[Federal Register Volume 76, Number 54 (Monday, March 21, 2011)]
[Rules and Regulations]
[Page 15212]
[FR Doc No: 2011-6489]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 129

[Docket No. FAA-2009-0140; Amdt. No. 129-49-A]
RIN 2120-AJ45

Operations Specifications; Correction

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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SUMMARY: The FAA is correcting a final rule published on February 10,
2011 (76 FR 7482). In that rule, the FAA amended its regulations to
clarify and standardize the rules for applications by foreign air
carriers and foreign persons for part 129 operations specifications and
establish new standards for amendment, suspension, and termination of
those operations specifications. This document corrects errors in the
codified text of that document.

DATES: The final rule and this correction will become effective on
April 11, 2011.

FOR FURTHER INFORMATION CONTACT: For technical questions contact Darcy
D. Reed, International Programs and Policy Division, AFS-50, Flight
Standards Service, Federal Aviation Administration, 800 Independence
Avenue, SW., Washington DC 20591; e-mail<EMAIL_ADDRESS>
Telephone:<PHONE_NUMBER>. For legal questions contact Lorna John, Office
of the Chief Counsel, Regulations Division, AGC-200, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591; e-
mail<EMAIL_ADDRESS>Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On February 10, 2011, the FAA published a final rule entitled,
``Operations Specifications'' (76 FR 7482).
    In that final rule the FAA revised its regulations to clarify and
standardize the rules for applications by foreign air carriers and
foreign persons for part 129 operations specifications and establish
new standards for amendment, suspension, and termination of those
operations specifications. As part of the amendment, the FAA added new
Sec.  129.9(a)(2) and (b)(2) concerning the designation of an agent for
service. The DATES section correctly listed the compliance date for
Sec.  129.9(a)(2) and (b)(2) as February 10, 2012. Section 129.9(a)(2)
and (b)(2) in the regulatory text incorrectly stated that the
compliance date was ``Within 1 year after February 10, 2012.''

Correction

    In FR Doc. 2011-2834, beginning on page 7484 in the Federal
Register of February 10, 2011, make the following corrections:

Corrections to Regulatory Text

Sec.  129.9  [Corrected]

    1. On page 7489, in the third column, in Sec.  129.9(a)(2) and
(b)(2), remove the words ``February 10, 2012'' and add in their place
the words ``February 10, 2011''.

    Issued in Washington, DC, on March 15, 2011.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.
[FR Doc. 2011-6489 Filed 3-18-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 41 (Friday, March 1, 2019)]
[Notices]
[Pages 7138-7140]
[FR Doc No: 2019-03623]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85188; File No. SR-NASDAQ-2019-008]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to Communications With the Public

February 25, 2019.
    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 February

19, 2019, The Nasdaq Stock Market LLC (``Nasdaq'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. 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 2210, titled ``Communications
with the Public.''
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaq.cchwallstreet.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 Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to update the reference
to NASD Rule 2210 to FINRA Rule 2210.\3\ The change is non-substantive
as it simply reflects a change in the reference from the NASD rulebook
to the FINRA rulebook. The Exchange believes the proposed rule change
will remove confusion among Nasdaq members as to their obligations when
communicating with the public.
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    \3\ See Securities Exchange Act Release No. 66681 (March 29,
2012), 77 FR 20452 (April 4, 2012) (SR-FINRA-2011-035).
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\4\ in general, and Section 6(b)(5) of the
Act,\5\ in particular, as it merely corrects a reference to the current
FINRA rule. The proposed rule change will have no impact on just and
equitable principles of trade or the protection of investors and the
public interest.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The proposed rule change does not impose any burden on competition
because it is a non-substantive change that imposes no new requirement
on Nasdaq members.

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) of the Act \6\ and Rule 19b-4(f)(6) thereunder.\7\ Because
the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it 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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    \6\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \7\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \8\ normally
does not become operative for 30 days after the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\9\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. In its filing with the
Commission, Nasdaq has asked the Commission to waive the 30-day
operative delay to allow Nasdaq to immediately reflect the proper rule
reference regarding the marketing materials requirement. Immediate
implementation of the proposed rule change will avoid confusion by
correcting the reference to the relevant FINRA rule regarding
communications with the public.
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    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 17 CFR 240.19b-4(f)(6)(iii).
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    The Commission believes that waiver of the 30-day operative delay
is consistent with the protection of investors and the public interest
and hereby waives the 30-day operative delay and designates the
proposed rule change operative upon filing.\10\
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    \10\ For purposes only of waiving the operative delay, the
Commission has considered the proposed rule's impact 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 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. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \11\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \11\ 15 U.S.C. 78s(b)(2)(B).
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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-NASDAQ-2019-008 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-NASDAQ-2019-008. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of 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. Persons submitting comments are cautioned that we do not redact
or edit personal identifying information from comment submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-NASDAQ-2019-
008, and should be submitted on or before March 22, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-03623 Filed 2-28-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18542-18543]
[FR Doc No: 2014-07308]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12455-011]

