[Federal Register Volume 77, Number 236 (Friday, December 7, 2012)]
[Notices]
[Pages 73106-73109]
[FR Doc No: 2012-29567]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68340; File No. SR-NYSEMKT-2012-65]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending Rule
123C(9)(a)(1)(ii)--Equities To Delete the Requirement That the Order
Acceptance Cut-Off Time Cannot Be Past 4:30 p.m.

 December 3, 2012.
    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 November 20, 2012, NYSE MKT LLC (``NYSE MKT'' or ``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 change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \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 Rule 123C(9)(a)(1)(ii)--Equities to
delete the requirement that the order acceptance cut-off time cannot be
past 4:30 p.m. The text of the proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Rule 123C(9)(a)(1)(ii)--Equities to
delete the requirement that the order acceptance cut-off time cannot be
past 4:30 p.m. (or 30 minutes after the scheduled close in the case of
an earlier close).\3\
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    \3\ The Exchange notes that parallel changes are proposed to be
made to the rules of New York Stock Exchange LLC (``NYSE''). See
Securities Exchange Act Release No. 68282 (Nov. 21, 2012), 77 FR
71023 (Nov. 28, 2012) (SR-NYSE-2012-63).
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Background
    Pursuant to Rule 123C(9)(a)(1)--Equities, the Exchange may suspend
Rule 52--Equities (Hours of Operation) to resolve an extreme order
imbalance that may result in a price dislocation at the close as a
result of an order entered into Exchange systems, or represented to a
Designated Market Maker (``DMM'') orally at or near the close. Rule
123C(9)(a)(1)--Equities was intended to be and has been invoked to
attract offsetting interest in rare circumstances where there exists an
extreme imbalance at the close such that a DMM is unable to close the
security without significantly dislocating the price.
    Pursuant to Rule 123C(9)(a)(1)(ii)--Equities, once it has been
determined to suspend Rule 52 and solicit offsetting interest, the
Exchange is responsible for soliciting such offsetting interest from
both on-Floor and off-Floor participants. Such solicitation requests
include, at a minimum, the security symbol, the imbalance amount and
side, the last sale price, and an order acceptance cut-off time. The
Exchange designates the order acceptance cut-off time, but the Rule
currently provides that in no event shall the order acceptance cut-off
time be later than 4:30 p.m. (or 30 minutes after the scheduled close
in the case of an earlier close).
    Currently, the Exchange uses Trader Updates to solicit interest
from off-Floor participants. The Exchange's Trader Updates are posted
on the Exchange's Web site and are distributed both by RSS feed and by
email to anyone who subscribes to receive such free updates.
    Since January 3, 2011, when the Rule, which was previously operated
on a pilot bases, became a permanent rule, the Exchange and NYSE, which
has an identical rule, have invoked the relief available pursuant to
the Rule only once, on September 21, 2012. In 2010, Rule
123C(9)(a)(1)--Equities was invoked only three times on both markets.
Proposed Amendment
    The Exchange proposes to amend Rule 123C(9)(a)(1)(ii)--Equities to
delete the requirement that the order acceptance cut-off time shall be
no later than 4:30 p.m., or in the case of an early scheduled close, 30
minutes after the closing time. The Exchange believes it is appropriate
to delete the bright-line cut off time because it hinders the ability
of the Exchange to ensure a fair and orderly close if adhering to the
4:30 p.m. order acceptance cut-off time is not possible under the
particular circumstances.
    In particular, the Exchange notes that for two of the four times
that the rule has been invoked since 2010 on both the Exchange and the
NYSE, the NYSE has extended the order acceptance cut-off time past 4:30
p.m. The reasons for the extensions differed, but the Exchange believes
that given the rarity of the need to invoke the provisions of Rule
123C(9)(a)(1)--Equities in the first instance, together with what the
NYSE has experienced in those few events with its parallel rule, it is
appropriate to delete the bright-line 4:30 p.m. cut-off time.
    For example, on February 12, 2010, due to corporate actions in
Berkshire Hathaway (BRK) Class A and B securities, an NYSE-listed
security, there was significant trading volume in those securities,
including at the close. In the circumstances, it was determined that
the most efficient manner to effect the close of trading in those
securities was to effect the closing transaction in BRK-B before
closing the BRK-A shares. After closing the BRK-B security at 4:19
p.m., the DMM assessed the shares eligible to be executed for the BRK-A
close and determined that the imbalance was significant enough to
invoke the procedures of NYSE Rule 123C(9)(a)(1). Due to the complexity
of the situation, the NYSE was not able to issue its solicitation of
offsetting interest until 4:27 p.m. Because three minutes was not
sufficient time to receive incoming offsetting interest and close the
security, the NYSE accepted order flow past the 4:30 p.m. order
acceptance cut-off time. The NYSE filed with the Commission a rule
proposal that permitted the temporary suspension of NYSE Rule
123C(9)(a)(1)(ii) 4:30 p.m. order acceptance cut-off time.\4\
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    \4\ See Securities Exchange Act Release No. 61549 (Feb. 19,
2010), 75 FR 9009 (Feb. 26, 2010) (SR-NYSE-2010-09).
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    More recently, on Friday, September 21, 2012, there was a buy
imbalance in Weatherford International LTD (WFT), an NYSE-listed
security, that could not be satisfied by sell orders on the Book.
Accordingly, the NYSE invoked procedures pursuant to NYSE Rule 123C(9)
to solicit interest from both off-Floor and on-Floor participants to
offset that imbalance. While the Exchange initiated publication of
solicitation for such offsetting interest immediately following 4:00
p.m., due to delays in the Exchange's web and email systems, the
Exchange's two solicitations of interest, which were sent at 4:22 p.m.
and 4:28 p.m., did not leave Exchange systems until 4:29 p.m. and 4:35
p.m., respectively, and were time-stamped accordingly. Because of these
delays, the Exchange extended the order acceptance cut-off time to 4:35
p.m., which is past the time prescribed in NYSE Rule 123C(9)(a)(1)(ii).
By extending the order acceptance cut-off time to 4:35 p.m., the
Exchange was able to attract sufficient sell-side interest to offset
the buy imbalance and the stock was closed shortly thereafter on a
transaction of 7.822 million shares,

