[Federal Register Volume 76, Number 89 (Monday, May 9, 2011)]
[Rules and Regulations]
[Page 26583]
[FR Doc No: C1-2011-9613]

=======================================================================
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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 774

[Docket No. 110106012-1013-01]
RIN 0694-AF04

Implementation of the Understandings Reached at the 2010
Australia Group (AG) Plenary Meeting and Other AG-Related
Clarifications and Corrections to the EAR

Correction

    In rule document 2011-9613 appearing on pages 22017-22019 in the
issue of April 20, 2011, make the following correction:

PART 774--[CORRECTED]

Supplement No. 1 to Part 774--[Corrected]

    On page 22019, in the first column, instruction 4.c. is corrected
to read as follows:
    c. By removing the phrase ``Glass or glasslined (including
vitrified or enameled coatings),'' where it appears in paragraph g.4,
and adding in its place the phrase ``Glass (including vitrified or
enameled coating or glass lining);'' and

[FR Doc. C1-2011-9613 Filed 5-6-11; 8:45 am]
BILLING CODE 9613-P


[Federal Register Volume 79, Number 36 (Monday, February 24, 2014)]
[Notices]
[Page 10220]
[FR Doc No: 2014-03799]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71562; File No. SR-TOPAZ-2013-20]

Self-Regulatory Organizations; Topaz Exchange, LLC; Notice of
Designation of a Longer Period for Commission Action on Proposed Rule
Change to More Specifically Address the Number and Size of
Counterparties to a Qualified Contingent Cross Order

February 18, 2014.
    On December 18, 2013, the Topaz Exchange, LLC (n/k/a ISE Gemini,
LLC) (``Topaz'' or ``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 amend Rule 715 to more
specifically address the number and size of counterparties to a
Qualified Contingent Cross Order. The proposed rule change was
published for comment in the Federal Register on January 7, 2014.\3\
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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. 71209 (December 31,
2013), 79 FR 867.
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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 for this filing is February 21, 2014. 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 this proposed rule change.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates April 7, 2014, as the date by which the Commission
should either approve or disapprove, or institute proceedings to
determine whether to disapprove, the proposed rule change (File No. SR-
TOPAZ-2013-20).
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    \5\ 15 U.S.C. 78s(b)(2).
    \6\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-03799 Filed 2-21-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44766-44767]
[FR Doc No: 2014-18191]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CD14-23-000]

Amador Water Agency; Notice of Preliminary Determination of a
Qualifying Conduit Hydropower Facility and Soliciting Comments and
Motions To Intervene

    On July 14, 2014, the Amador Water Agency filed a notice of intent
to construct a qualifying conduit hydropower facility, pursuant to
section 30 of the Federal Power Act (FPA), as amended by section 4 of
the Hydropower Regulatory Efficiency Act of 2013 (HREA). The proposed
Tanner In-Conduit Hydroelectric Project would have an installed
capacity of 160 kilowatts (kW) and would utilize water from an existing
20-inch diameter pipeline from a pressure reducing station that feeds
both the Tanner Water Treatment Plant and a small storage reservoir.
The project would be located near the town of Sutter Creek in Amador
County, California.
    Applicant Contact: Chris McKeage, Amador Water Agency, 12800 Ridge
Road, Sutter Creek, CA 95685, Phone No.<PHONE_NUMBER>.
    FERC Contact: Robert Bell, Phone No.<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Qualifying Conduit Hydropower Facility Description: The proposed
project would consist of: (1) A proposed 86-foot-long, 20-inch-diameter
intake pipe from the pressure reducing station; (3) a proposed
powerhouse containing two generating units with a total installed
capacity of 160 kW; (4) a proposed 27-foot-long, 16-inch-diameter
discharge pipe back into the pressure reduce station; and (5)
appurtenant facilities. The proposed project would have an estimated
annual generating capacity of 564 megawatt-hours.
    A qualifying conduit hydropower facility is one that is determined
or deemed to meet all of the criteria shown in the table below.

                          Table 1--Criteria for Qualifying Conduit Hydropower Facility
----------------------------------------------------------------------------------------------------------------
                                                                                Satisfies (Y/
         Statutory provision                                   Description                               N)
----------------------------------------------------------------------------------------------------------------
FPA 30(a)(3)(A), as amended by HREA..  The conduit the facility uses is a tunnel, canal, pipeline,            Y
                                        aqueduct, flume, ditch, or similar manmade water
                                        conveyance that is operated for the distribution of water
                                        for agricultural, municipal, or industrial consumption and
                                        not primarily for the generation of electricity.
FPA 30(a)(3)(C)(i), as amended by      The facility is constructed, operated, or maintained for               Y
 HREA.                                  the generation of electric power and uses for such
                                        generation only the hydroelectric potential of a non-
                                        federally owned conduit.
FPA 30(a)(3)(C)(ii), as amended by     The facility has an installed capacity that does not exceed            Y
 HREA.                                  5 megawatts.
FPA 30(a)(3)(C)(iii), as amended by    On or before August 9, 2013, the facility is not licensed,             Y
 HREA.                                  or exempted from the licensing requirements of Part I of
                                        the FPA.
----------------------------------------------------------------------------------------------------------------

    Preliminary Determination: Based upon the above criteria,
Commission staff preliminarily determines that the proposal satisfies
the requirements for a qualifying conduit hydropower facility, which is
not required to be licensed or exempted from licensing.
    Comments and Motions to Intervene: Deadline for filing comments
contesting whether the facility meets the qualifying criteria is 45
days from the issuance date of this notice.
    Deadline for filing motions to intervene is 30 days from the
issuance date of this notice.
    Anyone may submit comments or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210 and 385.214. Any motions to intervene must be received on or
before the specified deadline date for the particular proceeding.
    Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the ``COMMENTS CONTESTING QUALIFICATION FOR
A CONDUIT HYDROPOWER FACILITY'' or ``MOTION TO INTERVENE,'' as
applicable; (2) state in the heading the name of the applicant and the
project number of the application to which the filing responds; (3)
state the name, address, and telephone number of the person filing; and
(4) otherwise comply with the requirements of sections 385.2001 through
385.2005 of the Commission's regulations.\1\ All comments contesting
Commission staff's preliminary determination that the facility meets
the qualifying criteria must set forth their evidentiary basis.
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    \1\ 18 CFR 385.2001-2005 (2013).
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    The Commission strongly encourages electronic filing. Please file
motions to intervene and comments using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. A copy of all other filings in
reference to this application must be accompanied by proof of service
on all persons listed in the service list prepared by the Commission in
this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    Locations of Notice of Intent: Copies of the notice of intent can
be obtained directly from the applicant or such copies can be viewed
and reproduced at the Commission in its Public Reference Room, Room 2A,
888 First Street NE., Washington, DC 20426. The filing may also be
viewed on the Web at http://www.ferc.gov/docs-filing/elibrary.asp using
the ``eLibrary'' link. Enter the docket number (e.g., CD14-23-000) in
the docket number field to access the document. For assistance, call
toll-free 1-866-208-3676 or email<EMAIL_ADDRESS>For TTY,
call<PHONE_NUMBER>.

    Dated: July 28, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-18191 Filed 7-31-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Pages 27681-27683]
[FR Doc No: 2022-09854]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94837; File No. SR-NYSECHX-2022-06]

Self-Regulatory Organizations; NYSE Chicago, Inc.; Notice of
Filing of Proposed Rule Change To Modify Rule 7.31 To Add Subparagraph
(f)(4) Regarding Directed Orders

May 3, 2022.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on April 20, 2022, the NYSE Chicago, Inc. (``NYSE Chicago''
or the ``Exchange'') 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 self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify Rule 7.31 to add subparagraph
(f)(4) regarding Directed Orders and make other conforming changes. The
proposed change is available on the Exchange's website at www.nyse.com,
at the principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to modify Rule 7.31 (Orders and Modifiers) to
add

new subparagraph (f)(4) to provide for Directed Orders and to make
other conforming changes to its Rules in connection with the addition
of this new order type on the Exchange. The Directed Order, as further
defined below, would be an order sent to the Exchange to be routed
directly to an alternative trading system (``ATS'') specified by a
Participant.
    The Exchange proposes to add Rule 7.31(f)(4), which would define a
Directed Order as a Limit Order with instructions to route on arrival
at its limit price to a specified ATS with which the Exchange maintains
an electronic linkage. Proposed Rule 7.31(f)(4) would further provide
that Directed Orders would be available for all securities eligible to
trade on the Exchange. Proposed Rule 7.31(f)(4) would also provide that
a Directed Order would not be assigned a working time or interact with
interest on the Exchange Book. The Exchange also proposes to provide in
Rule 7.31(f)(4) that the ATS to which a Directed Order is routed would
be responsible for validating whether the order is eligible to be
accepted, and if such ATS determines to reject the order, the order
would be cancelled.
    Proposed Rule 7.31(f)(4)(A) would provide that a Directed Order
must be designated for the Exchange's Core Trading Session, as defined
in Rule 7.34(a)(2).\4\
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    \4\ Because the Exchange proposes that Directed Orders may only
be designated for the Core Trading Session, the Exchange also
proposes conforming changes to Rule 7.34 (Trading Sessions).
Specifically, the Exchange proposes to modify Rule 7.34(c)(1)(E) to
provide that Directed Orders designated for the Early Trading
Session would be rejected and Rule 7.34(c)(3)(C) to provide that
Directed Orders designated for the Late Trading Session would be
rejected. The Exchange also proposes an additional change to correct
a typographical error in Rule 7.34(c)(1), to update the reference to
``paragraphs (c)(1)(A)-(E)'' to ``paragraphs (c)(1)(A)-(F)'' to
accurately reflect the number of subparagraphs under Rule
7.34(c)(1).
---------------------------------------------------------------------------

