[Federal Register Volume 84, Number 167 (Wednesday, August 28, 2019)]
[Rules and Regulations]
[Pages 45071-45073]
[FR Doc No: 2019-18523]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0718]
RIN 1625-AA00

Safety Zone; Gulf Intracoastal Waterway, Lafitte, LA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the Gulf Intracoastal Waterway in Lafitte, LA. The
safety zone is necessary to protect persons, vessels, and the marine
environment from potential hazards created by the Jean Lafitte Pirogue
Race. Entry of vessels or persons into this zone is prohibited unless
specifically authorized by the Captain of the Port Sector New Orleans
or a designated representative.

DATES: This rule is effective from 10 a.m. through 5 p.m. on September
7, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0718 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Corinne Plummer, Sector New Orleans,
U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector New Orleans
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. It is
impracticable to publish an NPRM because we must establish this safety
zone by September 7, 2019 and lack sufficient time to provide a
reasonable comment period and then consider those comments before
issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because immediate
action is needed to respond to the potential safety hazards associated
with the boat race.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector New
Orleans (COTP) has determined that potential hazards associated with a
boat race on September 7, 2019, will be a safety concern for anyone
within a one-mile section of the Gulf Intracoastal Waterway. Possible
hazards include risks of injury or death from near or actual contact
among participant vessels and mariners traversing through the safety
zone. This rule is necessary to protect persons, vessels, and the
marine environment during the race.

IV. Discussion of the Rule

    This rule establishes a safety zone from 10 a.m. through 5 p.m. on
September 7, 2019. The safety zone will encompass all navigable waters
of the Gulf Intracoastal Waterway between mile markers (MMs) 11 and 12
west of the Harvey Locks in Lafitte, LA. The duration of the zone is
intended to protect persons, vessels, and the marine environment during
the race and will include breaks and opportunity for vessels to transit
through the regulated area.
    No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard assigned to units under the
operational control of USCG Sector New Orleans. Vessels requiring entry
into this safety zone must request permission from the COTP or a
designated representative. They may be contacted on VHF-FM Channel 16
or 67 or by telephone at<PHONE_NUMBER>.
    A designated representative may be a Patrol Commander (PATCOM). The
PATCOM may be aboard either a Coast Guard or Coast Guard Auxiliary
vessel. The PATCOM may be contacted on Channel 16 VHF-FM (156.8 MHz) by
the call sign ``PATCOM''. The ``official patrol vessels'' consist of
any Coast Guard, state, or local law enforcement and sponsor provided
vessels assigned or approved by the COTP or a designated representative
to patrol the zone. All persons and vessels not registered with the
sponsor as participants or official patrol vessels are considered
spectators.
    Spectator vessels desiring to transit the zone may do so only with
prior approval of the COTP or a designated representative and when so
directed by that officer must be operated at a minimum safe navigation
speed in a manner that will not endanger any other vessels. No
spectator vessel shall anchor, block, loiter, or impede the through
transit of official patrol vessels in the zone during the effective
date and times, unless cleared for entry by or through the COTP or a
designated representative. Any spectator vessel may anchor outside the
zone, but may not anchor in, block, or loiter in a navigable channel.
Spectator vessels may be moored to a waterfront facility within the
zone in such a way that they shall not interfere with the progress of
the event. Such mooring must be complete at least 30 minutes prior to
the establishment of the zone and remain moored through the duration of
the event.
    The COTP or a designated representative may forbid and control the
movement of all vessels in the zone. When hailed or signaled by an
official patrol vessel, a vessel shall come to an immediate stop and
comply with the directions given. Failure to do so may result in
expulsion from the zone, citation for failure to comply, or both.
    The COTP or a designated representative may terminate the

operation of any vessel at any time it is deemed necessary for the
protection of life or property. The COTP or a designated representative
will terminate enforcement of the safety zone at the conclusion of the
event.
    The COTP or a designated representative will inform the public of
the enforcement periods of this safety zone through Broadcast Notices
to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine
Safety Information Bulletins (MSIBs) as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size and
duration of the temporary safety zone. This temporary safety zone
covers a one-mile section of the Gulf Intracoastal Waterway for only
seven hours on one day. Moreover, the rule allows vessels to seek
permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please call or email the person listed in the FOR FURTHER INFORMATION
CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone lasting only seven hours
on one day that will prohibit entry within a one-mile stretch of the
Gulf Intracoastal Waterway. It is categorically excluded from further
review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard
Environmental Planning Implementing Procedures. A Record of
Environmental Consideration supporting this determination is available
in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.
    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0718 to read as follows:

