[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]
[Page 69704-69706]
[DOCID:fr19no08-128]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58936; File No. SR-NYSE-2008-117]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Delete Section (3) of Exchange Rule 123D, Which Provides for the ``Sub-
Penny Trading'' Condition

November 13, 2008.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on November 6, 2008, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to delete section (3) of Exchange Rule 123D,
which provides for the ``Sub-penny trading'' condition. The text of the
proposed rule change is available at www.nyse.com, NYSE's principal
office, and 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Regulation NMS, adopted by the Securities and Exchange Commission
(``SEC''),\4\ provides that each trading center intending to qualify
for trade-through protection under Regulation NMS Rule 611 \5\ is
required to have a Regulation NMS-compliant trading system fully
operational by March 5, 2007 (the ``Trading Phase Date'').\6\
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    \4\ 17 CFR 242.600 to 242.612. See Securities Exchange Act
Release No. 51808 (June 9, 2005), 70 FR 37496 (June 29, 2005)
(``Regulation NMS Adopting Release'').
    \5\ See 17 CFR 242.611.
    \6\ See Securities Exchange Act Release No. 55160 (January 24,
2007), 72 FR 4202 (January 30, 2007) (S7-10-04).
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    For stocks priced below $1.00 per share, Regulation NMS Rule 612
\7\ permits markets to accept bids, offers, orders and indications of
interest in increments smaller than a $0.01, but not less than $0.0001,
and to quote and trade such stocks in sub-pennies. Markets may choose
not to accept such bids, offers, orders or indications of interest and
the NYSE has done so, maintaining a minimum trading and quoting
variation of $0.01 for all securities trading below $100,000. See NYSE
Rule 62.
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    \7\ 17 CFR 242.612. Rule 612 originally was to become effective
on August 29, 2005, but the date was later extended to January 31,
2006. See Securities Exchange Act Release No. 52196 (Aug. 2, 2005),
70 FR 45529 (Aug. 8, 2005) (S7-10-04).
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    The SEC's interpretation of Rule 612 requires a market that routes
an order to another market in compliance with Rule 611 and receives a
sub-penny execution, to accept the sub-penny execution, report that
execution to the customer, and compare, clear and settle that trade.
The SEC, however, provided a limited exemption to Rule 611's
proscription against trade-throughs to protected quotes that include a
sub-penny component to such quotes that are better-priced by a minimum
of $0.01.\8\
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    \8\ See Securities and Exchange Act Release No. 54714 (November
6, 2006), 71 FR 66352 (November 14, 2006). (Order Granting National
Securities Exchanges a Limited Exemption from Rule 612 of Regulation
NMS under the Securities Exchange Act of 1934 to Permit Acceptance
by Exchanges of Certain Sub-Penny Orders.)
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    In March, 2007, the Exchange amended Rule 123D to provide for a
``Sub-penny trading'' condition because the Exchange's trading systems
did not then accommodate sub-penny executions on orders routed to
better-priced protected quotations, nor could it recognize a quote
disseminated by another market center if such quote had a sub-penny
component and, therefore, could have inadvertently traded through
better protected quotations. The amended rule allowed the Exchange to
halt trading in a security whose price was about to fall below $1.00,
without delisting the security, so that the security could continue to
trade on other markets that deal in bids, offers, orders or indications
of interest in sub-penny prices, until the price of the security had
recovered sufficiently to permit the Exchange to resume trading in
minimum increments of no less than one penny or the issuer is delisted
for failing to correct the price condition within the time provided
under NYSE rules.\9\ A subsequent amendment established that any orders
received by the NYSE in a security subject to a ``Sub-penny trading''
condition would be routed to NYSE Arca, Inc. and handled in accordance
with the rules governing that market.\10\
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    \9\ See Securities and Exchange Act Release No. 55398, 72 FR
11072 (March 12, 2007) (SR-NYSE-2007-25).
    \10\ See Securities and Exchange Act Release No. 55537 (Mar. 27,
2007), 72 FR 15749 (April 2, 2007) (SR-NYSE-2007-30).
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    Through this filing, the Exchange proposes to eliminate the ``Sub-
penny trading'' condition in its entirety. The NYSE now has the
technical capability to recognize protected quotations with a sub-penny
component in its round-lot market and accommodate away market
executions in sub-pennies, in compliance with SEC Rules 611 and 612.
    The Exchange system enhancements that will enable recognition of
sub-penny quotations for pricing of odd-lots in the odd-lot system are
contained in the technology associated with Phase 2 implementation of
the New Market Model.\11\ Until the conclusion of the second Phase of
implementation, which is scheduled to be completed no longer than ten
weeks after October 24, 2008, those odd-lot orders that would receive
an execution price based on the NBBO as set forth in NYSE Rule 124 will
be priced at the last NBBO that did not contain a sub-penny price.
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    \11\ See Securities Exchange Act Release No. 58845 (October 24,
2008), 73 FR 64379 (October 29, 2008) (SR-NYSE-2008-46).
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    Given that Exchange systems will now be able to accommodate these
orders and away-market executions, the Sub-penny trading condition halt
is no longer required.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \12\ of
the Securities Exchange Act of 1934 (the ``Act''), in general, and
furthers the objectives of Section 6(b)(5) \13\ in particular in that
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system.
The Exchange believes that the instant proposal is in keeping with
these principles in that it seeks to operate technology on the NYSE
that allows the Exchange to recognize protected quotations with a sub-
penny component and accommodate away market executions in sub-pennies,
in compliance with SEC Rules 611 and 612.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The 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