    Proposed Rule 7.31(f)(4)(A) would further provide that a Directed
Order must be designated with a Time in Force modifier of IOC \5\ or
Day \6\ and would be routed to the specified ATS with such modifier.
The Exchange proposes that a Directed Order designated IOC would be
traded in whole or in part on the ATS to which it is routed after
receipt of the order, and any untraded quantity would be cancelled. The
Exchange proposes that a Directed Order designated Day would expire at
the end of the Core Trading Session on the day it is entered. Proposed
Rule 7.31(f)(1)(A) would also provide that a Directed Order may not be
designated with any other modifiers defined in Rule 7.31.
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    \5\ See Rule 7.31(b)(2), which provides that a Limit Order may
be designated with an Immediate-or-Cancel (``IOC'') modifier.
    \6\ See Rule 7.31(b)(1), which provides that orders may be
designated with a Day modifier, and that an order to buy or sell
designated Day, if not traded, will expire at the end of the
designated session on the day on which it was entered.
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    Proposed Rule 7.31(f)(4)(B) would provide that, during a trading
halt or pause, an incoming Directed Order would be rejected.
    Proposed Rule 7.31(f)(4)(C) would provide that a request to cancel
a Directed Order designated Day would be routed to the ATS to which the
order was routed.
    The Exchange also proposes the following conforming changes to Rule
7.19 (Pre-Trade Risk Controls) and Article 17, Rule 5 (Brokerplex).
     The Exchange proposes to modify Rule 7.19(a)(5), which
sets forth the definition of Gross Credit Risk Limit and currently
provides that unexecuted orders in the Exchange Book, orders routed on
arrival pursuant to Rule 7.37(a)(1), and executed orders are included
for purposes of calculating the Gross Credit Risk Limit. The Exchange
proposes to modify Rule 7.19(a)(5) to specify that orders routed on
arrival pursuant to Rule 7.31(f)(4) would also be included for purposes
of the Gross Credit Risk Limit calculation.
     The Exchange proposes to modify Article 17, Rule 5, which
describes the Brokerplex system used by Institutional Brokers
(``IBs''). Specifically, the Exchange proposes to modify Rule 5(c)(1),
which enumerates the order types and modifiers defined in Rule 7.31
that are not available via Brokerplex, to include Directed Orders
because the order type will not be available to IBs.
    The Exchange believes that the proposed rule change would
facilitate additional trading opportunities by offering Participants
the ability to designate orders submitted to the Exchange to be routed
to an ATS of their choosing for execution. The Exchange believes the
proposed change would encourage Participants to utilize the Exchange as
a venue for order entry and further believes that the proposed change
could create efficiencies for Participants by enabling them to send
orders that they wish to route to an alternate destination through the
Exchange, thereby enabling them to leverage order entry protocols and
specifications already configured for their interactions with the
Exchange. The Exchange notes that the Directed Order, as proposed,
would operate similarly to the Primary Only Order already offered by
the Exchange, which is an order that is routed directly to the primary
listing market on arrival, without being assigned a working time or
interacting with interest on the Exchange Book.\7\ The Exchange also
believes that the Directed Order would offer its Participants
functionality akin to order types and routing options that currently
exist on other equities exchanges.\8\
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    \7\ See Rule 7.31(f)(1). NYSE Chicago also offers variations of
the Primary Only Order, including the Primary Only Until 9:45 Order,
which is a Limit or Inside Limit Order that, on arrival and until
9:45 a.m. Eastern Time, routes to the primary listing market, and
the Primary Only Until 3:55 Order, which is a Limit or Inside Limit
Order entered on the Exchange until 3:55 p.m. Eastern Time, after
which time the order is cancelled on the Exchange and routed to the
primary listing market. See Rules 7.31(f)(2) and (f)(3). The
Exchange's affiliated exchanges NYSE American LLC (``NYSE
American''), NYSE Arca, Inc. (``NYSE Arca''), and NYSE National,
Inc. (``NYSE National'') (collectively, the ``Affiliated
Exchanges'') also offer the Primary Only Order and variations
thereof. See NYSE American Rules 7.31E(f)(1)-(f)(3); NYSE Arca Rules
7.31-E(f)(1)-(f)(3); NYSE National Rules 7.31(f)(1)-(f)(3).
    \8\ See, e.g., Nasdaq Stock Market LLC (``Nasdaq''), Equity 4,
Equity Trading Rules, Rule 4758(a)(ix) (defining the Nasdaq Directed
Order as an order designed to use a routing strategy under which the
order is directed to an automated trading center other than Nasdaq,
as directed by the entering party, without checking the Nasdaq
Book); Cboe EDGX Exchange, Inc. (``EDGX'') Rules 11.8(c)(7)
(defining the Routing/Directed ISO order type as an ISO that
bypasses the EDGX system and is immediately routed by EDGX to a
specified away trading center for execution) and 11.11(g)(2)
(providing for the DRT routing option, in which an order is routed
to an alternative trading system as instructed); Cboe EDGA Exchange,
Inc. (``EDGA'') Rules 11.8(c)(7) (defining the Routing/Directed ISO
order type as an ISO that bypasses the EDGA system and is
immediately routed by EDGA to a specified away trading center for
execution) and 11.11(g)(2) (providing for the DRT routing option, in
which an order is routed to an alternative trading system as
instructed); Cboe BZX Exchange, Inc. (``BZX'') Rules 11.13(b)(3)(D)
(providing for the DRT routing option, in which an order is routed
to an alternative trading system as instructed) and 11.13(b)(3)(F)
(defining the Directed ISO routing option, under which an ISO order
would bypass the BZX system and be sent to a specified away trading
center); Cboe BYX Exchange, Inc. (``BYX'') Rules 11.13(b)(3)(D)
(providing for the DRT routing option, in which an order is routed
to an alternative trading system as instructed) and 11.13(b)(3)(F)
(defining the Directed ISO routing option, under which an ISO order
would bypass the BYX system and be sent to a specified away trading
center). The Exchange also believes that the Directed Order would
provide functionality similar to the C-LNK routing strategy formerly
offered by EDGA, in which C-LNK orders bypassed EDGA's local book
and routed directly to a specified Single Dealer Platform
destination. See Securities Exchange Act Release No. 82904 (March
20, 2018), 83 FR 12995 (March 26, 2018) (SR-CboeEDGA-2018-004)
(Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change To Expand an Offering Known a Cboe Connect To Provide
Connectivity to Single-Dealer Platforms Connected to the Exchange's
Network and To Propose a Per Share Executed Fee for Such Service).
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    Because of the technology changes associated with this proposed
rule change, the Exchange will announce the

implementation date by Trader Update.\9\ Subject to effectiveness of
this proposed rule change, the Exchange anticipates that the proposed
change will be implemented in the second quarter of 2022.
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    \9\ The Exchange will also provide information regarding the
ATS(s) to which a Directed Order may be designated to route by
Trader Update.
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2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934,\10\ in general, and furthers the
objectives of Section 6(b)(5),\11\ in particular, because 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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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change is designed to
remove impediments to and perfect the mechanism of a free and open
market and promote just and equitable principles of trade because the
Directed Order would offer Participants access to additional trading
opportunities by permitting them to designate orders submitted to the
Exchange to be routed directly to a specified ATS for execution. The
Exchange further believes that the proposed change would remove
impediments to and perfect the mechanism of a free and open market by
offering Participants the option to send orders that they wish to route
to an alternate destination for execution through the Exchange, which
would create efficiencies to the extent Participants are able to
leverage existing protocols and specifications. Finally, the Exchange
notes that the proposed functionality is not novel, as both the
Exchange and other exchanges offer their members functionality whereby
an exchange routes orders on behalf of a member to a specified trading
center without such order interacting with the exchange's book.\12\
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    \12\ See notes 7 & 8, supra.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed rules governing Directed Orders would promote competition
because they would provide for an order type on the Exchange that would
facilitate additional trading opportunities for market participants.
The Exchange further believes that the proposed rules would allow it to
offer Participants functionality similar to order types and routing
options that exist on other equities exchanges, thereby enabling the
Exchange to compete with such exchanges.\13\
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    \13\ See note 8, supra.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

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

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

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

IV. Solicitation of Comments

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

Electronic Comments:

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSECHX-2022-06 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSECHX-2022-06. 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSECHX-2022-06 and should be submitted
on or before May 31, 2022.

    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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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-09854 Filed 5-6-22; 8:45 am]
BILLING CODE 8011-01-P


The N252 LOAEL for male and female beagle dogs is 3000 ppm ( 98.98 and 92.87 mg/ kg bw/ day, respectively) based upon decreased body weight gain, reduced food consumption, and a negative food efficiency. The NOAEL is 1000 ppm ( 29.85 and 34.42 mg/ kg bw/ day for males and females, respectively).

This chronic study is Unacceptable/ Guideline and does not satisfy the guideline requirement for a chronic oral study [ OPPTS 870.4100, OECD 452] in dogs. This study may be upgradable to acceptable pending submission of historical control data, diet homogeneity and stability, and replacement of illegible data.

STUDY TYPE: 21 Day Dermal Toxicity  Rat [ OPPTS 870.3200 ( § 82 2)] OECD 410.

EXECUTIVE SUMMARY:

In a 21 day dermal toxicity study ( MRID 41944901), Harvade ® Technical ( Dimethipin; 98.62% a. i., Lot # R047232) was applied to the intact shaved skin of 6 CD ® rats/ sex/ dose at dose levels of 0, 10, 100, or 1000 mg/ kg bw/ day, 6 hours/ day for 7 days/ week during a 21 day period.

There were no treatment related effects on mortality, clinical signs, body weight, food consumption, hematology, clinical chemistry, or gross pathology, and there were no observations of dermal irritation ( erythema or edema). At the highest dose level, relative ( to body) liver weights were increased in both males and females ( 20 and 15% greater than controls, respectively; p< 0.01). Treatment related histopathological changes were limited to diffuse trace hyperkeratosis of treated skin in 6/ 6 high dose males and 2/ 6 high dose females ( vs. none of the controls). Multifocal trace hyperkeratosis of treated skin was noted in 5/ 6 low and mid dose males and 2/ 6 mid and high dose females but was not considered toxicologically significant. The dermal LOAEL is 1000 mg/ kg bw/ day, based on diffuse trace hyperkeratosis of treated skin. The dermal NOAEL is 100 mg/ kg bw/ day. The systemic NOAEL is 1000 mg/ kg bw/ day and the systemic LOAEL is not identified.

This 21 day dermal toxicity study in the rat is Acceptable/ Guideline and satisfies the guideline requirement for a 21 day dermal toxicity study ( OPPTS 870.3200; OECD 410). 53 54 STUDY TYPE: 28 Day Oral Toxicity Feeding Mouse; OPPTS 870.3100 [ § 82 1a]; OECD 408.

EXECUTIVE SUMMARY:

In a 28 day oral toxicity study ( MRID 00160460) N 252 Harvade technical ( Dimethipin; purity and batch/ lot # not reported) was administered to 10 albino mice/ sex/ group in the diet at dietary concentrations of 0, 250, 500, 1000, or 2000 ppm ( by standard conversion factor, equivalent to 0, 37.5, 75, 150, or 300 mg/ kg bw/ day).