unchanged from the last sale price of $13.54.\5\
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    \5\ On September 27, 2012, the NYSE published a Trader Update
that provided the public with notice of this issue: http://traderupdates.nyse.com/2012/09/weatherford_international_ltd.html.
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    Although the NYSE did not have rule authority to extend the order
acceptance cut-off time in the WFT closing situation to 4:35 p.m., the
NYSE believes that it acted appropriately under the circumstances to
ensure that WFT could close in a fair and orderly manner at a price
that was not significantly dislocated from the last sale price. In
particular, the issue that the NYSE experienced with respect to its web
and email system was unanticipated and the NYSE sought to respond in a
manner that protected investors and the public interest by ensuring a
fair and orderly close.
    The Exchange believes it is appropriate to provide the Exchange
with authority to designate an order acceptance cut-off time that is
tailored to the particular situation, rather than have to adhere to the
4:30 p.m. time frame. The Exchange's ultimate goal is to ensure a fair
and orderly close in a manner that is as close to the official 4:00
p.m. closing time as possible. However, depending on the circumstances,
whether because of the complexity of the closing process for a
particular security or because of a system or technology issue,
requiring a bright-line order acceptance time may not be appropriate.
    Moreover, the Exchange believes that adhering to such a bright-line
cut-off time could harm investors and the public. For example, in both
the BRK-A and WFT closes, if the NYSE had adhered to the 4:30 p.m. cut-
off time, the NYSE would not have been able to complete its
solicitation of offsetting interest. Without such offsetting interest,
the Exchange had two alternatives, either close the stock at a price
significantly dislocated from the last sale price, or invoke an order
imbalance halt and not hold a closing transaction. The Exchange does
not believe that either alternative is in the best interest of
investors or the public. Rather, the Exchange believes that ensuring
that the closing price is not significantly dislocated from the last
sale, even if that means a delayed closing time, would benefit
investors and the public.\6\
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    \6\ The Exchange proposes to make clarifying changes to
paragraphs (a)(1), (a)(1)(v), (a)(2), and (b) of Rule 123C(9)--
Equities and Supplementary Material .20 and .30 to Rule 123C--
Equities to either add the phrase ``Equities'' or delete the term
``NYSE'' in connection with references to other equity rules in the
rule text.
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2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \7\ of the
Securities Exchange Act of 1934 (the ``Act''), in general, and furthers
the objectives of Section 6(b)(5),\8\ in particular, in that it is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system and, in general, to
protect investors and the public interest, and it is not designed to
permit unfair discrimination among customers, brokers, or dealers.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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    In particular, the Exchange believes that providing the Exchange
with the authority to designate the order cut-off time as appropriately
tailored to the particular situation removes impediments to and
perfects the mechanism of a free and open market because it enables the
Exchange to complete the process to solicit interest to offset an
imbalance at the close that would otherwise result in a significant
price dislocation. Without the relief requested herein, the Exchange
may not be able to complete the process to solicit offsetting interest,
which would result in either the stock closing at a dislocated price,
or require the Exchange to invoke an order imbalance halt in the
security. The Exchange believes such solutions could harm investors and
the public because of either an unnecessarily dislocated closing price,
or in the case of an imbalance halt, orders intended for the closing
transaction would not be executed. The Exchange further believes that
the proposed rule change would protect investors and the public
interest because it would enable the Exchange to complete the process
to ensure that the closing price that may be closer to the last sale
price, rather than a closing price that is significantly dislocated
from the last sale price.