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms, does not become operative for 30 days after the
date of filing, 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 \14\ and Rule 19b-4(f)(6) thereunder.\15\
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    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing.\16\ However,
Rule 19b-

4(f)(6)(iii) permits the Commission to designate a shorter time if such
action is consistent with the protection of investors and the public
interest. NYSE requested that the Commission waive the 30-day operative
delay, as specified in Rule 19b-4(f)(6)(iii),\17\ which would make the
rule change effective and operative upon filing.
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    \16\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires the self-regulatory organization to give the
Commission notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. NYSE has satisfied this requirement.
    \17\ 17 CFR 240.19b-4(f)(6)(iii).
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    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because the Exchange systems are now capable of recognizing protected
quotations with a sub-penny component in its round-lot market and can
accommodate away market executions in sub-pennies, in compliance with
SEC Rules 611 and 612. The Commission finds that it is appropriate to
waive the 30-day operative delay for this proposed rule change because
the ``Sub-penny trading'' condition no longer serves any purpose and
waiving the delay should allow the Exchange to immediately come into
full compliance with Regulation NMS with respect to sub-pennies. For
these reasons, the Commission designates the proposed rule change as
operative upon filing.\18\
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    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's effect on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2008-117 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2008-117. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing will also be available for
inspection and copying at the principal office of the self-regulatory
organization. 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-
NYSE-2008-117 and should be submitted on or before December 10, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-27404 Filed 11-18-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 109 (Thursday, June 6, 2019)]
[Rules and Regulations]
[Pages 26352-26359]
[FR Doc No: 2019-11676]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0674; FRL-9994-08]

Penthiopyrad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
penthiopyrad in or on multiple commodities that are identified and
discussed later in this document. In addition, this regulation removes
certain established penthiopyrad tolerances that are superseded by new
tolerances established in this final rule. Interregional Research
Project Number 4 (IR-4) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective June 6, 2019. Objections and
requests for hearings must be received on or before August 5, 2019, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0674, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_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
Publishing 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-2017-0674 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
August 5, 2019. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0674, 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 July 24, 2018 (83 FR 34968) (FRL-9980-
31), 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
7E8616) by Interregional Research Project Number 4 (IR-4), IR-4 Project
Headquarters, Rutgers, The State University of New Jersey, 500 College
Road East, Suite 201W, Princeton, NJ 08540. The petition requested that
40 CFR 180.658 be amended by establishing tolerances for residues of
the fungicide penthiopyrad, (N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-
methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide), in or on
Brassica, leafy greens, subgroup 4-16B at 50 parts per million (ppm);
Bushberry subgroup 13-07B at 6 ppm; Caneberry subgroup 13-07A at 10
ppm; Celtuce at 30 ppm; Fennel, Florence at 30 ppm; Fruit, stone, group
12-12 at 4.0 ppm; Kohlrabi at 5.0 ppm; Leaf petiole vegetable subgroup
22B at 30 ppm; Leafy greens subgroup 4-16A at 30 ppm; Nut, tree, group
14-12 at 0.06 ppm; Oilseed group 20 at 1.5 ppm; and Vegetable,
brassica, head and stem, group 5-16 at 5.0 ppm.
    The petitioner also requested that the following established
tolerances be removed upon establishment of the petitioned-for
tolerances: Brassica, head and stem, subgroup 5A at 5.0 ppm; Brassica,
leafy greens, subgroup 5B at 50 ppm; Canola at 1.5 ppm; Cotton, seed at
1.5 ppm; Fruit, stone, group 12 at 4.0 ppm; Nut, tree, group 14 at 0.06
ppm; Pistachio at 0.06 ppm; Sunflower, seed at 1.5 ppm and Vegetable,
leafy, except Brassica, group 4 at 30 ppm. That document referenced a
summary of the petition prepared by DuPont, 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 has made
certain corrections and modifications to petitioned-for tolerances. The
reasons for these changes are explained in Unit IV.C.

