[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Notices]
[Page 55262-55264]
[DOCID:fr28se07-139]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56495; File No. SR-Amex-2007-105]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Require That the AEMI Trading Platform Function To Assure Compliance
With the Exchange's Priority and Parity Rules

September 21, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 18, 2007, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared substantially by the
Amex. The Amex has designated the proposed rule change as one
constituting a stated policy, practice, or interpretation with respect
to the meaning, administration, or enforcement of an existing rule
under section 19(b)(3)(A)(i) of the Act \3\ and Rule 19b-4(f)(1)
thereunder,\4\ which renders the proposal 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)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    In compliance with a Commission order in a recent administrative
proceeding,\5\ the Amex proposes to adopt new Commentary .06 to Amex
Rule 126-AEMI, ``Precedence of Bids and Offers,'' to provide that the
Amex's new hybrid trading platform for equity products and exchange-
traded funds (``ETFs''), designated as AEMISM (``AEMI''),
shall function at all times in a manner that assures compliance with
the Amex's priority and parity rules. In particular, AEMI shall
systemically prevent a Specialist attempting to execute his/her
proprietary order from trading ahead of a customer order in the
Specialist's possession or for which the Specialist otherwise has
responsibility and which customer order could trade in place of some or
all of the Specialist's side of the trade, unless the trade meets a
specified exemption in the Exchange's rules.
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    \5\ See In the Matter of American Stock Exchange LLC, Order
Instituting Administrative and Cease-and-Desist Proceedings, Making
Findings, and Imposing Remedial Sanctions, a Censure, and a Cease-
and-Desist Order Pursuant to Sections 19(h)(1) and 21C of the
Securities Exchange Act of 1934, Securities Exchange Act Release No.
55507 (March 22, 2007) (Administrative Proceeding File No. 3-12594)
(``Settlement Order'').
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    The proposed rule change is available at the Amex, in the
Commission's Public Reference Room, and on the Amex's Web site at
http://www.amex.com.

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 Amex 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 Amex 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 is proposing to add to its AEMI rules a provision
requiring that the AEMI platform function at all times in a manner that
assures compliance with the Exchange's priority and parity rules. More
specifically, AEMI must ensure that, when a Specialist is in the
process of executing his/her proprietary order while a customer order
in the Specialist's possession or for which the Specialist otherwise
has responsibility could trade in place of some or all of the
Specialist's side of the trade, AEMI will systemically (i) prevent the
reporting of the execution, and (ii) allocate the appropriate portion
of the Specialist's trade to the customer order, unless the trade meets
a specified exemption in the Exchange's rules and has thereby been
programmed into the AEMI system as an allowable trade. All of the
Exchange's priority and parity rules for equity products and ETFs are
pre-programmed into AEMI and may not be disabled or otherwise changed
by the Specialist or any other market participant. The provision with
the foregoing requirements is being added as new Commentary .06 to Amex
Rule 126-AEMI.\6\
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    \6\ As noted above, the Amex is making this rule filing in
compliance with the Settlement Order. See note 5, supra. The Amex
has withdrawn its original filing with respect to this proposed rule
change, SR-Amex-2007-50, which the Amex filed on May 21, 2007, and
is replacing it with the current rule filing.
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    The Exchange believes that the new AEMI platform, as currently
operational, does in fact meet the foregoing requirements.\7\ The
implementation of AEMI, whose operation has been described in detail in
previous filings, goes well beyond simply adding enhancements to the
Amex's legacy trading systems to bring the Exchange into compliance.
AEMI is an entirely new trading platform whose design and operation
will, in transactions involving equity products and ETFs,\8\ prevent
Specialists from violating the Exchange's priority and parity rules in
ways that the Amex's legacy systems could not.
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    \7\ There are two exceptions to this statement that the Amex has
recently become aware of and that the Amex is working to correct in
the near future. First, there are certain circumstances immediately
following the opening or reopening pair-off in an equity or ETF
under which the Specialist's quotation could be routed out to
execute against a better priced protected quotation of another
market ahead of a marketable customer order on the AEMI Book.
Secondly, the Exchange's rules provide for a post-opening pair-off
of marketable orders held in the message queue during the opening
pair-off. This post-opening pair-off is handled by the AEMI system
in such a way that it could result in the Specialist's quote being
executed ahead of marketable customer orders on the AEMI Book.
Although the Amex does not believe that either of these situations
occurs with any frequency and the Specialist has no ability to
direct their occurrence, the Exchange is currently working to
implement in a timely manner the software changes necessary to
correct these system flaws and will make an additional rule filing
at the time that the corrections become effective.
    \8\ Options are not traded on AEMI at this time.
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    Under normal circumstances, when auto-ex is enabled in AEMI,
incoming orders are executed against resting orders on the AEMI Book in
accordance with the Exchange's priority and parity rules that are pre-
programmed into the system. The system also permits manual trades to
occur when auto-ex is enabled in the form of negotiated trades (between
two crowd members), crosses in the crowd (one crowd member), and
auctions (between multiple crowd members). When auto-ex is disabled,
only auctions performed by the Specialists may occur (see discussion of
auctions below).
    The following illustrates the steps involved in negotiated trades,
which have been relatively infrequent during the first few months that
AEMI has been in effect. Suppose two Floor Brokers negotiate the terms
of a trade between them while standing in the crowd. They would then
verbally request that the Specialist enter the trade into AEMI. Within
a few seconds, the Specialist