Borough of Lehighton, Pennsylvania; Notice of Application
Accepted for Filing, Soliciting Comments, Motions To Intervene, and
Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Types of Proceeding: Surrender of License.
    b. Project No.: 12455-011.
    c. Date Filed: March 4, 2014.
    d. Licensee: Borough of Lehighton, Pennsylvania.
    e. Name of Project: Beltzville Hydroelectric Project.
    f. Location: The unconstructed project was to be connected to the
U.S. Army Corps of Engineers Beltzville dam which is located on
Pohopoco Creek about 5 miles upstream of its confluence with the Lehigh
River, and approximately 4 miles northeast of the Borough of Lehighton
in Carbon County, Pennsylvania.
    g. Filed Pursuant to: 18 CFR 6.2.
    h. Licensee Contact: Nicole Beckett, Manager, Borough of Lehighton,
Borough Hall, 1 Constitutional Avenue, Lehighton, PA 18235.
    i. FERC Contact: Ms. Krista Sakallaris,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments and protests is 30 days from the
issuance of this notice by the Commission. Please file your submittal
electronically via the Internet (eFiling) in lieu of paper. Please
refer to the instructions on the Commission's Web site under http://www.ferc.gov/docs-filing/efiling.asp and filing instructions in the
Commission's Regulations at 18 CFR section 385.2001(a)(1)(iii). To
assist you with eFilings you should refer to the submission guidelines
document at http://www.ferc.gov/help/submission-guide/user-guide.pdf.
In addition, certain filing requirements have statutory or regulatory
formatting and other instructions. You should refer to a list of these
``qualified documents'' at http://www.ferc.gov/docs-filing/efiling/filing.pdf. You must include your name and contact information at the
end of your comments. Please include the project number (P-12455-011)
on any documents or motions filed. The Commission strongly encourages
electronic filings; otherwise, you should submit an original and seven
copies of any submittal to the following address: The Secretary,
Federal Energy Regulatory Commission, Mail Code: DHAC, PJ-12, 888 First
Street NE., Washington, DC 20426.
    k. Description of Proceeding: On March 4, 2014, the Borough of
Lehighton, Pennsylvania filed a letter stating that the Lehighton
Borough Council decided to no longer pursue the Beltzville
hydroelectric project. The licensee has not started construction and no
ground disturbance has occurred at the project. As such, the surrender
of the licensee's license is an administrative action.
    l. This notice is available for review and reproduction at the
Commission in the Public Reference Room, Room 2A, 888 First Street NE.,
Washington, DC 20426. The filing may also be viewed on the Commission's
Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the
Docket number (P-12455-011) excluding the last three digits in the
docket number field to access the notice. You may also register online
at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via
email of new filings and issuances related to this or other pending
projects. For assistance, call toll-free 1-866-208-

3676 or email<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions To Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the license surrender.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described proceeding. If any agency does not
file comments within the time specified for filing comments, it will be
presumed to have no comments.

    Dated: March 24, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-07308 Filed 4-1-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Rules and Regulations]
[Pages 69642-69648]
[FR Doc No: 2011-28947]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0876; FRL-9325-6]

Flutriafol; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
flutriafol, (()-[alpha]-(2-fluorophenyl)-[alpha]-(4-
fluorophenyl)-1H-1,2,4-triazole-1-ethanol, in or on multiple
commodities which are identified and discussed later in this document.
Cheminova A/S, c/o Cheminova, Inc. requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 9, 2011. Objections and
requests for hearings must be received on or before January 9, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0876. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Tamue L. Gibson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How can I 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://ecfr.gpoaccess.gov/cgi/t/text/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-2010]-0876 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
January 9, 2012. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0876, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 15, 2010 (75 FR 78241) (FRL-
8853-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of

