[Federal Register Volume 78, Number 6 (Wednesday, January 9, 2013)]
[Notices]
[Pages 1889-1892]
[FR Doc No: 2013-00200]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68573; File No. SR-C2-2012-043]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change,
as Modified by Amendment No. 1 Thereto, To Adopt a HAL System

January 3, 2013.
    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 December 21, 2012, C2 Options Exchange, Incorporated (the
``Exchange'' or ``C2'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been prepared by the
Exchange. On January 2, 2013, the Exchange submitted Amendment No. 1 to
the

proposed rule change.\3\ 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\ In Amendment No. 1, the Exchange modified the description of
the proposed rule change to reflect the proposed rule text that
provides that HAL will be open to all Trading Permit Holders.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to adopt a HAL system. The text of the
proposed rule change is provided in Exhibit 5. The text of the proposed
rule change is also available on the Exchange's Web site (http://www.c2exchange.com/Legal/ Legal/), at the Exchange's Office of the Secretary,
and at the Commission.

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

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

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

1. Purpose
    The Exchange proposes to adopt a rule that governs the operation of
its new HAL system (``HAL''). HAL is a feature within the C2 System
that provides automated order handling in designated classes for
qualifying electronic orders that are not automatically executed by the
System. Regarding HAL eligibility, the Exchange shall designate
eligible order size, eligible order type, eligible order origin code
(i.e., public customer orders, non-Market Maker broker-dealer orders,
and Market Maker broker-dealer orders), and classes in which HAL shall
be activated. HAL shall automatically process upon receipt: (i) An
eligible order that is marketable against the Exchange's disseminated
quotation while that quotation is not the national best bid or offer
(``NBBO''), unless the Exchange's quotation contains resting orders and
does not contain sufficient Market-Maker quotation interest to satisfy
the entire order; (ii) an eligible order that would improve the
Exchange's disseminated quotation and that is marketable against
quotations disseminated by other exchanges that are participants in the
Options Order Protection and Locked/Crossed Market Plan (the ``Linkage
Plan''); or (iii) an order submitted to HAL as a result of the price
check parameters of Rule 6.17.
    For order handling and responses regarding HAL, orders that are
received by HAL pursuant to the paragraph above shall immediately upon
receipt be electronically exposed at the NBBO price. The exposure shall
be for a period of time determined by the Exchange on a class-by-class
basis, which period of time shall not exceed one second. All Trading
Permit Holders (``TPHs'') may submit responses to the exposure message
during the exposure period. Responses (i) must be priced equal to or
better than the Exchange's best bid/offer; (ii) must be limited to the
size of the order being exposed; and (iii) may be cancelled and/or
replaced any time during the exposure period.
    Regarding the allocation of exposed orders, any responses priced at
the prevailing NBBO or better shall immediately trade against the order
(on a first come, first served basis). At the conclusion of the
exposure period, the Exchange will evaluate all remaining responses as
well as the disseminated best bid/offer on other exchanges and execute
any remaining portion of the exposed order to the fullest extent
possible at the best price(s) by first executing against responses
(pursuant to the matching algorithm in effect for the class except that
the participation entitlement and market turner status shall not apply
to responses), and, second, routing Immediate-or-Cancel (``IOC'')
Intermarket Sweep Orders (``ISOs'') to other exchanges. Any portion of
a routed IOC ISO that returns unfilled shall trade against the
Exchange's best bid/offer unless another exchange is quoting at a
better price in which case new IOC ISOs shall be generated and routed
to trade against such better prices. Any executions at the Exchange's
best bid/offer will first trade against interest that was resting at
the price at the time the exposed order was received, and any remaining
balance will trade against all new interest at that price (in both
cases pursuant to the matching algorithm for that class). All
executions on the Exchange pursuant to this paragraph shall comply with
Rule 6.81. Executions will be subject to price check parameters set
forth in Rule 6.17 when such price check functionality is enabled.
    Regarding the early termination of the exposure period, in addition
to the receipt of a response to trade the entire exposed order at the
NBBO or better, the exposure period will also terminate early under the
following circumstances: (i) If during the exposure period the Exchange
receives an unrelated order (or quote) on the opposite side of the
market from the exposed order that could trade against the exposed
order at the prevailing NBBO price or better, then the orders will
trade at the prevailing NBBO price unless the unrelated order is a
customer order in which case the orders will trade at the midpoint of
the unrelated order's limit price and the prevailing NBBO. The exposure
period shall not terminate if a quantity remains on the exposed order
after such trade; (ii) If during the exposure period the Exchange
receives an unrelated order on the same side of the market as the
exposed order that is priced equal to or better than the exposed order,
then the exposure period shall terminate and the exposed order shall be
processed in accordance with paragraph (c) (which regards allocation of
exposed orders); (iii) If during the exposure of an order that is
marketable against the Exchange's best bid/offer at the time the order
was exposed (``Exchange Initial BBO''), Market-Maker interest at the
Exchange Initial BBO decrements to a contract size equal to the size of
the exposed order, then the exposure period shall terminate and the
exposed order shall be processed in accordance with paragraph (c)
(which regards allocation of exposed orders).
    The purpose of the proposed change is to provide C2 TPHs with the
opportunity to improve their prices and ``step up'' to meet the NBBO in
order to interact with orders sent to the Exchange. This will allow the
market participant sending an order to C2 to increase its chances of
receiving an execution at C2 (the market participant's chosen venue)
instead of having the order be routed to another exchange. This ``step
up'' process allows market participants to take into account factors
beyond just disseminated prices, such as execution costs, system
reliability, and quality of service, when determining the exchange to
which to route an order. A market participant that prefers C2 due to
some combination of these other factors will know that, even if C2 is
not displaying a price that is the NBBO, the market participant may
still receive an execution at C2 because a C2 TPH may ``step up'' to
match the NBBO.
    Further, HAL and the ``step up'' process enable C2 TPHs to add
liquidity that is available to interact with orders sent to the
Exchange. Indeed, when a C2 TPH ``steps up'' to match the NBBO that is
displayed on another exchange, more