Sec.  165.T08-0718   Safety Zone; Gulf Intracoastal Waterway, Lafitte,
LA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Gulf Intracoastal Waterway, from mile markers (MMs) 11 to
12 west of the Harvey Locks, Lafitte, LA.
    (b) Effective period. This section is effective from 10 a.m.
through 5 p.m. on September 7, 2019.
    (c) Enforcement periods. This section will be enforced during the
effective period. However, breaks in the racing may occur during the
enforcement periods, which will allow for vessels to pass through the
safety zone. The Captain of the Port Sector New Orleans (COTP) or a
designated representative will provide notice of breaks as appropriate
under paragraph (e) of this section.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into this zone is prohibited unless authorized by
the COTP or designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Sector New
Orleans. They may be contacted on VHF-FM Channel 16 or 67 or by
telephone at<PHONE_NUMBER>. A designated representative may be a
Patrol Commander (PATCOM). The PATCOM may be aboard either a Coast
Guard or Coast Guard Auxiliary vessel. The Patrol Commander may be
contacted on Channel 16 VHF-FM (156.8 MHz) by the call sign ``PATCOM''.
    (2) All persons and vessels not registered with the sponsor as
participants or official patrol vessels are considered spectators. The
``official patrol vessels'' consist of any Coast Guard, state, or local
law enforcement and sponsor provided vessels assigned or approved by
the COTP or a designated representative to patrol the regulated area.
    (3) Spectator vessels desiring to transit the regulated area may do
so only with prior approval of the Patrol Commander and when so
directed by that officer will be operated at a minimum safe navigation
speed in a manner which will not endanger participants in the regulated
area or any other vessels.
    (4) No spectator vessel shall anchor, block, loiter, or impede the
through transit of participants or official patrol vessels in the
regulated area during the effective dates and times, unless cleared for
entry by or through an official patrol vessel.
    (5) Any spectator vessel may anchor outside the regulated area, but
may not anchor in, block, or loiter in a navigable channel. Spectator
vessels may be moored to a waterfront facility within the regulated
area in such a way that they shall not interfere with the progress of
the event. Such mooring must be complete at least 30 minutes prior to
the establishment of the regulated area and remain moored through the
duration of the event.
    (6) The COTP or a designated representative may forbid and control
the movement of all vessels in the regulated area. When hailed or
signaled by an official patrol vessel, a vessel shall come to an
immediate stop and comply with the directions given. Failure to do so
may result in expulsion from the area, citation for failure to comply,
or both.
    (7) The COTP or a designated representative may terminate the event
or the operation of any vessel at any time it is deemed necessary for
the protection of life or property.
    (8) The COTP or a designated representative will terminate
enforcement of the special local regulations at the conclusion of the
event.
    (e) Informational broadcasts. The COTP or a designated
representative will inform the public of the effective period for the
safety zone as well as any changes in the dates and times of
enforcement through Local Notice to Mariners (LNMs), Broadcast Notices
to Mariners (BNMs), and/or Marine Safety Information Bulletins (MSIBs)
as appropriate.

    Dated: August 22, 2019.
K.M. Luttrell,
Captain, U.S. Coast Guard, Captain of the Port Sector New Orleans.
[FR Doc. 2019-18523 Filed 8-27-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29932-29936]
[FR Doc No: 2016-11293]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77784; File No. SR-BatsBZX-2016-14]

Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Related to
Fees as They Apply to the Equity Options Platform

May 9, 2016.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 2, 2016, Bats BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') 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
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)

thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-members of the Exchange pursuant to BZX Rules
15.1(a) and (c).
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    \5\ The term ``Member'' is defined as ``any registered broker or
dealer that has been admitted to membership in the Exchange.'' See
Exchange Rule 1.5(n).
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    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.com, at the principal office of the
Exchange, 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 parts of such
statements.

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

1. Purpose
    The Exchange proposes to modify its fee schedule applicable to the
Exchange's equity options platform (``BZX Options'') to: (1) Modify the
standard fee for Non-Customer \6\ orders that remove liquidity in Non-
Penny Pilot Securities \7\ and to adopt a new tier in connection with
such executions; (2) modify an existing tier and add a new tier to its
tiered pricing structure for the Exchange's Quoting Incentive Program
(``QIP''); and (3) simplify the Exchange's routing fees, as further
described below.
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    \6\ The term ``Non-Customer'' applies to any transaction that is
not a Customer order. In turn, the term ``Customer'' applies to any
transaction identified by a Member for clearing in the Customer
range at the Options Clearing Corporation (``OCC''), excluding any
transaction for a Broker Dealer or a ``Professional'' as defined in
Exchange Rule 16.1.
    \7\ The term ``Non-Penny Pilot Security'' applies to those
issues that are not Penny Pilot Securities quoted pursuant to
Exchange Rule 21.5, Interpretation and Policy .01.
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Non-Customer Orders That Remove Liquidity in Non-Penny Pilot Securities
    The Exchange is proposing to modify the standard fee for Non-
Customer orders that remove liquidity in Non-Penny Pilot Securities.
Such orders when executed on the Exchange currently yield fee code NP
and are assessed a standard fee of $0.94 per contract. The Exchange is
proposing to increase the standard fee for Non-Customer orders that
remove liquidity in Non-Penny Pilot Securities under fee code NP from
$0.94 to $0.99 per contract.
    In addition, the Exchange proposes to adopt a new tier that would
apply to Non-Customer orders that remove liquidity in Non-Penny Pilot
Securities that result in a reduced fee for Members that meet the
qualifications of the tier. Specifically, the Exchange is proposing to
create a new footnote 13 entitled ``Non-Customer Non-Penny Pilot Take
Volume Tier,'' which would apply to orders that receive fee code NP.
Under the proposed new tier, Non-Customer orders that remove liquidity
in Non-Penny Pilot Securities would be assessed a reduced fee of $0.95
per contract where the Member has: (1) an ADAV \8\ in Customer orders
in Non-Penny Pilot Securities equal to or greater than 0.05% of average
TCV; \9\ and (2) an ADV \10\ in Non-Customer Orders that remove
liquidity in Non-Penny Pilot Securities equal to or greater than 0.10%
of average TCV.
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    \8\ ``ADAV'' means average daily volume calculated as the number
of contracts added per day.
    \9\ ``TCV'' means total consolidated volume calculated as the
volume reported by all exchanges to the consolidated transaction
reporting plan for the month for which the fees apply, excluding
volume on any day that the Exchange experiences an Exchange System
Disruption and on any day with a scheduled early market close.
    \10\ ``ADV'' means average daily volume calculated as the number
of contracts added or removed, combined, per day.
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    In addition to the modification to the Fee Codes and Associated
Fees table and the addition of footnote 13 described above, the
Exchange proposes to update the Standard Rates table of the fee
schedule to reflect these changes.
QIP Tiers
    The Exchange currently offers three QIP tiers that provide an
additional rebate per contract for an order that adds liquidity to the
BZX Options Book \11\ in options classes in which a Member is a Market
Maker registered on BZX Options pursuant to Rule 22.2. The Market Maker
must be registered with BZX Options in an average of 20% or more of the
associated options series in a class in order to qualify for QIP
rebates for that class. The Exchange proposes to amend QIP Tier 3 and
to add a new QIP Tier 4, as further described below.
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    \11\ ``BZX Options Book'' is defined as ``the electronic book of
options orders maintained by the Trading System. See Exchange Rule
16.1(a)(9).
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    Under QIP Tier 3, a Market Maker receives an additional rebate of
$0.06 per contract where that Market Maker has an ADV equal to or
greater than 2.5% of average TCV. The Exchange proposes to decrease the
rebate provided pursuant to QIP Tier 3 from an additional rebate of
$0.06 per contract to an additional rebate of $0.05 per contract. The
Exchange does not propose to amend the qualifying criteria for QIP Tier
3.
    In addition, the Exchange proposes to adopt new QIP Tier 4. Under
proposed QIP Tier 4, a Market Maker will receive an additional rebate
of $0.06 per contract where the Member has an ADV equal to or greater
than 3.5% of average TCV. Thus, QIP Tier 4 will provide the same rebate
as is provided under current QIP Tier 3.
Routing Fees
    The Exchange proposes to modify the fees charged for orders routed
away from the Exchange and executed at various away options exchanges.
The Exchange currently has specific rates and associated fee codes for
each away options exchange.\12\ Such rates are further divided at each
options exchange into either two categories in order to differentiate
between Customer and Non-Customer orders or into four categories in
order to differentiate between Customer and Non-Customer orders and
then into Penny Pilot Securities \13\ and Non-Penny Pilot
Securities.\14\ In order to simplify routing fees for executions at
away options exchanges, the Exchange proposes to charge flat rates for
routing to other options exchanges that have been placed into groups
based on the