There were no treatment related effects on mortality, clinical signs, body weight, food consumption, or gross pathology. Hematology, clinical chemistry, and histopathology were not evaluated. Males treated at 1000 and 2000 ppm had increased absolute liver weights ( 115% and 127% of controls, respectively; p< 0.05 for 2000 ppm only) and increased relative liver weights ( 106% and 120% of controls, respectively; p< 0.05 for 2000 ppm only). Females treated at 500, 1000, and 2000 ppm had increased absolute liver weights ( 118, 110, and 116% of controls, respectively; p< 0.05 except at 1000 ppm) and increased relative liver weights ( 113, 108, and 118% of controls, respectively; p< 0.05 except at 1000 ppm). These increases were considered treatment related adaptive responses and not considered toxicologically significant, especially in the absence of a clear dose response pattern. The LOAEL is not identified and the NOAEL is 2000 ppm ( 300 mg/ kg bw/ day by standard conversion factor).

This 28 day oral toxicity study in the mouse is classified Acceptable/ Non guideline and fulfills its intended purpose as a range finding study. Alone it does not satisfy the guideline requirements for a 90 day oral toxicity study in a rodent species ( OPPTS 870.3100; OECD 408).

STUDY TYPE: 90 Day Oral Toxicity ( feeding) rats [ OPPTS 870.3100 ( § 82 1a)] ( rodent) OECD 408.

EXECUTIVE SUMMARY: In a 90 day oral toxicity study ( MRID 43065901), dimethipin ( 98.51% a. i., batch/ lot # 204R026) was administered to 10 Crl: CD BR VAF/ Plus rats/ sex/ dose in the diet at concentrations of 0, 40, 1750, or 3500 ppm ( equivalent to 0, 2.5, 108, and 220 mg/ kg bw/ day in males and 0, 3.1, 131, and 260 mg/ kg bw/ day in females). There were no treatmentrelated effects on mortality, clinical signs, food consumption, hematology, clinical chemistry, or gross or microscopic pathology. At the end of the study, body weight of the 1750 and 3500 ppm females was reduced by 10% and14%, respectively, compared to controls, while body weight of treated males was unaffected. Total body weight gain by the 1750 and 3500 ppm females was reduced by 21% and 29%, respectively, while total body weight gain by males was comparable to that of controls.

Under the conditions of this study, the LOAEL for dimethipin in rats was not established for males, and is 1750 ppm ( 131 mg/ kg/ day) for females, based on decreased body weight and body weight gain. The NOAEL is 3500 ppm ( 220 mg/ kg/ day) for males, and 40 ppm ( 3.1 mg/ kg/ day) for females. 55 This 90 day oral toxicity study in the rat is Acceptable/ Guideline, and satisfies the guideline requirement for a 90 day oral toxicity study ( OPPTS 870.3100; OECD 408) in rats.

STUDY TYPE: In vitro Mammalian Cytogenetics in Chinese hamster ovary CHO cells [ OPPTS 870.5375 ( § 84 2)] OECD 473 EXECUTIVE SUMMARY: In a mammalian cell cytogenetics ( Chromosomal aberrations) assay ( MRID 133302 and 93089013), Chinese hamster ovary CHO K1 BH 4 cell cultures were exposed to Harvade ® technical ( 100% a. i., batch # not provided) in DMSO at concentrations of 0, 5, 25 or 50 µ g/ mL for 5 hours with and without metabolic activation ( S9 mix) and harvested 6  8 and 14  18 hours post exposure. Duplicate cultures were used at each test material concentration and for the solvent and positive controls. The S9 fraction was obtained from Aroclor 1254 induced rat liver. The rat strain and sex were not identified.

Harvade ® technical was tested up to cytotoxic concentrations. Cytotoxicity, as based on a reduction of the mitotic index, was seen at concentrations of 33 µ g/ mL and higher. No statistically significant increase in the percentage of cells with structural aberrations ( excluding gaps) over solvent control values was seen at any concentration, with or without S9 mix. The positive control used in the experiment with activation, dimethylnitrosamine ( DMN), gave abnormally low values in the original assay; therefore, this part of the study was repeated at the same test material concentrations and with two different lots of DMN. The positive control values were acceptable with both lots of DMS in the repeat assay and no statistically significant increase in the percentage of cells with structural aberrations ( excluding) gaps was seen at any test material concentration. The solvent and positive controls induced the appropriate responses. There was no evidence that the test material increased the incidence of chromosome aberrations over background levels.

This study is classified as Acceptable/ Guideline and satisfies the guideline requirement for Test Guideline OPPTS 870.5375; OECD 473 for in vitro cytogenetic mutagenicity data.

STUDY TYPE: Other Genotoxicity: Unscheduled DNA Synthesis in Rat Hepatocytes/ Mammalian Cells  in vivo/ in vitro Procedure [ OPPTS 870.5550 ( § 84 2)]

EXECUTIVE SUMMARY: In an in vivo/ in vitro unscheduled DNA synthesis ( UDS) assay ( MRIDs 40479601 and 93089016) in rat hepatocytes, Harvade, in 1.25% methylcellulose, was administered by gavage to three male Wistar rats per test group in two experiments at doses of 0, 100, 300 or 1000 mg/ kg body weight. The test material was delivered in a volume of 10 mL/ kg. Hepatocytes were isolated at 2 hours post treatment in the first experiment and at 12 hours posttreatment in the second experiment and cultured for determination of tritiated thymidine incorporation using the autoradiographic procedure. The positive control was methylmethanesulfonate ( MMS) in the first experiment and 2 acetylaminofluorene ( 2 AAF) in the second experiment. 56 The upper dose of Harvade used was considered near the LD 50 in rats. No mortality occurred during the study but all rats dosed at 1000 mg/ kg were lethargic and lachrymating 1 to 2 hours after treatment. The rats appeared normal by 12 hours after treatment. The mean net nuclear grain counts were below zero and also below the solvent control values of  1.15 ± 0.57 at 2 hours and  0.98 ± 0.21 at 12 hours at all test material concentrations at both treatment times. Also, little difference in the percentage of cells in repair ( defined as a cell with a net nuclear grain count of five or more) was seen between test material and solvent control groups. The mean net nuclear grain count of the MMS positive control was 3.66 ± 1.16 and that of the 2 AAF positive control was 4.93 ± 0.23. The solvent and positive control values were appropriate. There was no evidence that Harvade increased the incidence of UDS over the solvent control values indicating no induction of DNA damage.

This study is classified as an Acceptable/ Guideline study. It satisfies the guideline requirements in [ OPPTS 870.5550 ( § 84 2)].

STUDY TYPE: In Vivo Mammalian Cytogenetics  Erythrocyte Micronucleus assay in mouse bone marrow [ OPPTS 870.5395 ( § 84 2)] OECD 474.

EXECUTIVE SUMMARY: In a Swiss CD 1 mouse bone marrow micronucleus assay ( MRID 40479602), five mice/ sex/ dose were treated orally on two occasions 24 hours apart with Dimethipin technical ( 98.9% a. i., batch # SI 251). Males received two doses of test material at 0, 22.0, 73.3 or 220.0 mg/ kg body weight and females received two doses at 0, 30, 100 or 300 mg/ kg. Bone marrow cells were harvested at 6 hours after the second treatment. The vehicle was 0.5% Carboxymethylcellulose ( CAC).

Dimetipin technical was tested to toxic concentrations. One male in the 220 mg/ kg dose group died a short time after the first dose and all females in the 300 mg/ kg dose group appeared sedated several hours after the first dose and were found dead the following day. The incidence of micronucleated PCEs was slightly increased over the solvent control value in the high dose males, but not in any other treatment group, in the initial scoring ( data not presented). The slides from the high dose males and those from the male and female solvent control groups were recoded and rescored. No increase in the incidence of micronucleated PCEs over the solvent control value was seen in the combined data from the initial and repeat scoring of slides from the high dose males. The Mitomycin C positive control induced statistically significant increases in the mean incidence of micronucleated PCEs per 1000 PCE in both males and females over the respective solvent control values and the solvent control values were appropriate. The PCE/ NCE ratios were similar in the solvent control and test material treated groups and did not indicate bone marrow cytotoxicity. There was no statistically significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow from either sex at any dose.

This study is classified as Acceptable/ Guideline and satisfies the guideline requirement for Test Guideline OPPTS 870.5395; OECD 474 for in vivo cytogenetic mutagenicity data. 57 STUDY TYPE: In Vivo Mammalian Cytogenetics  Erythrocyte Micronucleus assay in mice; [ OPPTS 870.5395 ( § 84 2)] OECD 474.

EXECUTIVE SUMMARY: In a Swiss CD 1 mouse bone marrow micronucleus assay ( MRID 41708201), five mice/ sex/ dose/ harvest time were treated once orally with Dimethipin Technical ( 98.8% a. i., batch/ lot # not provided) in 0.5% carboxymethyl cellulose ( CMC) at a dose of 0 or 220 mg/ kg body weight. Bone marrow cells were harvested at 24, 48 and 72 hours posttreatment

Dimethipin Technical was tested at a toxic concentration with 27 of 30 mice showing piloerection and 9 of 15 male mice having reduced body temperature following treatment. Bone marrow cytotoxicity, as based on an elevated NCE/ PCE ratio, was seen in test material treated mice at 48 and 72 hours post treatment. At least 1000 PCEs per mouse were scored for micronuclei. There was no statistically significant increase in the incidence of micronucleated polychromatic erythrocytes ( PCEs) over the concurrent solvent control value in either sex at any harvest time. The solvent and positive control induced the appropriate responses. There was no statistically significant increase in the frequency of micronucleated polychromatic erythrocytes in mouse bone marrow at any harvest time.

This study is classified as Acceptable/ Guideline and satisfies the guideline requirement for Test Guideline OPPTS 870.5395; OECD 474 for in vivo cytogenetic mutagenicity data.

STUDY TYPE: In vitro Bacterial Gene Mutation ( Bacterial system, Salmonella typhimurium; E. coli)/ mammalian activation gene mutation assay; OPPTS 870.5100 [ § 84 2]; OECD 471 ( formerly OECD 471 & 472).

EXECUTIVE SUMMARY: In a reverse gene mutation assay in bacteria ( MRID 93089035 and 93089012), strains TA98, TA100, TA1535, TA1537 and TA1538 of S. typhimurium were exposed to Harvade ( N252)( 98% a. i., lot # D 11401) in DMSO at concentrations of 0, 1, 10, 100, 500, 1000, 2500, 5000 or 10,000 µ g/ plate in the presence and absence of mammalian metabolic activation ( S9 mix). A second assay was conducted using TA98 and TA100 without S9 mix and a third assay conducted using TA98 and TA1538 with S9 mix. All plating was in duplicate. The S9 fraction was obtained from Aroclor 1254 induced male Sprague Dawley rat liver. MRID 93089035 is a reformat prepared by Uniroyal Chemical Co., Inc. dated July 5, 1990 of the original study dated March 18, 1981. MRID 93089012 is a summary prepared by D. L. Story dated June 14, 1990.