would enter the badge identifiers of both Floor Brokers along with the
terms of the trade (price and number of shares) into AEMI and click the
``GO'' button, during which time the two Floor Brokers would be
physically present. It would be very obvious to these Floor Brokers,
and to other crowd members as well, if the Specialist were to attempt
to delay the entry of the order into AEMI or take other action that
would disadvantage the parties to the negotiated trade and benefit the
Specialist (e.g., moving his quotation). AEMI would automatically
validate that the trade meets all required parameters (e.g., the trade
price relative to the Amex Published Quote (``APQ'')) and, if so,
accepts the trade into AEMI for execution. If the price of the trade is
outside the national best bid or offer (``NBBO''), then intermarket
sweep orders are immediately generated as required to execute against
the protected quotations of away markets, while the balance of the
order prints on the Amex and is allocated based on the Exchange's
priority and parity rules. In that allocation, electronic orders and
quotations that already exist on the AEMI Book at the price of the
verbal trade have priority over the verbal trade that has just been
accepted by AEMI for execution. Following the allocation, AEMI will
send a trade execution message to each Floor Broker's hand held
terminal (``HHT'') with the number of shares allocated to the Floor
Broker at the trade price. Each Floor Broker would then further
allocate those shares among the customer orders in his/her HHT.
    The following example illustrates the automatic application of the
priority and parity rules by AEMI in a situation involving a manual
trade with auto-ex enabled. As provided in Rule 128B--AEMI, ``Auction
Trades,'' a negotiated trade may take place only at or inside the APQ.
A negotiated trade that takes place at the APQ automatically
incorporates electronic orders and quotes already resident on the AEMI
Book at the time of the print, because these orders and quotes have
priority and standing over the verbal trade. For example, assume that
the APQ for an ETF is 34.55 x 35.10 and the AEMI Book has 4,000 shares
on the bid side at that price, comprised of a customer order for 3,000
shares and the Specialist's bid for 1,000 shares. Assume that the
customer order is a reserve order with a display size of 1,000 shares.
Therefore, the size of the APQ on the bid side is 2,000 shares (the
visible size of the reserve order and the Specialist's bid). Two Floor
Brokers in the crowd wish to transact a negotiated trade for 5,000
shares at the price of 34.55, a price that has been agreed to verbally
and that must be entered into AEMI by the Specialist in order for the
trade to represent a valid contract. When the Specialist prints the
trade for the two Floor Brokers, the electronic orders at the price
take priority and the seller will sell 3,000 shares to the customer
reserve order (displayed and non-displayed liquidity), 1,000 shares to
the Specialist's quote, and 1,000 shares to the contra party in the
negotiated trade. The remaining 4,000 shares on the buy side of the
negotiated trade expire. The 4,000 shares on the AEMI Book, including
the Specialist's quote, take priority at the price because they
represent passive liquidity already resident on the AEMI Book and the
Specialist is not agent to the negotiated trade in the crowd.
Similarly, a cross from a crowd member must interact with orders on the
AEMI Book, with the exception of crosses that meet the size and value
requirements outlined in Commentary .01 and .02 of Rule 126--AEMI, in
which case they do not interact with orders already on the AEMI Book.
    Next, suppose that the negotiated trade in the crowd in the
foregoing example is for only 1,000 shares. The priority and parity
rules for ETFs in AEMI will automatically result in the seller
executing all 1,000 shares against the displayed size of the customer
reserve order, which has a higher priority than the Specialist's quote.
On the other hand, if the negotiated trade had been for 2,000 shares,
1,000 shares would have executed against the displayed size of the
customer reserve order and 1,000 shares would have executed against the
Specialist's quote, because the latter has a higher priority than the
replenished reserve size (which is not visible liquidity). This is an
example of a specified exemption in the Exchange's priority and parity
rules that allows the Specialist to have a higher priority than part of
a customer order.\9\
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    \9\ In addition to executing ahead of the replenished reserve
size of customer reserve orders for both ETFs and equities, as
provided by the Amex's priority and parity rules, the Specialist's
quotation may also be executed, for both ETFs and equities under
those rules, ahead of a percentage order that is a customer order
and is elected by a trade event. In addition, for equities only, the
Specialist's quotation may be executed ahead of some customer orders
pursuant to the Amex priority and parity rules (and depending on
whether public orders are also involved) under the following
circumstances: (i) Parity allocation takes place among the
Specialist's quotation in parity and the visible size of crowd
customer orders in parity; and (ii) the Specialist's quotation and
the visible size of certain crowd customer orders not in parity are
executed based on time priority. See Amex Rule 126--AEMI (b) and
(d).
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    Finally, a Specialist may conduct an auction when auto-ex is either
enabled or disabled. In both circumstances, resting orders on the AEMI
Book are automatically incorporated into the pair-off, and the parity
and priority rules referred to above are systematically applied. When
conducting a pair-off, the Specialist has agency responsibility to
orders on the AEMI Book and may participate at the pair-off price but
only after all other orders at the pair-off price trade first.
    In the circumstance when auto-ex is disabled, an auction pair-off
would be conducted to resolve any imbalance and re-enable auto-ex. (If
there were no imbalance, auto-ex could be re-enabled based simply on a
quotation.) The only auction trade that can take place in this
situation is one to resolve the imbalance. During the time that auto-ex
is disabled, incoming orders, amendments, and cancellations continue to
enter the AEMI Book and members may not trade in the open-outcry market
except as part of the auction trade that re-enables AEMI. Any verbal
involvement by crowd members would take place during the post-trade
allocation process as follows. The Specialist would set the price of
the pair-off, with the contra interest that is applied against the
imbalance coming from marketable orders on the contra side of the AEMI
Book (and with intermarket sweep orders being generated to away markets
as necessary).\10\ Once the Specialist has set the auction price, he
does not exercise any additional discretion that would influence the
number of shares of the imbalance that he is allocated vis-[agrave]-vis
the other members of the crowd. He must announce the price of the trade
to the crowd before it is printed to the tape, so crowd members will
know whether they are entitled to be part of the trade. Any remainder
of the imbalance will be parity-allocated against the Specialist and/or
eligible crowd participants represented electronically on the contra
side of the AEMI Book. Each active crowd participant with a bid, offer,
or order on the contra side of the aggressing order will receive a
message from AEMI with the initial allocation that AEMI has
automatically calculated for that crowd member. Following this initial
post-trade allocation, those crowd participants who receive an initial
allocation will verbally confirm their