approximate cost of routing to such venues. The grouping of away
options exchanges is based on the cost of transaction fees assessed by
each venue as well as costs to the Exchange for routing (i.e., clearing
fees, connectivity and other infrastructure costs, membership fees,
etc.) (collectively, ``Routing Costs''). To address different fees at
various other options exchanges, the Exchange proposes to adopt five
different fees and associated fee codes applicable to routing to away
options exchanges, as further described below.
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    \12\ Other options exchanges to which the Exchange routes
include: BOX Options Exchange LLC (``BOX''), Chicago Board Options
Exchange, Inc. (``CBOE''), C2 Options Exchange, Inc. (``C2''), Bats
EDGX Exchange, Inc. (``EDGX Options''), International Securities
Exchange, Inc. (``ISE''), ISE Gemini, LLC (``ISE Gemini''), ISE
Mercury, LLC (``ISE Mercury''), Miami International Securities
Exchange, LLC (``MIAX''), Nasdaq Options Market LLC (``NOM''),
Nasdaq OMX BX LLC (``BX Options''), Nasdaq OMX PHLX LLC (``PHLX''),
NYSE Arca, Inc. (``ARCA''), and NYSE MKT LLC (``AMEX'').
    \13\ The term ``Penny Pilot Security'' applies to those issues
that are quoted pursuant to Exchange Rule 21.5, Interpretation and
Policy .01.
    \14\ The Exchange notes that it still applies a single rate for
orders routed to and executed at the newest options exchange, ISE
Mercury.
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    With respect to Non-Customer orders, the Exchange proposes to adopt
two fee codes: (1) Fee code RN, which would result in a fee of $0.85
per contract and would apply to all Non-Customer orders in Penny Pilot
Securities; and (2) fee code RO, which would result in a fee of $1.20
per contract and would apply to all Non-Customer orders in Non-Penny
Pilot Securities. The Exchange notes that the current range of fees
applicable to Non-Customer orders routed to other options exchanges is
from $0.56 per contract (fee code RF, applicable to Non-Customer orders
in Penny Pilot Securities executed at EDGX Options) to $1.25 per
contract (fee code QG, applicable to Non-Customer orders executed at
NOM in Non-Penny Pilot Securities).
    With respect to Customer orders, the Exchange proposes to adopt
three fee codes: (1) Fee code RP, which would result in a fee of $0.25
per contract and would apply to all Customer orders routed to and
executed at AMEX, BOX, BX Options, CBOE, EDGX Options, ISE Mercury,
MIAX or PHLX; (2) fee code RQ, which would result in a fee of $0.70 per
contract and would apply to all Customer orders in Penny Pilot
Securities routed to and executed at ARCA, C2, ISE, ISE Gemini or NOM;
and (3) fee code RR, which would result in a fee of $0.90 per contract
and would apply to all Customer orders in Non-Penny Pilot Securities
routed to and executed at ARCA, C2, ISE, ISE Gemini or NOM. The
Exchange notes that the current range of fees applicable to Customer
orders routed to other options exchanges is from no charge per contract
(fee codes BD, applicable to Customer orders in Non-Penny Pilot
Securities executed at BX Options, and fee codes RC and RD, applicable
to Customer orders in Penny Pilot Securities and Non-Penny Pilot
Securities, respectively, executed at EDGX Options) to $0.90 per
contract (fee codes AD, GD and QD, applicable to Customer orders
executed at ARCA, ISE Gemini, and NOM, respectively, in Non-Penny Pilot
Securities).\15\
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    \15\ The Exchange again notes that it currently applies a single
rate for orders routed to and executed at the newest options
exchange, ISE Mercury. As such, Customer orders execute at ISE
Mercury technically pay the highest rate today, a fee of $0.99 per
contract.
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    As a general matter, the groupings described above in most
instances attempt to differentiate between the Routing Costs applicable
to either executions of orders in Penny Pilot Securities versus those
in Non-Penny Pilot Securities or between fee ranges typical of
exchanges that operate primarily a maker/taker or price/time market
model (generally imposing higher fees, including for Customer orders)
versus exchanges that operate primarily a pro rata or customer priority
market model (generally imposing lower fees, especially for Customer
orders).
    As set forth above, the Exchange's proposed approach to routing
fees is to set forth in a simple manner certain flat fees that
approximate the cost of routing to other options exchanges. The
Exchange will then monitor the fees charged as compared to the costs of
its routing services, as well as monitoring for specific fee changes by
other options exchanges, and intends to adjust its flat routing fees
and/or groupings to ensure that the Exchange's fees do indeed result in
a rough approximation of overall Routing Costs, and are not
significantly higher or lower in any area. Although there may be
instances where the Exchanges fee to a particular options exchange is
indeed significantly higher than the fee charged by such options
exchange, the Exchange believes that this is appropriate for several
reasons discussed in further detail below, including the simplicity
that it will provide Users of the Exchange's routing services.
Implementation Date
    The Exchange proposes to implement these amendments to its fee
schedule immediately.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of section 6 of the Act.\16\
Specifically, the Exchange believes that the proposed rule change is
consistent with section 6(b)(4) of the Act,\17\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and other persons using any facility or system which the
Exchange operates or controls. The Exchange notes that it operates in a
highly competitive market in which market participants can readily
direct order flow to competing venues if they deem fee levels to be
excessive.
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    \16\ 15 U.S.C. 78f.
    \17\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    Volume-based rebates such as those currently maintained on the
Exchange have been widely adopted by options exchanges, including the
Exchange, and are equitable because they are open to all Members on an
equal basis and provide additional benefits or discounts that are
reasonably related to the value to an exchange's market quality
associated with higher levels of market activity, such as higher levels
of liquidity provision and/or growth patterns, and introduction of
higher volumes of orders into the price and volume discovery processes.
    The Exchange believes that its proposal to change the standard fee
charged for Non-Customer orders that remove liquidity in Non-Penny
Pilot Securities under fee code NP from $0.94 to $0.99 per contract is
reasonable, fair and equitable and non-discriminatory, because the
change will apply equally to all participants, and because, while the
change marks an increase in fees for orders in Non-Penny Pilot
Securities, such proposed fees remain consistent with pricing
previously offered by the Exchange as well as competitors of the
Exchange and does not represent a significant departure from the
Exchange's general pricing structure and will allow the Exchange to
earn additional revenue that can be used to offset the addition of new
pricing incentives, including those introduced as part of this
proposal. The Exchange also believes that its proposal to adopt a
tiered pricing structure that will result in a reduced fee for all
Members qualifying for the tier mitigates the increased fee. The tier
is itself reasonable, fair and equitable and non-discriminatory for the
reasons set forth above with respect to volume-based pricing generally,
and also because the change will apply equally to all participants, the
proposed fee under the tier remains consistent with pricing previously
offered by the Exchange as well as competitors of the Exchange and does
not represent a significant departure from the Exchange's general
pricing structure.
    The Exchange believes that its proposal to amend QIP Tier 3 and add
a new QIP Tier 4 under footnote 5 is reasonable, fair and equitable and
non-discriminatory, for the reasons set forth above with respect to
volume-based