contracts may be executed at this NBBO price here on C2 than are
available at that same price on the other exchange.
    C2's proposed HAL and the ``step up'' process are not novel
concepts. C2's proposed HAL is nearly identical to the Hybrid Agency
Liaison (``CBOE HAL'') offered on the Chicago Board Options Exchange,
Incorporated (``CBOE''), which provides the same manner of ``step up''
process. There are a couple of differences between CBOE HAL and the
proposed C2 HAL. First, CBOE HAL operates on CBOE's Hybrid Trading
System, which combines both open outcry and electronic trading, whereas
the proposed C2 HAL would be entirely electronic (as C2 is an all-
electronic exchange). The proposed C2 HAL rule does not incorporate the
minimal CBOE HAL language regarding Hybrid.\4\
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    \4\ See CBOE Rule 6.14A.
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    Second, on CBOE HAL, only Market-Makers with an appointment in the
relevant option class and TPHs acting as agent for orders resting at
the top of CBOE's book in the relevant option series opposite the order
submitted to CBOE HAL may submit responses to the exposure message
during the exposure period (unless CBOE determines, on a class-by-class
basis, to allow all TPHs to submit responses to the exposure message).
C2 has determined that, on its proposed C2 HAL, all TPHs may submit
responses to the exposure message during the exposure period. As such,
Interpretation and Policy .01 to CBOE Rule 6.14A (the CBOE rule
regarding HAL), which prohibits the redistribution of exposure messages
to market participants not eligible to respond to such messages (except
in classes in which CBOE allows all TPHs to respond to such messages)
does not apply to the proposed C2 HAL, as all C2 TPHs are permitted to
respond to all exposure messages. Despite these differences, the
proposed C2 HAL would otherwise operate in an identical manner to the
CBOE HAL, which has been approved by the Securities and Exchange
Commission (the ``Commission'').\5\
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    \5\ See Securities Exchange Act Release No. 60551 (August 20,
2009), 74 FR 43196 (August 26, 2009) (SR-CBOE-2009-040).
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    The Exchange believes that the Commission has always been clear
that honoring better prices on other markets can be accomplished by
matching those better prices.\6\ The proposed HAL and a ``step up''
process would allow C2 TPHs to do just that. And if a C2 market
participant wants to ensure that an order does not go through the
proposed HAL process, that market participant can submit an Immediate-
or-Cancel order (which is not exposed to HAL).
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    \6\ For example, in adopting the Order Protection Rule (Rule
611) under Regulation NMS in 2005, the Commission stated: ``The
Order Protection Rule generally requires that trading centers match
the best quoted prices, cancel orders without an execution, or route
orders to the trading centers quoting the best prices.'' See
Securities Exchange Act Release No. 51808 (June 9, 2005), 70 FR
37496 (June 29, 2005), at 37525 (S7-10-04).
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    The Exchange also proposes to adopt Interpretation and Policy .01
to new Rule 6.18, which will state that the Exchange may determine, on
a class-by-class basis, to not route ISOs to other exchanges on behalf
of non-public customer orders that are exposed pursuant to this Rule.
In such cases, any unexecuted balance of such non-public customer
orders shall be cancelled at the conclusion of the exposure period.
Under the Linkage Plan, the Exchange is not obligated to route orders
to another exchange; the Linkage Plan only requires that C2 not trade
through a better price at another exchange. In certain circumstances,
particularly with orders of non-public customer market participants,
the Exchange may elect not to route an order to another exchange in
order to not incur the costs associated with routing such order.
    The Exchange also proposes to adopt Interpretation and Policy .02
to new Rule 6.18, which will state that all pronouncements regarding
determinations by the Exchange pursuant to Rule 6.18 and the
Interpretations and Policies thereunder will be announced to Trading
Permit Holders via Regulatory Circular. This method of notification
will allow the Exchange to promptly inform TPHs of any new or
modification to any determinations made by the Exchange.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\7\ Specifically, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \8\ requirements that the rules of
an exchange be designed to promote just and equitable principles of
trade, to prevent fraudulent and manipulative acts, to remove
impediments to and to perfect the mechanism for a free and open market
and a national market system, and, in general, to protect investors and
the public interest.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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    Adopting HAL, a ``step up'' program, on C2 will provide TPHs with
the opportunity to improve their prices to match the NBBO in order to
interact with orders sent to the Exchange. This will allow the market
participant sending an order to C2 to increase its chances of receiving
an execution at C2 (the market participant's chosen venue) instead of
having the order be routed to another exchange. This ``step up''
process allows market participants to take into account factors beyond
just disseminated prices, such as execution costs, system reliability,
and quality of service, when determining the exchange to which to route
an order. A market participant that prefers C2 due to some combination
of these other factors will know that, even if C2 is not displaying a
price that is the NBBO, the market participant may still receive an
execution at C2 because a C2 TPH may ``step up'' to match the NBBO.
Therefore, the fact that HAL allows a market participant who elects to
send an order to C2 to have a greater likelihood of achieving execution
at this chosen venue without the risk of paying a lower price removes
an impediment to and perfects the mechanism for a free and open
national market system.
    Further, HAL and the ``step up'' process enable C2 TPHs to add
liquidity that is available to interact with orders sent to the
Exchange. Indeed, when a C2 TPH ``steps up'' to match the NBBO that is
displayed on another exchange, more contracts may be executed at this
NBBO price here on C2 than are available at that same price on the
other exchange. This increased liquidity benefits all market
participants on C2, thereby perfecting the mechanism for a free and
open national market system and protecting investors and the public
interest.
    C2's proposed HAL is nearly identical to CBOE HAL, which provides
the same manner of ``step up'' process. The only differences between
CBOE HAL and the proposed C2 HAL are that (1) CBOE HAL operates on
CBOE's Hybrid Trading System, which combines both open outcry and
electronic trading, whereas the proposed C2 HAL would be entirely
electronic (as C2 is an all-electronic exchange), and (2) the proposed
C2 HAL will be open to all C2 TPHs.\9\ Despite these differences, the
proposed C2 HAL would otherwise operate in an identical manner to the
CBOE HAL, which has been approved