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 penthiopyrad including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with penthiopyrad follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The liver and thyroid are target organs for penthiopyrad toxicity.
Metabolism studies show higher radioactive residues in the liver,
compared to other tissues. Short-term oral exposure resulted in liver
alterations (weight increases, enzyme changes, hypertrophy, and/or
histopathology) in rats and mice at similar doses, and dogs at higher
doses. Of the three species, the liver effects observed in rats were
more significant (fatty change, hepatocellular degeneration, and
Kupffer cell proliferation) than the liver effects in the other species
(e.g., increased liver weight, hepatocellular hypertrophy).
    Short-term exposure also resulted in thyroid changes in mice
(hypertrophy) and rats (decreased weight, hypertrophy/proliferation,
and hormone changes). Other effects observed were body weight changes
and hematological alterations in rats and dogs, along with gallbladder
effects (inflammation and edema) in dogs. Short-term dermal exposure
did not result in dermal irritation or systemic effects up to the limit
dose.
    Subchronic rat studies are also available for penthiopyrad
metabolites PCA and DM-PCA. Short-term exposure to PCA did not result
in treatment-related effects up to the limit dose. Short-term exposure
to DM-PCA resulted in decreased body weight gain and food consumption
at high doses. However, the effects with DM-PCA were seen at higher
doses than the effects observed in subchronic rat studies with the
technical grade active ingredient.
    Long-term exposure in rats (at lower doses) resulted in liver
effects comparable to those seen in subchronic studies, as well as
adrenal and thyroid hypertrophy. Higher doses resulted in more
progressive liver effects (vacuolation, periportal cell swelling, and
necrosis), thyroid tumors (males), and ovarian hypertrophy. No effects
were observed in the ovaries in other toxicity studies. In mice,
chronic exposure led to liver and thyroid effects and liver tumors
(males). Alveolar foamy cell accumulation was also seen in mice, but it
was not considered to be an adverse effect. In dogs, effects noted
(liver, gallbladder, and adrenal gland) were similar to those seen in
subchronic dog studies, with the addition of gallbladder hypertrophy/
hyperplasia.
    In the developmental toxicity study in rats, comparable toxicity
was noted in fetal and maternal animals. Effects observed were
decreased body weight gain and food consumption, increased resorptions
(resulting in decreased post-implantation survival), decreased litter
size, and decreased gravid uterine weight at the limit dose. No effects
were noted in a preliminary study in rats up to the limit dose. In the
developmental toxicity study in rabbits, decreased fetal body weight
was seen in the presence of maternal toxicity. Abortion was noted in
one maternal animal, preceded by a period of markedly reduced food
consumption and body weight loss, at the highest dose tested. In a
preliminary study, decreased fetal body weight was seen at the limit
dose. At lower doses, maternal effects including decreased water and
food consumption, body