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

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

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

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

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \9\ and Rule 19b-4(f)(6) thereunder.\10\
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 prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of such 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.

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-NYSEMKT-2012-65 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2012-65. 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
such filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEMKT-2012-65 and should be submitted on or before
December 28, 2012.
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    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-29567 Filed 12-6-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 98 (Wednesday, May 21, 2014)]
[Rules and Regulations]
[Pages 29103-29108]
[FR Doc No: 2014-11496]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0269; FRL-9905-80]

Cyflumetofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
cyflumetofen in or on multiple commodities which are identified and
discussed later in this document. BASF Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 21, 2014. Objections and
requests for hearings must be received on or before July 21, 2014, 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-2012-0269, 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), EPA West 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: Lois Rossi, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 305-7090; 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-2012-0269 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
July 21, 2014. 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-2012-0269, 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.htm.

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 May 23, 2012 (77 FR 30481) (FRL-9347-8),
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 2F7973)
by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709.
The petition requested that 40 CFR part 180 be

amended by establishing tolerances for residues of the insecticide
cyflumetofen (2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-
dimethylethyl)phenyl]-[beta]-oxo-2-(trifluoromethyl)benzenepropanoate),
in or on almond, hulls at 4.0 parts per million (ppm); citrus, oil at
16 ppm; fruit, citrus, group 10 at 0.3 ppm; fruit, pome, group 11 at
0.3 ppm; grape at 0.6 ppm; grape, raisin at 0.9 ppm; nut, tree, group
14 at 0.01 ppm; strawberry at 0.6 ppm; and tomato at 0.2 ppm. That
document referenced a summary of the petition prepared by BASF
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA modified
some of the tolerance levels and commodity names requested by the
applicant. The reasons for these changes are 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 including exposure resulting
from the tolerances established by this action. EPA's assessment of
exposures and risks associated with 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. The major target organ in rats, mice, and dogs following
short-term and long-term oral administration of cyflumetofen is the
adrenal glands characterized by increased organ weight and
histopathology (vacuolation and hypertrophy of the adrenal cortical
cells).
    Cyflumetofen has low acute toxicity by oral, dermal, and inhalation
routes of exposure. It is minimally irritating to the eyes but not to
the skin. It is a skin sensitizer.
    Decreased serum hormone concentrations (FSH, progesterone, and 17
[beta]-estradiol) were observed in the mid- and high-dose F1
females in a rat reproduction study while no hormonal effect was
observed in the F1 male rats at any dose level. However,
there were no corresponding changes in reproductive performance at any
dose level. In the developmental toxicity study in rats, an increased
incidence of wavy ribs was noted at the high-dose (1,000 milligrams/
kilogram/day (mg/kg/day)), while an increased incidence of incompletely
ossified sternal centra was observed at the mid- and high-dose levels.
These incidences occurred in the presence of maternal toxicity. In the
developmental toxicity study in rabbits, a downward flexion of the
forepaws and/or hind paws was observed in the high-dose (1,000 mg/kg/
day) group pups and delays in skeletal ossification were observed in
pups at the mid- and high-doses. Maternal toxicity (adrenal effects)
was also observed at the mid- and high- doses.
    No evidence of neurotoxicity or immunotoxicity was observed in any
of the submitted studies for cyflumetofen.
    Although there is some evidence of thyroid tumors in rats, the
Agency has determined that quantification of risk using a non-linear
approach (i.e., reference dose (RfD)) will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to cyflumetofen. This conclusion is based on the following
reasons. The single tumor type (thyroid c-cell) occurred in only one
sex (male) and one species (rat). This tumor effect was seen only at
high doses (250 mg/kg/day), which far exceeds the chronic no-observed-
adverse-effect-level (NOAEL) the Agency is using for its risk
assessment (16.5 mg/kg/day). And there is no concern for mutagenicity.
    Specific information on the studies received and the nature of the
adverse effects caused by cyflumetofen as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at http://www.regulations.gov in document ``Cyflumetofen:
New Active Ingredient Human Health Risk Assessment to Support Uses on
Citrus (Crop Group 10-10), Pome Fruits Crop Group 11-10), Tree Nuts
(Crop Group 14-12), Grape, Strawberry, and Tomato'' section IV, pg. 12
in docket ID number EPA-HQ-OPP-2012-0269.