pesticide petitions (PP 0E7772, 0F7770, 0F7771) by Cheminova A/S, c/o
Cheminova, Inc. 1600 Wilson Blvd., Arlington, VA 22209. The petitions
requested that 40 CFR part 180 be amended by establishing tolerances
for residues of the fungicide flutriafol, including its metabolites and
degradates, in or on banana, whole (import tolerance) at 0.50 parts per
million (ppm) (PP 0E7772). Corn, field, forage at 4.0 ppm; corn, field,
stover at 6.0 ppm; corn, field, grain at 0.01 ppm; corn, field, flour
at 0.03 ppm; corn, field, oil at 0.07 ppm; corn, field, meal at 0.03
ppm; corn, pop, stover at 6.0 ppm; corn, pop, grain at 0.01 ppm; grape
at 1.1 ppm; grape, raisin at 2.5 ppm; peanut at 0.08 ppm; peanut, hay
at 18 ppm; fruit, pome (Crop Group 11) at 0.60 ppm; fruit, stone (Crop
Group 12) at 0.80 ppm; beet, sugar, root at 1.5 ppm; beet, sugar, tops
at 2.5 ppm; beet, sugar, refined at 0.70 ppm; beet, sugar, molasses at
1.0 ppm; beet, sugar, dried pulp at 1.0 ppm; wheat, forage at 25 ppm;
wheat, hay at 9.0 ppm; wheat, straw at 6.0 ppm; wheat, grain at 0.15
ppm; wheat, grain, bran at 0.20 ppm; wheat, grain, germ at 0.20 ppm;
barley, hay at 9.0 ppm; barley, straw at 6.0 ppm; barley, grain at 0.15
ppm; barley, grain, bran at 0.20 ppm; buckwheat, grain at 0.15 ppm;
oats, forage at 25 ppm; oats, hay at 9.0 ppm; oats, straw at 6.0 ppm;
oats, grain at 0.15 ppm; oats, grain, bran at 0.20 ppm; rye, forage at
25 ppm; rye, straw at 6.0 ppm; rye, grain at 0.15 ppm; cattle, liver at
0.12 ppm; goat, liver at 0.12 ppm; horse, liver at 0.12 ppm; sheep,
liver at 0.12 ppm; and milk at 0.02 ppm (PP 0F7771). The petition also
requested that the 40 CFR part 180 be amended by establishing
tolerances for the indirect or inadvertent residues of the fungicide
flutriafol, including its metabolites and degradates, in or on sweet
corn, field corn and cotton raw agricultural commodities (corn, sweet,
forage at 0.05 ppm; corn, sweet, stover at 0.09 ppm; corn, sweet,
kernels plus cob with husks removed at 0.01 ppm; corn, field, forage at
0.10 ppm; corn, field, stover at 0.07 ppm; corn, field, grain at 0.01
ppm; cotton, undelinted seed at 0.01 ppm; and cotton, gin byproducts at
0.05 ppm) grown in fields previously planted with soybeans that were
treated with flutriafol (PP 0F7770). That notice referenced a summary
of the petitions prepared by Cheminova A/S, c/o Cheminova, Inc., 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 raised
the requested tolerance levels for direct application to grape; peanut;
fruit, stone, group 12-10; and rotational crop tolerances for corn,
sweet, forage. EPA lowered tolerance levels for direct application to
banana (import); grape, raisin; fruit, pome, group 11-09; beet, sugar;
and rotational crop tolerances for corn, sweet, stover; corn, field,
forage; and cotton, gin byproducts. EPA is not granting, at this time,
tolerances for direct application to beet, sugar, top; peanut, hay;
beet, sugar, refined; beet, sugar, molasses; beet, sugar, dried pulp;
milk; corn, field, forage; corn, field, stover; corn, field, grain;
corn, field, flour; corn, field, refined oil; corn, field, meal; corn,
pop; corn, pop, stover; wheat, forage; wheat, hay; wheat, straw; wheat,
grain; wheat, bran; wheat, germ; triticale, grain; barley, hay; barley,
straw; barley, grain; barley, grain, bran; buckwheat, grain; oat,
forage; oat, hay; oat, straw; oat, grain; oat, grain, bran; rye,
forage; rye, straw; and rye, grain. 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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for flutriafol including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with flutriafol
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.
    Flutriafol has high oral acute toxicity in the mouse. It has low
acute toxicity via the oral, dermal and inhalation routes in rats.
Flutriafol is minimally irritating to the eyes and is not a dermal
irritant. Flutriafol was not shown to be a skin sensitizer when tested
in guinea pigs.
    Short-term, subchronic, and chronic toxicity studies in rats, mice,
and dogs identified the liver as the primary target organ of
flutriafol. Hepatotoxicity was first evident in the subchronic studies
(rats and dogs) in the form of increases in liver enzyme release
(alkaline phosphatase), liver weights, and histopathology findings
ranging from hepatocyte vacuolization to centrilobular hypertrophy and
slight increases in hemosiderin-laden Kupffer cells. It is noteworthy
that with chronic exposures, there are no indications of progression of
liver toxicity in any of the species tested. After over 1 year of
exposure, hepatotoxicity in rats, dogs, and mice took the form of:
    1. Minimal to severe fatty changes;
    2. Bile duct proliferation/cholangiolarfibrosis;
    3. Hemosiderin accumulation in Kupffer cells;
    4. Centrilobular hypertrophy, and
    5. Increases in alkaline phosphatase release.
Slight indications of effects in the hematopoietic system are
sporadically seen in the database. These effects were manifested in the
form of slight anemia (rats and dogs) and increased platelet, white
blood cell, neutrophil, and lymphocyte counts (mice). These effects,
however, were minimal in severity.
    Specific information on the studies received and the nature of the
adverse effects caused by flutriafol as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Flutriafol: Human Health Risk
Assessment for Proposed Uses on Corn, Grapes, Peanuts, Pome Fruit (Crop
Group 11), Stone Fruit (Crop Group 12),