Harvade ( N252) was tested up to 10,000 µ g/ plate, twice the accepted limit concentration of 5000 µ g/ plate. The test material was slightly cytotoxic to TA1537 at 10,000 µ g/ plate. The number of revertants per plate was not increased over the respective solvent control value at any test material concentration, with or without S9 mix, in any bacterial strain. The tests with TA98 and TA100 without S9 mix were repeated because of a low positive control value in TA100 and low number of revertants per plate at several test material concentrations in TA98. The tests with TA98 and TA1538 with S9 mix were repeated because of a low positive control value in 58 TA1538 and fungal contamination of one duplicate plate of the TA98 solvent control. The repeat assays were acceptable and confirmed the negative results of the initial assay. The solvent and positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.

This study is classified as Acceptable/ Guideline and satisfies the intent of the guideline requirement for Test Guideline OPPTS 870.5100; OECD 471 for in vitro mutagenicity ( bacterial reverse gene mutation) data.

STUDY TYPE: In Vitro Mammalian Cells in Culture Gene Mutation assay in L5178Y mouse lymphoma cells; OPPTS 870.5300 [ § 84 2]; OECD 476.

EXECUTIVE SUMMARY: In a mammalian cell gene mutation assay at the TK locus ( MRID 93089041 and 93089029), mouse lymphoma L5178Y TK ± cells cultured in vitro were exposed for four hours to Harvade ( N252) ( 98% a. i., batch No. D 11401) in DMSO in two independent assays. In the first assay, cells were exposed at concentrations of 0, 1.56, 12.5, 25.0, 50.0 or 75.0 µ g/ mL without metabolic activation ( S9 mix) and at concentrations of 0, 12.5, 50.0, 75.0, 100.0 or 150.0 µ g/ mL with S9 mix. In the second assay, cells were exposed at concentrations of 0, 25.0, 50.0, 75.0, 100.0, 150.0 or 200.0 µ g/ mL with S9 mix only. The S9 fraction was obtained from Aroclor 1254 induced male Fischer 344 rat liver.

Harvade ( N252) was tested up to cytotoxic concentrations. In the first mutation assay, the test material reduced the percent relative growth to 9.5% at 75.00 µ g/ mL without S9 mix and to 6.1% at 150 µ g/ mL with S9 mix. The mutant frequency did not exceed the background mutant frequency or approach the minimum for a positive response ( calculated as 32.6 x 10 6 for the current test) at any test material concentration without S9 mix. However, in the presence of S9 mix, weak mutagenicity was seen at test material concentrations of 75.0 µ g/ mL and higher. The highest mutant frequency of 56.4 x 10 6 was seen at 100 µ g/ mL. The minimum mutant frequency for a positive response with S9 mix was calculated as 41.1 x 10 6. In the confirmatory assay conducted in the absence of S9 mix only, positive results were again seen at test material concentrations of 75.0 µ g/ mL and higher. The mutant frequencies ranged from 47.0 x 10 6 at 75.0 µ g/ mL to 127.9 x 10 6 at 200 µ g/ mL, exceeding the minimum value for a positive response for the test of 43.9 x 10 6. The positive results, however, were seen only at very cytotoxic concentrations, at cell survivals less than 10% in most cases. The mutant frequency reached a doubling of that calculated as minimal for a positive response in the repeat assay only at relative growth rates of 2.4%, 3.9% and 1.6%. Results at such low survival rates are unreliable. In addition, the current acceptance criteria for this assay require data on colony sizing and some indication that pH and osmolality of the treatment medium did not affect the results. This information was not provided. The testing laboratory's protocol specifies that either BrdU or TFT could be used as the selective agent but the investigators did not report which was used in this study. The solvent and positive controls ( Ethyl methanesulfonate without S9 mix and Dimethylnitrosamine with S9 mix) induced the appropriate responses. There was an indication of mutant induction in the presence of S9 mix but only at very cytotoxic doses of Harvade ( N252). 59 This study is classified as Unacceptable/ Guideline. It does not satisfy the guideline requirement for Test Guideline OPPTS 870.5300, OECD 476 for in vitro mutagenicity ( mammalian forward gene mutation) data.

3.0 METABOLISM CONSIDERATIONS 1.01 Introduction 1.1 Description of Issues  What are the residues of concern for the tolerance expression and risk assessment in plant commodities, animal commodities, rotational crops and water?

1.2 Team Proposal  The Team proposes that:

 for the tolerance expression and risk assessment in plant commodities the residue of concern is dimethipin per se.

 for the tolerance expression in animal commodities the residue of concern is dimethipin per se. The residue of concern for risk assessment is dimethipin per se in all animal commodities except liver and dimethipin plus the metabolite, acetyl dithiane tetraoxide, in the liver of cattle, goats, horses and sheep.

 the residue of interest in rotational crops is dimethipin per se.

 the residue of concern in water for risk assessment is dimethipin per se.

2.0 Nature of the Residue Studies in Plants Metabolism was studied only in cotton because dimethipin is registered only for food use on cotton.

2.1.1 Executive Summary of Plant Study No. 1 [ MRID 43436901]

Greenhouse grown cotton was treated with [ 2,3 14C] dimethipin at 1.22 lb ai/ A and 3.06 lb ai/ A ( 2.2x and 5.4x the maximum seasonal rate) two weeks prior to harvest. Total radioactive residues were 97.1 ppm in foliage and 0.291 ppm in seeds from plants treated at the 2.2x rate, and 341.3 ppm in foliage and 1.42 ppm in seeds from plants treated at the 5.4x rate. Matrices from the 2.2x treated plants were subjected to extraction and characterization/ identification. Dimethipin per se was found to comprise 74% of foliage radioactivity and 80% of seed radioactivity; no additional metabolites were identified. 60 2.1.2 Tabular Summary of Plant Study No. 1 Table 2.1.2 Summary of Characterization and Identification of Radioactive Residues in Cotton MATRIX TRR Recovery % Extractable TRR Dimethipin1 Cotton Foliage 95.2% 74 Cotton Mature Seeds 86.2% 80 1No additional metabolites were identified.

3.0 Nature of the Residue in Livestock 3.1.1 Executive Summary of Ruminant Study [ MRID 43922101]

Three lactating goats were orally administered a gelatin capsule containing either [ 14C] dimethipin or a mixture of [ 14C and 13C] dimethipin once daily for five consecutive days. The administered dose levels of dimethipin in the diet were 3.066 ppm ( low dose) for the first goat, 1010.8 ppm ( high dose) for the second goat, and 1290.0 ppm ( high dose) for the third goat. The daily feeding levels were, respectively, equivalent to 0.5x, 177x and 226x the maximum theoretical dietary burden of 5.7 ppm for dairy cattle ( based on residues in cottonseed meal at the 0.5 ppm tolerance level and a high end estimate of cotton gin trash residues at 25 ppm).

The TRR were 0.005 0.006 ppm in milk, 0.27 ppm in liver, 0.15 ppm in kidney, 0.002 ppm in muscle, and 0.001 ppm in fat from the goat dosed at 3.066 ppm, 0.68 1.20 ppm in milk, 78.5 ppm in liver, 28.4 ppm in kidney, 0.64 ppm in muscle, and 0.32 ppm in fat from the goat dosed at 1010.8 ppm, and 3.13 4.26 ppm in milk, 45.0 ppm in liver, 55.2 ppm in kidney, 2.04 ppm in muscle, and 0.99 ppm in fat from the goat dosed at 1290.0 ppm.

Dimethipin was not detected in milk and tissues from the goat dosed at 3.066 ppm. In milk from this goat, dimethipin cysteine conjugate ( 34.8 52.8% TRR, 0.001 0.002 ppm) was the only residue identified. In kidney, the only metabolite identified was ethane disulfonic acid ( 75.6% TRR, 0.11 ppm). In liver, two metabolites were identified: ethane disulfonic acid ( 14.6% TRR, 0.38 ppm) and acetyl dithiane tetraoxide ( 16.6% TRR, 0.045 ppm). No attempts were made to characterize/ identify radioactive residues in fat and muscle because the total radioactive residues in these tissues were 0.001 and 0.002 ppm, respectively.

The parent dimethipin was also not detected in the milk and tissues of the goats dosed at higher levels. Dimethipin cysteine conjugate was also the only residue identified in milk ( 25.2 50.6% TRR, 0.22 0.55 ppm). In kidney, ethane disulfonic acid ( 27.6% TRR, 7.8 ppm) and acetyl dithiane tetraoxide ( 32.3% TRR, 9.2 ppm) were identified. In muscle, reduced dimethipin ( 2,3 61 dimethyl 1,1,4,4 tetraoxo 1,4 dithiane; 21.9% TRR, 0.140 ppm) was identified. In liver, ethane disulfonic acid ( 44.8% TRR, 20.1 ppm) was identified. Based on several fractionation and extraction procedures employed in the study, the registrant believes that majority of radioactive residues in kidney and liver were covalently bound to proteins.

3.1.2 Tabular Summary of Ruminant Study Table 3.1.2a Distribution, characterization and identification of total radioactive residues in milk and tissues from goats dosed with [ 14C] dimethipin at 3.066 ppm ( low dose) in the diet for five consecutive days.

Fraction % TRR ppm Characterization/ Identification a Milk, Day 1 ( TRR = 0.005 ppm)

Aqueous 81.3 0.004 Anion exchange HPLC analysis resolved:

dimethipin cysteine 52.8% TRR 0.002 ppm Nonextractable NR b NR Not further analyzed ( N/ A).

Milk, Day 2 ( TRR = 0.005 ppm)

Aqueous 76.5 0.004 Anion exchange HPLC analysis resolved:

dimethipin cysteine 34.8% TRR 0.001 ppm Nonextractable NR NR N/ A.

Milk, Day 3 ( TRR = 0.006 ppm)

Aqueous 72.3 0.004 Anion exchange HPLC analysis resolved:

dimethipin cysteine 44.2% TRR 0.002 ppm Nonextractable NR NR N/ A.

Milk, Day 4 ( TRR = 0.006 ppm)

Aqueous 70.3 0.004 Anion exchange HPLC analysis resolved:

dimethipin cysteine 41.1% TRR 0.002 ppm Nonextractable NR NR N/ A.

Milk, Day 5 ( TRR = 0.005 ppm)

Aqueous 69 0.003 Anion exchange HPLC analysis resolved:

dimethipin cysteine 38.5% TRR 0.001 ppm Nonextractable NR NR N/ A.

Kidney ( TRR = 0.15 ppm)

Aqueous 99.7 0.15 Anion exchange HPLC analysis resolved:

Ethane disulfonic acid 75.6% TRR 0.11 ppm Ion pairing HPLC analysis resolved:

Ethane disulfonic acid 69.6% TRR 0.10 ppm Nonextractable 1.46 0.014 N/ A.