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 the NOAEL and the LOAEL are identified.
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 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 Cyflumetofen used for
human risk assessment is shown in the following Table 1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Cyflumetofen for Use in FFDCA Human Health Risk
                                                   Assessment
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                                                  Uncertainty/   RfD, PAD, level
      Exposure/scenario            Point of       FQPA safety     of concern for      Study and toxicological
                                  departure         factors      risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (All                  An acute reference dose has not been established for either the general
 populations).                    population or for Females 13-49 years of age since there were no appropriate
                                studies that demonstrated evidence of toxicity attributable to a single dose for
                                                               these populations.
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Chronic Dietary (All           NOAEL = 16.5 mg/ UFA = 10x......  Chronic RfD =    Three co-critical studies:
 Populations).                  kg/day.         UFH = 10x......   0.17 mg/kg/day. 90-day feeding study in rats:
                                                FQPA SF = 1x...  cPAD = 0.17 mg/  LOAEL = 54.5/62.8 mg/kg/day (M/
                                                                  kg/day.          F) based on hematology and
                                                                                organ weight changes in the
                                                                                liver, adrenal, kidney and
                                                                                ovaries; and histopathology
                                                                                effects in the adrenals and
                                                                                the ovaries. NOAEL = 16.5/19
                                                                                mg/kg/day (M/F).
                                                                                Chronic toxicity/
                                                                                carcinogenicity study in
                                                                                rats:
                                                                                LOAEL = 49.5/61.9 mg/kg/day in
                                                                                (M/F) based on increased
                                                                                adrenal weights and
                                                                                histopathology. NOAEL = 16.5/
                                                                                20.3 mg/kg/day (M/F).
                                                                                Two generation reproduction
                                                                                study in rats:
                                                                                Parental: LOAEL = 30.6/46.6 mg/
                                                                                kg/day (M/F) based on
                                                                                increased organ weight and
                                                                                histopathology in adrenals.
                                                                                NOAEL = 9.2/13.8 mg/kg/day (M/
                                                                                F).
----------------------------------------------------------------------------------------------------------------
Inhalation (Short-,            NOAEL = 16.5 mg/ UFA = 10x......  LOC for MOE =    Same as chronic dietary
 Intermediate- and Long-Term).  kg/day.         UFH = 10x......   100.             endpoint.
                                                FQPA SF = 1x...
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal,          The quantification of risk using a non-linear approach (i.e., cRfD) will
 inhalation).                   adequately account for all chronic toxicity, including carcinogenicity.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyflumetofen, EPA considered exposure under the petitioned-
for tolerances in 40 CFR 180. EPA assessed dietary exposures from
cyflumetofen 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 cyflumetofen; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 2003-2008
food consumption data from the U.S. Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, What We Eat
in America, (NHANES/WWEIA). The partially refined chronic analysis
conducted was based on tolerance-level residues, 100% percent crop
treated (PCT) assumptions, and both empirically derived and default
processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., the
Agency has determined that quantification of risk using a nonlinear
approach (i.e., RfD) would adequately account for all chronic toxicity,
including carcinogenicity, that could result from exposure to
cyflumetofen. Therefore, a separate cancer dietary exposure analysis