pricing generally. In addition, the Exchange believes the reduction of
the rebate offered under QIP Tier 3 is equitable and reasonable because
of the adoption of QIP Tier 4, which will still provide Members with
the ability to earn the current rebate provided by QIP Tier 3, albeit
only if such Members satisfy the increased criteria. The Exchange also
notes that although registration as a Market Maker is required to
qualify for QIP, such registration is available to all Members on an
equal basis. The Exchange also believes that proposed QIP Tier 4 is
reasonable, fair and equitable, and non-discriminatory because it, like
the QIP generally, is aimed to incentivize active market making on the
Exchange.
    With respect to the proposed routing structure, the Exchange again
notes that it operates in a highly competitive market in which market
participants can readily direct order flow to competing venues or
providers of routing services if they deem fee levels to be excessive.
As explained above, the Exchange proposes to approximate the cost of
routing to other options exchanges, including other applicable costs to
the Exchange for routing, in order to provide a simplified and easy to
understand pricing model. The Exchange believes that a pricing model
based on approximate Routing Costs is a reasonable, fair and equitable
approach to pricing. Specifically, the Exchange believes that its
proposal to modify fees is fair, equitable and reasonable because the
fees are generally an approximation of the cost to the Exchange for
routing orders to such exchanges. The Exchange believes that its flat
fee structure for orders routed to various venues is a fair and
equitable approach to pricing, as it will provide certainty with
respect to execution fees at groups of away options exchanges. In order
to achieve its flat fee structure, taking all costs to the Exchange
into account, the Exchange will necessarily charge a higher premium to
route to certain options exchanges than to others. As a general matter,
the Exchange believes that the proposed fees will allow it to recoup
and cover its costs of providing routing services to such exchanges and
to make some additional profit in exchange for the services it
provides. The Exchange also believes that the proposed fee structure
for orders routed to and executed at these away options exchanges is
fair and equitable and not unreasonably discriminatory in that it
applies equally to all Members. Finally, the Exchange notes that it
intends to consistently evaluate its routing fees, including profit and
loss attributable to routing, as applicable, in connection with the
operation of a flat fee routing service, and would consider future
adjustments to the proposed pricing structure to the extent it was
recouping a significant profit or loss from routing to away options
exchanges.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes the proposed amendments to its fee schedule
would not impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. Rather, the
proposal is a competitive proposal that is seeking to further the
growth of the Exchange and to simplify the Exchange's fees for routing
orders to away options exchanges. With respect to the tiered pricing
changes, the Exchange has structured the proposed fees and rebates to
attract additional volume to the Exchange based on pricing that is
competitive with that offered by other options exchanges. In
particular, by offering tiered pricing the Exchange is incentivizing
Members to maintain and/or increase the liquidity provided to the
Exchange, which is representative of the competitive nature of the
options markets. With respect to the proposed routing fee structure,
the Exchange believes that the proposed fees are competitive in that
they will provide a simple approach to routing pricing that some
Members may favor. Additionally, Members may opt to disfavor the
Exchange's pricing, including pricing for transactions on the Exchange
as well as routing fees, if they believe that alternatives offer them
better value. In particular, with respect to routing services, such
services are available to Members from other broker-dealers as well as
other options exchanges. The Exchange also notes that Members may
choose to mark their orders as ineligible for routing to avoid
incurring routing fees.\18\ Accordingly, the Exchange does not believe
that the proposed change will impair the ability of Members or
competing venues to maintain their competitive standing in the
financial markets.
---------------------------------------------------------------------------