Liver ( TRR = 0.27 ppm)  Trypsin/ pepsin digest/ RP C18 Water 36.5 0.098 Subjected to amino SPE cleanup with the following fractions isolated for HPLC analysis.

Water 12.6 0.034 Anion exchange HPLC analysis resolved:

Ethane disulfonic acid 0.8% TRR 0.002 ppm Unknown Rt = 3 5 mins 3.6% TRR 0.010 ppm Unknown Rt = 23 25 mins 4.7% TRR 0.013 ppm Unknown Rt = 26 28 mins 0.6% TRR 0.002 ppm Table 3.1.2a Distribution, characterization and identification of total radioactive residues in milk and tissues from goats dosed with [ 14C] dimethipin at 3.066 ppm ( low dose) in the diet for five consecutive days.

Fraction % TRR ppm Characterization/ Identification a 62 1% TFA 7.4 0.027 Anion exchange HPLC analysis resolved:

Ethane disulfonic acid 1.3% TRR 0.003 ppm Unknown Rt = 3 5 mins 1.6% TRR 0.004 ppm Unknown Rt = 23 25 mins 0.5% TRR 0.001 ppm Unknown Rt = 26 28 mins 1.6% TRR 0.004 ppm Unknown Rt = 36 38 mins 0.7% TRR 0.002 ppm 25% TFA 17 0.045 Anion exchange HPLC analysis resolved:

Ethane disulfonic acid 12.1% TRR 0.032 ppm Unknown Rt = 23 25 mins 1.4% TRR 0.004 ppm 25% Aqueous methanol 48.6 0.13 Subjected to amino SPE cleanup with the following fractions isolated for HPLC analysis.

Water 25.1 0.067 Anion exchange HPLC analysis resolved:

Acetyl dithiane tetraoxide 14.9% TRR 0.040 ppm Unknown Rt = 23 25 mins 5.5% TRR 0.015 ppm 1% TFA 18.6 0.05 Anion exchange HPLC analysis resolved:

Acetyl dithiane tetraoxide 1.7% TRR 0.005 ppm Unknown Rt = 3 5 mins 2.3% TRR 0.006 ppm Unknown Rt = 26 28 mins 5.1% TRR 0.014 ppm Unknown Rt = 33 34 mins 2.1% TRR 0.006 ppm Unknown Rt = 35 mins 1.2% TRR 0.003 ppm Unknown Rt = 36 38 mins 1.7% TRR 0.005 ppm Subjected to non specific protease digestion.

Protease digest NR NR Anion exchange HPLC analysis resolved:

Acetyl dithiane tetraoxide 1.6% TRR 0.004 ppm Unknown Rt = 4 5 mins 7.2% TRR 0.019 ppm Unknown Rt = 22 mins 0.9% TRR 0.002 ppm Unknown Rt = 23 24 mins 4.2% TRR 0.011 ppm Unknown Rt = 26 27 mins 1.5% TRR 0.004 ppm 25% TFA 4.6 0.012 Anion exchange HPLC analysis resolved:

Ethane disulfonic acid 0.4% TRR 0.001 ppm Unknown Rt = 3 5 mins 2.0% TRR 0.005 ppm Unknown Rt = 17 19 mins 0.3% TRR 0.001 ppm Unknown Rt = 26 28 mins 0.6% TRR 0.002 ppm 50% Aqueous methanol 14.1 0.038 Anion exchange HPLC analysis resolved:

Unknown Rt = 17 19 mins 1.3% TRR 0.003 ppm Unknown Rt = 36 38 mins 2.7% TRR 0.007 ppm Unknown Rt = 41 43 mins 2.4% TRR 0.006 ppm Unknown Rt = 44 47 mins 2.3% TRR 0.006 ppm Nonextractable NR NR N/ A.

aRefer to Table 3.4 for the structures of identified metabolites.

bNR = not reported. 63 Table 3.1.2b Distribution, characterization and identification of total radioactive residues in milk and tissues from goats dosed with [ 14C] dimethipin at 1010.8 ppm ( high dose) or with a mixture of [ 14C and 13C] dimethipin at 1290 ppm in the diet for five consecutive days.

Fraction % TRR ppm Characterization/ Identification a Milk, Day 1 ( TRR = 0.68 ppm)

Aqueous 86.4 0.588 Ion pairing HPLC analysis resolved:

dimethipin cysteine 32.9% TRR 0.22 ppm Unknown # 1 15.4% TRR 0.10 ppm Unknown # 2 8.2% TRR 0.056 ppm Nonextractable NR b NR Extracted with hexane.

Hexane 3.7 0.025 Not further analyzed ( N/ A).

Nonextractable NR NR N/ A.

Milk, Day 2 ( TRR = 1.20 ppm)

Aqueous 88.4 1.061 Ion pairing HPLC analysis resolved:

dimethipin cysteine 25.2% TRR 0.30 ppm Unknown # 1 20.3% TRR 0.24 ppm Unknown # 2 9.3% TRR 0.11 ppm Nonextractable NR NR Extracted with hexane.

Hexane 3.5 0.042 N/ A.

Nonextractable NR NR N/ A.

Milk, Day 3 ( TRR = 1.12 ppm)

Aqueous 92.8 1.039 Ion pairing HPLC analysis resolved:

dimethipin cysteine 35.8% TRR 0.40 ppm Unknown # 1 20.7% TRR 0.23 ppm Unknown # 2 11.9% TRR 0.13 ppm Nonextractable NR NR Extracted with hexane.

Hexane 4.9 0.055 N/ A.

Nonextractable NR NR N/ A.

Milk, Day 4 ( TRR = 0.99 ppm)

Aqueous 88.5 0.876 Ion pairing HPLC analysis resolved:

dimethipin cysteine 39.3% TRR 0.39 ppm Unknown # 1 16.7% TRR 0.17 ppm Unknown # 2 12.1% TRR 0.12 ppm Nonextractable NR NR Extracted with hexane.

Hexane 5.3 0.052 N/ A.

Nonextractable NR NR N/ A.

Milk, Day 5 ( TRR = 1.08 ppm)

Aqueous 89.7 0.969 Ion pairing HPLC analysis resolved:

dimethipin cysteine 50.6% TRR 0.55 ppm Unknown # 1 11.6% TRR 0.13 ppm Unknown # 2 8.2% TRR 0.088 ppm Nonextractable NR NR Extracted with hexane.

Hexane 5.4 0.058 N/ A.

Nonextractable NR NR N/ A.

Fat ( TRR = 0.32 ppm) Table 3.1.2b Distribution, characterization and identification of total radioactive residues in milk and tissues from goats dosed with [ 14C] dimethipin at 1010.8 ppm ( high dose) or with a mixture of [ 14C and 13C] dimethipin at 1290 ppm in the diet for five consecutive days.

Fraction % TRR ppm Characterization/ Identification a 64 Hexane 6.4 0.02 Partitioned with ACN and methanol; partitioned phases were combined with the ACN and methanol extracts of the nonextractable.

Nonextractable NR NR Sequentially extracted with ACN and methanol; extracts combined with ACN and methanol partitioned phases of the hexane extract.

Methanol/ ACN 28.1 0.09 Ion pairing HPLC analysis resolved:

Unknown  early eluting 11.5% TRR 0.004 ppm Partitioned with hexane.

Hexane 2.9 0.0093 N/ A.

Precipitate 23.3 0.075 N/ A.

Nonextractable 37.5 0.012 N/ A.

Kidney ( TRR = 28.4 ppm)

Aqueous 104.4 29.65 Anion exchange HPLC analysis resolved:

Ethane disulfonic acid 34.2% TRR 9.7 ppm Ion pairing HPLC analysis resolved:

Ethane disulfonic acid 30.5% TRR 8.7 ppm Hydrolyzed with HCl BuOH.

BuOH/ HCl 91.7 26.04 Reverse phase HPLC analysis resolved:

Ethane disulfonic acid 18.3% TRR 5.2 ppm Acetyl dithiane tetraoxide 34.6% TRR 9.8 ppm Ion pairing HPLC analysis resolved:

Ethane disulfonic acid 27.6% TRR 7.8 ppm Acetyl dithiane tetraoxide 32.3% TRR 9.2 ppm Nonextractable NR NR N/ A.

Liver ( 13C/ 14C Label; TRR = 44.9 ppm)

Trypsin/ pepsin digest 106 45 Reverse phase HPLC analysis resolved:

Acetyl dithiane tetraoxide 11.3% TRR 5.1 ppm Unknown Rt = 3 5 mins 51.5% TRR 23.1 ppm Unknown Rt = 29 31 mins 7.9% TRR 3.5 ppm Subsample 1: Supernatant was subjected to C18 column chromatography and the water fraction ( 106% TRR, 44.9 ppm) was subjected to bonded phase amino SPE cleanup; the 25% TFA fraction ( 75.8% TRR, 34.0 ppm) was subjected to anion exchange SPE with the following fractions isolated for HPLC analysis.

Subsample 2: A subsample was hydrolyzed with BuOH HCl and TFA.

Subsample 1 2.5% TFA 22.9 10.3 Anion exchange HPLC analysis resolved:

Ethane disulfonic acid8.5% TRR 3.8 ppm Unknown Rt = 14 15 mins 1.8% TRR 0.79 ppm Unknown Rt = 21 22 mins 3.8% TRR 1.7 ppm Unknown Rt = 23 25 mins 2.6% TRR 1.1 ppm Unknown Rt = 26 29 mins 1.7% TRR 0.77 ppm Table 3.1.2b Distribution, characterization and identification of total radioactive residues in milk and tissues from goats dosed with [ 14C] dimethipin at 1010.8 ppm ( high dose) or with a mixture of [ 14C and 13C] dimethipin at 1290 ppm in the diet for five consecutive days.

Fraction % TRR ppm Characterization/ Identification a 65 5.0% TFA 50.9 22.8 Anion exchange HPLC analysis resolved:

Ethane disulfonic acid 36.3% TRR 16.3 ppm Unknown Rt = 21 22 mins 3.9% TRR 1.7 ppm Subsample 2 BuOH/ HCl hydrolysate NR NR Reverse phase HPLC analysis resolved:

Acetyl dithiane tetraoxide 20.4% TRR 9.2 ppm Unknown Rt = 3 5 mins 13.1% TRR 5.9 ppm Unknown Rt = 8 9 mins 5.9% TRR 2.6 ppm Unknown Rt = 18 20 mins 26.3% TRR 11.8 ppm Unknown Rt = 29 31 mins 7.0% TRR 3.1 ppm TFA NR NR Reverse phase HPLC analysis resolved:

Acetyl dithiane tetraoxide 19.3% TRR 8.7 ppm Unknown Rt = 3 5 mins 19.2% TRR 8.6 ppm Unknown Rt = 18 20 mins 24.7% TRR 11.1 ppm Unknown Rt = 29 31 mins 6.1% TRR 2.7 ppm Nonextractable NR NR N/ A.

