[Federal Register: January 22, 2008 (Volume 73, Number 14)]
[Notices]
[Page 3762-3765]
[DOCID:fr22ja08-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57148; File No. SR-Amex-2007-137]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing and Order Granting Accelerated Approval of a Proposed
Rule Change, as Modified by Amendment No. 1 Thereto, To Amend Section
107D of the Amex Company Guide

January 15, 2008.
    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 December 14, 2007, the American Stock Exchange LLC (``Exchange'' or
``Amex'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which items have been substantially prepared by the Amex. On
January 8, 2008, the Exchange filed Amendment No. 1 to the proposed
rule change. The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons and is approving the proposed rule change on an accelerated
basis.
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    \1\ 15 U.S.C. 78s(b)(l).
    \2\ 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 amend section 107D of the Amex Company
Guide (``Company Guide'') to: (i) Eliminate the requirement that an
eligible index for index-linked securities (``Index Securities'') be
calculated and weighted following a specified methodology; (ii) provide
that indexes based on the equal-dollar or modified equal-dollar
weighting methods be rebalanced semi-annually rather than quarterly, as
is currently the case; and (iii) eliminate the continued listing
requirement prohibiting an index from increasing or decreasing by more
than 33\1/3\% from the number of index components initially listed.
    The text of the proposed rule change is available at the Amex, at
the Commission's Public Reference Room, and at http://www.amex.com.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, its 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 III below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange proposes to amend section 107D of the Company Guide
to: (i) Eliminate the requirement that an eligible index for Index
Securities be calculated and weighted following a specified
methodology; (ii) provide that indexes based on the equal-dollar or
modified equal-dollar weighting methods be rebalanced semi-annually
rather than quarterly, as is currently the case; and (iii) eliminate
the continued listing requirement prohibiting an index from increasing
or decreasing by more than 33\1/3\% from the number of index components
initially listed.

Generic Listing Standards--Index Weighting Methodologies

    Section 107D of the Company Guide sets forth the generic listing
standards for Index Securities. The generic listing standards permit
the listing and trading of various qualifying Index Securities, subject
to the procedures contained in Rule 19b-4(e) under the Act.\3\ The
existence of generic listing standards allows qualifying Index
Securities to list or trade without the need to file a rule change for
each security under Rule 19b-4 under the Act. By amending its generic
listing standards for Index Securities, the Exchange intends to reduce
the timeframe for listing Index Securities and thereby reduce the
burdens on issuers and other market participants.
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    \3\ 17 CFR 240.19b-4(e).
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    The generic listing standards for Index Securities in section
107D(i)(i) of the Company Guide currently provide that eligible indexes
must be calculated based on either a capitalization,\4\ modified
capitalization,\5\ price,\6\ equal-

dollar \7\ or modified equal-dollar \8\ weighting methodology. The
indexes potentially underlying an issue of Index Securities may differ
based on various criteria such as broad-based market measures and
narrow-based or industry-specific market measures. Ultimately, it is
the diversity of the underlying securities as well as their market
coverage that determine whether an index is broad-based or narrow-
based. Further, indexes can be calculated using different methodologies
and, thus, even where indexes are based on the same underlying
securities, they may measure the relevant market differently because of
differences in their calculation methodology. The methodologies
currently permitted under section 107D(i)(i) of the Company Guide for
Index Securities are not all-inclusive and there are other calculation
methodologies that are not currently permitted under the Exchange's
generic listing standards.\9\ The Amex proposes to eliminate the
current limitations in the generic listing standards for Index
Securities relating to index calculation methodologies, thereby
reducing the time-frame for listing Index Securities based on other
index calculation methodologies and promoting competition. The Exchange
believes that the proposal will further alleviate unnecessary burdens
on issuers and other market participants without compromising investor
protection.
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    \4\ A ``capitalization-weighted'' index is constructed so that
weightings are biased toward the securities of larger companies. In
calculating the index value, the market price of each component
security is multiplied by the total number of shares outstanding to
determine the market capitalization for each company in the index.
The sum of the market capitalizations of all components determines
the total capitalization for the index. The total market
capitalization is then divided by an index divisor to scale the
index to a desired reference level, e.g. 100, to establish a
baseline for gauging future performance of the index. This will
allow a security's size and capitalization to have a greater impact
on the value of the index.
    \5\ A ``modified capitalization-weighted'' index is weighted
using criteria other than the total, actual number of shares
outstanding.
    \6\ In a ``price-weighted'' index, the component securities are
included based on their price. The value of the price-weighted index
is calculated by adding together the last transaction price for each
security in the index and dividing the resulting sum by an index
divisor to scale the index.
    \7\ An ``equal dollar-weighted'' index is calculated by
establishing an aggregate market value for every component security
of the index and then determining the number of shares of each
security by dividing this aggregate market value by the current
market price of the security. This method of calculation does not
give more weight to price changes of the more highly capitalized
component securities. Additionally, the weights of each component
security are reset to equal values at regular intervals (e.g.,
quarterly).
    \8\ A ``modified equal dollar-weighted'' index resets component
securities at regular intervals, but not necessarily to equal
values.
    \9\ For example, an index can also be a simple average,
calculated by simply adding up the prices of the securities in the
index and dividing by the number of securities, disregarding the
number of shares outstanding. Another type measures daily percentage
movements of prices by averaging the percentage of the types of
stocks constituting the index.
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    The Exchange notes that the Commission recently approved a proposal
\10\ by the Amex to remove similar requirements in the Amex's generic
listing standards for exchange-traded funds (``ETFs'') \11\ that
eligible indexes be calculated based on the market capitalization,
modified market capitalization, price, equal-dollar, or modified equal
dollar weighting methodology. In approving Amex-2007-07, the Commission
found that ``[a]s the market for ETFs has grown, the variety of
weighting and calculation methodologies for underlying indexes has also
expanded, limiting the applicability of Amex's current generic ETF
listing standards.'' Similarly, the Exchange believes that growth in
the market for Index Securities as well as an expansion in the
weighting and calculation methods for underlying indexes has limited
the applicability of Amex's current generic listing standards for Index
Securities. The Exchange further notes that the Commission recently
approved a similar filing by NYSE Arca, LLC (``NYSEArca'') in which
NYSEArca proposed the elimination of its requirement that an underlying
index used in connection with an issuance of Equity Index-Linked
Securities must be calculated based on either a capitalization,
modified capitalization, price, equal-dollar, or modified equal-dollar
weighting methodology.\12\
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    \10\ See Securities Exchange Act Release No. 55544 (Mar. 27,
2007), 72 FR 15923 (Apr. 3, 2007) (``Amex-2007-07'').
    \11\ See Amex Rule 1000-AEMI for portfolio depository receipts
and Amex Rule 1000A-AEMI for index fund shares.
    \12\ See Securities Exchange Act Release No. 56838 (Nov. 26,
2007), 72 FR 67774 (Nov. 30, 2007) (SR-NYSE-Arca-2007-118). In this
filing NYSEArca stated that it was seeking to harmonize NYSEArca
rules with the New York Stock Exchange (``NYSE'') Equity Index-
Linked Securities listing standard in Section 703.22 of the NYSE
Listed Company Manual, which has no requirements concerning
weighting methodologies.
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Rebalancing of Equal-Dollar and Modified Equal-Dollar Indexes