participation or non-participation to the Specialist.\11\ The
Specialist enters the necessary adjustments into AEMI, and AEMI will
compute the revised individual allocations for each crowd member. AEMI
will then immediately send a message to each of these crowd
participants with their respective individual final trade allocations,
with Floor Brokers completing an additional allocation of their
individual trades to existing orders in their HHTs.
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    \10\ The Specialist may not be part of the pair-off at that
price; he participates only in the absorption of the imbalance.
    \11\ If the Specialist were to ignore a particular crowd
member's confirmation of participation (arguably so that the
Specialist could execute more of the imbalance himself), this would
be very obvious to the disadvantaged crowd member (because his
allocation would go to zero from the number that he initially was
assigned by AEMI), who could challenge the result. The Amex
believes, in other words, that it is highly unlikely that the
Specialist could get away with such a blatant act.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Regulation NMS, as well as Section 6(b) of the Act,\12\ in
general, and furthers the objectives of Section 6(b)(5) of the Act,\13\
in particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Amex believes that the proposed rule change does not impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were either solicited or received with respect
to the proposed rule change.

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

    Because the foregoing proposed rule change constitutes a stated
policy, practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule, it has become
effective pursuant to section 19(b)(3)(A)(i) of the Act \14\ and Rule
19b-4(f)(1) thereunder.\15\ At any time within 60 days of the filing of
the proposed rule change, the Commission may summarily abrogate 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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    \14\ 15 U.S.C. 78s(b)(3)(A)(i).
    \15\ 17 CFR 240.19b-4(f)(1).
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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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-Amex-2007-105 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Amex-2007-105. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Amex. 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-Amex-2007-105 and should be
submitted on or before October 19, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-19163 Filed 9-27-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 53 (Friday, March 18, 2011)]
[Notices]
[Pages 14964-14965]
[FR Doc No: 2011-6430]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following exempt
wholesale generator filings:
    Docket Numbers: EG11-68-000.
    Applicants: FRV AE Solar, LLC.
    Description: Notice of Self-Certification as an Exempt Wholesale
Generator by FC of FRV AE Solar, LLC.
    Filed Date: 03/08/2011.
    Accession Number: 20110308-5124.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 29, 2011.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER11-2201-002.
    Applicants: Evergreen Wind Power III, LLC.
    Description: Evergreen Wind Power III, LLC submits tariff filing
per 35.17(b): Amendment to Evergreen Wind Power III, LLC MBR
Application to be effective 7/1/2011.
    Filed Date: 03/08/2011.
    Accession Number: 20110308-5112.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 29, 2011.

    Docket Numbers: ER11-2558-001; ER11-2557-001; ER11-2555-001; ER11-
2556-001; ER11-2549-001; ER11-2552-001; ER11-2554-001.
    Applicants: Niagara Mohawk Power Corporation.
    Description: Errata to Exhibits of National Grid USA.
    Filed Date: 03/08/2011.
    Accession Number: 20110308-5126.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 29, 2011.

    Docket Numbers: ER11-3034-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc submits informational filing for
qualification in the Forward Capacity Market for the 2014-2015 Capacity
Commitment Period.
    Filed Date: 03/08/2011.
    Accession Number: 20110308-0201.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 23, 2011.

    Docket Numbers: ER11-3035-000.
    Applicants: Midland Cogeneration Venture Limited Partnership.
    Description: Midland Cogeneration Venture Limited Partnership
submits tariff filing per 35.1: Rate Schedule 1 for Reactive Supply
Service to be effective 6/1/2011.
    Filed Date: 03/08/2011.
    Accession Number: 20110308-5088.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 29, 2011.

    Docket Numbers: ER11-3036-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits tariff filing per
35.13(a)(2)(iii: V4-052 WMPA Original Service Agreement No. 2787 to be
effective 2/14/2011.
    Filed Date: 03/08/2011.
    Accession Number: 20110308-5090.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 29, 2011.

    Docket Numbers: ER11-3037-000.
    Applicants: Geodyne Energy, LLC.
    Description: Geodyne Energy, LLC submits tariff filing per 35:
Geodyne Energy, LLC Baseline Filing to be effective 3/8/2011.
    Filed Date: 03/08/2011.
    Accession Number: 20110308-5105.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 29, 2011.