weight loss, and abnormal feces were seen. At the limit dose, increased
abortions and mortality were noted in maternal animals. In the
reproductive toxicity study in rats, body weight changes, liver,
adrenal, and thyroid effects were seen in maternal animals in
preliminary and definitive studies. Offspring effects included body
weight changes, delay in preputial separation, and decreased thymus
weights at similar doses. Decreased spleen weights were seen in
offspring animals in the preliminary reproduction study. No
reproductive toxicity was observed.
    In the developmental neurotoxicity study in rats (definitive
study), decreased body weight, increased motor activity, and tremors
were seen in offspring animals in the absence of maternal toxicity. In
the preliminary study, decreased pup weight, deterioration, and
mortality were seen in offspring animals in the absence of maternal
toxicity. Clinical signs were observed in the acute neurotoxicity study
with penthiopyrad. Transient functional alterations (hunched posture,
unsteady gait, reduced body temperature, and increased landing
footsplay) and decreased motor activity were seen at the estimated
time-to-peak-effect (4 hours). In a subchronic neurotoxicity study,
decreased body weight gain was seen at the highest dose tested;
however, no clinical signs were observed, and there was no evidence of
neurotoxicity.
    Immunotoxicity studies were conducted in both mice and rats for
penthiopyrad. In the immunotoxicity study in mice, decreased plaque
forming ability was observed at the limit dose. However, in the
immunotoxicity study in rats, no evidence of immunotoxicity was
observed up to the highest dose tested. General toxicity noted in the
rat study included decreased body weight gain and food consumption,
increased liver weight, and decreased spleen weight.
    A mutagenicity battery is available for penthiopyrad technical
ingredient and the majority of the studies were negative; however,
chromosome aberrations were observed at cytotoxic concentrations in an
in vitro assay. Mutagenicity studies are also available for several
penthiopyrad metabolites (PCA, DM-PCA, PAM, and 753-A-OH). These
studies were usually negative; however, the PAM metabolite induced
chromosome aberrations (-S9 after 24 hours) and PCA induced a weakly
positive mutant frequency (after 24 hours); however, based on the
overall analysis of the available data, penthiopyrad is not considered
to be mutagenic.
    EPA classified penthiopyrad as having ``suggestive evidence of
carcinogenicity,'' based on an increased incidence of treatment-related
liver tumors in male mice. Thyroid tumors were observed in male rats
but were not considered to be treatment related. In accordance with the
EPA's Final Guidelines for Carcinogen Risk Assessment (March 2005), the
Agency has determined that the quantification of risk using a non-
linear approach based on the chronic reference dose (i.e., cRfD) which
is 7x lower than the dose at which tumors were observed will adequately
account for all chronic toxicity, including carcinogenicity, that could
result from penthiopyrad exposure.
    Specific information on the studies received and the nature of the
adverse effects caused by penthiopyrad as well as the no-observed-
adverse-effects-level (NOAEL) and the lowest-observed-adverse-effects-
level (LOAEL) identified from the toxicity studies can be found at
http://www.regulations.gov in document SUBJECT: Penthiopyrad. Human
Health Risk Assessment for Proposed New Use on Caneberry Subgroup 13-
07A and Bushberry Subgroup 13-07B; and Crop Group/Subgroup Conversions
and Expansions at page 39 in docket ID number EPA-HQ-OPP-2017-0674.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (PODs) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the previously applied penthiopyrad toxicological
endpoints for human risk assessment is discussed in Unit III of the
final rule published in the Federal Register of March 9, 2012 (77 FR
14291) (FRL-9335-7). That database was recently re-evaluated/updated
based on current practices and includes updated dermal endpoints and
PODs selected for adults and children. As a result of the database
update, one endpoint and POD based on the 28-day oral toxicity study in
the dog is used for all populations, and also used to derive the
endpoints/PODs for the incidental oral and inhalation routes of
exposure. The updated NOAELs, LOAELs, and the PODs are summarized below
for the affected exposure/scenarios:
    i. Children and adult dermal exposures. Children and adult dermal
exposures were previously assessed with separate endpoints/PODs. Dermal
exposure is now being evaluated using the same endpoint and POD for all
ages, from the 28-day dog study. The revised dermal NOAEL is 80
milligrams per kilogram (mg/kg/day), based on mucosal edema in gall
bladder as well as clinical chemistry and increased organ weight/
histopathology in the livers of females at the LOAEL of 269 mg/kg/day.
    ii. Previous adult dermal assessment. The developmental rabbit
study was previously used for the adult dermal assessment with a NOAEL
of 75 mg/kg/day based on abortions in one animal at the LOAEL of 225
mg/kg/day. The endpoint is not strong, and the dose spacing is
comparable to the selected 28-day dog study.
    iii. Previous children's dermal assessment. Previously the
developmental neurotoxicity (DNT) was selected for the children's
dermal assessment. The respective NOAEL and LOAEL for that study are
100 mg/kg/day and 250 mg/kg/day. Again, due to dose spacing, the study
is comparable to the 28-dog study, whose NOAEL is protective of the DNT
NOAEL. In addition, the effects seen in the 28-day dog study include
gallbladder effects, an organ rats do not have, which is a potentially
human-relevant effect.
    iv. Inhalation and incidental oral assessments. The 28-day dog
study, which previously was used and continues to also be used for the
inhalation and incidental oral assessments was also updated. The NOAEL
is now 80 mg/kg/day, based on mucosal edema in the gallbladder; as well
as clinical chemistry, increased

organ weight and histopathology in the liver of females at the LOAEL of
269 mg/kg/day. The updated NOAEL is comparable to or protective of
other NOAEL and LOAEL values in the database, including those relating
to susceptibility.
    v. Residential incidental oral, inhalation, and dermal exposures.
The 28-day dog study is now being used to assess residential incidental
oral, inhalation, and dermal exposures.
    A summary of the toxicological endpoints for penthiopyrad used for
dietary and non-occupational human health risk assessment is shown in
the Table of this unit.