by the Commission.\10\ As such, C2 merely desires to adopt a mechanism
that is nearly identical to one that already exists on CBOE. Permitting
C2 to operate on an even playing field relative to other exchanges
removes impediments to and to perfects the mechanism for a free and
open market and a national market system.
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    \9\ On CBOE HAL, only Market-Makers with an appointment in the
relevant option class and Trading Permit Holders acting as agent for
orders resting at the top of CBOE's book in the relevant option
series opposite the order submitted to CBOE HAL may submit responses
to the exposure message during the exposure period (unless CBOE
determines, on a class-by-class basis, to allow all TPHs to submit
responses to the exposure message).
    \10\ See Securities Exchange Act Release No. 60551 (August 20,
2009), 74 FR 43196 (August 26, 2009) (SR-CBOE-2009-040).
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    The Commission has always been clear that honoring better prices on
other markets can be accomplished by matching those better prices.\11\
The proposed HAL and a ``step up'' process would allow C2 TPHs to do
just that.
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    \11\ For example, in adopting the Order Protection Rule (Rule
611) under Regulation NMS in 2005, the Commission stated: ``The
Order Protection Rule generally requires that trading centers match
the best quoted prices, cancel orders without an execution, or route
orders to the trading centers quoting the best prices.'' See
Securities Exchange Act Release No. 51808 (June 9, 2005), 70 FR
37496 (June 29, 2005), at 37525 (S7-10-04).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    C2 does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The proposed C2 HAL is open to
all market participants. The ``step-up'' feature of the proposed C2 HAL
allows for price improvement. When such price improvement is achieved
via this ``stepping up'' to meet (or beat) the best quoted price at
another exchange, market participants are able to receive the best
quoted price while still achieving execution on C2, the exchange to
which they elected to send their orders.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    Because the foregoing proposed rule change does not:
    A. significantly affect the protection of investors or the public
interest;
    B. impose any significant burden on competition; and
    C. become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) of the Act \12\ and
Rule 19b-4(f)(6) \13\ thereunder. 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.
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6).
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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-C2-2012-043 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-C2-2012-043. 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 NW.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-C2-2012-043, and should be
submitted on or before January 30, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-00200 Filed 1-8-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Rules and Regulations]
[Pages 19965-19968]
[FR Doc No: 2018-09667]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0376]
RIN 1625-AA00

