[Federal Register Volume 78, Number 93 (Tuesday, May 14, 2013)]
[Notices]
[Page 28224]
[FR Doc No: 2013-11364]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0902]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Prescription Drug Product Labeling;
Medication Guide Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Prescription Drug Product
Labeling; Medication Guide Requirements'' has been approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On April 30, 2012, the Agency submitted a
proposed collection of information entitled ``Prescription Drug Product
Labeling; Medication Guide Requirements'' to OMB for review and
clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor,
and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. OMB has now
approved the information collection and has assigned OMB control number
0910-0393. The approval expires on January 31, 2016. A copy of the
supporting statement for this information collection is available on
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: May 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11364 Filed 5-13-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8913-8916]
[FR Doc No: 2015-03402]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74267; File No. SR-BOX-2015-009]

Self-Regulatory Organizations; BOX Options Exchange, LLC; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change
Regarding the Acceptance of the Transfer, by Citadel Securities, LLC
(``Citadel Securities'') to Its Affiliate, Citadel Securities Principal
Investments, LLC, of Citadel Securities' Ownership Interest in BOX
Options Exchange, LLC and BOX Holdings Group, LLC, an Affiliate of the
Exchange

February 12, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 29, 2015, BOX Options Exchange, LLC (the ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the self-regulatory organization. The Commission
is publishing this notice to solicit comments on the proposed rule from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to accept the transfer, by Citadel Securities
LLC (``Citadel Securities'') to its affiliate, Citadel Securities
Principal Investments LLC, a Delaware limited liability

company (``CSPI''), of Citadel Securities' ownership interest in the
Exchange and BOX Holdings Group LLC, an affiliate of the Exchange
(``BOX Holdings''). The text of the proposed rule change is available
from the principal office of the Exchange, at the Commission's Public
Reference Room and also on the Exchange's Internet Web site at http://boxexchange.com.

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

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

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

1. Purpose
    The Exchange is a limited liability company, organized under the
laws of the State of Delaware on August 26, 2010. The Exchange's
charter is a Limited Liability Company Agreement, dated as of May 10,
2012 (the ``Exchange LLC Agreement''). Citadel Securities is a Member
of the Exchange.
    BOX Holdings is a limited liability company, organized under the
laws of the State of Delaware on August 26, 2010. BOX Holdings is the
sole owner of BOX Market LLC, a facility of the Exchange. The BOX
Holdings charter is a Limited Liability Company Agreement, dated as of
May 10, 2012 (the ``Holdings LLC Agreement''). Citadel Securities is a
Member of the Exchange.
    Citadel Securities is a limited liability company organized under
the laws of the State of Delaware. Citadel Securities is a wholly-owned
subsidiary of CLP Holdings Three LLC, a limited liability company
organized under the laws of the State of Delaware (``Citadel Parent''
and, collectively with Citadel Securities and CSPI, ``Citadel''). CSPI,
like Citadel Securities, is also a wholly-owned subsidiary of Citadel
Parent.
    Citadel Securities currently holds 6,445 Economic Units and 12,855
Voting Units of the Exchange, representing 6.455% of the outstanding
Economic Units and 12.855% of the outstanding Voting Units of the
Exchange, respectively (the ``Exchange Units''). Citadel Securities
also currently holds 500 Class A Units of BOX Holdings, representing
4.203% of the outstanding Units of BOX Holdings (the ``Holdings Units''
and, together with the Exchange Units, the ``Citadel Units'').
    Citadel has informed the Exchange that, for its own internal
business purposes, it desires to restructure its holdings of assets
including all of the Citadel Units. Accordingly, it is proposed that
Citadel Securities transfer all of the Citadel Units to CSPI (the
``Transfer''). After the Transfer, Citadel Parent will remain the sole
owner of CSPI, the Citadel entity holding the Citadel Units, and CSPI
will then hold all of the Citadel Units.
    As provided in Section 7.1(c) of the Exchange LLC Agreement, ``a
Person shall be admitted to the Exchange as an additional or substitute
Member of the Exchange, if such Person is not already a Member, only
upon (i) such Person's execution of a counterpart of this Agreement to
evidence its written acceptance of the terms and provisions of this
Agreement, and acceptance by the affirmative vote of Members holding a
majority of the Voting Percentage Interest, which vote may be given or
withheld in the sole discretion of each such voting Member, (ii) if
such Person is a transferee, its agreement in writing to its assumption
of the obligations hereunder of its assignor, and acceptance thereof by
the affirmative vote of Members holding a majority of the Voting
Percentage Interest, which vote may be given or withheld in the sole
discretion of each such voting Member and (iii) if such Person is a
transferee, a determination by the Board that the Transfer was
permitted by this Agreement.'' In addition, as provided in Section 18.1
of the Exchange LLC Agreement, the Exchange LLC Agreement ``may only be
changed, amended or supplemented by an agreement in writing that is
approved by the affirmative vote of Members holding at least a majority
of the Voting Percentage Interest \3\ without the consent of any Member
or other Person.''
---------------------------------------------------------------------------