    Section 107D(i)(ii) of the Company Guide currently requires that
indexes based upon the equal-dollar or modified equal-dollar weighting
method be rebalanced quarterly. The Exchange is proposing to amend this
requirement to require that the equal-dollar or modified equal-dollar
weighting method be rebalanced at least semi-annually. A significant
number of currently existing equity indexes that utilize the equal-
dollar or modified equal-dollar weighting methodology are rebalanced
semi-annually rather than quarterly. As the issuer of Index Securities
generally licenses the right to utilize the underlying index from a
third party index sponsor, it is often not within the issuer's control
to have the index rebalanced more frequently. As such, it is not
possible currently under section 107D(i)(ii) of the Company Guide to
list Index Securities based on indexes that are rebalanced semi-
annually. However, as these types of indexes are relatively common and
detailed information concerning the procedures governing the
construction of the underlying index will be available to investors
either in the issuer's prospectus or on the index sponsor's Web site,
the Exchange believes that it is appropriate to allow investors to make
their own decisions as to the sufficiency of a semi-annual rebalancing
of an equal-dollar index underlying an issuance of Index Securities.
Investors and issuers would also benefit from the Amex's ability to
list--without the delay associated with a stand-alone rule filing--
Index Securities based on a broader group of indexes. The Exchange
further notes that the Commission recently approved a similar proposal
by NYSEArca.\13\
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    \13\ See supra note 12.
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Continued Listing Criteria for Index-Linked Securities

    Section 107D(h) of the Company Guide provides the continued listing
criteria for Index Securities. In particular, section 107D(h)(ii) of
the Company Guide provides, as a condition of continued listing that,
``the total number of components in the index may not increase or
decrease by more than 33\1/3\% from the number of components in the
index at the time of its initial listing, and in no event may be less
than ten (10) components.'' The Exchange proposes to delete the 33\1/
3\% prohibition, but maintain the 10-component requirement of the rule.
    The Exchange believes that investors purchase Index Securities
because they believe that the underlying index method is accurately
described in the offering documentation and that the index sponsor will
maintain the index methodology appropriately so that the index will
continue to represent the sector, geographic region or other investment
characteristics it is designed to track. As such, rather than buying
Index Securities on the basis of the current contents of the index,
investors are relying on the index sponsor to define and manage the
index selection rules so that, over time, the index is sustainable in
response to changing market conditions.
    Because Index Securities can have a duration of up to thirty (30)
years, it is likely that some Index Securities will ultimately change
in ways that render them noncompliant with section 107D(h)(ii) of the
Company Guide. The Exchange believes that an unintended consequence of
the 33\1/3\% requirement is that it penalizes Index Securities with
long-term maturities. Specifically, total industry/country composite
indexes are at risk of being delisted prior to the stated maturity date
for the Index Security. As a result, issuers may not launch new Index
Securities due to

concerns regarding the negative impact of delisting the index-linked
security based on component changes that reflect expanding or
retracting industry sectors or changes in the geographical business
environment. The Exchange does not believe that it is protective of
investors to require the delisting of Index Securities in such an
event. The Exchange further notes that the Commission recently approved
a similar proposal by NYSEArca.\14\
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    \14\ See Securities Exchange Act Release No. 57132 (Jan. 11,
2008) (SR-NYSEArca-2007-125).
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations under the Act applicable to
national securities exchanges and, in particular, the requirements of
section 6(b) of the Act.\15\ Specifically, the Exchanges believe the
proposed rule change is consistent with the requirements of section
6(b)(5) of the Act \16\ that the rules of an exchange be designed to
prevent fraudulent and manipulative acts, 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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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes that the proposed rule change would impose no
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    The Exchange has neither solicited nor received comments on this
proposal.