    Docket Numbers: ER11-3038-000.
    Applicants: Entergy Arkansas, Inc.
    Description: Entergy Arkansas, Inc. submits tariff filing per
35.13(a)(2)(iii: ICT Extension Compliance Filing to be effective 11/17/
2010.
    Filed Date: 03/08/2011.
    Accession Number: 20110308-5106.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 29, 2011.

    Docket Numbers: ER11-3047-000.
    Applicants: PJM Interconnection L.L.C.
    Description: Request for Limited Wavier of Tariff of PJM
Interconnection L.L.C.
    Filed Date: 03/08/2011.
    Accession Number: 20110308-5138.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 29, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status

may do so by filing a motion pursuant to 18 CFR 292.207(d)(iii).
Intervention and protests may be filed in response to notices of
qualifying facility dockets other than self-certifications and self-
recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 9, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-6430 Filed 3-17-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Rules and Regulations]
[Pages 34775-34780]
[FR Doc No: 2018-15449]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0224; FRL-9977-82]

Flonicamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
flonicamid in or on multiple commodities that are identified and
discussed later in this document as well as tolerances with regional
registrations on clover, forage and clover, hay. In addition, this
regulation removes certain 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 July 23, 2018. Objections and
requests for hearings must be received on or before September 21, 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-2017-0224, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0224 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
September 21, 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-2017-0224, 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 January 26, 2018 (83 FR 3658) (FRL-9971-
46), 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
7E8556) by IR-4 Project Headquarters, 500 College Road East, Suite
201W, Princeton, New Jersey, 08540. The petition requested that 40 CFR
180.613 be amended by establishing tolerances for residues of the
insecticide flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-
pyridinecarboxamide, and its metabolites, TFNA (4-
trifluoromethylnicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG (N-(4-
trifluoromethylnicotinoyl)glycine), calculated as the stoichiometric
equivalent of flonicamid as follows:

    1. Amend Sec.  180.613(a)(1) by establishing a tolerance in or
on Celtuce at 4.0 ppm; Florence fennel at 4.0 ppm; Kohlrabi at 1.5
ppm; and Crop Group Expansions/Conversions for Brassica, leafy
greens, subgroup 4-16B at 16 ppm; Cottonseed subgroup 20C at 0.60
ppm; Leaf petiole vegetable subgroup 22B at 4.0 ppm; Leafy greens
subgroup 4-16A, except spinach at 4.0 ppm; and Vegetable, brassica,
head and stem, group 5-16 at 1.5 ppm; and
    2. Amend Sec.  180.613(c), Tolerances with regional
registrations, by establishing a tolerance for Clover, forage at 0.9
ppm and Clover, hay at 4.0 ppm.

    In addition, upon establishing the above tolerances, the petitioner
requests to remove existing tolerances in 40 CFR 180.613(a) including
Vegetable, leafy, except brassica, group 4, except spinach at 4.0 ppm;
Brassica, head and stem, subgroup 5A at 1.5 ppm; Brassica, leafy
greens, subgroup 5B at 16 ppm; Radish, tops, at 16 ppm; Turnip, greens
at 16

ppm; and Cotton, undelinted seed at 0.50 ppm.
    That document referenced a summary of the petition prepared by ISK
Bioscience Corporation, the registrant, which is available in the
docket, http://www.regulations.gov. One comment was received on the
petition notice of filing as outlined and responded to in Unit IV.C.
    Consistent with the authority in FFDCA 408(d)(4)(A)(i), EPA is
issuing tolerances that vary from what the petitioner sought. The
reason for these changes is explained in Unit IV.D.

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 flonicamid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flonicamid 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.
    Flonicamid and its metabolites of concern, TFNA, TFNA-AM, TFNG,
TFNG-AM (N-(4-trifluoromethylnicotinoyl)glycinamide), and TFNA-OH (6-
hydro-4-trifluoromethylnicotinic acid), demonstrated low toxicity in
acute oral toxicity studies. Flonicamid showed no systemic toxicity in
a 28-day dermal study at the limit dose.
    Feeding studies in rats and dogs show the kidney and liver are the
target organs for flonicamid toxicity. In repeat-dose subchronic and
chronic oral toxicity studies, the consistently observed adverse effect
in rats and mice were kidney toxicity (i.e., hyaline deposition and
nephritis); in dogs, vomiting and increased percentage of reticulocytes
(an indicator for potential anemia).
    There is no evidence that flonicamid results in increased
susceptibility (qualitative or quantitative) in utero in rats or
rabbits in the prenatal developmental studies or in young rats in the
2-generation reproduction study. In the rat prenatal developmental
toxicity study, maternal toxicity consisted of kidney toxicity (i.e.,
nephritis) in the absence of developmental toxicity at the highest-dose
tested (HDT); in the rabbit, maternal toxicity consisted of decreased
food consumption in the absence of developmental toxicity at the HDT.
In the rat reproduction and fertility effects study, parental toxicity
(i.e., kidney hyaline deposition and luteinizing hormone level
increases) occurred at doses much lower than doses causing offspring
effects (i.e., decreased body weight and delayed sexual maturation).
    There are no concerns for flonicamid neurotoxicity. In the acute
neurotoxicity study in rats, signs of toxicity such as decreased motor
activity, tremors, impaired gait, and impaired respiration were
observed at lethal dose levels (1,000 mg/kg). In the subchronic
neurotoxicity study, decreased body weight, food consumption, foot
splay, and motor activity were observed in males at doses greater than
67 mg/kg/day, and in females at 722 mg/kg/day. In the immunotoxicity
study in mice, there were no indications of increased immunotoxic
potential in the T-cell dependent antibody response (TDAR) assay at the
limit dose.
    Mutagenicity studies were negative for flonicamid and its
metabolites of concern. Treatment-related lung tumors were observed in
CD-1 mice. This tumor type, however, is associated with species and
strain sensitivity and is not directly correlated with cancer risks in
humans. Nasal cavity tumors in male Wistar rats were linked to incisor
inflammation. Nasolacrimal duct tumor findings for females were
confounded by the lack of a dose-response, and the biological
significance of these tumors is questionable. The determination of
carcinogenicity potential for flonicamid was based on the weight of the
evidence approach and resulted in the classification of ``suggestive
evidence of carcinogenicity, but not sufficient to assess human
carcinogenic potential.'' The Agency determined that quantification of
risk using a non-linear approach (i.e., using a chronic reference dose
(cRfD)) adequately accounts for all chronic toxicity, including
carcinogenicity that could result from exposure to flonicamid.
    Specific information on the studies received and the nature of the
adverse effects caused by flonicamid 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: Flonicamid. Human Health
Risk Assessment for the Petition for the Establishment of Permanent
Tolerances for Clover, Crop Group Conversions to Brassica, Head and
Stem Vegetable, Group 5-16; Brassica, Leafy Greens, Subgroup 4-16B;
Leaf Petiole Vegetable, Subgroup 22B; Leafy Greens, Subgroup 4-16A,
Except Spinach; Celtuce; Florence Fennel; and Kohlrabi (DP439902);
Expansion of Cottonseed Tolerances to Cottonseed Subgroup 20C, and
Revised Use Directions for Citrus (DP441385),'' at pages 20-21 in
docket ID number EPA-HQ-OPP-2017-0224.