Safety Zone; Neches River, Beaumont, TX

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule; request for comments.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
navigable waters of the Neches River extending 500-feet on either side
of the Kansas City Southern Railroad Bridge that crosses the Neches
River in Beaumont, TX. The safety zone is necessary to protect the
bridge as well as persons and property on or near the bridge from
potential damage from passing vessels until missing and/or damaged
fendering systems are repaired or replaced. Entry of certain vessels or
persons into this zone is prohibited unless specifically authorized by
the Captain of the Port Marine Safety Unit Port Arthur or a designated
representative. We invite your comments on this rule.

DATES: This rule is effective without actual notice from May 7, 2018
through midnight on August 31, 2018. For the purposes of enforcement,
actual notice will be used from May 1, 2018 through May 7, 2018.
Comments and related material must be received before May 29, 2018.

ADDRESSES: You may submit comments identified by docket number USCG-
2018-0376 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comment'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments. To view documents mentioned in
this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0376 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 Mr. Scott Whalen, Marine Safety Unit Port Arthur, U.S.
Coast Guard; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Marine Safety Unit Port Arthur
DHS Department of Homeland Security
FR Federal Register
KCS Kansas City Southern Railroad Company
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
VTS Vessel Traffic Service

II. Background Information and Regulatory History

    On April 19, 2018, the Coast Guard was notified that the wood
fendering systems designed to protect bridge support columns of the
Kansas City Southern Railroad Company's bridge (KSC) from strikes by
vessels transiting under the bridge had been damaged or destroyed by
Hurricane Harvey. The south bank column protection fenders are missing
and the north bank column protection fenders are severely damaged. KCS
indicated that strikes to the support columns could compromise the
bridge structure.
    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)(3)(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. The
fendering systems protecting the bridge from strikes by passing marine
traffic are missing or severely damaged and we must establish this
safety zone immediately to protect the bridge and those persons that
use the bridge. The Coast Guard is providing an opportunity to comment
while the rule is in effect and may amend the rule after it becomes
effective, if necessary.
    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 impracticable and contrary to the public interest
because immediate action is needed to respond to potential safety
hazards posed by and to passing vessel traffic by and to the
unprotected bridge columns supporting the KCS Bridge.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Marine Safety Unit Port Arthur (COTP) has
determined that potential hazards posed by the unprotected bridge
columns are a safety concern to the KCS Bridge and to persons and
property on or near the bridge. The purpose of this rule is to provide
for the safety of the KCS Bridge and persons and property on or near
the bridge.