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-Amex-2007-137 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Amex-2007-137. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submissions, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filings also will be available for
inspection and copying at the principal offices 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 No. SR-Amex-2007-137 and should be
submitted on or before February 12, 2008.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Changes

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder, applicable to national securities
exchanges.\17\ In particular, the Commission finds that the proposal is
consistent with the provisions of section 6(b)(5) of the Act \18\ in
that it is designed to prevent fraudulent and manipulative acts and
practices, 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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    \17\ In approving this proposal, the Commission has considered
its impact on efficiency, competition, and capital formation. See
U.S.C. 78c(f).
    \18\ 15 U.S.C. 78f(b)(5).
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    The Commission notes that the proposal to eliminate the requirement
that an eligible index for Index Securities be calculated based on
certain specified methodologies would conform the Exchange's
requirements to the current listing standards for similar securities on
other national securities exchanges.\19\ The Commission further
believes that the proposal to provide that indexes based on the equal-
dollar or modified equal-dollar weighting methods be rebalanced at
least semi-annually should benefit investors by providing a wider
selection of derivative products based on such indexes. The Commission
believes that the proposal to adjust the minimum rebalancing frequency
requirement is reasonable, given the increasing number of equal-dollar
or modified equal-dollar weighted indexes that are rebalanced on a
semi-annual basis, and should allow for the listing and trading of
certain Index Securities that would otherwise not be able to be listed
and traded on the Exchange.
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    \19\ See supra note 12. See also Section 703.22 of the NYSE
Listed Company Manual.
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    In addition, the Commission believes that eliminating the
requirement prohibiting an index from increasing or decreasing by more
than 33\1/3\% from the number of index components initially listed
reasonably balances the removal of impediments to a free and open
market with the protection of investors and the public interest, two
principles set forth in section 6(b)(5) of the Act.\20\ The Commission
notes that each issue of Index Securities must continue to maintain all
of the initial listing standards for Index Securities, including the
continued requirement that each underlying index have a minimum of 10
component securities of different issuers. Given the variety of certain
equity indexes that focus on specific industry sectors and geographic
markets, for example, and the extended duration of maturities for
certain Index Securities, the Commission believes that the number of
components in an index may increase or decrease by more than 33\1/3\%
from the number of components in the index at the time of initial
listing without adversely impacting the interests of investors. At the
same time, the Commission believes that the proposal should benefit
investors by creating additional alternatives to

investing in such products and competition in the market for Index
Securities, while maintaining transparency of the underlying components
comprising an index. As such, the Commission believes it is reasonable
and consistent with the Act for the Exchange to eliminate the 33\1/3\%
requirement from the listing standards for Index Securities in the
manner described in the proposal.
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    \20\ Id.
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    The Commission finds good cause for approving the proposed rule
change before the 30th day after the date of publication of notice of
filing thereof in the Federal Register. With respect to the Exchange's
proposals to: (i) Eliminate the requirement that an eligible index for
Index Securities be calculated and weighted following a specified
methodology; (ii) provide that indexes based on the equal-dollar or
modified equal-dollar weighting methods be rebalanced semi-annually
rather than quarterly, as is currently the case; and (iii) eliminate
the continued listing requirement prohibiting an index from increasing
or decreasing by more than 33\1/3\% from the number of index components
initially listed rule change, the Commission notes that it has recently
approved substantially similar proposals for other national securities
exchanges.\21\ The Commission does not believe that these proposals
raise any novel regulatory issues. Therefore, the Commission finds good
cause, consistent with section 19(b)(2) of the Act,\22\ to approve the
proposed rule change on an accelerated basis.
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    \21\ See supra notes 12 and 14.
    \22\ 15 U.S.C. 78s(b)(2).
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V. Conclusion

    It is therefore ordered, pursuant to section 19(b)(2) of the
Act,\23\ that the proposed rule change (SR-Amex-2007-137), as modified
by Amendment No. 1, be, and it hereby is, approved on an accelerated
basis.
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    \23\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-995 Filed 1-18-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Notices]
[Page 35342]
[FR Doc No: 2015-15096]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of the Commission's staff may attend the following
meeting related to the transmission planning activities of the
Southeastern Regional Transmission Planning (SERTP) Process.
    The SERTP Process Second Quarter Meeting.