    \3\ ``Voting Percentage Interest'' as defined in Section 1.1 of
the Exchange LLC Agreement means, with respect to each Member, ``the
ratio of the number of Voting Units held by the Member, directly or
indirectly, of record or beneficially, to the total of all of the
issued and outstanding Voting Units held by Members, expressed as a
percentage.''
---------------------------------------------------------------------------

    Upon the effectiveness of the Transfer, CSPI proposes to become a
Member of the Exchange. Accordingly, in connection with the Transfer,
CSPI will execute an Instrument of Accession to the Exchange LLC
Agreement substantially in the form set forth in Exhibit 5 hereto (the
``Exchange Instrument of Accession''). By executing and delivering the
Exchange Instrument of Accession and obtaining the acceptance and
approval of Members and the determination of the Board described above,
CSPI will fulfill the requirements described in Sections 7.1(c) and
18.1 of the Exchange LLC Agreement in connection with the Transfer. The
Exchange proposes to replace references to Citadel Securities in the
Exchange LLC Agreement with references to CSPI in connection with the
Transfer.
    As provided in Section 7.1(b) of the Holdings LLC Agreement, ``a
Person shall be admitted to BOX Holdings as an additional or substitute
Member of BOX Holdings, if such Person is not already a Member, only
upon (i) such Person's execution of a counterpart of this Agreement to
evidence its written acceptance of the terms and provisions of this
Agreement, and acceptance thereof by resolution of the Board, which
acceptance may be given or withheld in the sole discretion of the
Board, (ii) if such Person is a transferee, its agreement in writing to
its assumption of the obligations hereunder of its assignor, and
acceptance thereof by resolution of the Board, which acceptance may be
given or withheld in the sole discretion of the Board, (iii) if such
Person is a transferee, a determination by the Board that the Transfer
was permitted by this Agreement, and (iv) approval of the Board.'' In
addition, as provided in Section 18.1 of the Exchange LLC Agreement,
the Exchange LLC Agreement ``may only be changed, amended or
supplemented by an agreement in writing that is approved by Directors
holding a majority of the Total Votes \4\ without the consent of any
Member or other Person.''
---------------------------------------------------------------------------

    \4\ ``Total Votes'' means a total of 100 votes available to be
voted on any action to be taken by the Board. As provided in Section
4.3(a) of the Holdings LLC Agreement, each Director ``shall be
entitled to vote that percentage of the Total Votes equal to the
quotient obtained by dividing (i) the quotient of (A) the number of
Units held by the Member that designated such Director (if
applicable, rounded down to the nearest whole Unit) divided by (B)
the aggregate number of Units held by all Members that designated
Directors by (ii) the number of Directors designated by such
Member.''
---------------------------------------------------------------------------