IV. Discussion of the Rule

    This rule establishes a safety zone from 1 p.m. on May 1, 2018
through midnight on August 31, 2018 until missing and/or damaged
fendering systems are repaired or replaced, whichever occurs first. The
safety zone will extend 500-feet on either side of the KCS Bridge that
crosses the Neches River in Beaumont, TX in approximate location
30[deg] 04'54.8'' N 094[deg]05'29.4'' W. The duration of the zone is
intended to protect the bridge support columns as well as persons and
property on or near the bridge until the bridge fendering is repaired
or replaced. Only vessels less than 65 feet in length and not engaged
in towing are authorized to enter the zone, unless otherwise permitted
by the COTP or a designated representative are permitted to enter the
safety zone.
    Persons and vessels not permitted to enter the safety zone must
request permission from the COTP or a designated representative. They
may be contacted through Vessel Traffic Service (VTS) on channels 65A
or 13 VHF-FM, or by telephone at<PHONE_NUMBER>.
    Permission to transit through the bridge will be based on weather,
tide and current conditions, vessel size, horsepower, and availability
of assist vessels. All persons and vessels permitted to enter this
temporary safety zone shall comply with the lawful orders or directions
given to them by COTP or a designated representative.
    Intentional or unintentional contact with any part of the bridge or
associated structure, including fendering systems, support columns,
spans or any other portion of the bridge, is strictly prohibited.
Report any contact with the bridge or associated structures immediately
to VTS Port Arthur on channels 65A, 13 or 16 VHF-FM or by telephone at
(409) 719-5070.
    The Coast Guard will inform the public through public of the
effective period of this safety zone through VTS Advisories, Broadcast
Notices to Mariners (BNMs), Local Notice 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 as 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, location
and duration of the safety zone. This rule will only affect certain
vessels transiting the upper reaches of the Neches River in Beaumont,
TX. The Coast Guard will issue a VTS Advisory concerning the zone, and
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
contact 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 contact 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 Commandant Instruction M16475.1D, 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 that will prohibit entry within 500-feet of either side
of the KCS Bridge that crosses the Neches River in Beaumont, TX. It is
categorically excluded from further review under paragraph L60(d) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. 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 contact 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.

VI. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. The Coast Guard may amend this temporary final rule if we
receive comments from the public that indicate that a change is
warranted. If you submit a comment, please include the docket number
for this rulemaking, indicate the specific section of this document to
which each comment applies, and provide a reason for each suggestion.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit http://www.regulations.gov/privacyNotice.
    Documents mentioned in this temporary final rule as being available
in the docket, and all public comments, will be in our online docket at
http://www.regulations.gov and can be viewed by following that
website's instructions. Additionally, if you go to the online docket
and sign up for email alerts, you will be notified when comments are
posted.

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: 33 U.S.C. 1231; 50 U.S.C. 191; 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.T08-0376 to read as follows:

Sec.  165.T08-0376  Safety Zone; Neches River, Beaumont, TX.

    (a) Location. The following area is a safety zone: all navigable
waters extending 500-feet on either side of the Kansas City Southern
Railroad Bridge that crosses the Neches River in Beaumont, TX in
approximate location 30[deg]04'54.8'' N 094[deg]05'29.4'' W.
    (b) Effective period. This section is effective from 1 p.m. on May
1, 2018 through midnight on August 31, 2018 or until missing and/or
damaged fendering systems are repaired or replaced, whichever occurs
first.
    (c) Regulations. (1) No vessel may enter or remain in the safety
zone except:
    (i) A vessel less than 65 feet in length and not engaged in towing;
or
    (ii) A vessel authorized by the Captain of the Port Marine Safety
Unit Port Arthur (COTP) or a designated representative
    (2) Persons and vessels not permitted to enter the safety zone must
request permission from the COTP or a designated representative. They
may be contacted through Vessel Traffic Service (VTS) on channels 65A
or 13 VHF-FM, or by telephone at<PHONE_NUMBER>.
    (3) Permission to transit through the bridge will be based on
weather, tide and current conditions, vessel size, horsepower, and
availability of assist vessels. All persons and vessels permitted to
enter this temporary safety zone shall comply with the lawful orders or
directions given to them by COTP or a designated representative.
    (4) Intentional or unintentional contact with any part of the
bridge or associated structure, including

fendering systems, support columns, spans or any other portion of the
bridge, is strictly prohibited. Report any contact with the bridge or
associated structures immediately to VTS Port Arthur on channels 65A,
13 or 16 VHF-FM or by telephone at<PHONE_NUMBER>.
    (d) Informational broadcasts. The Coast Guard will inform the
public of the effective period of this safety zone through VTS
Advisories, Broadcast Notices to Mariners (BNMs), Local Notice to
Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs) as
appropriate.