June 25, 2015, 10:00 a.m.-2:00 p.m. (Eastern Time)

    The above-referenced meeting will be via web conference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: www.southeasternrtp.com.
    The discussions at the meeting described above may address matters
at issue in the following proceedings:

Docket Nos. ER13-83, ER13-1928, Duke Energy Carolinas/Carolina Power &
Light
Docket Nos. ER13-908, ER13-1941, Alabama Power Company et al.
Docket Nos. ER13-913, ER13-1940, Ohio Valley Electric Corporation.
Docket Nos. ER13-897, ER13-1930, Louisville Gas and Electric Company
and Kentucky Utilities Company.
    For more information, contact Valerie Martin, Office of Energy
Market Regulation, Federal Energy Regulatory Commission at (202) 502-
6139 or<EMAIL_ADDRESS>
    Dated: June 12, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-15096 Filed 6-18-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Rules and Regulations]
[Pages 59627-59634]
[FR Doc No: 2015-24467]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0141; FRL-9933-03]

Benzovindiflupyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
benzovindiflupyr in or on multiple commodities that are identified and
discussed later in this document. Syngenta Crop Protection, LLC.,
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective October 2, 2015. Objections and
requests for hearings must be received on or before December 1, 2015,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0141, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room

is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Public Reading Room is
(202) 566-1744, and the telephone number for the OPP Docket is (703)
305-5805. Please review the visitor instructions and additional
information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0141 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
December 1, 2015. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0141, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2),
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of two pesticide petitions (PP 2E8123
and 2F8121) by Syngenta Crop Protection, LLC., P.O. Box 18300,
Greensboro, NC 27419. Petition 2E8123 requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the fungicide,
benzovindiflupyr in or on coffee, bean, green at 0.09 parts per million
(ppm) and sugarcane, cane at 0.04 ppm. Petition 2F8121 requested that
40 CFR part 180 be amended by establishing tolerances for residues of
the fungicide, benzovindiflupyr in or on apple, wet pomace at 0.6 ppm;
barley, grain at 1.5 ppm; barley, hay at 15 ppm; barley, straw at 15
ppm; corn, field, grain at 0.02 ppm; corn, field, forage at 3 ppm;
corn, field, stover at 15 ppm; corn, pop, grain at 0.02 ppm; corn, pop,
stover at 15 ppm; corn, sweet, ear at 0.01 ppm; corn, sweet, forage at
4 ppm; corn, sweet, stover at 5 ppm; cottonseed, subgroup 20C at 0.15
ppm; cotton, gin byproducts at 3 ppm; vegetables, cucurbits, crop group
9 at 0.2 ppm; fruits, pome, crop group 11-10 at 0.2 ppm; fruits, small
vines climbing, except fuzzy kiwi subgroup 13-07F at 1 ppm; grain,
aspirated fractions at 7 ppm; oat, grain at 1.5 ppm; oat, hay at 15
ppm; oat, straw at 15 ppm; peas and bean, dried shelled, except
soybean, subgroup 6C at 0.2 ppm; peas, hay at 7 ppm; peas, vine at 1.5
ppm; peanut, nutmeat at 0.01 ppm; peanut, hay at 15 ppm; potato, wet
peel at 0.1 ppm; raisin at 4 ppm; rapeseed, subgroup 20A at 0.15 ppm;
rye, grain at 0.1 ppm; rye, hay at 15 ppm; rye, straw at 10 ppm;
soybean, seed at 0.07 ppm; soybean, forage at 15 ppm; soybean, hay at
50 ppm; vegetables, fruiting, crop group 8-10 at 0.8 ppm; vegetables,
tuberous and corm subgroup 1C at 0.02 ppm; wheat, grain at 0.1 ppm;
wheat, forage at 4 ppm; wheat, hay at 15 ppm; wheat, straw at 10 ppm;
and at 0.01 ppm in or on the following animal commodities: cattle,
goat, horse, and sheep fat, kidney, liver, meat, and meat byproducts;
egg; hog, fat, liver, meat, and meat byproducts; milk; milk, fat; and
poultry, byproducts, fat, liver, meat, and skin.
    That document referenced a summary of the petition prepared by
Syngenta Crop Protection, the registrant, which is available in the
docket, http://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
IV.C.
    Based upon review of the data supporting the petition, EPA has
modified the requested tolerances and levels for the reasons explained
in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from

aggregate exposure to the pesticide chemical residue . . . .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for benzovindiflupyr including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with
benzovindiflupyr 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.
    Benzovindiflupyr has low acute toxicity by the dermal and
inhalation routes, with moderate toxicity via the oral route. It is not
a dermal sensitizer, but causes mild skin irritation and moderate eye
irritation. The target organs for effects of benzovindifulpyr are the
liver, thyroid, and kidneys.
    Benzovindiflupyr produced effects in rat fetuses (i.e. decreased
fetal weight and ossification) in developmental toxicity studies but
only at maternally toxic doses. In the rabbit developmental study,
there were no adverse effects in either the does or the fetuses at the
highest dose tested. In reproduction studies, offspring effects
occurred at doses higher than the doses causing parental effects; thus,
there was no quantitative increase in sensitivity in rat pups. There
are indications of reproductive toxicity in rats such as decreased
follicle counts, but these effects did not result in reduced fertility.
    No evidence of specific neurotoxicity was observed in the acute
neurotoxicity (ACN) or subchronic neurotoxicity (SCN) studies.
Benzovindiflupyr caused decreased activity and decreased grip strength
in the neurotoxicity studies; however, there were no supportive
neurohistopathology in any toxicological study, even at the highest
doses tested.
    There was no evidence of immune system toxicity in a study
conducted in the mouse, or in any other toxicity studies in the
database.
    Benzovindiflupyr caused tumors in the thyroid in the chronic rat
study at the highest dose tested. In mice, no tumor formation was
observed. Benzovindiflupyr was negative in all mutagenicity studies.
Based on the fact that evidence of tumors were found in only one
species at only the highest dose tested and lack of mutagenicity, the
Agency has determined that using a non-linear approach (i.e., RfD;
reference dose) will adequately account for all chronic toxicity,
including carcinogenicity, that could result from exposure to
benzovindiflupyr.
    Specific information on the studies received and the nature of the
adverse effects caused by benzovindiflupyr as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Benzovindiflupyr New Active Ingredient
Human Health Risk Assessment to Support the Proposed Uses on Cereals
(wheat, triticale, barley, rye, and oat), Blueberries (non-bearing),
Corn (field, pop, and sweet), Peanuts, Turf, and Ornamentals; Crop
Groups 8-10, 9, and 11-10; Crop Subgroups 1C, 6C, 13-07F, 20A, and 20C;
and Establishment of Tolerances on Imported Coffee and Sugarcane in
docket ID number EPA-HQ-OPP-2013-0141.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for benzovindiflupyr used for human risk assessment is shown
in Table 1 of this unit.