Sugar Beets, Wheat, Barley, Triticale, Buckwheat, Oats, Rye, Teosinte
and Imported Bananas'' at page 40 in docket ID number EPA-HQ-OPP-2010-
0876.

B. Toxicological Points of Departure/Levels of Concern

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

   Table--Summary of Toxicological Doses and Endpoints for Flutriafol for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                 effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years   NOAEL = 7.5 mg/kg/day)  Acute RfD = 0.075 mg/   Developmental study-rabbit
 of age).                            UFA = 10x.............   kg/day.                 LOAEL = 15 mg/kg/day based
                                     UFH = 10x.............  aPAD = 0.075mg/kg/day.   on decreased number of
                                     FQPA SF = 1x..........  FQPA SF = 1x..........   live fetuses, complete
                                                                                litter resorptions and
                                                                                increased post-
                                                                                implantation loss.
Acute dietary (General population    NOAEL = 250 mg/kg/day.  Acute RfD = 2.5 mg/kg/  Neurotoxicity screening
 including infants and children).    UFA = 10x.............   day.                    battery-rat LOAEL = 750 mg/
                                     UFH = 10x.............  aPAD = 2.5 mg/kg/day..   kg/day based on decreased
                                     FQPA SF = 1x..........                           body weight, body-weight
                                                                                gain, absolute and
                                                                                relative food consumption,
                                                                                and clinical signs of
                                                                                toxicity in both sexes:
                                                                                Dehydration, urine-stained
                                                                                abdominal fur, ungroomed
                                                                                coat, ptosis, decreased
                                                                                motor activity,
                                                                                prostration, limp muscle
                                                                                tone, muscle flaccidity,
                                                                                hypothermia, hunched
                                                                                posture, impaired or lost
                                                                                righting reflex, scant
                                                                                feces; in males: red or
                                                                                tan perioral substance,
                                                                                chromodacryorrhea,
                                                                                chromorhinorrhea and
                                                                                labored breathing, and in
                                                                                females: piloerection and
                                                                                bradypnea.
Chronic dietary (All populations)..  NOAEL= 5 mg/kg/day....  Chronic RfD = 0.05 mg/  Chronic toxicity-dog LOAEL
                                     UFA = 10x.............   kg/day.                 = 20 mg/kg/day based on
                                     UFH = 10x.............  cPAD = 0.05 mg/kg/day.   adverse liver findings
                                     FQPA SF = 1x..........                           (increased liver weights,
                                                                                increased centrilobular
                                                                                hepatocyte lipid in the
                                                                                liver, and increases in
                                                                                alkaline phosphatase,
                                                                                albumin, and
                                                                                triglycerides), increased
                                                                                adrenal cortical
                                                                                vacuolation of the zona
                                                                                fasciculata, and marked
                                                                                hemosiderin pigmentation
                                                                                in the liver and spleen in
                                                                                both sexes; mild anemia
                                                                                (characterized by
                                                                                decreased hemoglobin,
                                                                                hematocrit, and red blood
                                                                                cell count) in the males;
                                                                                and initial body weight
                                                                                losses, decreased
                                                                                cumulative body-weight
                                                                                gains, and increased
                                                                                adrenal weights in the
                                                                                females.
Dermal short-term (1 to 30 days)--   Dermal (or oral) study  LOC for MOE = 100.....  Developmental toxicity-
 and Intermediate (1-6 months)--      NOAEL = 7.5 mg/kg/day                           rabbit LOAEL = 15 mg/kg/
 Term.                                (dermal absorption                              day based on decreased