    \18\ See Exchange Rule 21.1(d)(7) (describing ``Book Only''
orders) and Exchange Rule 21.9(a)(1) (describing the Exchange's
routing process, which requires orders to be designated as available
for routing).
---------------------------------------------------------------------------

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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

    The foregoing rule change has become effective pursuant to section
19(b)(3)(A) of the Act \19\ and paragraph (f) of Rule 19b-4
thereunder.\20\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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-BatsBZX-2016-14 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BatsBZX-2016-14. 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
10:00 a.m. and 3:00 p.m. Copies of such filing will also 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-BatsBZX-2016-14 and should
be submitted on or before June 3, 2016.
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-11293 Filed 5-12-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3615-3622]
[FR Doc No: 2018-01479]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0254; FRL-9971-95]

Difenoconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
difenoconazole in or on multiple commodities which are identified and
discussed later in this document. In addition, this regulation removes
several previously established tolerances that are superseded by this
final rule. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective January 26, 2018. Objections and
requests for hearings must be received on or before March 27, 2018, 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-2016-0254, 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 Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(703) 305-7090; 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-2016-0254 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
March 27, 2018. 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-2016-0254, 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 July 26, 2017 (82 FR 34664) (FRL-9963-
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
6E8484) by IR-4 Headquarters, Rutgers, The State University of New
Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The
petition requested that 40 CFR 180.475 be amended by establishing
tolerances for residues of the fungicide difenoconazole, 1-[2-[2-
chloro-4-(4-chlorophenoxy)phenyl]-4-methy-1,3-dioxolan-2-ylmethyl]-1H-
1,2,4-triazole, in or on Brassica, leafy greens, subgroup 4-16B at 35
parts per million (ppm); cranberry at 0.6 ppm; fruit, small, vine
climbing, except fuzzy kiwifruit, subgroup 13-07F at 4.0 ppm; guava at
3.0 ppm; kohlrabi at 2.0 ppm; papaya at 0.6 ppm; and vegetable,
Brassica, head and stem, group 5-16 at 2.0 ppm. Upon establishment of
proposed tolerances above, the petition requested that 40 CFR part
180.475 be amended by removing existing tolerances for residues of
difenoconazole in or on Brassica, head and stem, subgroup 5A at 1.9
ppm, Brassica, leafy greens, subgroup 5B at 35 ppm; grape at 4.0 ppm;
and turnip, greens at 35 ppm. That document referenced a summary of the
petition prepared by Syngenta Crop Protection, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Tolerances being established vary from what was requested, for the
reasons 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 difenoconazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with difenoconazole
follows.

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.
    Difenoconazole exhibits low acute toxicity by the oral, dermal and
inhalation routes of exposure. It is not an eye or skin irritant and is
not a sensitizer. Subchronic and chronic toxicity studies with
difenoconazole in mice and rats showed decreased body weights and
effects on the liver (e.g. hepatocellular hypertrophy, liver necrosis,
fatty changes in the liver). No systemic toxicity was observed at the
limit dose in a rat dermal toxicity study.
    The available toxicity studies indicated no increased
susceptibility of rats or rabbits from in utero or postnatal exposure
to difenoconazole. In prenatal developmental toxicity studies in rats
and rabbits and in the 2-generation reproduction study in rats, fetal
and offspring toxicity, when observed, occurred at equivalent or higher
doses than in the maternal and parental animals. In a rat developmental
toxicity study, developmental effects were observed at doses higher
than those which caused maternal toxicity. Developmental effects in the
rat included increased incidence of ossification of the thoracic
vertebrae and thyroid, decreased number of sternal centers of
ossification, increased number of ribs and thoracic vertebrae, and
decreased number of lumbar vertebrae. In the rabbit study,
developmental effects (increases in post-implantation loss and
resorptions and decreases in fetal body weight) were also seen at
maternally toxic (decreased body weight gain and food consumption)
doses. Since the developmental effects are more severe than the
maternal effects, qualitative susceptibility is indicated in the rabbit
developmental study; however, the selected POD is protective of this
effect. In the 2-generation reproduction study in rats, toxicity to the
fetuses and offspring, when observed, occurred at equivalent or higher
doses than in the maternal and parental animals.
    In an acute neurotoxicity study in rats, reduced fore-limb grip
strength was observed on day one in males at the lowest-observed-
adverse-effect-level of 200 mg/kg (LOAEL), and clinical signs of
neurotoxicity were observed in females only at the highest dose tested
(2,000 mg/kg). In a subchronic neurotoxicity study in rats, decreased
hind limb strength was observed in males only at doses >=17.5 mg/kg/
day. The effects observed in acute and subchronic neurotoxicity studies
are transient with no histologic findings.
    Although there is some evidence that difenoconazole affects
antibody levels at doses that cause systemic toxicity, there are no
indications in the available studies that organs associated with immune
function, such as the thymus and spleen, are affected by
difenoconazole. Difenoconazole is not mutagenic, and no evidence of
carcinogenicity was seen in rats. Evidence for carcinogenicity was seen
in mice as induction of liver tumors at doses which were considered to
be excessively high for carcinogenicity testing. Difenoconazole has
been classified as ``Suggestive Evidence of Carcinogenic Potential''
based on liver tumors observed in mice at 46.3 mg/kg/day and higher,
the absence of tumors at two lower doses of 1.5 and 4.6 mg/kg/day,
respectively, excessive toxicity