     Table 1--Summary of Toxicological Doses and Endpoints for Benzovindiflupyr for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                                                          RfD, PAD, level of       Study and
        Exposure/scenario              Point of        Uncertainty/FQPA    concern for risk      toxicological
                                       departure        safety factors        assessment            effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations,   NOAEL = 10 mg/kg/   UFA = 10x.........  Acute RfD = 0.10    Acute
 including infants and children).  day.               UFH = 10x.........   mg/kg/day.          neurotoxicity
                                                      FQPA SF= 1x.......  aPAD =0.10 mg/kg/    screening battery
                                                                           day.                (rat).
                                                                                NOAEL = 10 mg/kg/
                                                                                day.
                                                                                LOAEL = 30 mg/kg/
                                                                                day based on
                                                                                multiple clinical
                                                                                observations,
                                                                                decreases in mean
                                                                                body temperature,
                                                                                decreases in
                                                                                locomotor
                                                                                activity
                                                                                parameters,
                                                                                reduced food
                                                                                consumption and/
                                                                                or decreases in
                                                                                mean grip
                                                                                strength.
----------------------------------------------------------------------------------------------------------------

Chronic dietary (All              Parental/Off-       UFA = 10x.........  Chronic RfD =       2-generation
 populations).                     spring.            UFH = 10x.........   0.082 mg/kg/day.    reproduction
                                  NOAEL = 8.2         FQPA SF= 1x.......  cPAD = 0.082 mg/kg/  study (rat).
                                   (females) mg/kg/                        day.               Parental/Offspring
                                   day.                                                        NOAEL = 8.2 mg/kg/
                                                                                day (F).
                                                                                LOAEL = 19.4 mg/kg/
                                                                                day (F) based on
                                                                                decreased body
                                                                                weight and
                                                                                decreased food
                                                                                consumption in
                                                                                parental animals
                                                                                as well as
                                                                                increases in
                                                                                liver weights,
                                                                                centrilobular
                                                                                hepatocellular
                                                                                hypertrophy,
                                                                                increased
                                                                                incidence of cell
                                                                                hypertrophy in
                                                                                the pars distalis
                                                                                of the pituitary,
                                                                                reduced body
                                                                                weight, delayed
                                                                                preputial
                                                                                separation, and
                                                                                decreased spleen
                                                                                weights in the F1
                                                                                and/or F2
                                                                                offspring.
Incidental oral Short -term (1-   Parental/Off-       UFA = 10x.........  Residential LOC     2-generation
 30 days).                         spring.            UFH = 10x.........   for MOE = 100.      reproduction
                                  NOAEL = 8.2         FQPA SF= 1x.......                       toxicity study
                                   (females) mg/kg/                                            (rat).
                                   day.                                                       Parental/Offspring
                                                                                NOAEL = 8.2 mg/kg/
                                                                                day (F).
                                                                                LOAEL = 19.4 mg/kg/
                                                                                day (F) based on
                                                                                decreased body
                                                                                weight and
                                                                                decreased food
                                                                                consumption in
                                                                                parental animals
                                                                                as well as
                                                                                increases in
                                                                                liver weights,
                                                                                centrilobular
                                                                                hepatocellular
                                                                                hypertrophy,
                                                                                increased
                                                                                incidence of cell
                                                                                hypertrophy in
                                                                                the pars distalis
                                                                                of the pituitary,
                                                                                reduced body
                                                                                weight, delayed
                                                                                preputial
                                                                                separation, and
                                                                                decreased spleen
                                                                                weights in the F1
                                                                                and/or F2
                                                                                offspring.
Inhalation Short-term (1-30       Parental/Off-       UF A = 10x........  Residential LOC     2-generation
 days) and Intermediate-term (1-   spring NOAEL: 8.2  UF H = 10x........   for MOE = 100.      reproduction
 6 months).                        mg/kg/day (F).     FQPA SF = 1x......                       study (rat).
                                                                                Parental/Offspring
                                                                                NOAEL = 8.2 mg/kg/
                                                                                day (F).
                                                                                LOAEL = 19.4 mg/kg/
                                                                                day (F) based on
                                                                                decreased body
                                                                                weight and
                                                                                decreased food
                                                                                consumption in
                                                                                parental animals
                                                                                as well as
                                                                                increases in
                                                                                liver weights,
                                                                                centrilobular
                                                                                hepatocellular
                                                                                hypertrophy,
                                                                                increased
                                                                                incidence of cell
                                                                                hypertrophy in
                                                                                the pars distalis
                                                                                of the pituitary,
                                                                                reduced body
                                                                                weight, delayed
                                                                                preputial
                                                                                separation, and
                                                                                decreased spleen
                                                                                weights in the F1
                                                                                and/or F2
                                                                                offspring.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal,             The Agency is using a non-linear (RfD) approach to assess carcinogenic
 inhalation).                      potential; the RfD would be protective of non-carcinogenic and carcinogenic
                                   effects observed in the rat carcinogenicity study or mode of action studies
                                   conducted at higher doses.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
  risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to benzovindiflupyr, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
benzovindiflupyr in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for benzovindiflupyr. In estimating
acute dietary exposure, EPA used food consumption information from the
United States Department of Agriculture (USDA), Nationwide Continuing
Surveys of Food Intake by Individuals (CSFII). As to residue levels in
food, EPA conducted a highly conservative acute dietary risk assessment
which used tolerance-level residues for food except for livestock
commodities, anticipated residues (based on maximum theoretical diets)
for livestock commodities, and 100% crop treated for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA, CSFII. As
to residue levels in food, EPA conducted a highly conservative chronic
dietary risk assessment which used tolerance-level residues for food,
anticipated residues (based on maximum theoretical diets) for livestock
commodities, and 100% crop treated for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach was appropriate for assessing
cancer risk to benzovindiflupyr; therefore, a separate dietary exposure
assessment for the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Tolerance-level residues for food and anticipated residues (based on
maximum theoretical diets) for livestock commodities were used and 100%
CT was assumed for all commodities.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under

FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for benzovindiflupyr in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of benzovindiflupyr. 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 Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of
benzovindiflupyr for acute exposures are estimated to be 8.4 parts per
billion (ppb) for surface water and 0.14 ppb for ground water. For
chronic exposures for non-cancer assessments are estimated to be 5.4
ppb for surface water and <0.14 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 8.4 parts per billion
(ppb) for surface water was used to assess the contribution to drinking
water. For chronic dietary risk assessment, the water concentration of
value 5.4 ppb for surface water was used to assess the contribution to
drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Benzovindiflupyr is proposed for registration for the following
uses that could result in residential exposures: turf (e.g. golf
courses, recreational parks, home lawns, and sod farms) and ornamentals
(residential landscape areas). EPA assessed residential exposure using
the following assumptions. The proposed uses of benzovindiflupyr on
turf and ornamentals in a residential setting by homeowners may result
in residential handler (adults who are involved in the pesticide
application process) exposure.
    Residential handler exposure is expected to be short-term (ST) in
duration. Intermediate-term (IT) exposures are not likely because of
the intermittent nature of applications by homeowners. In addition,
since the toxicity endpoints and PODs are the same for all durations,
the ST assessment will be protective of any longer term exposures that
may result from residential uses. Since no dermal hazard was identified
for benzovindiflupyr in the toxicological database, only inhalation
exposure assessments were conducted for residential handlers.
    There is the potential for post-application exposure to individuals
(adults and children) as a result of being in an environment that has
been previously treated with benzovindiflupyr. Post-application
inhalation exposures while performing activities in previously treated
turf or ornamentals are not expected and were not assessed primarily
due to the very low vapor pressure and the expected dilution in outdoor
air after an application has occurred. In addition, no dermal hazard
was identified in the toxicity database for benzovindiflupyr and,
therefore, a quantitative residential post-application dermal risk
assessment is not required and was not completed. However, incidental
oral exposures to children contacting treated turf have been assessed.
Residential post-application exposures are generally considered to be
intermittent and short-term in duration. Since the benzovindiflupyr
toxicity endpoints and PODs are the same regardless of duration, the
short-term assessment is protective of any longer term exposures that
may occur from the residential uses of benzovindiflupyr. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found
benzovindiflupyr to share a common mechanism of toxicity with any other
substances, and benzovindiflupyr does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that benzovindiflupyr does
not have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at  http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. Benzovindiflupyr produced
effects in rat fetuses (i.e. decreased fetal weight and delayed
ossification) in developmental toxicity studies at maternally toxic
doses (i.e., ataxia, hunched posture, and decreased activity); the
Agency does not consider the fetal effects to be evidence of increased
qualitative susceptibility since ossification is not considered to be a
malformation and is reversible (based on the reproduction study), and
maternal effects are fairly severe at the same dose levels. In the
rabbit developmental study, there were no adverse effects in either the
dose or the fetuses at the highest dose tested. In rat reproduction
studies, offspring effects occurred at higher doses higher than those
causing parental effects, thus there was no quantitative increase in
sensitivity in rat pups. There were no single-dose developmental
effects identified in the developmental toxicity studies in rats or
rabbits. Although decreases in growing follicle counts were noted in
the reproduction toxicity study, this effect did not result in reduced
functional fertility in the rat. Furthermore, the antral follicle
counts at a later stage in development were not decreased, so the
decreased growing follicle count effect is not considered adverse.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for benzovindiflupyr is complete.
    ii. There is no indication that benzovindiflupyr is a neurotoxic

chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that benzovindiflupyr results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to benzovindiflupyr
in drinking water. EPA also made conservative assumptions for dietary
food exposures (residues on food and feed crops based on tolerance
level residues, assuming 100% crop treated) resulting in high-end
estimates of dietary food. EPA used similarly conservative assumptions
based on conservative default (non-chemical specific) assumptions to
assess postapplication exposure of children, including incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by benzovindiflupyr.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to benzovindiflupyr will occupy 30% of the aPAD for children 1-2 years
old.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
benzovindiflupyr from food and water will utilize 14% of the cPAD for
children 1-2 years old. Based on the explanation in Unit III.C.3.,
regarding residential use patterns, chronic residential exposure to
residues of benzovindiflupyr is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Benzovindiflupyr is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to benzovindiflupyr. Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded the combined short-term food, water, and residential
exposures result in aggregate MOEs of >=180,000 for all scenarios.
Because EPA's level of concern for benzovindiflupyr is a MOE of 100 or
below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Intermediate-term exposures are not likely because of the
intermittent nature of applications by homeowners and the likely short-
term duration of exposures.
    5. Aggregate cancer risk for U.S. population. Based on the results
of the chronic risk assessment, the Agency does not expect
benzovindiflupyr to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to benzovindiflupyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (A Quick, Easy, Cheap, Effective,
Rugged, and Safe (QuEChERS) multi-residue method (EN15662:2009)) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for benzovindiflupyr.

C. Response to Comments

    EPA received a comment to the notice of filing, which requested
that the Agency reconsider the acceptable residue levels of toxic
chemicals on food. The Agency understands the commenter's concerns and
recognizes that some individuals believe that pesticides should be
banned on agricultural crops. However, the existing legal framework
provided by section 408 of the Federal Food, Drug and Cosmetic Act
(FFDCA) states that tolerances may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. This citizen's comment appears
to be directed at the underlying statute and not EPA's implementation
of it; the citizen has made no contention that EPA has acted in
violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

    Benzovindiflupyr was evaluated by undergoing a global joint review
between the EPA, the Pest Management Regulatory Agency (PMRA) of
Canada, and the Federal Commission for the Protection against Sanitary
Risk (COFEPRIS) of Mexico. Based upon review of the data supporting the
petition and calculation procedures for tolerance determination,
several tolerances modifications were required. Specifically, commodity
definitions were modified for pea, hay; pea, vine; peanut, nutmeat;
raisin; and potato, processed waste to reflect the current nomenclature
used by the Agency. Several tolerance levels were adjusted to account
for differences in the input data used for the calculation procedures
for tolerance determination. For example, several trials considered to
be independent trials by the petitioner were determined by the Agency
to be replicate (not independent) trials and, as such, these data are
inputed differently than data from independent trails. Based on this
discrepancy, the Agency is establishing tolerances for the following
commodities that are different

from what the petitioner requested: Cattle, fat; cattle, liver; coffee,
green bean; fruit, pome, group 11-10; goat, fat; goat, liver; horse,
fat; horse, liver; milk, fat; pea and bean, dried shelled, except
soybean, subgroup 6C; potato, processed waste; rye, straw; sheep, fat;
sheep, liver; vegetable, cucurbit, group 9; vegetable, fruiting, group
8-10; wheat, grain; and wheat, straw. Also, based on the Agency's
calculation, the available data supports reducing the raisin tolerance
(from 4 ppm to 3 ppm) and increasing the aspirated grain fractions
tolerance (from 7 ppm to 15 ppm).
    A tolerance was recommended for lowbush variety of blueberry in
non-cropping years following a 365-day PHI. However, no tolerance will
be established on the basis that it would cover non-bearing blueberries
which are considered to be a non-food use. Also, the petitioner did not
include this use in their notice filing. Although the petitioner did
not request a separate tolerance for tomato, dried, tomato processing
study data show that residues concentrate in dried tomatoes (7.8X). To
cover the higher residues and to harmonize with Canada, EPA is
establishing a tolerance for tomato, dried at 4 ppm. Finally, the
applicant requested tolerances for apple, wet pomace. As a fruit, pome,
group 11-10 tolerance of 0.2 ppm will cover any potential residues in
processed apple, a separate tolerance is not needed.

V. Conclusion

    Therefore, tolerances are established for residues of
benzovindiflupyr, in or on barley, grain at 1.5 ppm; barley, hay at 15
ppm; barley, straw at 15 ppm; cattle, fat at 0.02 ppm; cattle, liver at
0.06 ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts, except
liver at 0.01 ppm; coffee, green bean at 0.09 ppm; corn, field, forage
at 3.0 ppm; corn, field, grain at 0.02 ppm; corn, field, stover at 15
ppm; corn, pop, grain at 0.02 ppm; corn, pop, stover at 15 ppm; corn,
sweet, forage at 4.0 ppm; corn, sweet, kernel plus cob with husks
removed at 0.01 ppm; corn, sweet, stover at 5.0 ppm; cottonseed,
subgroup 20C at 0.15 ppm; cotton, gin byproducts at 3.0 ppm; fruit,
pome, group 11-10 at 0.20 ppm; fruit, small vine climbing, except fuzzy
kiwifruit, subgroup 13-07F at 1 ppm; goat, fat at 0.02 ppm; goat, liver
at 0.06 ppm; goat, meat at 0.01 ppm; goat, meat byproducts, except
liver at 0.01 ppm; grain, aspirated fractions at 15 ppm; horse, fat at
0.02 ppm; horse, liver at 0.06 ppm; horse, meat at 0.01 ppm; horse,
meat byproducts, except liver at 0.01 ppm; milk at 0.01 ppm; milk, fat
at 0.02 ppm; oat, grain at 1.5 ppm; oat, hay at 15 ppm; oat, straw at
15 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at
0.20 ppm; pea, field, hay at 7.0 ppm; pea, field, vine at 1.5 ppm;
peanut at 0.01 ppm; peanut, hay at 15 ppm; potato, processed potato
waste at 0.10 ppm; grape, raisin at 3.0 ppm; rapeseed, subgroup 20A at
0.15 ppm; rye, grain at 0.1 ppm; rye, hay at 15 ppm; rye, straw at 15
ppm; sheep, fat at 0.02 ppm; sheep, liver at 0.06 ppm; sheep, meat at
0.01 ppm; sheep meat byproducts, except liver at 0.01 ppm; soybean,
forage at 15 ppm; soybean, hay at 50 ppm; soybean, hulls at 0.20 ppm;
soybean, seed at 0.07 ppm; sugarcane, cane at 0.04 ppm; tomato, dried
at 4.0 ppm; vegetable, cucurbit, group 9 at 0.30 ppm; vegetable,
fruiting, group 8-10 at 1.5 ppm; vegetable, tuberous and corm, subgroup
1C at 0.02 ppm; wheat, forage at 4 ppm; wheat, grain at 0.10 ppm;
wheat, hay at 15 ppm; and wheat, straw at 15 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 28, 2015.
Jack E. Housenger,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Add Sec.  180.686 to subpart C to read as follows:

Sec.  [emsp14]180.686  Benzovindiflupyr; tolerances for residues.

    (a) General. Tolerances are established for residues of the
fungicide benzovindiflupyr, including its metabolites and degradates,
in or on the commodities in the table below. Compliance with the
tolerance levels specified below is to be determined by measuring only
benzovindiflupyr (N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-
methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-
carboxamide) in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, grain..............................................         1.5
Barley, hay................................................        15.0
Barley, straw..............................................        15.0
Cattle, fat................................................         0.02
Cattle, liver..............................................         0.06
Cattle, meat...............................................         0.01
Cattle, meat byproducts, except liver......................         0.01
Coffee, green bean\1\......................................         0.09
Corn, field, forage........................................         3.0
Corn, field, grain.........................................         0.02
Corn, field, stover........................................        15.0
Corn, pop, grain...........................................         0.02
Corn, pop, stover..........................................        15.0
Corn, sweet, forage........................................         4.0
Corn, sweet, kernel plus cob with husks removed............         0.01
Corn, sweet, stover........................................         5.0
Cottonseed, subgroup 20C...................................         0.15
Cotton, gin byproducts.....................................         3.0
Fruit, pome, group 11-10...................................         0.20
Fruit, small vine climbing, except fuzzy kiwifruit,                 1.0
 subgroup 13-07F...........................................
Goat, fat..................................................         0.02
Goat, liver................................................         0.06
Goat, meat.................................................         0.01
Goat, meat byproducts, except liver........................         0.01
Grain, aspirated fractions.................................        15.0
Grape, raisin..............................................         3.0
Horse, fat.................................................         0.02
Horse, liver...............................................         0.06
Horse, meat................................................         0.01
Horse, meat byproducts, except liver.......................         0.01
Milk.......................................................         0.01
Milk, fat..................................................         0.02
Oat, grain.................................................         1.5
Oat, hay...................................................        15.0
Oat, straw.................................................        15.0
Pea and bean, dried shelled, except soybean, subgroup 6C...         0.20
Pea, field, hay............................................         7.0
Pea, field, vine...........................................         1.5
Peanut.....................................................         0.01
Peanut, hay................................................        15.0
Potato, processed potato waste.............................         0.10
Rapeseed, subgroup 20A.....................................         0.15
Rye, grain.................................................         0.1
Rye, hay...................................................        15.0
Rye, straw.................................................        15.0
Sheep, fat.................................................         0.02
Sheep, liver...............................................         0.06
Sheep, meat................................................         0.01
Sheep meat byproducts, except liver........................         0.01
Soybean, forage............................................        15.0
Soybean, hay...............................................        50.0
Soybean, hulls.............................................         0.20
Soybean, seed..............................................         0.07
Sugarcane, cane\1\.........................................         0.04
Tomato, dried..............................................         4.0
Vegetable, cucurbit, group 9...............................         0.30
Vegetable, fruiting, group 8-10............................         1.5
Vegetable, tuberous and corm, subgroup 1C..................         0.02
Wheat, forage..............................................         4.0
Wheat, grain...............................................         0.10
Wheat, hay.................................................        15.0
Wheat, straw...............................................        15.0
------------------------------------------------------------------------
\1\ There is no U.S. registration for use of benzovindiflupyr.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2015-24467 Filed 10-1-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Notices]
[Page 72126]
[FR Doc No: 2015-29501]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold an Open Meeting on Wednesday,
November 18, 2015 at 3:00 p.m., in the Auditorium, Room L-002.
    The subject matter of the Open Meeting will be:
     The Commission will consider whether to propose amendments
to Rule 3a1-1 and Regulation ATS and new Form ATS-N under the
Securities Exchange Act of 1934 related to certain alternative trading
systems.
    Commissioner Stein, as duty officer, voted to consider the item
listed for the Open Meeting in open session, and determined that
Commission business required consideration earlier than one week from
today. No earlier notice of this Meeting was practicable.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted, or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: November 13, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-29501 Filed 11-16-15; 2:00 pm]
 BILLING CODE 8011-01-P