    Upon the effectiveness of the Transfer, CSPI proposes to become a
Member of BOX Holdings. Accordingly, in connection with the Transfer,
CSPI will execute an Instrument of Accession to the Holdings LLC
Agreement substantially in the form set forth in

Exhibit 5 hereto (the ``Holdings Instrument of Accession''). By
executing and delivering the Holdings Instrument of Accession and
obtaining the acceptance, determination and approval of the Board
described above, CSPI will fulfill the requirements described in
Sections 7.1(b) and 18.1 of the Holdings LLC Agreement in connection
with the Transfer. BOX Holdings proposes to replace references to
Citadel Securities in the Holdings LLC Agreement with references to
CSPI in connection with the Transfer.
    For the reasons stated above, the Exchange is submitting to the
Commission the proposed Instruments of Accession to the Exchange LLC
Agreement and the Holdings LLC Agreement as a rule change.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\5\ in general, and furthers
the objectives of Section 6(b)(1),\6\ in particular, in that it enables
the Exchange to be so organized so as to have the capacity to be able
to carry out the purposes of the Act and to comply, and to enforce
compliance by its exchange members and persons associated with its
exchange members, with the provisions of the Act, the rules and
regulations thereunder, and the rules of the Exchange. The Exchange
also believes that this filing furthers the objectives of Section
6(b)(5) of the Act \7\ in that it is designed to facilitate
transactions in securities, 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 regulating,
clearing, settling, processing information with respect to, and
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.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

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

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

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \8\ and Rule 19b-4(f)(6) thereunder.\9\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(6)
thereunder.\10\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to
give the Commission written notice of the Exchange's intent to file
the proposed rule change, along with a brief description and text of
the proposed rule change, at least five business days prior to the
date of filing of the proposed rule change, or such shorter time as
designated by the Commission. The Commission has waived the 5-day
prefiling requirement in this case.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange has asked the Commission to waive the
30-day operative delay because the Transfer is intended to be completed
in less than 30 days. The Exchange notes that the Commission has
previously waived the operative delay for similar filings.\11\ Based on
the foregoing, the Commission believes that waiving the 30-day
operative delay is consistent with the protection of investors and the
public interest.\12\ The Commission hereby grants the Exchange's
request and designates the proposal operative upon filing.
---------------------------------------------------------------------------

    \11\ See Securities Exchange Act Release Nos. 58445 (August 29,
2008), 73 FR 52434 (September 9, 2008) (SR-BSE-2008-43); 58445A
(September 10, 2008), 73 FR 53469 (September 16, 2008) (SR-BSE-2008-
43; Correction); 57260 (February 1, 2008), 73 FR 7617 (February 8,
2008) (SR-BSE-2008-06); 57713 (April 25, 2008), 73 FR 24327 (May 2,
2008) (SR-BSE-2008-28); and 62400 (June 29, 2010), 75 FR 39299 (July
8, 2010) (SR-BX-2010-042).
    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-SR-BOX-2015-009 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-BOX-2015-009. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of 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; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-BOX-2015-009 and should be
submitted on or before March 12, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-03402 Filed 2-18-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 24, 2007 (Volume 72, Number 15)]
[Rules and Regulations]
[Page 3075-3079]
[DOCID:fr24ja07-19]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0667; FRL-8110-3]

Spiromesifen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation revises a tolerance for combined residues of
spiromesifen in or on vegetables, fruiting, group 8 and establishes
tolerances for inadvertent or indirect combined residues in or on oat
(grain, forage, hay, straw). Interregional Research Project No. 4 (IR-
4) and Bayer CropScience (respectively) requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective January 24, 2007. Objections and
requests for hearings must be received on or before March 26, 2007, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0667. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

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

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

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

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

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

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

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0667 in the
subject line on the first page of your submission. All requests must be
in writing, and must be

mailed or delivered to the Hearing Clerk on or before March 26, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0667, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