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 flonicamid used for
human risk assessment is presented in the following Table.

   Table--Summary of Toxicological Doses and Endpoints for Flonicamid for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 3.7 mg/kg/    Chronic RfD = 0.04   Reproduction and Fertility Effects
                                    day.                  mg/kg/day.           Study in Rats
                                   UFA = 10x...........  cPAD = 0.04 mg/kg/   Parental LOAEL = 22 mg/kg/day
                                   UFH = 10x...........   day.                 based on increased kidney
                                   FQPA SF = 1x........                        weights, kidney hyaline
                                                                               deposition, increased blood serum
                                                                               LH (F1 females).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification; ``Suggestive evidence of carcinogenicity, but not sufficient
                                    to assess human carcinogenic potential'' based on the results of
                                    carcinogenicity studies in rats and mice.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-
  effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flonicamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing flonicamid tolerances in 40 CFR
180.613. EPA assessed dietary exposures from flonicamid in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for flonicamid; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA).
The chronic dietary (food and drinking water) exposure assessment was
conducted using the Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID), Version 3.16. As to residue
levels in food, an unrefined chronic dietary exposure assessment was
conducted for all proposed and established food uses of flonicamid.
Tolerance-level residues were combined with 100 percent crop treated
(PCT) estimates. Separate tolerances established for potato granules/
flakes, tomato paste, and tomato puree were based on processing studies
and DEEM default processing factors were used for the other processed
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 flonicamid. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for flonicamid. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flonicamid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flonicamid. 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.
    The drinking water assessment was conducted using both a parent
only exposure, and a total toxic residue approach, which considers the
parent compound and its major degradates of concern. Total toxic
residues include 4-trifluoromethylnicotinic acid (TFNA), 4-
trifluoromethylnictinamide (TFNA-AM), 6-hydro-4-
trifluoromethylnicotinic acid (TFNA-OH), N-(4-
trifluoromethylnicotinoyl)glycine (TFNG), and N-(4-
trifluoromethylnicotinoyl)glycinamide (TFNG-AM).
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW),
version 1.0, the estimated drinking water concentrations (EDWCs) of
flonicamid for chronic exposures for non-cancer assessments are
estimated to be 0.94 parts per billion (ppb) for surface water and 9.92
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary exposure
assessment, the water concentration value of 9.92 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).
    Flonicamid is not registered for any specific use patterns that
would result in residential exposure. 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.''
    EPA has not found flonicamid to share a common mechanism of
toxicity with any other substances, and flonicamid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flonicamid does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for flonicamid includes prenatal developmental
toxicity studies in rats and rabbits and a multigeneration reproduction
toxicity study in rats. There is no evidence that flonicamid results in
increased susceptibility (qualitative or quantitative) in utero in rats
or rabbits in the prenatal developmental studies or in young rats in
the multi-generation reproduction study. No developmental effects were
seen in rabbits. In the multi-generation reproduction study,
developmental delays in the offspring (decreased body weights, delayed
sexual maturation) were seen only in the presence of parental toxicity
(kidney and blood effects). Also, there are clear NOAELs and LOAELs for
all effects. The degree of concern for prenatal and/or post-natal
susceptibility is, therefore, low due to the lack of evidence of
qualitative and quantitative susceptibility.
    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, except where assessing risks from
inhalation exposure as discussed below. Those decisions are based on
the following findings:
    i. The toxicity database for flonicamid is essentially complete,
except for an outstanding subchronic 28-day inhalation study. In the
absence of a subchronic inhalation study, EPA has retained a 10X FQPA
SF to assess risks from inhalation exposure, although at present,
residential inhalation exposure is not expected from existing or
pending uses of flonicamid.
    ii. There is no indication that flonicamid is a neurotoxic
chemical. As discussed in Unit III.A., EPA has concluded that the
clinical signs observed from available acute and subchronic
neurotoxicity studies were not the result of a neurotoxic mechanism.
Therefore, there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that flonicamid results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary food exposure assessment was based on
100 PCT, tolerance-level residues and where applicable, default
processing factors. EPA made conservative (protective) assumptions in
the ground and surface water modeling used to assess exposure to
flonicamid in drinking water. These assessments will not underestimate
the exposure and risks posed by flonicamid.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
flonicamid is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flonicamid from food and water will utilize 60% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for flonicamid.
    3. Short- and Intermediate-term risks. Short- and intermediate-term
aggregate exposures take into account short- and intermediate-term
residential exposures plus chronic exposure to food and water
(considered to be a background exposure level). Flonicamid is not
registered for any use patterns that would result in short- and
intermediate-term residential exposures.
    4. Aggregate cancer risk for U.S. population. Based on the
information referenced in Unit III.A., EPA has concluded that the cPAD
is protective of possible cancer effects from flonicamid, and as
evidenced in Unit III.E.2, aggregate exposure to flonicamid is below
the cPAD. Aggregate cancer risk from existing and proposed food uses is
below EPA's level of concern.
    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, or to infants and children from aggregate
exposure to flonicamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the
tolerance expression. FMC Method No. P-3561M, a liquid chromatography-
tandem mass spectrometry (LC/MS/MS) method, is an acceptable
enforcement method for flonicamid and its metabolites in plant
commodities. The method determines residues of flonicamid and its
metabolites TFNA-AM, TFNA, and TFNG. The method has been sufficiently
validated in five diverse crops. Depending on the matrix, the limit of
quantitation (LOQ) is 0.01 or 0.02 ppm. The limit of detection (LOD)
can be estimated as one-third the LOQ.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350;