Muscle ( TRR = 0.64 ppm)  HCl BuOH hydrolysis and SPE cleanup Aqueous 27 0.17 Ion pairing HPLC analysis resolved:

Unknown Rt = 5 mins 16.7% TRR 0.107 ppm Unknown Rt = 11 mins 1.5% TRR 0.009 ppm Anion exchange HPLC analysis resolved:

Unknown Rt = 26 mins 4.0% TRR 0.025 ppm Unknown Rt = 41 mins 1.8% TRR 0.012 ppm Unknown Rt = 54 mins 7.1% TRR 0.045 ppm Unknown Rt = 57 mins 2.7% TRR 0.017 ppm Methanol 59.6 0.38 Ion pairing HPLC analysis resolved:

Reduced dimethipin 21.9% TRR 0.140 ppm Unknown Rt = 7 mins 2.8% TRR 0.018 ppm Unknown Rt = 11 mins 6.2% TRR 0.040 ppm Unknown Rt = 15 mins 7.2% TRR 0.046 ppm Unknown Rt = 35 mins 3.6% TRR 0.023 ppm Anion exchange HPLC analysis resolved:

Reduced dimethipin 22.9% TRR 0.146 ppm Unknown Rt = 17 mins 7.3% TRR 0.047 ppm Unknown Rt = 26 mins 2.9% TRR 0.018 ppm Unknown Rt = 61 mins 6.5% TRR 0.041 ppm Ethyl acetate 4.8 0.031 N/ A.

Nonextractable NR NR N/ A.

aRefer to Table 3.4 for the structures of identified metabolites.

bNR = not reported.

3.1.3 Executive Summary of Poultry Study [ MRID 42706001]

Two groups of hens were orally dosed with [ 14C] dimethipin for five consecutive days. Five hens ( Group I) received a low dose ( 203.5 ppm) of [ 14C] dimethipin with a specific activity of 0.6592 66 mCi/ mmole ( 6906 dpm/  g), and two hens ( Group II) received a high dose ( 2772 ppm) with a specific activity of 0.1341 mCi/ mmole ( 1405 dpm/  g). The low and high doses were equivalent to 2035x and 27,720x the maximum theoretical dietary burden for poultry of 0.1 ppm, calculated based on the cottonseed meal tolerance of 0.5 ppm. The [ 14C] dimethipin had a radiochemical purity of > 95%. The position of the radiolabel was at the 2 and 3 carbons in the dithiin ring. Five additional hens were used as controls.

The TRR were 0.12 12 ppm in egg whites, 0.34 16 ppm in egg yolks, 2.4 ppm in fat, 10 ppm in thigh muscle, 10 ppm in breast muscle, 39 ppm in kidney, and 65 ppm in liver. Dimethipin per se was not detected in any poultry matrices, however reduced dimethipin was found in all matrices except thigh muscle and fat, 0.98 7.8% TRR ( 0.21 5.0 ppm). In all matrices except liver, the predominant metabolite was Glu Cys S Harv [ S( 2,3 dimethyl 1,1,4,4 tetraoxo 1,4 dithian yl) Lcysteinyl   glutamic acid], at 19 36% TRR ( 0.48 7.5 ppm); this metabolite was found in liver at 7.4% TRR ( 4.8 ppm). The most significant liver metabolite was dimethipin cysteine conjugate ( Harv S Cys), at 21.5% TRR ( 14 ppm); this metabolite was found in all other matrices except fat, at 0.1 7.0% TRR ( 0.01 2.8 ppm). The major metabolic pathway proposed by the registrant involved the formation of thioethers of dimethipin; other minor pathways involved reduction and hydroxylation of dimethipin. 67 3.1.4 Tabular Summary of Poultry Study Table 3.1.4 Characterization/ Identification of 14C residues in egg and tissues from hens fed uniformly labeled [ 14C] dimethipin at the high dose ( 2772 ppm).

Metabolite ID Egg White Egg Yolk Liver Kidney Gizzard Breast Muscle Thigh Muscle Fat % TRR PPM ( 6.6) % TRR PPM ( 6.9) % TRR PPM ( 65) % TRR PPM ( 39) % TRR PPM ( 20) % TRR PPM ( 10) % TRR PPM ( 10) % TRR PPM ( 2.4)

Reduced dimethipin 7.8 0.51 4.7 0.33 7.6 5.0 0.98 0.34 2.5 0.51 2.1 0.21

Harv S Methyl  a  0.62 0.04 7.3 4.7

Harv prim

OH 2.3 0.15 2.9 0.20 3.1 2.0   0.77 0.15

Harv tert OH 1.2 0.08   2.9 1.9 4.4 1.7

Harv SOMethyl 6.0 0.40 0.95 0.07 0.95 0.62 1.2 0.48   0.20 0.02

Harv S Cys 0.10 0.01 3.9 0.27 21.5 14 7.0 2.8 11 2.2 2.3 0.23 5.0 0.50

Harv GSH 3.4 0.23 8.1 0.56 5.9 3.9 3.5 1.4 4.1 0.83 1.0 0.10 4.3 0.43

Glu Cys

SHarv 25 1.7 36 2.5 7.4 4.8 19 7.5 21 4.3 32 3.2 28 2.8 20 0.48 Harv SAcetate   6.8 0.47       0.60 0.06

Harv SH 3.8 0.25 0.92 0.60 0.92 0.60   0.71 0.14

Identified 49.6 3.27 64.9 4.48 57.7 37.8 36.08 16.32 39.98 8.13 38.2 3.82 37.3 3.73 20 0.48 Unknown # 1 0.25 0.017   1.3 0.82   0.29 0.059 0.13 0.013 1.7 0.17 3.1 0.074 Unknown # 2 1.1 0.07 7.6 0.53 3.1 2.0 17 6.5 15 3.1 28 2.8 16 1.6

Unknown # 3     0.45 0.29

Unknown # 4     2.4 1.6 2.8 1.1   2.2 0.22

Unknown # 5     0.58 0.38 1.6 0.6

Unknown # 6   5.0 0.34 0.36 0.24

Unknown # 7 3.8 0.25

Unknown # 8 12 0.82 4.1 0.28 0.91 0.59 4.0 1.6 8.8 1.7 3.4 0.34 3.6 0.36

Unknown # 9     0.25 0.16   0.86 0.17   0.51 0.051   Table 3.1.4 Characterization/ Identification of 14C residues in egg and tissues from hens fed uniformly labeled [ 14C] dimethipin at the high dose ( 2772 ppm). 68 Characterized 17.15 1.16 16.7 1.15 9.35 6.08 25.4 9.8 24.95 5.03 33.73 3.37 21.81 2.18 3.1 0.074 Totalb 66.75 4.43 81.6 5.63 67.1 43.88 61.48 26.12 64.93 13.16 71.93 7.19 59.11 5.91 23.1 0.55 Baselinec 20 1.3 15 1.1 26 17 12 4.7 31.0 5.0 14 1.4 13 1.3 16 0.39 Boundd 20 1.3 1.9 0.13 1.3 0.85 2.3 0.86 1.3 0.26 0.96 0.096 2.1 0.22 24 0.58 a None reported.

b Includes identified and characterized residues.

c Baseline radioactivity refers to radioactivity which did not elute, or eluted but was not associated with a specific peak.

d Bound residues remaining after enzyme hydrolysis. There is a discrepancy in the registrant's report regarding the bound residues in fat ( the bound TRR is either 5% or 24% of the total). 69 4.0 Confined Rotational Crop Studies 4.1 Summary of Rotational Crop Studies Two confined rotational crop studies [ MRID 42666301, 42757801, 43768201, 43768202 and 43931301] and two limited field rotational crop studies [ MRID 43979101 and 43979102] were submitted.

In the confined studies [ 14C] Dimethipin was applied to the soil at 0.54 lb ai/ A ( 1x the maximum seasonal rate), and rotational crops of lettuce, carrots, and barley were planted 30 and 183 days after application. Samples of immature and mature lettuce; immature and mature carrot root and top; and barley forage, grain, and straw were collected. In samples from the 30 day plant back interval, dimethipin was identified in immature and mature lettuce ( 0.064 0.091 ppm), mature carrot tops ( 0.024 ppm), immature and mature carrot root ( 0.016 0.039 ppm), barley forage ( 0.025 ppm), and barley straw ( 0.012 ppm). Hydroxylated dimethipin ( metabolite H 5) was identified at low levels ( 0.009 ppm) in barley straw. Two additional metabolites, dimethipin cysteine conjugate ( H 80) and a mercaptolactic acid conjugate, were identified in immature lettuce at 0.023 ppm ( 2.1% TRR) and 0.151 ppm ( 13.68% TRR), respectively. In samples from the 183 day plant back interval, dimethipin was identified in immature carrot tops ( 0.041 ppm) but was not identified in any other matrix. No additional metabolites were identified at the 183 day plant back interval.

5.0 Analytical Methodology For enforcement of tolerances for residues of dimethipin, PAM Vol. II lists two methods, Method I for cottonseed and Method II for animal tissues and eggs. The stated detection limits are 0.1 ppm for cottonseed and 0.02 ppm for animal commodities. In Method I, samples are extracted with methanol/ water, the extract is washed with hexane to remove oil, the residues are partitioned into chloroform, the chloroform extract is evaporated to dryness and redissolved in benzene/ chloroform, and the extract is cleaned up on a Florisil/ alumina column prior to analysis using GC/ FPD. In Method II, samples are extracted with acetonitrile, the extract is washed with petroleum ether, the acetonitrile phase is evaporated to dryness and redissolved in benzene/ chloroform, and the extract is cleaned up on a Florisil/ alumina column prior to analysis by GC/ MS with selected ion monitoring.

The registrant has submitted a revised version of the enforcement method for cottonseed to include instructions for the analysis of cottonseed processed commodities, the use of toluene instead of benzene as a solvent, and a GPC cleanup step. The revised method has undergone adequate independent laboratory validation. The requested waiver of the requirement for additional method validation ( including Agency method validation) for this method has been approved. The method ( in MRID 43109801) should be forwarded to FDA for publication in PAM Vol. II as a replacement for Method I. 70 The FDA PESTDATA database dated 11/ 01 ( PAM Volume I, Appendix I) indicates that dimethipin is completely recovered using Multiresidue Methods Section 302 ( Luke Method; Protocol D) but is not recovered using Section 303 ( Mills, Onley, and Gaither Method; Protocol E, nonfatty food) or Section 304 ( Mills Method; Protocol F, fatty food).