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

II. Background and Statutory Findings

    In the Federal Register of September 13, 2006 (71 FR 54057) (FRL-
8091-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5E6901) by Interregional Research Project No. 4 (IR-4), Rutgers, The
State University of New Jersey, 500 College Road East, Suite 201,
Princeton, NJ 08540. The petition requested that 40 CFR 180.607 be
amended by revising a tolerance for combined residues of the
insecticide/miticide spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol
metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one), calculated as the parent compound equivalents, in or on
vegetable, fruiting, crop group 8 from 0.30 to 0.45 parts per million
(ppm). The same notice also announced the filing of a pesticide
petition (PP 6F7039) by Bayer CropScience, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709. That petition requested that 40 CFR
180.607 be amended by establishing a tolerance for inadvertent or
indirect combined residues of the insecticide/miticide spiromesifen (2-
oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate), its enol metabolite (4-hydroxy-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), and its metabolites
containing the 4-hydroxymethyl moiety (4-hydroxy-3-[4-(hydroxymethyl)-
2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one), calculated as the
parent compound equivalents, in or on oat, forage; oat, fodder; and
oat, straw at 0.25 ppm and in or on the food commodity oat, grain at
0.03 ppm. The notice included summaries of the petitions prepared by
Bayer CropScience, the registrant. Comments were received on the notice
of filing from one private citizen. EPA's response to these comments is
discussed in Unit IV.C.
    Based on the EPA analysis of the residue chemistry and
toxicological databases, petition PP 6F7039 was subsequently revised to
express the oat tolerances as inadvertent or indirect combined residues
of the insecticide/miticide spiromesifen (2-oxo-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate),
its enol metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-2-one), and its metabolites containing the 4-
hydroxymethyl moiety (4-hydroxy-3-[4-(hydroxymethyl)-2,6-
dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one), calculated as the
parent compound equivalents, in or on oat, forage at 0.20 ppm; oat,
grain at 0.03 ppm; oat, hay at 0.25 ppm; and oat, straw at 0.25 ppm.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
*.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm and http://

://

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for combined residues of the
insecticide/miticide spiromesifen and its enol metabolite, in or on
vegetable, fruiting, crop group 8 at 0.45 ppm and the inadvertent or
indirect combined residues of the insecticide/miticide spiromesifen and
its enol metabolite, in or on oat, forage at 0.20 ppm; oat, grain at
0.03 ppm; oat, hay at 0.25 ppm; and oat, straw at 0.25 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by spiromesifen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in Unit III.A. of
the final rule published in the Federal Register of April 27, 2005 (70
FR 21631) (FRL-7705-1) at http://www.epa.gov/fedrgstr/EPAFR-CONTENTS/2005/April/Day-27/contents.htm
.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study

selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk and estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for spiromesifen used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of April 27, 2005 (70 FR 21631) (FRL-
7705-1) at http://www.epa.gov/fedrgstr/EPAFR-CONTENTS/2005/April/Day-27/contents.htm
.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.607) for the combined residues of spiromesifen,
in or on a variety of raw agricultural commodities. In addition,
tolerances have been established for combined residues on several
livestock (cattle, goat, horse, sheep) commodities which feed on these
raw agricultural commodities and for inadvertent or indirect combined
residues on some rotational crop (alfalfa, barley, sugar beet, wheat)
commodities. Risk assessments were conducted by EPA to assess dietary
exposures from spiromesifen in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
spiromesifen. Therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessments: (1) Established/recommended tolerances for all plant and
livestock except the leafy-green and leafy-Brassica vegetable
subgroups; (2) EPA calculated residues of concern (parent and
metabolites) for the leafy-green and leafy-Brassica vegetable subgroup;
(3) 100% crop treated (CT) information for all proposed and existing
uses; and (4) DEEM\TM\ Version 7.81 default processing factors for all
commodities.
    The metabolism studies show that the hydroxymethyl metabolite is
formed along with the enol metabolite only in the leafy-green and
leafy-Brassica vegetable subgroups. EPA determined that these two
metabolites along with the spiromesifen should be included in the
chronic dietary risk assessment for these crops. Residue data are
unavailable for the 4-hydroxymethyl metabolite; to account for this
metabolite in the risk assessment, the recommended tolerance levels for
these crops was multiplied by a correction factor of 1.3X, where 1.3 =
metabolites in risk assessment (ppm) / metabolites in tolerance
expression (ppm).
    iii. Cancer. A cancer exposure assessment was not performed because
spiromesifen is classified as ``not likely to be carcinogenic to
humans.''
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for spiromesifen in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of spiromesifen. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
spiromesifen for chronic exposures are estimated to be 11 ppb for
surface water and 28 ppb for ground water. Drinking water estimates
were incorporated directly into the DEEM-FCID\TM\ using the estimated
drinking water concentration generated by the SCI-GROW (version 2.3)
model of 28 ppb.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Spiromesifen is not registered for use on any sites that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency considers ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to spiromesifen and any other
substances and spiromesifen does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that spiromesifen has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
Margin of Exposure (MOE) analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional safety

factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility of rats or rabbits to in utero prenatal or
postpostnatal exposure to spiromesifen. In a rat developmental toxicity
study, no developmental toxicity was observed at doses up to 500
milligrams/kilograms/day (mg/kg/day) (the highest dose tested) in the
presence of maternal toxicity. The rat maternal LOAEL was determined to
be 70 mg/kg/day based on decreased body-weight gain and reduced food
consumption. In the rabbit developmental toxicity study, there was no
developmental toxicity observed at doses up to 250 mg/kg/day (the
highest dose tested), but the maternal LOAEL was determined to be 35
mg/kg/day based on body weight loss and reduced food consumption. There
is no qualitative and/or quantitative evidence of increased
susceptibility to spiromesifen following pre/postnatal exposure in a 2-
generation reproduction study in rats.
    There is no concern for developmental neurotoxicity resulting from
exposure to spiromesifen. Neurotoxic effects such as reduced motility,
spastic gait, increased reactivity, tremors, clonic-tonic convulsions,
reduced activity, labored breathing, vocalization, avoidance reaction,
piloerection, limp, cyanosis, squatted posture, and salivation were
observed in two studies (5-day inhalation and subchronic oral rat).
However, these effects were considered as secondary, not neurotoxic,
effects due to the high dosage. There was no evidence of neurotoxicity
in the acute or subchronic neurotoxicity or any other studies.
    3. Conclusion. For spiromesifen, EPA determined that the 10X safety
factor to protect infants and children should be removed. A 1X safety
factor is appropriate because:
     There is a complete toxicity database for spiromesifen.
     There was no evidence of increased susceptibility of rat
or rabbit fetuses to in utero exposure in developmental studies, nor
following prenatal or postnatal exposure by rats in the 2-generation
reproduction study.
     There are no neurotoxicity concerns based on acute and
subchronic neurotoxicity studies.
     The dietary food exposure assessment uses proposed
tolerance levels or higher residues for most commodities and assumed
100% crop-treated information for all commodities. By using these
screening-level assessments, chronic exposures and risks will not be
underestimated. The ``higher residues'' are those that were calculated
using a modifying factor to account for the lack of spiromesifen-4-
hydroxymethyl residue data.
     The dietary drinking water assessment (Tier 2 estimates)
uses values generated by model and associated modeling parameters which
are designed to provide conservative, health protective, and high-end
estimates of water concentrations.
     Residential exposure is not expected, spiromesifen will be
registered for agricultural and greenhouse/ornamental uses only.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. As there were no toxic effects attributable to a
single dose, an endpoint of concern was not identified to quantitate
acute dietary risk to the general population or any subpopulation. No
acute risk is expected from exposure to spiromesifen.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
spiromesifen from food and water will utilize 31% of the chronic
population adjusted dose (cPAD) for the U.S. population, 23% of the
cPAD for all infants less than 1 year old, and 38% of the cPAD for
children 1-2 years old, the most highly exposed population subgroups.
There are no residential uses for spiromesifen that result in chronic
residential exposure to spiromesifen. Therefore, EPA does not expect
the aggregate exposure to exceed 100% of the cPAD.
    3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Spiromesifen is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
    4. Aggregate cancer risk for U.S. population. Spiromesifen is not
expected to pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to spiromesifen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical enforcement methodologies, high-performance
liquid chromatography (HPLC)/mass spectrometry (MS)/MS, exist and have
been successfully validated by independent laboratories.