telephone number:<PHONE_NUMBER>; email address:
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are Codex MRLs for residues of flonicamid in or on celery at
1.5 ppm, head lettuce at 1.5 ppm, leaf lettuce at 8.0 ppm, radish tops
at 20 ppm, and cottonseed at 0.60 ppm. The Codex MRL and U.S. tolerance
on cottonseed are harmonized. The petitioned-for tolerance on
Brasssica, leafy greens subgroup 4-16B which includes radish tops is
being established for Brasssica, leafy greens subgroup 4-16B, except
radish tops at 16 ppm. An existing radish, tops tolerance at 16 ppm is
being revised to 20 ppm to harmonize with the established Codex MRL.
EPA is not harmonizing the relevant U.S. tolerances with the other
established Codex MRLs for the following reasons. The U.S. tolerance
for celery is set at 4.0 ppm as part of the Leaf Petiole vegetable
subgroup 22B. The U.S. tolerance for lettuce, head and lettuce, leaf is
set at 4.0 as part of the Leafy greens, subgroup 4-16A, is harmonized
with Canada since the greatest percentage of U.S. exports are to
Canada. This subgroup is not harmonized with the Codex tolerance at 8.0
ppm. In the case of celery and head lettuce, lowering the tolerances
could result in exceedances when domestic growers apply flonicamid in
accordance with label directions.

C. Response to Comments

    One anonymous public comment was received on the notice of filing
raising concern about the need to assess impacts of regulations on the
American people. This comment did not raise issues within the scope of
the FFDCA, which directs the Agency's to assess certain information in
determining whether tolerances are safe.

D. Revisions to Petitioned-For Tolerances

    The EPA-established tolerances are identical to the proposed
tolerance levels, except for the tolerances for clover. First, EPA
adjusted the number of significant figures in the tolerance levels
clover, forage proposed at 0.9 was revised to 0.90 ppm. In accordance
with its standard practice to provide greater precision about the
levels of residues that are permitted by a tolerance, EPA is adding an
additional significant figure to the petitioned-for tolerance values.
This is intended to avoid the situation where residues may be higher
than the tolerance level, but as a result of rounding would be
considered non-violative. For example, Clover, forage tolerance
proposed at 0.9 ppm was established at 0.90 ppm, to avoid an observed
hypothetical tolerance at 0.94 ppm being rounded to 0.9 ppm.
    Also, EPA established a tolerance for clover, hay at 5.0 ppm, not
at proposed 4.0 ppm because some of the residue data submitted by IR-4
were not converted to parent equivalents while all the residue data
used by EPA were converted to parent equivalents.
    EPA calculated tolerance levels using the Organization for Economic
Cooperation and Development (OECD) tolerance calculation procedures and
available field trial data residues. Additionally, the petitioned-for
tolerance on Brasssica, leafy greens subgroup 4-16B which includes
radish tops is being established for Brasssica, leafy greens subgroup
4-16B, except radish tops at 16 ppm. Lastly, the existing radish, tops
tolerance at 16 ppm is being revised to 20 ppm to harmonize with the
established Codex MRL.