    Dated: May 1, 2018.
Jacqueline Twomey,
Captain, U.S. Coast Guard, Captain of the Port Marine Safety Unit Port
Arthur.
[FR Doc. 2018-09667 Filed 5-4-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: June 5, 2008 (Volume 73, Number 109)]
[Notices]
[Page 32041]
[DOCID:fr05jn08-73]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1763-DR]

Iowa; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Iowa (FEMA-1763-DR), dated May 27, 2008, and
related determinations.

DATES: Effective Date: May 27, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, Washington, DC 20472,
(202) 646-2705.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated May 27, 2008, the President declared a major disaster under the
authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows:

    I have determined that the damage in certain areas of the State
of Iowa resulting from severe storms, tornadoes, and flooding
beginning on May 25, 2008, and continuing, is of sufficient severity
and magnitude to warrant a major disaster declaration under the
Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121-5206 (the Stafford Act). Therefore, I declare that such
a major disaster exists in the State of Iowa.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance and
assistance for emergency protective measures (Category B), limited
to direct Federal assistance, under the Public Assistance program in
the designated areas; Hazard Mitigation throughout the State; and
any other forms of assistance under the Stafford Act that you deem
appropriate subject to completion of Preliminary Damage Assessments
(PDAs), unless you determine that the incident is of such unusual
severity and magnitude that PDAs are not required to determine the
need for supplemental Federal assistance pursuant to 44 CFR
206.33(d).
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation, and Other Needs Assistance will be limited to 75
percent of the total eligible costs. Federal funds provided under
the Stafford Act for Public Assistance also will be limited to 75
percent of the total eligible costs, except for any particular
projects that are eligible for a higher Federal cost-sharing
percentage under the FEMA Public Assistance Pilot Program instituted
pursuant to 6 U.S.C. 777.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, William
L. Vogel, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared disaster.
    I do hereby determine the following area of the State of Iowa to
have been affected adversely by this declared major disaster:

    Butler County for Individual Assistance.
    Butler County for emergency protective measures (Category B),
limited to direct Federal assistance, under the Public Assistance
program.
    All counties within the State of Iowa are eligible to apply for
assistance under the Hazard Mitigation Grant Program.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services Program; 97.034,
Disaster Unemployment Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individual and Household Housing; 97.049,
Individual and Household Disaster Housing Operations; 97.050,
Individual and Household Program--Other Needs; 97.036, Public
Assistance Grants; 97.039, Hazard Mitigation Grant Program.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-12527 Filed 6-4-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register: August 23, 2006 (Volume 71, Number 163)]
[Rules and Regulations]
[Page 49350-49354]
[DOCID:fr23au06-14]

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

40 CFR Part 180

[EPA-HQ-OPP-2006-0165; FRL-8079-3]

Dimethenamid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
dimethenamid in or on leek;onion, green; onion,Welsh; shallot, fresh
leaves. Interregional Research Project No.4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 23, 2006. Objections and
requests for hearings must be received on or before October 23, 2006,
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:  EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0165. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