was not performed.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for cyflumetofen. Tolerance level residues and/or
100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for cyflumetofen in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of cyflumetofen. 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 Ground Water Model
as well as Pesticide Root Zone Model--Groundwater, the estimated
drinking water concentrations (EDWCs) of cyflumetofen for chronic
exposure assessments are estimated to be 0.33 parts per billion (ppb)
for surface water and 0.0024 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 0.33 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). EPA assessed
residential exposure using the following assumptions: The use of
cyflumetofen on ornamentals in residential landscapes may result in
residential handler exposure. Residential handler exposure is expected
to be short-term in duration as

intermediate- or long-term exposures are not likely because of the
intermittent nature of applications by homeowners. The quantitative
exposure/risk assessment developed for residential handlers is based on
the following scenarios:
     Mixing/loading/applying liquid to ornamentals with hose-
end sprayer.
     Mixing/loading/applying liquid to ornamentals with
manually-pressurized handwand.
     Mixing/loading/applying liquid to ornamentals with
backpack.
     Mixing/loading/applying liquid to ornamentals with a
sprinkler can.
    Since no dermal hazard was identified for cyflumetofen in the
toxicological database, only inhalation exposure assessments were
conducted for residential handlers. EPA did not assess post-application
exposure from the use of cyflumetofen in residential settings because:
    1. No dermal hazard was identified in the toxicity database for
cyflumetofen, so a quantitative residential post-application dermal
risk assessment is not required;
    2. Post-application inhalation exposure while performing activities
in previously treated gardens was not assessed due to the low vapor
pressure and the expected dilution in outdoor air after an application
has occurred;
    3. The potential for post-application non-dietary ingestion
exposure for children (1 < 2 years old) is greatly diminished since
young children are not expected to engage in the types of activities
associated with these areas (e.g., gardening) or utilize these areas
for prolonged periods of play.
    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 cyflumetofen to share a common mechanism of
toxicity with any other substances, and cyflumetofen does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
cyflumetofen 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. There is no evidence of
increased qualitative or quantitative susceptibility in the rat 2-
generation reproduction study; however, the rat and rabbit
developmental studies indicate susceptibility in the pups. There is
evidence of increased quantitative susceptibility in the rabbit
developmental toxicity study, since developmental effects (changes in
ossicification, paw flexion, and decreased fetal body weights) at the
limit dose were observed where no maternal toxicity was present. There
is evidence of increased qualitative susceptibility in the rat
developmental toxicity study as developmental effects (increased
incidence of incompletely ossified sternal centra) were seen at the
same dose that caused an increase in adrenal weights and organ-to-body
weight ratio in the maternal animals. Notwithstanding, the degree of
concern for these effects in infants and children is low because the
rat and rabbit developmental effects have clearly defined NOAEL/LOAELs
and the dose selected for chronic risk assessment is protective of
these effects. Therefore, the PODs based on adrenal effects in rat are
health protective of all lifestages.
    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 cyflumetofen is complete.
    ii. There is no indication that cyflumetofen is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is some evidence that cyflumetofen results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies. However, as described in Unit III.D.2., because
of the low degree of concern for these effects, it is not necessary to
retain the 10X FQPA factor to adequately protect infants and children.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to cyflumetofen in drinking water. These assessments
will not underestimate the exposure and risks posed by cyflumetofen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
cyflumetofen is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyflumetofen from food and water will utilize 2.3% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
cyflumetofen 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).
    Cyflumetofen is currently proposed 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 cyflumetofen.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures are above the Level of Concern (LOC) of 100
and are not of concern (MOEs >= 100).
    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). Because no intermediate-term adverse effect was identified,
cyflumetofen is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the data
summarized in Unit III.A., EPA has concluded that the cPAD is
protective of potential cancer effects. Given the results of the
chronic risk assessment, cyflumetofen is not expected 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 cyflumetofen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid
chromatography) 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 cyflumetofen.