B. International Residue Limits

    There are no international residue limits for spiromesifen listed
in CODEX.

C. Response to Comments

    Several comments were received from one private citizen objecting
to pesticide body load, registrant profiteering, establishing
tolerances, pollution by pesticides, and lack of notification when
pesticides are applied to neighboring areas. The Agency has received
similar comments from this commenter on numerous previous occasions.
Refer to Federal Register 70 FR 37686 (June 30, 2005), 70 FR 1354
(January 7, 2005), and 69 FR 63096-63098 (October 29, 2004) for the
Agency's response to these objections.

V. Conclusion

    Therefore, the tolerance is revised for combined residues of the
insecticide/miticide spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol
metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one), calculated as the parent compound equivalents, in or on
vegetable, fruiting, crop group 8 to 0.45 ppm. Also, the tolerance is
established for inadvertent or indirect combined residues of the
insecticide/miticide spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate), its enol metabolite
(4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one),
and its metabolites containing the 4-hydroxymethyl moiety (4-hydroxy-3-
[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one),
calculated as the parent compound equivalents, in or on oat, forage at
0.20 ppm; oat, grain at 0.03 ppm; oat, hay at 0.25 ppm; and oat, straw
at 0.25 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735,

October 4, 1993). Because this rule has been exempted from review under
Executive Order 12866 due to its lack of significance, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: January 17, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.607 is amended in the table to paragraph (a)(1) by
revising the entry for ``Vegetable, fruiting group 8'' and in the table
to paragraph (d) by adding alphabetically commodities to read as
follows:

Sec. 180.607  Spiromesifen; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Vegetable, fruiting, group 8...............................         0.45
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (d) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Oat, forage................................................         0.20
Oat, grain.................................................         0.03
Oat, hay...................................................         0.25
Oat, straw.................................................         0.25
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E7-990 Filed 1-23-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Page 7036]
[FR Doc No: 2018-03182]

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

ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9037-6]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www2.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements
Filed 02/05/2018 Through 02/09/2018
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://cdxnodengn.epa.gov/cdx-nepa-public/action/eis/search.

EIS No. 20180017, Final Supplement, FERC, FL, Southeast Market
Pipelines Project, Review Period Ends: 03/19/2018, Contact: John
Peconom<PHONE_NUMBER>.

EIS No. 20180018, Final, USFS, MT, Tenmile--South Helena Project,
Review Period Ends: 03/19/2018, Contact: Allen Byrd<PHONE_NUMBER>.

EIS No. 20180019, Draft, USFS, ID, Lolo Insect & Disease Project,
Comment Period Ends: 04/02/2018, Contact: Sara Daugherty<PHONE_NUMBER>.

EIS No. 20180020, Draft, FERC, OK, Midcontinent Supply Header
Interstate Pipeline Project, Comment Period Ends: 04/02/2018, Contact:
Elaine Baum<PHONE_NUMBER>.

    Dated: February 12, 2018.
Kelly Knight,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2018-03182 Filed 2-15-18; 8:45 am]
BILLING CODE 6560-50-P