observed at the two highest doses of 423 and 819 mg/kg/day,
respectively, the absence of genotoxicity, and no evidence of
carcinogenicity in rats. EPA has concluded that the chronic point of
departure (POD) for assessing chronic risk (0.96 mg/kg/day) will be
protective of any cancer effects for the following reasons: (1) Tumors
were seen in only one species; (2) carcinoma tumors were observed only
at the two highest doses (2,500 and 4,500 ppm) in the mouse
carcinogenicity study; (3) benign tumors and necrosis were observed at
the mid- dose (300 ppm) ; (4) the absence of tumors at the study's
lower doses (30 ppm); (5) the absence of genotoxic or mutagenic
effects. The cRfD of 0.96 mg/kg/day is well below the no-observed-
adverse-effect-level (NOAEL) of the mouse carcinogenicity study of 30
ppm (4.7 and 5.6 mg/kg/day in males and females, respectively), at
which no effects on the biological endpoints relevant to tumor
development (i.e., hepatocellular hypertrophy, liver necrosis, fatty
changes in the liver and bile stasis) were seen. As a result, EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to difenoconazole and a separate quantitative cancer
exposure assessment is unnecessary.
    Specific information on the studies received and the nature of the
adverse effects caused by difenoconazole 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 ``SUBJECT: Difenoconazole. Human Health
Risk Assessment for Proposed New Foliar Uses on Cranberry, Guava, and
Papaya. Expansion of Registered Foliar Use on Grape to Crop Subgroup
13-07F (Fruit, Small, Vine Climbing, Except Fuzzy Kiwifruit).
Conversion of Registered Foliar Uses on Crop Subgroups 5A and 5B to
Crop Group 5-16 (Vegetable, Brassica, Head and Stem), Crop Subgroup 4-
16B (Brassica, Leafy Greens (includes Watercress)), and Kohlrabi,
October 11, 2017'' at pp. 42-50 in docket ID number EPA-HQ-OPP-2016-
0254.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for difenoconazole used
for human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of April 2, 2015 (80 FR 17697) (FRL-
9923-82).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to difenoconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing difenoconazole
tolerances in 40 CFR 180.475. EPA assessed dietary exposures from
difenoconazole 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.
    Such effects were identified for difenoconazole. In estimating
acute dietary exposure, EPA used Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database DEEM-FCID which
incorporates consumption data from the United States Department of
Agriculture's (USDA) National Health and Nutrition Examination Survey,
What We Eat in America, (NHANES/WWEIA) conducted from 2003 to 2008. As
to residue levels in food, EPA assumed tolerance-level residues, 100
percent crop treated (PCT), and available empirical or DEEM (ver. 7.81)
default processing factors.
    ii. Chronic exposure. In conducting a refined chronic dietary
exposure assessment EPA used the food consumption data from USDA's
NHANES/WWEIA survey program. As to residue levels in food, EPA assumed
tolerance-level residues for some commodities, average field trial
residues and USDA Pesticide Data Program monitoring samples for the
remaining commodities, available empirical or DEEM (ver.7.81) default
processing factors, and average PCT assumptions for some commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to difenoconazole. Therefore, a separate quantitative
cancer exposure assessment is unnecessary since the chronic dietary
risk estimate will be protective of potential cancer risk.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    For the chronic dietary exposure analysis, the Agency used average
PCT

estimates for existing uses as follows: Almond 10%, apple 20%, apricot
10%, broccoli 2.5%, Brussels sprout 2.5%, cabbage 5%, cantaloupe 2.5%,
carrot 5%, cauliflower 2.5%, cherry 2.5%, cucumber 5%, garlic 5%, grape
10%, grapefruit 5%, hazelnut 1%, nectarine 2.5%, onion 5%, orange 2.5%,
pecan 2.5%, peach 2.5%, pear 10%, pepper 5%, pistachio 5%, plum 10%,
potato 20%, pumpkin 2.5%, soybean 2.5%, squash 5%, strawberry 2.5%,
sugar beet 15%, tangerine 2.5%, tomato 25%, walnut 1%, watermelon 5%,
and wheat 10%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT value for chronic dietary risk analysis.
The average PCT value for each existing use is derived by combining
available public and private market survey data for that use and
averaged across all observations and is rounded up to the nearest
multiple of 5%, for use in the analysis unless the average PCT value is
estimated at less than 2.5% or 1%, in which case the Agency uses 2.5%
or 1%, respectively, as the average PCT value in the analysis. EPA uses
a maximum PCT value for acute dietary risk analysis. The maximum PCT
value is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5% for use in
the analysis, unless the maximum PCT value is estimated at less than
2.5%, in which case the Agency uses 2.5% as the maximum PCT value in
the analysis.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which difenoconazole may be applied in a particular area.
    2. Dietary exposure from drinking water. The drinking water
assessment was performed using a total toxic residue method, which
considers both parent difenoconazole and its major metabolite, CGA
205375, or total toxic residues (TTR) from difenoconazole uses, in
surface and groundwater. The Agency used screening level water exposure
models in the dietary exposure analysis and risk assessment for
difenoconazole and CGA 205375 in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of difenoconazole, plus CGA 205375. 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 Tier II Pesticide in Water Calculator (PWC v1.52)
model and Tier 1 Rice Model, the estimated drinking water
concentrations (EDWCs) of TTR of difenoconazole for acute exposures are
estimated to be 33.4 parts per billion (ppb) for surface water and 2.0
ppb for ground water. For chronic exposures EDWCs of TTR of
difenoconazole for non-cancer assessments are estimated to be 27.8 ppb
for surface water and 0.60 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 33.4 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 27.8 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).
    Difenoconazole is currently registered for the following uses that
could result in residential exposures: Treatment of ornamental plants
in commercial and residential landscapes and interior plantscapes. EPA
assessed residential exposure using the following assumptions: For
residential handlers, adult short-term dermal and inhalation exposure
is expected from mixing, loading, and applying difenoconazole on
ornamentals (gardens and trees). For residential post-application
exposures, short-term dermal exposure is expected for both adults and
children from post-application activities in treated residential
landscapes.
    The scenarios used in the aggregate assessment were those that
resulted in the highest exposures. The highest exposures consist of the
short-term dermal exposure to adults from post-application activities
in treated gardens and short-term dermal exposure to children 6 to 11
years old from post-application activities in treated gardens. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at http://www2.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.''
    Difenoconazole is a member of the conazole class of fungicides
containing the 1,2,4-triazole moiety. Although conazoles act similarly
in plants (fungi) by inhibiting ergosterol biosynthesis, there is not
necessarily a relationship between their pesticidal activity and their
mechanism of toxicity in mammals. Structural similarities do not
constitute a common mechanism of toxicity. Evidence is needed to
establish that the chemicals operate by the same, or essentially the
same, sequence of major biochemical events (EPA, 2002).
    In conazoles, however, a variable pattern of toxicological
responses is found; some are hepatotoxic and hepatocarcinogenic in
mice. Some induce thyroid tumors in rats. Some induce developmental,
reproductive, and neurological effects in rodents. Furthermore, the
conazoles produce a diverse range of biochemical events including
altered cholesterol levels, stress responses, and altered DNA
methylation. It is not clearly understood whether these biochemical
events are directly connected to their toxicological outcomes. Thus,
there is currently no evidence to indicate that difenoconazole shares a
common mechanism of toxicity with any other conazole pesticide, and