6.0 Summary of Magnitude of Residue ( MOR) Studies 6.1 Plants [ MRIDs: 42920901, 42920902, 42920903, 43184101,42467001, 42467002]

Field Trials: Residues of dimethipin were < 0.10 0.215 ppm in/ on cottonseed treated with two applications of the 4.9 lb/ gal FlC formulation at 0.3125 lb ai/ A and 0.2344 lb ai/ A ( 1x the maximum registered seasonal rate); tests were conducted in AR, GA, LA, MS, TN, and TX. Additional data, from field trials conducted in CA, GA, MS, and TX, indicate that the residues of dimethipin are not likely to exceed the established tolerance of 0.5 ppm in/ on cottonseed harvested 7 days following two broadcast foliar applications of the 4.9 lb/ gal FlC formulation at 0.31 and 0.23 lb ai/ A ( 1x the maximum registered seasonal rate); dimethipin residues were < 0.10 0.260 ppm.

Data must be submitted depicting dimethipin residues in cotton gin byproducts which include burrs, leaves, stem, lint, immature seeds and sand ( dirt) obtained from ginning cotton.

Processed Food and Feed: The available processing data indicate that residues of dimethipin do not concentrate in cottonseed meal ( average processing factor of < 0.22x), hulls ( average processing factor of 0.96x), or refined oil ( average processing factor of < 0.22x) processed from cotton treated at 2x the maximum seasonal rate.

6.2 Livestock [ MRIDs: 43966401, 44147201, 44147202]

Cattle A dairy cattle feeding study with dimethipin has been conducted. Dimethipin was administered orally to 11 Holstein dairy cattle daily for 28 days. Dosing was made at 5, 16, and 55 ppm in the feed, equivalent to approximately 1x, 3x, and 10x the tentative maximum theoretical dietary burden to beef and dairy cattle. Milk samples were collected twice daily. Cows were sacrificed within 24 hours of the final dose, and samples of milk, muscle, liver, and kidney were collected. Residues of dimethipin were below the limit of quantitation (< 0.01 ppm) in samples of milk ( collected on study days 0, 7, 14, 21, and 28), muscle, liver, and kidney from the 55 ppm dosing group. As a result, samples of cattle commodities from the 5 and 16 ppm dosing groups were not analyzed.

The registrant did not collect or analyze samples of fat from dosed cattle in this study. Based on the available goat metabolism data, which indicated that total radioactive residues were lowest in fat ( as compared with muscle, liver, and kidney) following dosing with [ 14C] dimethipin at levels 71 similar to and greatly exceeding those of the feeding study, data depicting dimethipin residues in cattle fat are not required.

The registrant also submitted data from analyses of kidney samples, from the above described feeding study, for residues of a dimethipin metabolite, 1,2 ethanedisulfonic acid ( EDSA). Residues of EDSA were below the LOQ (< 0.100 ppm) in samples of kidney from cattle in the 5 ppm dosing group, 0.218 0.376 ppm in kidney from the 16 ppm dosing group, and 0.315 0.663 ppm in kidney from the 55 ppm dosing group. The results for kidney samples from the 55 ppm dosing group were confirmed by a second laboratory; residues were determined to be 0.22 0.54 ppm in these samples.

Poultry Based on the results of the poultry metabolism study, the Agency has concluded that dimethipin residues in poultry may be classified under 40 CFR § 180.6( a)( 3); i. e., there is no reasonable expectation of finite residues in poultry commodities. Therefore, no poultry feeding study is required.

7.0 International Considerations The Codex Alimentarius Commission has established several maximum residue limits ( MRLs) for residues of dimethipin in/ on various commodities. The Codex MRLs are expressed in terms of dimethipin per se. The Codex MRL and the U. S. tolerance expressions are compatible.

A comparison of the Codex MRLs and the corresponding reassessed U. S. tolerances is presented in Table 3.8. The U. S. tolerance and Codex MRL are identical in magnitude for cottonseed and livestock meat commodities. There are several Codex MRLs for which there are no U. S. tolerances, either because no U. S. registrations exist ( plant RAC MRLs) or because U. S. tolerances are not needed ( processed commodity, poultry commodities and milk MRLs).

There are no Canadian MRLs established for dimethipin. There are Mexican MRLs for " dimetipin" on cottonseed ( 0.5 mg/ kg) and potato ( 0.05 mg/ kg).

Table 7.0 Codex MRLs and applicable U. S. tolerances for dimethipin. Recommendations are based on conclusions following reassessment of U. S. tolerances.

Codex Reassessed U. S. Tolerance, ppm Recommendation And Comments Commodity, As Defined MRL ( mg/ kg) Step Cotton seed 0.5 CXL 0.5 Harmonized.

Cotton seed oil, Crude 0.1 CXL  No separate tolerance established in U. S. for cotton seed oil. Table 7.0 Codex MRLs and applicable U. S. tolerances for dimethipin. Recommendations are based on conclusions following reassessment of U. S. tolerances.

Codex Reassessed U. S. Tolerance, ppm Recommendation And Comments Commodity, As Defined MRL ( mg/ kg) Step 72 Cotton seed oil, Edible 0.02(*) 1 CXL  No separate tolerance established in U. S. for cotton seed oil.

Edible offal ( mammalian) 0.02(*) CXL 0.02 U. S tolerances established for meat by products.

Eggs 0.02(*) CXL  U. S. tolerances not necessary for poultry and egg commodities.

Linseed 0.2 CXL  No U. S. registrations for use on linseed.

Meat ( from mammals other than marine mammals) 0.02(*) CXL 0.02 Harmonized.

Milks 0.02(*) CXL  U. S. tolerances not necessary for milk.

Potato 0.05(*) CXL  No U. S. registrations for use on potato.

Poultry meat 0.02(*) CXL  U. S. tolerances not necessary for poultry commodities.

Poultry, Edible offal of 0.02(*) CXL  U. S. tolerances not necessary for poultry commodities.

Rape seed 0.1 CXL  No U. S. registrations for use on rape seed.

Sunflower seed 0.5 CXL  No U. S. registrations for use on sunflower.

Sunflower seed oil, Crude 0.1 CXL  No U. S. registrations for use on sunflower.

Sunflower seed oil, Edible 0.02 CXL  No U. S. registrations for use on sunflower.

8.0 Environmental Degradation 8.1 Environmental Persistence 73 Dimethipin degrades slowly under laboratory and field conditions, with the apparent primary route of dissipation in the field being leaching coupled with photodegradation at the soil surface and metabolic degradation throughout the soil column.

In buffered aqueous solutions, Dimithipin was stable to hydrolysis with half lives > 2 years at pHs 3 9 and photodegraded slowly to very slowly with half lives ranging from 60 days ( pH 5) to 224 days ( pH 7) at pH 5 9. In sandy loam soil, dimethipin photodegraded with a half life of 75 days. In metabolism studies, dimethipin degraded under aerobic conditions with a half life of 408 days and under anaerobic aquatic conditions with a half life of 277 days.

Octanol/ water partitioning ( Kow) data provided by the registrant indicate a low potential for dimethipin to accumulate in fish ( Kow for dimethipin = 0.66).

8.2 Expected Mobility Dimethipin has very high mobility in soils ranging from sand to clay, with Freundlich adsorption coefficients of

0.09. In field studies using bare ground and cropped plots, dimethipin leached to a depth of 75 90 cm.

Volatilization is not expected to be a significant since the reported vapor pressure is < 3.87 x 10 7 mm Hg at 24  C.

8.3 Environmental Metabolites No major transformation products were identified in any environmental fate study. 2,3 Dihydro 5 hydroxymethyl 6 methyl 1,4 dithiin 1,1,4,4 tetraoxide ( H 5) was a minor transformation product at < 2% of the applied in the photodegradation in water study only. The saturated carboxylic acid of dimethipin was identified in the anaerobic aquatic study but was not quantified.

Table 8.3 Summary of Environmental Fate Studies for Dimethipin Degradate Maximum Degradate Concentration (% of applied) in Study:

Hydrolysis ( 161 1) Aqueous Photo.

( 161 2) Soil Photo.

( 161 3) Aerobic Soil ( 162 1) Anaerobic Aquatic ( 162 3) Field Diss.

( 164 1)

2,3 Dihydro 5 hydroxymethyl 6 methyl 1,4 dithiin 1,1,4,4 tetraoxide ( aka H 5) Not detected 2% @ pH 5 0.8% @ pH 9 Not detected Not detected Not detected Not analyzed Table 8.3 Summary of Environmental Fate Studies for Dimethipin Degradate Maximum Degradate Concentration (% of applied) in Study:

Hydrolysis ( 161 1) Aqueous Photo.

( 161 2) Soil Photo.

( 161 3) Aerobic Soil ( 162 1) Anaerobic Aquatic ( 162 3) Field Diss.

( 164 1)

74 Saturated carboxylic acid of Dimethipin Not analyzed Not detected Not detected Detected, but not quantified Not detected Not analyzed 4.0 TOLERANCE REASSESSMENT SUMMARY The tolerances listed in 40 CFR § 180.406( a) are expressed in terms of dimethipin ( 2,3 dihydro 5,6 dimethyl 1,4 dithiin 1,1,4,4 tetraoxide; CAS Reg. No. 55290 64 7) per se. The current tolerance expression is adequate.

Tolerances Listed Under 40 CFR § 180.406( a):

Adequate residue data have been submitted to reassess the established tolerance for undelinted cotton seed; the tolerance is reassessed at the same level.

The available processing data indicate that dimethipin residues do not concentrate in cotton hulls. The established tolerance for cotton hulls should be revoked.

Although feeding study data, reflecting exaggerated dosing levels, indicate that there are no expectation of finite residues in the fat, meat, or meat byproducts of cattle, goats, horses, hogs or sheep, HED recommends that the tolerances for dimethipin in livestock meat and meat byproducts not be revoked in order to harmonize with the established Codex MRLs. The U. S. tolerances for livestock meat and meat byproducts and Codex MRLs for mammalian meat and edible offal are established at 0.02 ppm, which is at or about the limit of quantitation.

The U. S. tolerances for dimethipin in the fat of cattle, goats, horses, hogs and sheep should be revoked as there is no expectation of finite residues in these commodities and there are no Codex MRLs established.

There is no U. S. tolerance for dimethipin in milk. A tolerance for milk is not required as there is no expectation of finite residues of dimethipin in milk.

Tolerances To Be Proposed Under 40 CFR § 180.406( a):

A tolerance must be proposed for cotton gin byproducts; adequate crop field trial data must be submitted before the appropriate tolerance level may be determined. 75 A summary of dimethipin tolerance reassessments is presented in Table 4.0.

