explain the reasons for departing from the Codex level.
    There is no Codex MRL for sugar beet roots for fludioxonil.

C. Revisions to Petitioned-For Tolerances

    All tolerance levels are based upon the Organization for Economic
Co-operation and Development's (OECD) tolerance calculation procedures.
Based on the residue chemistry data and the OECD tolerance-calculation
procedure, the tolerance level established in this notice for
fludioxonil on beet, sugar, roots is lower (4.0 ppm) than that
requested by the petitioner (5.0 ppm).

V. Conclusion

    Therefore, the tolerance is amended for residues of fludioxonil:
[4-(2, 2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile], in
or on beet, sugar, roots from 0.02 ppm to 4.0 ppm.

VI. Statutory and Executive Order Reviews

    This action amends a tolerance 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) nor is it considered a regulatory
action under Executive Order 13771, entitled ``Reducing Regulations and
Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). 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 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).

VII. 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: October 16, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Program.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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.  180.516, revise the tolerance for ``Beet, sugar, roots'' in
the table of paragraph (a)(1), to read as follows:

Sec.  180.516  Fludioxonil; tolerance for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Beet, sugar, roots......................................             4.0

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

* * * * *
[FR Doc. 2018-24265 Filed 11-5-18; 8:45 am]
 BILLING CODE 6560-50-P