EPA is not following a cumulative risk approach for this tolerance
action. For information regarding EPA's procedures for cumulating
effects from substances found to have a common mechanism of toxicity,
see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
    Difenoconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
conjugated triazole metabolites (triazolylalanine and triazolylacetic
acid). To support existing tolerances and to establish new tolerances
for triazole-containing pesticides, including difenoconazole, EPA
previously conducted a human health risk assessment for exposure to
1,2,4-triazole, triazolylalanine, and triazolylacetic acid resulting
from existing and pending uses of any triazole-containing fungicide.
The risk assessment is a highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). The Agency retained a 3X
for the LOAEL to NOAEL safety factor when the reproduction study was
used. In addition, the Agency retained a 10X for the lack of studies
including a developmental neurotoxicity (DNT) study. The assessment
includes evaluations of risks for various subgroups, including those
comprised of infants and children. The Agency's complete risk
assessment is found in the propiconazole reregistration docket at
http://www.regulations.gov, docket ID number EPA-HQ-OPP-2005-0497.
    The Agency's latest updated aggregate risk assessment for the
triazole-containing metabolites was finalized on July 18, 2017 and
includes the new uses in this rule. It is titled, ``Common Triazole
Metabolites: Updated Aggregate Human Health Risk Assessment to Address
the New Section 3 Registrations for Use of Difenoconazole and
Tetraconazole.'' Aggregate risk estimates associated with 1,2,4-
triazole (T) and the conjugated triazole metabolites (i.e., combined
residues of triazolylalanine (TA) and triazolylacetic acid (TAA)), are
below the Agency's level of concern. There are no human health risk
issues for these metabolites that would preclude the new uses of
difenoconazole. The assessment may be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2016-0254.

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 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.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicology database for difenoconazole includes rat and rabbit prenatal
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. The available Agency guideline studies indicated no
increased qualitative or quantitative susceptibility of rats to in
utero and/or postnatal exposure to difenoconazole. In the prenatal
developmental toxicity studies in rats and rabbits and the 2-generation
reproduction study in rats, toxicity to the fetuses/offspring, when
observed, occurred at equivalent or higher doses than in the maternal/
parental animals. In a rat developmental toxicity study developmental
effects were observed at doses higher than those which caused maternal
toxicity. In the rabbit study, developmental effects (increases in
post-implantation loss and resorptions and decreases in fetal body
weight) were also seen at maternally toxic doses (decreased body weight
gain and food consumption). Since the developmental effects are more
severe than the maternal effects, qualitative susceptibility is
indicated in the rabbit developmental study; however, the selected POD
is protective of this effect. In the 2-generation reproduction study in
rats, toxicity to the fetuses/offspring, when observed, occurred at
equivalent or higher doses than in the maternal/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 difenoconazole is complete.
    ii. There are no clear signs of neurotoxicity following acute,
subchronic or chronic dosing in multiple species in the difenoconazole
database. The effects observed in acute and subchronic neurotoxicity
studies are transient and showed in one sex (males as reduced fore-limb
grip strength with no histologic findings), and the selected endpoints
of toxicity for risk assessment are protective of any potential
neurotoxicity. Based on the toxicity profile, and lack of concern for
neurotoxicity, there is no need for a developmental neurotoxicity study
or additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that difenoconazole 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. The qualitative susceptibility seen in the rabbit developmental
study is adequately protected by the selected POD.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary risk assessment utilized tolerance-level
residues and 100 PCT for the acute assessment; a refined chronic
assessment incorporated USDA PDP monitoring data, average field-trial
residues for some commodities, tolerance-level residues for remaining
commodities, and average PCT for some commodities. These assumptions
will not underestimate dietary exposure to difenoconazole. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to difenoconazole in drinking water.
EPA used similarly conservative assumptions to assess post application
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by difenoconazole.