V. Conclusion

    Therefore, tolerances are established for residues of flonicamid,
N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its
metabolites, TFNA (4-trifluoromethylnicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG (N-(4-
trifluoromethylnicotinoyl)glycine), calculated as the stoichiometric
equivalent of flonicamid, in or on Brassica leafy greens, subgroup 4-
16B, except radish tops at 16 ppm; Celtuce at 4.0 ppm; Cottonseed
subgroup 20C at 0.60 ppm; Florence fennel at 4.0 ppm; Kohlrabi at 1.5
ppm; Leaf petiole vegetable subgroup 22B at 4.0 ppm; Leafy greens
subgroup 4-16A, except spinach at 4.0 ppm; Radish, tops at 20 ppm, and
Vegetables, brassica, head and stem, group 5-16 at 1.5 ppm. In
addition, tolerances with regional restrictions are established on
Clover, forage at 0.90 ppm; and Clover, hay at 5.0 ppm. Lastly, certain
established flonicamid tolerances are being removed including entries
for Vegetable, leafy, except brassica, group 4, except spinach;
Brassica, head and stem, subgroup 5A; Brassica, leafy greens, subgroup
5B; Radish, tops; Turnip, greens; and Cotton, undelinted seed as they
are superseded by this regulatory 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: July 11, 2018.
Michael L. Goodis,
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.  180.613:
0
a. In the table in paragraph (a)(1):
0
i. Remove the entry ``Brassica, head and stem, subgroup 5A'';
0
ii. Add alphabetically the commodity ``Brassica, leafy greens, subgroup
4-16B, except radish, tops'';
0
iii. Remove the entry ``Brassica, leafy greens, subgroup 5B'';
0
iv. Add alphabetically the commodities ``Celtuce'' and ``Cottonseed
subgroup 20C'';
0
v. Remove the entry ``Cotton, undelinted seed'';
0
vi. Add alphabetically the commodities ``Florence fennel'';
``Kohlrabi''; ``Leaf petiole vegetable subgroup 22B''; and ``Leafy
greens subgroup 4-16A, except spinach'';
0
vii. Revise the entry for ``Radish, tops'';
0
viii. Remove the entry ``Turnip, greens'';
0
ix. Add alphabetically the commodity ``Vegetable, brassica, head and
stem, group 5-16''; and
0
x. Remove the entry ``Vegetable, leafy, except brassica, group 4,
except spinach''.
0
b. Revise paragraph (c).
    The additions and revisions read as follows:

Sec.  180.613  Flonicamid; tolerances for residues.

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

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

                                * * * * *
Brassica, leafy greens, subgroup 4-16B, except radish,                16
 tops...................................................
Celtuce.................................................             4.0

                                * * * * *
Cottonseed subgroup 20C.................................            0.60
Florence fennel.........................................             4.0

                                * * * * *
Kohlrabi................................................             1.5
Leaf petiole vegetable subgroup 22B.....................             4.0
Leafy greens subgroup 4-16A, except spinach.............             4.0

                                * * * * *
Radish, tops............................................              20

                                * * * * *
Vegetable, brassica, head and stem, group 5-16..........             1.5

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

* * * * *
    (c) Tolerances with regional registrations. Tolerances with
regional registration, as defined by Sec.  180.1(1), are established
for the residues of the insecticide flonicamid, including its
metabolites and degradates, in or on the commodities in the table
below. Compliance with the tolerance levels specified below is to be
determined by measuring only the sum of flonicamid, N-(cyanomethyl)-4-
(trifluoromethyl)-3-pyridinecarboxamide, and its metabolites, TFNA (4-
trifluoromethylnicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG (N-(4-
trifluoromethylnicotinoyl)glycine), calculated as the stoichiometric
equivalent of flonicamid, in or on the following commodities:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Clover, forage..........................................            0.90
Clover, hay.............................................             5.0
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-15449 Filed 7-20-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 18 (Monday, January 30, 2017)]
[Notices]
[Page 8746]
[FR Doc No: 2017-01923]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filing Instituting Proceedings

    Docket Numbers: RP17-301-000.
    Applicants: Alliance Pipeline L.P.
    Description: Alliance Pipeline L.P. submits tariff filing per
154.204: J. Aron Permanent Relocation Jan 2017 to be effective 1/1/
2017.
    Filed Date: 12/29/16.
    Accession Number: 20161229-5138.
    Comments Due: 5 p.m. ET 1/10/17.

    Docket Numbers: RP17-304-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Iroquois Gas Transmission System, L.P. submits tariff
filing per 154.204: 12/29/16 Negotiated Rates--Mercuria Energy America,
Inc. (RTS) 7540-02 to be effective 1/1/2017.
    Filed Date: 12/29/16.
    Accession Number: 20161229-5160.
    Comments Due: 5 p.m. ET 1/10/17.

    Docket Numbers: RP17-305-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Kern River Gas Transmission Company submits tariff
filing per 154.204: 2017 January Negotiated Rate Agreements to be
effective 1/1/2017.
    Filed Date: 12/30/16.
    Accession Number: 20161230-5000.
    Comments Due: 5 p.m. ET 1/11/17.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 30, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-01923 Filed 1-27-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Pages 74224-74225]
[FR Doc No: 2012-30044]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2012-0037]

OSHA Data Initiative (ODI); Extension of the Office of Management
and Budget's (OMB) Approval of Information Collection (Paperwork)
Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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

SUMMARY: OSHA solicits public comments concerning its proposal to
extend OMB approval of the information collection requirements for
OSHA's Data Initiative program.

DATES: Comments must be submitted (postmarked, sent, or received) by
February 11, 2013.