  Table--Summary of Toxicological Doses and Endpoints for Penthiopyrad for Use in Dietary and Non-Occupational
                                          Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure    RfD, PAD, level of
        Exposure/scenario            and uncertainty/      concern for risk     Study and toxicological effects
                                      safety factors          assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..  NOAEL = 125 mg/kg/    Acute RfD = 1.25 mg/ Acute Neurotoxicity in Rats.
                                    day.                  kg/day.             LOAEL = 500 mg/kg/day, based on
                                   UFA = 10x...........  aPAD = 1.25........   transient functional alterations
                                   UFH =10x............  mg/kg/day..........   (e.g., hunched posture, unsteady
                                   FQPA SF = 1x........                        gait, reduced body temperature,
                                                                               and increased landing footsplay)
                                                                               and decreased motor activity at
                                                                               the estimated time[dash]to-peak-
                                                                               effect (4 hours) on the day of
                                                                               administration.
Chronic dietary (All populations)  NOAEL = 27 mg/kg/day  Chronic RfD = 0.27   Co-Critical Studies:
                                   UFA = 10x...........   mg/kg/day.          Chronic Toxicity/Carcinogenicity
                                   UFH =10x............  cPAD = 0.27........   in Rats LOAEL = 83 mg/kg/day,
                                   FQPA SF = 1x........  mg/kg/day..........   based on decreased body weight
                                                                               gain and adrenal effects in
                                                                               females and hepatic periportal
                                                                               fatty degeneration in males
                                                                               (NOAEL = 27 mg/kg/day).
                                                                              Chronic Toxicity in Rats.
                                                                              LOAEL = 100 mg/kg/day, based on
                                                                               altered plasma chemistry profile,
                                                                               increased liver weight and
                                                                               alterations in the adrenal and
                                                                               thyroid glands. (NOAEL = 25 mg/kg/
                                                                               day).
Incidental oral short-term (1-30   NOAEL = 80 mg/kg/day  Residential LOC for  28-Day Oral Toxicity in Dogs.
 days) and Intermediate-term (1-6  UFA = 10x...........   MOE = 100.          LOAEL = 269 mg/kg/day, based on
 months).                          UFH = 10x...........                        mucosal edema in the gall
                                   FQPA SF = 1x........                        bladder; clinical chemistry,
                                                                               increased organ weight and
                                                                               histopathology in the liver of
                                                                               females.
Dermal short-term (1-30 days);     NOAEL = 80 mg/kg/day  Residential LOC for  28-Day Oral Toxicity in Dogs.
 Intermediate-term (1-6 months).   UFA = 10x...........   MOE = 100.          LOAEL = 269 mg/kg/day, based on
                                   UFH = 10x...........                        mucosal edema in the gall
                                   FQPA SF = 1x........                        bladder; clinical chemistry,
                                   DAF = 40%...........                        increased organ weight and
                                                                               histopathology in the liver of
                                                                               females.
Inhalation short-term (1-30        NOAEL = 80 mg/kg/day  Residential LOC for  28-Day Oral Toxicity in Dogs.
 days); Intermediate-term (1-6     UFA = 10x...........   MOE = 100.          LOAEL = 269 mg/kg/day, based on
 months).                          UFH = 10x...........                        mucosal edema in the gall
                                   FQPA SF = 1x........                        bladder; clinical chemistry,
                                                                               increased organ weight and
                                                                               histopathology in the liver of
                                                                               females.
                                  ------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Classification: ``Suggestive Evidence of Carcinogenicity'' based on liver
                                    tumors in male mice. The Agency has determined that a nonlinear approach
                                    based on the chronic reference dose will be protective of potential
                                    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 estimates 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. DAF = dermal absorption factor. IAF = inhalation absorption factor.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to penthiopyrad, EPA considered exposure under the petitioned-
for tolerances as well as all existing penthiopyrad tolerances in 40
CFR 180.658. EPA assessed dietary exposures from penthiopyrad 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 penthiopyrad. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption information from
the United States Department of Agriculture (USDA) National Health and
Nutrition Survey/What We Eat in America (NHANES/WWEIA). The acute
dietary (food and drinking water) exposure assessment was conducted
using the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID), Version 3.16. As to residue
levels in food, EPA assumed 100 percent crop treated (PCT) and
tolerance-level residues for all existing and proposed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the 2003-2008 food consumption information from the
USDA NHANES/WWEIA. The chronic dietary (food and drinking water)
exposure assessment was conducted using DEEM-FCID, Version 3.16. As to
residue levels in food, EPA assumed 100 PCT and tolerance-level
residues for all existing and proposed commodities.