Table 4.0. Tolerance Reassessment Summary for Dimethipin.

Commodity Current Tolerance ( ppm) Range of Residues ( ppm) Tolerance Reassessment ( ppm) Comment/[ Correct Commodity Definition]

Tolerances Listed Under 40 CFR § 180.406( a):

Cotton, undelinted seed 0.5 < 0.10 0.260 0.5 Cotton, hulls 0.7 average processing factor = 0.95x Revoke No tolerance for cotton hulls is necessary because residues do not concentrate.

Cattle, fat 0.02 < 0.01 at a 9.6x dosing level Revoke The available feeding study data, reflecting exaggerated dosing levels, indicate that there is no expectation of finite residues. However, tolerances should be maintained for meat and meat byproducts to harmonize with CODEX MRLs. Tolerances for fat should be revoked ( No CODEX MRL). Cattle, meat 0.02 0.02 Cattle, meat byproducts 0.02 0.02 Goat, fat 0.02 Revoke Goat, meat 0.02 0.02 Goat, meat byproducts 0.02 0.02 Hog, fat 0.02 Revoke Hog, meat 0.02 0.02 Hog, meat byproducts 0.02 0.02 Horse, fat 0.02 Revoke Horse, meat 0.02 0.02 Horse, meat byproducts 0.02 0.02 Sheep, fat 0.02 Revoke Sheep, meat 0.02 0.02 Sheep, meat byproducts 0.02 0.02 Tolerances to Be Proposed under 40 CFR 180.406( a):

Cotton, gin byproducts   TBD1 1 TBD = To be determined. Additional residue crop field trial data are required.


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[Federal Register Volume 77, Number 3 (Thursday, January 5, 2012)]
[Notices]
[Pages 536-537]
[FR Doc No: 2011-33779]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2011-0301]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt eighteen individuals
from its rule prohibiting persons with insulin-treated diabetes
mellitus (ITDM) from operating commercial motor vehicles (CMVs) in
interstate commerce. The exemptions will enable these individuals to
operate CMVs in interstate commerce.

DATES: The exemptions are effective January 5, 2012. The exemptions
expire on January 5, 2014.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room
W64-224, Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

Background

    On November 21, 2011, FMCSA published a notice of receipt of
Federal diabetes exemption applications from eighteen individuals and
requested comments from the public (76 FR 72031). The public comment
period closed on December 21, 2011, and no comments were received.
    FMCSA has evaluated the eligibility of the eighteen applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These eighteen applicants have had ITDM over a range of 1 to 31
years. These applicants report no severe hypoglycemic reactions
resulting in loss of consciousness or seizure, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning symptoms, in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the past 5 years.
In each case, an endocrinologist verified that the driver has
demonstrated a willingness to properly monitor and manage his/her
diabetes mellitus, received education related to diabetes management,
and is on a stable insulin regimen. These drivers report no other
disqualifying conditions, including diabetes-related

complications. Each meets the vision requirement at 49 CFR
391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the November 21, 2011, Federal
Register notice and they will not be repeated in this notice.

Discussion of Comment

    FMCSA received two comments in this proceeding. The comments were
considered and discussed below.
    Laura J. Krol of the Pennsylvania Department of Transportation has
reviewed the driving histories of Gerald R. Curran, Shawn K. Fleming
and Kenneth B. Pratt and supports granting them waivers.
    Michael R. Simmons of Hoenwald, Tennessee expressed his
disappointment that he cannot obtain a Federal waiver, as he is an
intrastate driver.
    In response to this comment, FMCSA's exemption process supports
drivers with ITDM who seek to operate in interstate commerce.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

Conclusion

    Based upon its evaluation of the eighteen exemption applications,
FMCSA exempts, Mark A. Aspden (MA), Rodney C. Backus (NY), Peter A.
Breister (WI), Gerald R. Curran (PA), Shawn K. Fleming (PA), Daniel C.
French (VA), Garry W. Garrison (WI), Gregory L. Horton (GA), Anthony B.
Jones (WI), Jay T. Kirschmann (ND), Patrick G. Landers (NY), Paul J.
Marshall (UT), Robert J. Pierce (MI), Kenneth B. Pratt (PA), James G.
Rahn (IA), Ward A. Stone (WI), Todd J. Timmerman (WI) and James L.
Weinert (OH) from the ITDM requirement in 49 CFR 391.41(b)(3), subject
to the conditions listed under ``Conditions and Requirements'' above.
    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption will
be valid for two years unless revoked earlier by FMCSA. The exemption
will be revoked if the following occurs: (1) The person fails to comply
with the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: December 27, 2011.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2011-33779 Filed 1-4-12; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: July 10, 2007 (Volume 72, Number 131)]
[Notices]
[Page 37557-37558]
[DOCID:fr10jy07-96]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56001; File No. SR-NYSEArca-2007-34]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving
Proposed Rule Change and Amendment No. 1 Thereto Relating to Trading a
Class of Options Without Designating a Lead Market Maker

July 2, 2007.
    On April 3, 2007, NYSE Arca, Inc. (``NYSE Arca'' or ``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\ the proposed rule change to
allow an options issue to trade without designating a Lead Market Maker
(``LMM''). On May 2, 2007, NYSE Arca filed Amendment No. 1 to the
proposed rule change. The proposed rule change, as amended, was
published for comment in the Federal Register on May 29, 2007.\3\ The
Commission received no comments regarding the proposal. This order
approves the proposed rule change as modified by Amendment No. 1.
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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. 55789 (May 21,
2007), 72 FR 29568.
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    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\4\ In
particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\5\ which requires that the
rules of the an exchange be designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest.
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    \4\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \5\ 15 U.S.C. 78f(b)(5).
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    The Exchange proposes to trade options classes without designating
an LMM, yet still meet the requirements of the Plan for the Purpose of
Creating and Operating an Intermarket Option Linkage (``Linkage
Plan'').\6\ Because the Exchange believes that certain highly liquid,
highly active options classes have sufficient participation by OTP
Holders \7\ and do not need an LMM to foster liquidity, the Exchange
proposes to remove from NYSE Arca Rule 6.35 the requirement that an LMM
be assigned to every option class.\8\
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    \6\ On July 28, 2000, the Commission approved the Options
Intermarket Linkage (``Linkage'') proposed by American Stock
Exchange LLC, Chicago Board Options Exchange, Incorporated, and
International Securities Exchange, LLC. See Securities Exchange Act
Release No. 43086 (July 28, 2000), 65 FR 48023 (August 4, 2000).
Subsequently, Philadelphia Stock Exchange, Inc., Pacific Exchange,
Inc. (n/k/a NYSE Arca), and Boston Stock Exchange, Inc. joined the
Linkage Plan. See Securities Exchange Act Release Nos. 43573
(November 16, 2000), 65 FR 70851 (November 28, 2000); 43574
(November 16, 2000), 65 FR 70850 (November 28, 2000); and 49198
(February 5, 2004), 69 FR 7029 (February 12, 2004).
    \7\ See NYSE Arca Rule 1.1(q) for the definition of ``OTP
Holder.''
    \8\ In not designating an LMM in certain option issues, orders
would be processed in price/time priority, meaning any market
participant, regardless of status, may gain priority by improving
the market.
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    The Exchange also proposes other rule changes to accommodate the
requirements of the Linkage Plan. Pursuant to the Linkage Plan, a
Principal Acting as Agent (``P/A'') Order may be routed to another
exchange only through the principal account of a market maker that is
authorized to represent customer orders, ``reflecting the terms of a
related unexecuted Customer order for which the Market Maker is acting
as agent.'' \9\ On NYSE Arca, the LMM currently is the responsible
Market Maker for outbound P/A Orders sent through the Intermarket
Options Linkage (``Linkage''). The Exchange now proposes to allow for
the designation of a Market Maker, assigned on a rotating basis, as the
responsible Intermarket Linkage Market Maker (``IMM'') \10\ for
outbound P/A Orders.
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    \9\ See Section 2(16)(a) of the Linkage Plan.
    \10\ The IMM would be selected from the pool of all Market
Makers who have been appointed in the particular class. Market
Makers requesting appointment to an options class would need to
agree to participate in the rotation of IMM assignment.
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    Currently, Market Makers on the Exchange other than LMMs are not
permitted under the Exchange's current rules to act as an agent on
behalf of an order submitted to the Exchange.\11\ Therefore, the
Exchange proposes to amend NYSE Arca Rule 6.38(a) to provide an
exception for a Market Maker acting as an IMM for the purpose of
settling P/A Orders sent to another exchange pursuant to NYSE Arca
Rules 6.92 and 6.93. To enable the IMM to carry out its agency
responsibilities with regard to P/A Orders submitted through the
Linkage, the IMM would be required to submit prior written instructions
to the Exchange for the routing of any P/A Orders through the Linkage.
Although the Exchange intends to rely solely on the use of its outbound
routing broker to access the quotes of other exchanges when the
Exchange is not disseminating the national best bid or offer, there may
be instances when the Exchange's routing broker is not available
because of system malfunctions. Therefore, the Exchange proposes that
designated IMMs be responsible for outbound P/A Orders sent through the
Linkage.
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    \11\ See NYSE Arca Rule 6.38(b)(1), which provides that Market
Makers other than LMMs are restricted from acting as a principal and
an agent in the same issue on the same business day. See also NYSE
Arca Rule 6.38(b)(5), which provides Market Makers are restricted
from acting as a floor broker in options covering the same
underlying security to which its primary appointment extends.
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    The Exchange also proposes to amend NYSE Arca Rule 6.93 to clarify
that the Exchange will be responsible for the receipt, processing, and
execution of inbound Linkage orders received from other exchanges.
Linkage orders sent to NYSE Arca are routed directly to the trading
system for immediate automatic execution. Any remaining unexecuted
order or portion of an order would be immediately returned by the
Exchange to the originating away market.
    The Commission believes that the proposed rule change is reasonably
designed in that it permits the Exchange to not utilize an LMM in
option classes where the Exchange does not believe an LMM is required
and promotes the

principle of price/time priority on the Exchange. Further, the
Commission believes that designating IMMs for the purpose of sending P/
A Orders to away markets is not inconsistent with the Linkage Plan,
because, among other things, the proposal will facilitate the sending
of P/A Orders to other exchanges through Linkage in accordance with the
requirements of the Linkage Plan's definition of P/A Orders. In
addition, the Commission also believes the proposal clarifies the
Exchange's role in the processing of orders it receives through
Linkage.
    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\12\ that the proposed rule change (SR-NYSEArca-2007-34), as
modified by Amendment No. 1, be, and it hereby is, approved.
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    \12\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-13311 Filed 7-9-07; 8:45 am]

BILLING CODE 8010-01-P