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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to difenoconazole will occupy 52% of the aPAD for all infants <1 year
old, the

population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
difenoconazole from food and water will utilize 51% of the cPAD for all
infants <1year 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
difenoconazole 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).
Difenoconazole 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 difenoconazole.
    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 aggregate MOEs of
250 for children and 180 for adults. Because EPA's level of concern for
difenoconazole 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). An intermediate-term adverse effect was identified; however,
difenoconazole is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
difenoconazole.
    5. Aggregate cancer risk for U.S. population. Based on the data
summarized in Unit III.A., the chronic dietary risk assessment is
protective of any potential cancer effects. Based on the results of
that assessment, EPA concludes that difenoconazole 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 difenoconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the
tolerance expression. An adequate enforcement method, gas
chromatography with nitrogen-phosphorus detection (GC/NPD) method AG-
575B, is available for the determination of residues of difenoconazole
per se in/on plant commodities. An adequate enforcement method, GC/MSD
method AG-676A, is also available for the determination of residues of
difenoconazole per se in/on canola and barley commodities. A
confirmatory method, GC/MSD method AG-676, is also available. The Limit
of Quantitation (LOQs) are 0.01-0.05 ppm.
    The methods 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.
    The Codex has established MRLs for difenoconazole in/on papaya at
0.2 ppm; grape at 3 ppm (a crop member of fruit, small, vine climbing,
except fuzzy kiwifruit crop subgroup 13-07F); dried grapes at 6 ppm;
and broccoli, Brussels sprouts, cabbage and cauliflower at 2 ppm (crop
members of vegetables, Brassica, head and stem crop group 5-16). The
U.S. tolerances are harmonized with these Codex MRLs with the exception
of the U.S. tolerance at 0.60 ppm in/on papaya due to differences in
U.S. good agricultural practices (GAP) and concerns that the Codex MRL
in/on papaya at 0.2 ppm is too low to cover residues in/on U.S. papaya
commodities treated in accordance with approved label directions for
difenoconazole.

C. Revisions to Petitioned-for Tolerances

    EPA is establishing the tolerance for Fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 3.0 ppm rather than the
requested 4.0 ppm for harmonization with the currently established
Codex MRL for residues of difenoconazole in/on grape which reflects
U.S. GAP. In addition, EPA corrected the tolerance level to include an
additional significant figure for cranberry and papaya from the
requested 0.6 ppm to 0.60 ppm. This is to avoid the situation where
rounding of an observed residue to the level of precision of the
tolerance expression would be considered non-violative (such as 0.64
ppm being rounded to 0.6 ppm).

V. Conclusion

    Therefore, tolerances are established for residues of the fungicide
difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methy-1,3-
dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on Brassica, leafy
greens, subgroup 4-16B at 35 ppm; Cranberry at 0.60 ppm; Fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 3.0 ppm;
Guava at 3.0 ppm; Kohlrabi at 2.0 ppm; Papaya at 0.60 ppm; and
Vegetable, Brassica, head and stem, group 5-16 at 2.0 ppm. In addition,
established tolerances for ``Brassica, head and stem, subgroup 5A'';
``Brassica, leafy greens, subgroup 5B''; ``Grape''; ``Papaya''; and
``Turnip, greens'' are removed because they are superseded by the
tolerances being established in this action.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or 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: December 27, 2017.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    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.  180.475, paragraph (a)(1):
0
a. Remove the entries for ``Brassica, head and stem, subgroup 5A'' and
``Brassica, leafy green, subgroup 5B'';
0
b. Add alphabetically the entry for ``Brassica, leafy greens, subgroup
4-16B'';
0
c. Add alphabetically the entries for ``Cranberry'' and ``Fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F'';
0
d. Remove the entry for ``Grape'';
0
e. Add alphabetically the entries for ``Guava'' and ``Kohlrabi'';
0
f. Revise the entry for ``Papaya'';
0
g. Remove the entry for ``Turnip, greens''; and
0
h. Add alphabetically the entry for ``Vegetable, Brassica, head and
stem, group 5-16''.
    The additions and revision read as follows:

Sec.  180.475   Difenoconazole; tolerances for residues.

    (a) * * * (1) * * *

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

                              * * * * * * *
Brassica, leafy greens, subgroup 4-16B..................              35

                              * * * * * * *
Cranberry...............................................            0.60

                              * * * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit,                 3.0
 subgroup 13-07F........................................

                              * * * * * * *
Guava...................................................             3.0
Kohlrabi................................................             2.0

                              * * * * * * *
Papaya..................................................            0.60

                              * * * * * * *
Vegetable, Brassica, head and stem, group 5-16..........             2.0

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

* * * * *
[FR Doc. 2018-01479 Filed 1-25-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31993-31994]
[FR Doc No: 2016-11874]

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

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request; Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736

Extension:
    Industry Guides, SEC File No. 270-069, OMB Control No. 3235-
0069.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this requests for extension of the previously approved
collections of information discussed below.
    Industries Guides are used by registrants in certain industries as
disclosure guidelines to be followed in presenting information to
investors in registration statements and reports under the Securities
Act (15 U.S.C. 77a et seq.) and Exchange Act (15 U.S.C. 78a et seq.).
The paperwork burden from the Industry Guides is imposed through the
forms that are subject to the disclosure requirements in the Industry
Guides and is reflected in the analysis of these documents. To avoid a
Paperwork Reduction Act inventory reflecting duplicative burdens and
for administrative convenience, the Commission estimates the total
annual burden imposed by the Industry Guides to be one hour. The
information required by the Industry Guides is filed on occasion and is
mandatory. All information is provided to the public. The Industry
Guides do not directly impose any disclosure burden.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the

Securities and Exchange Commission, Office of Information and
Regulatory Affairs, Office of Management and Budget, Room 10102, New
Executive Office Building, Washington, DC 20503, or by sending an email
to<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    Dated: May 16, 2016.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-11874 Filed 5-19-16; 8:45 am]
BILLING CODE 8011-01-P