ADDRESSES: Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit three copies of your comments
and attachments to the OSHA Docket Office, Docket No. OSHA-2012-0037,
U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-2625, 200 Constitution Avenue NW., Washington,
DC 20210. Deliveries (hand, express mail, messenger, and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the Information Collection Request (ICR) (OSHA-2012-
0037). All comments, including any personal information you provide,
are placed in the public docket without change, and may be made
available online at http://www.regulations.gov. For further information
on submitting comments see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Rex Tingle at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Dave Schmidt, Office of Statistical
Analysis, Occupational Safety and Health Administration, U.S.
Department of Labor, Room N-3507, 200 Constitution Avenue NW.,
Washington, DC 20210, telephone:<PHONE_NUMBER> or Todd Owen,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor,
Room N-3609, 200 Constitution Avenue NW., Washington, DC 20210;
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection

instruments are clearly understood, and OSHA's estimate of the
information collection burden is accurate. The Occupational Safety and
Health Act of 1970 (the OSH Act) (29 U.S.C. 651 et seq.) authorizes
information collection by employers as necessary or appropriate for
enforcement of the OSH Act or for developing information regarding the
causes and prevention of occupational injuries, illnesses, and
accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain
such information with minimum burden upon employers, especially those
operating small businesses, and to reduce to the maximum extent
feasible unnecessary duplication of efforts in obtaining information
(29 U.S.C. 657).
    To meet many of OSHA's program needs, OSHA is proposing to continue
its collection of occupational injury and illness data and information
on the number of workers employed and the number of hours worked from
establishments in portions of the private sector and from some state
and local government agencies. OSHA will collect the data on an annual
basis from up to 100,000 employers already required to create and
maintain records pursuant to 29 CFR part 1904. These data will allow
OSHA to calculate occupational injury and illness rates and to focus
its efforts on individual workplaces with ongoing serious safety and
health problems. Successful implementation of this data collection is
critical to OSHA's outreach and enforcement efforts and the data
requirements tied to the Government Performance and Results Act (GPRA).

II. Special Issues for Comment

    Public comment is invited on all issues raised by this Federal
Register Notice. OSHA has a particular interest in comments on the
following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    This notice requests public comments on an extension of the current
OMB approval of the paperwork requirements for the OSHA Data Initiative
program.
    Type of Review: Extension of a currently approved collection.
    Title: OSHA Data Initiative (ODI).
    OMB Control Number: 1218-0209.
    Affected Public: Business or other for-profits; Farms; and State,
Local and Tribal Government.
    Number of Respondents: 100,000.
    Frequency: Annually.
    Average Time per Response: 10 minutes (.17 hour).
    Estimated Total Burden Hours: 16,667.
    Estimated Cost (Operation and Maintenance): $439,509.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
e-Rulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and OSHA docket number for the ICR (Docket No. OSHA-2012-0037). You may
supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site.
    All submissions, including copyrighted material, are available for
inspection and copying at the OSHA Docket Office. Information on using
the http://www.regulations.gov Web site to submit comments and access
the docket is available through the Web site's ``User Tips'' link.
Contact the OSHA Docket Office for information about materials not
available through the Web site, and for assistance in using the
Internet to locate docket submissions.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 4-2010
(72 FR 55355).

    Signed at Washington, DC, on December 7, 2012.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2012-30044 Filed 12-12-12; 8:45 am]
BILLING CODE 4510-26-P


Comment Info: =================

General Comment:Blac Label Electronic Cigarettes
1412 Broadway
7th Floor
New York, NY 10018

July 2, 2014

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852

Re: Request for Extension of Comment Period: Docket No. FDA-2014-N-0189
We BLAC LABEL ELECTRONIC CIGARETTES have conducted preliminary review of your lengthy proposed regulations and respectfully request that the Food and Drug Administration (FDA) extend the comment period for the proposed rule entitled “Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.”
We, BLAC LABEL ELECTRONIC CIGARETTES, are small electronic cigarette manufacturer, employing fewer than 350 people. Based in NYC Blac Label is a newly launched line of electronic cigarettes, cigars, hookahs and vaporizers. Through extensive and costly research and development, we have developed a full line of products. Our collective mission is simple; to provide classic flavors with a smooth draw and a timeless taste while offering the most realistic experience our customers love. These sensational flavors cater to everyone from the seasoned smoker to occasional vapers. We proudly offer both nicotine and zero nicotine solutions. We translate our passion by focusing our attention to the smallest of details; from our patented, sleek and slim spring loaded disposable pack to our unique soft tip solutions we offer in our disposable, rechargeable and vaporizer product lines. As explained further below, the initial 75-day comment period does not provide enough time for companies like BLAC LABEL ELECTRONIC CIGARETTES to adequately analyze the entire proposal and provide substantive comments on the many questions posed by the agency. We need more time to address this 240-page document whose contents will deal a devastating economic blow to our business.
The preamble to the proposed rule identifies approximately 70 topics and issues the agency has requested comments on. Many of these issues are complex and difficult and relate to an extremely diverse array of products. Clearly, the lengthy time period that the Agency required to propose these regulations is evidence that the issues addressed in the proposal are multi-faceted and challenging. FDA cannot expect any interested party, and in particular, any manufacturer, to conduct a meaningful review and analysis of these issues and provide detailed and thoughtful comment in a 75-day period.
Therefore, BLAC LABEL ELECTRONIC CIGARETTES again respectfully requests that FDA extend the comment period by 105 days and agree to accept comments filed to the docket on or before October 22, 2014. This will help ensure that the final rule is based on an adequate and meaningful administrative record.
Thank you in advance for your consideration of this request.
Sincerely,
Harry Tawil
President & CEO
Blac Label LLC.