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

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing

Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr. To access

the OPPTS Harmonized Guidelines referenced in this document, go
directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2006-0165 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 23, 2006.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0165, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of March 22, 2006 (71 FR 14521) (FRL-7766-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4E6844) by Interregional Research Project No. 4 (IR-4), Technology
Center of New Jersey, Rutgers, the State University of New Jersey, 681
U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The
petition requested that 40 CFR 180.464 be amended by establishing a
tolerance for residues of the herbicide dimethenamid, (R,S)-2-chloro-N-
[(1-methyl-2-methoxy) ethyl]-N-(2,4-dimethylthien-3-yl)-acetamide in or
on the raw agricultural commodities: onion, green at 0.01 parts per
million (ppm); leek at 0.01 ppm; onion, Welsh at 0.01 ppm; and shallot,
fresh leaves at 0.01 ppm. That notice included a summary of the
petition prepared by BASF Corporation, the registrant. There were no
comments received in response to the notice of filing.
    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....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of dimethenamid,
(R,S)-2-chloro-N-(1-methyl-2-methoxy) ethyl-N-(2,4-dimethylthien-3-yl)-
acetamide in or on the raw agricultural commodities: onion, green at
0.01 ppm; leek at 0.01 ppm; onion, Welsh at 0.01 ppm; and shallot,
fresh leaves at 0.01 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by dimethenamid 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.epa.gov/fedrgstr/EPA-PEST/2004/September/Day-24/p21501.htm
.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for dimethenamid used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of September 24, 2004 (69 FR 57197)
(FRL-7680-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.464) for the residues of dimethenamid in or on
a variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from chemical name 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 one-day or single exposure.
     The Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID\TM\, Version 1.3) which
incorporates food consumption data as reported by respondents in the
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the acute exposure
assessments: one hundred percent of proposed and registered crops are
treated with dimethenamid (100% CT) and tolerance-level residues for
all commodities.
    ii. Chronic exposure.
     In conducting the chronic dietary exposure assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\, Version 1.3) which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessments: one hundred percent of proposed and registered crops are
treated with dimethenamid (100% CT) and tolerance-level residues for
all commodities
    iii. Cancer. Dimethenamid (50:50 S:R isomers) was classified as a
group < < C'' (possible human carcinogen). The Agency concluded that the
chronic risk assessment, making use of the cPAD, to be protective of
any potential carcinogenic risk. Therefore, the exposure estimates for
food and water discussed in Unit III.C.1.ii and III.C.2. for chronic
exposures were also used to assess cancer. Dimethenamid could be
considered a weak carcinogen. An intermediate dose showed marginally
significant results (p = 0.056) with liver adenomas one species (rat)
and one sex (males). The incidence of liver tumors was just slightly
increased from the level in the historical control data. Higher doses
did not demonstrate the occurrence of liver adenomas significantly
different from the controls. No dose-related tumors were seen in the
mouse carcinogenicity study, and a battery of mutagenicity studies with
dimethenamid-P (90:10 S:R isomers) were negative or equivocal for
genetic mutations including unscheduled DNA synthesis.
    2. Dietary exposure from drinking water.
    The Agency lacks sufficient monitoring exposure data to complete a
comprehensive dietary exposure analysis and risk assessment for
dimethenamid in drinking water. Because the Agency does not have
comprehensive monitoring data, drinking water concentration estimates
are made by reliance on simulation or modeling taking into account data
on the physical characteristics of dimethenamid. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.

    Based on the PRZM/EXAMS and SCI-GROW models, the estimated
environmental concentrations (EECs) of dimethenamid for acute exposures
are estimated to be 49 parts per billion (ppb) for surface water and
0.42 ppb for ground water. The EECs for chronic exposures are estimated
to be 7.9 ppb for surface water and 0.42 ppb for ground water.Modeled
estimates of drinking water concentrations were directly entered into
the dietary exposure model (DEEM-FCID\TM\, Version 1.3). For acute
dietary risk assessment, the peak water concentration value of 49 ppb
was used to access the contribution to drinking water. For chronic
dietary risk assessment, the annual average concentration of 7.9 ppb
was used to access 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).
    Dimethenamid is not registered for use on any sites that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to dimethenamid and any other
substances and dimethenamid does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that dimethenamid has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold 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 data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. No offspring pre- or
postnatal susceptibility to either dimethenamid (50:50 S:R isomers) or
dimethenamid-P (90:10 S:R isomers) was seen in a rabbit or two rat
developmental studies and reproduction study. There is low concern for
pre- or postnatal toxicity since the developmental effects from the

[S] and [RS] mixture are similar and occur at similar doses.
    3. Conclusion. There is a complete toxicity data base for
dimethenamid and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures.
    EPA determined that the safety factor for dimethenamid should be
100 (10X safety factor for interspecies extrapolation and 10X for
intraspecies variation). The additional FQPA SF was removed taking into
account the low concerns and lack residual uncertainties with regard to
prenatal and postnatal toxicity and the completeness of the toxicity
and exposure data base.

E. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated drinking water
concentrations (EDWCs). The DWLOC values are not regulatory standards
for drinking water, but are theoretical upper limits on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food and residential uses. More information on the use
of DWLOCs in dietary aggregate risk assessments can be found at http://www.epa.gov/
[fxsp0]oppfead1/trac/[fxsp0]science/

[fxsp0]screeningsop.pdfMore recently the Agency has used another
approach to estimate aggregate exposure through food, residential and
drinking water pathways. In this approach, modeled surface and ground
water EDWCs are directly incorporated into the dietary exposure
analysis, along with food. This provides a more realistic estimate of
exposure because actual body weights and water consumption from the
CSFII are used. The combined food and water exposures are then added to
estimated exposure from residential sources to calculate aggregate
risks. The resulting exposure and risk estimates are still considered
to be high end, due to the assumptions used in developing drinking
water modeling inputs.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to dimethenamid will occupy < 1% of the aPAD for females 13 years and
older. Therefore, EPA does not expect the aggregate exposure to exceed
100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
dimethenamid food and water will utilize < 1 % of the cPAD for the U.S.
population, 1.2 % of the cPAD for all infants <  1 year old, the
subpopulation at greatest exposure, and < 1 % of the cPAD for children
1-2 years old. There are no residential uses for dimethenamid.
Therefore, EPA does not expect the aggregate exposure to exceed 100% of
the cPAD.
    3. Short-term and Intermediate-term risk.
    Short-term and Intermediate-term aggregate exposures take into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Dimethenamid is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
    4. Aggregate cancer risk for U.S. population. The Agency considers
the chronic aggregate risk assessment, making use of the cPAD, to be
protective of any aggregate cancer risk. See Unit III.E.2.
    5. 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, and to infants and children from aggregate
exposure to dimethenamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (AM-0884-0193-1) is available to
enforce the tolerance expression. AM-0884-0193-1 is a gas
chromatography (GC) method using an HP-1 or HP-5 column and mass
selective detection (MSD). The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no Codex, Canadian, or Mexican MRLs for dimethenamid in
or on the proposed commodities. Therefore, harmonization of tolerances
is not an issue.

V. Conclusion

    Therefore, tolerance are established for residues of dimethenamid,
(R,S)-2-chloro-N-[(1-methyl-2-methoxy) ethyl]-N-(2,4-dimethylthien-3-
yl)-acetamide in or on the commodities onion, green at 0.01 ppm; leek
at 0.01 ppm; onion, Welsh at 0.01 ppm; and shallot, fresh leaves at
0.01 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that

have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects 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.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, 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, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this 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 this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 7, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.464 is amended by alphabetically adding commodities to
the table in paragraph (a) to read as follows:

Sec.  180.464   Dimethenamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Leek                                        0.01
                                * * * * *
Onion, green                                0.01
Onion, Welsh                                0.01
                                * * * * *
Shallot, fresh leaves                       0.01
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E6-13660 Filed 8-22-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Page 47337]
[FR Doc No: 2019-19333]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86855; File No. SR-NYSEArca-2019-51]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change Regarding Investments of the Janus Henderson Mortgage-Backed
Securities ETF Currently Listed and Traded on the Exchange Under NYSE
Arca Rule 8.600-E

September 3, 2019.
    On July 9, 2019, NYSE Arca, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to make certain
changes to the investments of the Janus Henderson Mortgage-Backed
Securities ETF, the shares of which are currently listed and traded on
the Exchange under NYSE Arca Rule 8.600-E. The proposed rule change was
published for comment in the Federal Register on July 25, 2019.\3\ The
Commission has received no comment letters on the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 86417 (July 19,
2019), 84 FR 35910.
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    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is September 8, 2019. The Commission is extending this 45-day time
period.
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    \4\ 15 U.S.C. 78s(b)(2).
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    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\5\ designates
October 23, 2019 as the date by which the Commission shall either
approve or disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-NYSEArca-2019-51).
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    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(31).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-19333 Filed 9-6-19; 8:45 am]
BILLING CODE 8011-01-P