    iii. Cancer. EPA classified penthiopyrad as having ``suggestive
evidence of carcinogenicity,'' based on an increased incidence of
treatment-related liver tumors in male mice and determined that the
quantification of risk using a non-linear approach (i.e., RfD) will
adequately account for all chronic toxicity, including carcinogenicity,
that could result from penthiopyrad exposure.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
penthiopyrad. Tolerance level residues and 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 penthiopyrad in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of penthiopyrad. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of penthiopyrad are based on the
use pattern of highest exposure, which is the currently labeled use on
turf at 2.9 lbs active ingredient per acre per year. The residues of
concern assessed in drinking water included penthiopyrad and its
cleavage product PAM. For acute exposures, EDWCs are estimated to be
240 parts per billion (ppb) for surface water and 1,330 ppb for ground
water. For chronic exposures for non-cancer assessments, EDWCs are
estimated to be 131 ppb for surface water and 978 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 1,330 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 978 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).
    Although the proposed new uses do not include any residential use,
registered residential uses including turf, lawn, and sod could result
in residential exposure and have been reassessed in support of this
rulemaking to reflect updates to new dermal, inhalation, and incidental
oral PODs. There is the potential for post-application exposure for
individuals exposed as a result of being in an environment that has
been previously treated with penthiopyrad. The quantitative exposure/
risk assessment for residential post-application exposures is based on
the following scenarios:
    i. Adult dermal post-application exposure resulting from contact
with treated turf;
    ii. Dermal post-application exposure to youth 11-16 yrs. old
resulting from mowing and playing golf on turf;
    iii. Dermal post-application exposure to children 6-11 yrs. old
resulting from playing golf on turf;
    iv. Dermal post-application exposure to children 1 to <2 yrs. old
resulting from playing on turf; and
    v. Incidental oral post-application exposure to children 1 to <2
yrs. old resulting from playing on turf.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found penthiopyrad to share a common mechanism of
toxicity with any other substances, and penthiopyrad does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
penthiopyrad does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the 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. No evidence of increased
quantitative or qualitative susceptibility was observed in
developmental toxicity studies in rats or rabbits or in a reproduction
toxicity study in rats. However, increased quantitative susceptibility
was seen in DNT studies in rats. Decreased body weight (250 mg/kg/day),
and increased motor activity and tremors were seen in offspring animals
at 500 mg/kg/day. Decreased body weight was seen at 300 mg/kg/day, and
mortality was noted at 1,000 mg/kg/day in offspring animals. The
effects observed in offspring animals in the DNT studies were seen in
the absence of maternal toxicity.
    EPA concluded that there is a low concern and no residual
uncertainties for prenatal and/or postnatal toxicity effects of
penthiopyrad, notwithstanding observed increased susceptibility seen in
the preliminary and definitive DNT studies, based on the following
data:
    i. The pup body weight changes noted in the definitive and
preliminary DNT studies were also observed in developmental and
reproduction studies at similar doses. Additionally, the body weight
changes in these studies occurred in the presence of significant
maternal toxicity. Although clinical signs (tremors and increased motor
activity) were noted in offspring animals in the definitive study, the
neurotoxic potential of penthiopyrad has been adequately characterized
in the available neurotoxicity studies. Tremors and changes in motor
activity were observed at very high doses in the acute neurotoxicity
study and were not present in the subchronic neurotoxicity study. In
the preliminary DNT study, mortality was observed in the offspring
animals at the limit dose. However, this finding is attributed to the
poor condition (body weight loss, under

activity, pallor) of the offspring animals in this dose group.
    ii. A clear NOAEL has been identified for all offspring effects in
the DNT studies, and the PODs used in the risk assessments are
protective of the observed effects.
    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 penthiopyrad is complete.
    ii. There is no concern for neurotoxicity after exposure to
penthiopyrad. A complete neurotoxicity battery is available for
penthiopyrad. The database includes acute neurotoxicity, subchronic
neurotoxicity, and DNT studies in rats. As a result, the neurotoxic
potential of penthiopyrad is well characterized, and no additional data
are needed.
    iii. As discussed in Unit IV.D.2., EPA has concluded that there are
no residual uncertainties concerning prenatal and postnatal effects,
that would warrant retaining the 10X FQPA safety factor.
    iv. There are no residual uncertainties identified in the exposure
databases. There are no residual uncertainties with regard to dietary
and residential exposure. The dietary food exposure assessments were
performed based on conservative assumptions that ensure that exposures
to penthiopyrad are not underestimated, including tolerance-level
residues and 100 PCT estimates for all registered commodities. The use
of default assumptions did not result in risk estimates of concern for
the proposed new uses. Actual exposures and risk estimates from
penthiopyrad will likely be lower. Furthermore, conservative, upper-
bound assumptions were used to determine exposure through drinking
water and residential sources, such that these exposures have not been
underestimated. EPA used similarly conservative assumptions to assess
post-application exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by penthiopyrad.