C. Revisions to Petitioned-For Tolerances

    EPA revised the commodity names for the requested tolerances
consistent with its policy to establish crop group tolerances using the
most recently established crop groups. This policy was explained in the
most recent rulemaking establishing crop groups in the Federal Register
on August 22, 2012 (77 FR 50617) (FRL-9354-3). Under this policy,
rather than establish new tolerances under the pre-existing crop
groups, EPA intends to conform petitions seeking tolerances for crop
groups to the newer established crop groups, as part of its effort to
eventually convert tolerances for any pre-existing crop group to
tolerances with coverage under the revised crop group. Therefore,
although the petitioner had requested tolerances on fruit, citrus,
group 10; fruit, pome, group 11; and nut, tree, group 14. EPA evaluated
and is establishing tolerances for fruit, citrus, group 10-10; fruit,
pome, group 11-10; and nut, tree, group 14-12, respectively.
    The petitioner requested a tolerance of 0.2 ppm for tomato based on
residues found in tomatoes that had been frozen and stored in
accordance with OECD Guideline 506 (October 16, 2007) to account for
residue loss that may have occurred during storage. EPA is establishing
a tolerance for tomato at 0.40 ppm. In addition, EPA is not
establishing a separate tolerance for grape, raisin of 0.9 ppm, as
requested, since the tolerance for the raw agricultural commodity grape
at 0.60 ppm is adequate to account for any residue concentration shown
in the processed commodity.

V. Conclusion

    Therefore, tolerances are established for residues of cyflumetofen,
in or on almond, hulls at 4.0 ppm; citrus, oil at 16 ppm; grape at 0.60
ppm; fruit, citrus, group 10-10 at 0.30 ppm; fruit, pome, group 11-10
at 0.30 ppm; nut, tree, group 14-12 at 0.01 ppm; strawberry at 0.60
ppm; and tomato at 0.40 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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 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.), 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 tolerances 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate

as described under Title II of the Unfunded Mandates Reform Act of 1995
(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 of 1995 (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: May 9, 2014.
Jack 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. Section 180.677 is added to subpart C to read as follows:

Sec.  180.677  Cyflumetofen; tolerances for residues.