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 penthiopyrad will occupy 21% of the aPAD for all infants (<1-year-
old), the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
penthiopyrad from food and water will utilize 29% of the cPAD for all
infants (<1-year-old), the population group receiving the greatest
exposure.
    3. Short-and Intermediate-term risk. Short- and intermediate-term
risk aggregate exposure takes into account short- and intermediate-term
risk residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). The short- and
intermediate-term toxicological endpoints for penthiopyrad are the same
for each route of exposure. Therefore, for residential exposure
scenarios, only short-term exposures were assessed, and are protective
of intermediate-term exposure and risk.
    Penthiopyrad is proposed for registration for uses that could
result in short-/intermediate-term residential exposures, and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short -term residential exposures
to penthiopyrad. These assessments include exposure through the dermal
route for adults and youth, and from dermal and incidental oral
exposure for children (1 to <2 yrs.).
    EPA selected the following two residential exposure scenarios which
represent the highest exposure and risk scenarios for each population:
(1) Adult post-application exposure and (2) children's (1 to <2 yrs.)
post-application exposure resulting from contact with treated turf. The
level of concern for these assessments is 100. The chronic dietary
exposure estimate for adults was the background exposure added to the
dermal residential post-application exposure estimates. The adult
short-term aggregate risk assessment resulted in estimated MOEs of 440.
The chronic dietary exposure estimate for the subgroup children 1 to <2
years old was the background exposure added to the children's dermal
and incidental oral residential post-application exposure estimates.
The children's short-term aggregate risk assessment resulted in
estimated MOEs of 220. These risk estimates are not of concern to EPA.
    5. Aggregate cancer risk for U.S. population. EPA classified
penthiopyrad as having ``suggestive evidence of carcinogenicity'' based
on liver tumors in male mice. The quantification of risk using a non-
linear approach (i.e., the RfD) adequately accounts for all chronic
toxicity, including carcinogenicity, therefore cancer risk is not of
concern.
    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 penthiopyrad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a Liquid chromatography-tandem
mass spectrometry (LC/MS/MS) method known as Method CEM 3399-001) 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 U.S. tolerance definition for penthiopyrad is harmonized with
those of Canada and Codex and most relevant established tolerance
levels are harmonized with Canadian and Codex MRLs. There are currently
no established Canadian or Codex MRLs for

the proposed new uses for bushberries or caneberries.

C. Revisions to Petitioned-For Tolerances

    In accordance with its authority in FFDCA section 408(d)(4)(A)(i),
EPA is establishing tolerances in this rule that vary slightly from
what the petitioner sought. These variations are explained below.
    1. The petitioner requested tolerances in Fruit, stone, group 12-12
at 4.0 ppm, Kohlrabi at 5.0 ppm, and Vegetable, brassica, head and
stem, group 5-16 at 5.0 ppm; EPA is establishing those tolerances
without the additional zero to be consistent with OECD calculation
procedures.
    2. The petitioner requested a tolerance for ``Fennel, Florence'';
EPA is establishing a tolerance for the commodity ``Fennel, Florence,
fresh leaves and stalk'' to be consistent with commodity terms the
Agency uses in tolerances.
    3. EPA is establishing a tolerance for the Nut, tree group 14-12
tolerance at 0.05 ppm instead of 0.06 ppm as requested in order to
harmonize with Codex MRL. The established tolerance level is
appropriate as the highest average field trial residue was 0.037 ppm
while other residues were below LOQ (0.01 ppm).