    (a) General. Tolerances are established for residues of the
insecticide cyflumetofen, including its metabolites and degradates, in
or on the commodities in the table below. Compliance with the tolerance
levels for cyflumetofen is to be determined by measuring only
cyflumetofen, 2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-
dimethylethyl)phenyl]-[beta]-oxo-2-(trifluoromethyl)benzenepropanoate,
in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................          4.0
Citrus, oil................................................           16
Fruit, citrus, group 10-10.................................         0.30
Fruit, pome, group 11-10...................................         0.30
Grape......................................................         0.60
Nut, tree, group 14-12.....................................         0.01
Strawberry.................................................         0.60
Tomato.....................................................         0.40
------------------------------------------------------------------------

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

[FR Doc. 2014-11496 Filed 5-20-14; 8:45 am]
BILLING CODE 6560-50-P


Deschutes River Dry River White River Little Deschutes River Shitike Creek Mill Creek Ochoco Creek Squaw Creek Warm Springs River Bear Creek Beaver Creek Metolius River Badger Creek Hay Creek Crescent Creek Willow Creek McKay Creek Wolf Creek Roc k Cr eek Fly Creek Deep Creek Buck Hollow Creek Marks Creek Antelope Creek Threemile Creek Gate Creek Dry Creek Crooked River Buck Creek Boulder Creek Tumalo Creek Ward Creek Seekseequa Creek Camp Creek Mud Springs Creek Grindstone Creek Twelvemile Creek Clear Creek First Creek Odell Creek Jordan Creek Deep Canyon Indian Ford Nena Creek Crane Creek Paulina Creek Wilson Creek Powell Creek Coyote Creek Big Marsh Creek Lytle Creek Whitewater River Foley Creek Frog Creek Canyon Creek Fall River Lost Creek Allen Creek Cultus River Hinton Creek Brush Creek Cultus Creek Trout Creek Pine Creek Eagle Creek Peterson Creek Long Hollow Amity Creek Old Dry Creek Pony Creek Alkali Creek Dry Paulina Creek Pole Creek Finnegan Creek Cold Camp Creek Six Creek Boot Creek Charlton Creek Indian Creek Sage Hollow Moore Creek Long Hollow Creek Tenino Creek Cottonwood Creek Little Bear Creek Beaverdam Creek Johnson Creek Salt Creek Newsome Creek Swamp Creek Veazie Creek Cedar Creek Conant Creek Trail Hollow Creek Jones Canyon Sagebrush Creek Yank Gulch Creek Auger Creek Potlid Creek Spring Branch Shotgun Creek Little Summit Creek Macks Canyon Jim Creek Basin Creek East Fork Mill Creek Parker Creek Little Trout Creek Odell Hollow La wson Creek Cabot Creek Evans Creek Duncan Creek McMeen Creek Sheep Creek Grub Hollow Creek Lone Pine Creek Dry Rock Creek Soldier Creek Mountain Creek Calivan Creek Crystal Creek Japanese Creek Indian Trail Creek Iron Creek Camp Creek Alkali Creek Dry Creek Beaver Creek Pole Creek Trout Creek Antelope Creek Dry River Badger Creek Deschutes River Bend Madras Redmond Prineville Legend Salmonid Use Designations 1:

Not Subject to EPA Rule Bull Trout Juvenile Rearing and Spawning: 12C/ 54F Salmon and Steelhead Core Juvenile Rearing: 16C/ 61F Salmon and Trout 2 Juvenile Rearing and Migration: 18C/ 64F Subbasins ( HUCs)

Lower Crooked River Lower Deschutes River South Fork Crooked River Trout Creek Upper Crooked River Upper Deschutes River Warm Springs Reservation Map produced by Bill Bogue, EPA Region 10, September 16, 2003 Washington Oregon Salmonid Use Designations1, Deschutes Basin, Oregon DRAFT September 16, 2003 Pelton Dam The Deschutes River is shown with heavier lines. 1 Based upon summertime salmonid use. 2 Includes all salmon species, steelhead and rainbow trout.