D. International Trade Considerations

    In this final rule, EPA is reducing the existing tolerances for the
commodities in the nut, tree group 14-12 from 0.06 ppm to 0.05 ppm. The
Agency is reducing these tolerances to harmonize with Codex MRLs, and
available residue data demonstrates that tolerances at 0.05 ppm are
sufficient to cover residues on these commodities.
    In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the
WTO of this revision. In addition, the SPS Agreement requires that
members provide a ``reasonable interval'' between the publication of a
regulation subject to the agreement and its entry into force to allow
time for producers in exporting member countries to adapt to the new
requirement. At this time, EPA is establishing an expiration date for
the existing tolerances to allow those tolerances to remain in effect
for a period of six months after the effective date of this final rule,
in order to address the requirement to provide a reasonable interval.
After the six-month period expires, residues of penthiopyrad on
commodities included in the nut, tree group 14-12 cannot exceed the
newly established tolerances of 0.05 ppm.
    This reduction in tolerance levels is not discriminatory; the same
food safety standard contained in the FFDCA applies equally to
domestically produced and imported foods. The new tolerance levels are
supported by available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of penthiopyrad,
(N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-
pyrazole-4-carboxamide), in or on Brassica, leafy greens, subgroup 4-
16B at 50 ppm; Bushberry subgroup 13-07B at 6 ppm; Caneberry subgroup
13-07A at 10 ppm; Celtuce at 30 ppm; Fennel, Florence, fresh leaves and
stalk at 30 ppm; Fruit, stone, group 12-12 at 4 ppm; Kohlrabi at 5 ppm;
Leaf petiole vegetable subgroup 22B at 30 ppm; Leafy greens subgroup 4-
16A at 30 ppm; Nut, tree, group 14-12 at 0.05 ppm; Oilseed group 20 at
1.5 ppm; and Vegetable, brassica, head and stem, group 5-16 at 5 ppm.
In addition, EPA is removing the following tolerances from paragraph
(a)(1) because they are superseded by the new tolerances being
established in this rulemaking: Brassica, head and stem, subgroup 5A at
5.0 ppm; Brassica, leafy greens, subgroup 5B at 50 ppm; Canola at 1.5
ppm; Cotton, seed at 1.5 ppm; Fruit, stone, group 12 at 4.0 ppm;
Sunflower, seed at 1.5 ppm; and Vegetable, leafy, except brassica,
group 4 at 30 ppm. Finally, EPA is establishing a six-month expiration
date for the established pistachio and tree nut group tolerances.

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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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 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: May 29, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In the table in Sec.  180.658(a)(1):
0
a. Remove the entries ``Brassica, head and stem, subgroup 5A'' and
``Brassica, leafy greens, subgroup 5B'';
0
b. Add alphabetically the commodities ``Brassica, leafy greens,
subgroup 4-16B'', ``Bushberry subgroup 13-07B'', and ``Caneberry
subgroup 13-07A'';
0
c. Remove the entry ``Canola'';
0
d. Add alphabetically the commodity ``Celtuce'';
0
e. Remove the entry ``Cotton, seed'';
0
f. Add alphabetically the commodity ``Fennel, Florence, fresh leaves
and stalk'';
0
g. Remove the entry ``Fruit, stone, group 12'';
0
h. Add alphabetically the commodities ``Fruit, stone, group 12-12'',
``Kohlrabi'', ``Leaf petiole vegetable subgroup 22B'', and ``Leafy
greens subgroup 4-16A'';
0
i. Revise the entry ``Nut, tree, group 14'';
0
j. Add alphabetically the commodities ``Nut, tree, group 14-12'' and
``Oilseed group 20'';
0
k. Revise the entry ``Pistachio'';
0
l. Remove the entry ``Sunflower, seed'';
0
m. Add alphabetically the commodity ``Vegetable, brassica, head and
stem, group 5-16'';
0
n. Remove the entry ``Vegetable, leafy, except brassica, group 4''; and
0
o. Add footnote 1 to the table.
    The additions and revisions read as follows:

Sec.  180.658  Penthiopyrad; tolerances for residues.

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

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

                                * * * * *
Brassica, leafy greens, subgroup 4-16B......................          50

                                * * * * *
Bushberry subgroup 13-07B...................................           6
Caneberry subgroup 13-07A...................................          10
Celtuce.....................................................          30

                                * * * * *
Fennel, Florence, fresh leaves and stalk....................          30

                                * * * * *
Fruit, stone, group 12-12...................................           4

                                * * * * *
Kohlrabi....................................................           5
Leaf petiole vegetable subgroup 22B.........................          30
Leafy greens subgroup 4-16A.................................          30

                                * * * * *
Nut, tree, group 14 \1\.....................................        0.06
Nut, tree, group 14-12......................................        0.05

                                * * * * *
Oilseed group 20............................................         1.5

                                * * * * *
Pistachio \1\...............................................        0.06

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

                                * * * * *
------------------------------------------------------------------------
\1\ This tolerance expires on December 6, 2019.

* * * * *
[FR Doc. 2019-11676 Filed 6-5-19; 8:45 am]
 BILLING CODE 6560-50-P