                                      rate = 21%).                                    number of live fetuses,
                                     UFA = 10x.............                           complete litter
                                     UFH = 10x.............                           resorptions and increased
                                     FQPA SF = 1x..........                           post-implantation loss
Inhalation short-term (1 to 30       Inhalation (or oral)    LOC for MOE = 100.....  Developmental toxicity-
 days)--and Intermediate (1-6         study NOAEL= 7.5 mg/                            rabbit LOAEL = 15 mg/kg/
 months)--Term.                       kg/day (inhalation                              day based on decreased
                                      absorption rate =                               number of live fetuses,
                                      100%).                                          complete litter
                                                                                resorptions and increased
                                                                                post-implantation loss.
                                     UFA = 10x
                                     UFH = 10x
                                     FQPA SF = 1x
                                    ----------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..    Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                                       carcinogenicity studies in rats and mice.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. mg/kg/day = milligrams/
  kilogram/day. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flutriafol, EPA considered exposure under the petitioned-
for tolerances as well as all existing flutriafol tolerances in 40 CFR
180.629. EPA assessed dietary exposures from flutriafol 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 flutriafol. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, EPA
made the following assumptions for the acute exposure assessment:
tolerance-level residues and 100% crop treated (CT). EPA used
DEEMTM version 7.81 default processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA made the following
assumptions for the chronic exposure assessment: tolerance-level
residues and 100% crop treated (CT). EPA used DEEMTM version
7.81 default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that flutriafol does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for flutriafol. Tolerance level residues and 100% CT 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 flutriafol in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flutriafol. 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 FQPA Index Reservoir Screening Tool (FIRST), and
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of flutriafol for acute exposures
are estimated to be 48.5 parts per billion (ppb) for surface water and
310 ppb for ground water.
    For chronic exposures for non-cancer assessments the EDWC's are
estimated to be 5.70 ppb for surface water and 202 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 310 ppb was used to assess
the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration value
of 202 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). Flutriafol is not
registered for any specific use patterns that would result in
residential exposure.
    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.''
    Flutriafol is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events (EPA, 2002). In conazoles, however, a variable
pattern of toxicological responses is found; some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
    Triazole-derived pesticides can form the metabolite 1,2,4-triazole
(T) and two triazole conjugates triazolylalanine (TA) and
triazolylacetic acid (TAA). To support existing tolerances and to
establish new tolerances for triazole-derivative pesticides, EPA
conducted an initial human-health risk assessment for exposure to T,
TA, and TAA resulting from the use of all current and pending uses of
any triazole-derived fungicide as of September 1, 2005. The risk
assessment was a highly conservative, screening-level evaluation in
terms of hazards associated with common metabolites (e.g., use of a
maximum combination of uncertainty factors) and potential dietary and
non-dietary exposures (i.e., high-end estimates of both dietary and
non-dietary exposures). In addition, the Agency retained the additional
10X FQPA SF for the protection of infants and children. The assessment
included evaluations of risks for various subgroups, including those
comprised of infants and children. The Agency's complete risk
assessment can be found in the propiconazole reregistration docket at
http://www.regulations.gov, docket ID Number EPA-HQ-OPP-2005-0497 and
an update to assess the addition of the commodities included in this
action may be found in docket ID EPA-HQ-OPP-2011-0120 in the document
entitled ``Common Triazole Metabolites: Updated Dietary (Food + Water)
Exposure and Risk Assessment to Address the Amended metconazole Section
3 Registration to Add uses on Tuberous and Corm Vegetables (Group 1C)
and Bushberry Subgroup 13-07B''.

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. The potential impact of in
utero and perinatal flutriafol exposure was investigated in three
developmental toxicity studies (two in rats, one in rabbits) and two
multigenerational reproduction toxicity studies in rats. In the first
of two rat developmental toxicity studies, a quantitative
susceptibility was observed (delayed ossification or non-ossification
of the skeleton in the fetuses) at a lower dose than maternal effects.
In the second rat developmental study, a qualitative susceptibility was
noted. Although developmental toxicity occurred at the same dose level
that elicited maternal toxicity, the developmental effects (external,
visceral, and skeletal malformations; embryo lethality; skeletal
variations; a generalized delay in fetal development; and fewer live
fetuses) were more severe than the decreased food consumption and body-
weight gains observed in the dams. For rabbits, intrauterine deaths
occurred at a dose level that also caused adverse effects in maternal
animals. In the two-generation reproduction studies, a qualitative
susceptibility was also seen. Effects in the offspring--decreased
litter size and percentage of live births (increased pup mortality) and
liver toxicity can be attributed to the systemic toxicity of the
parental animals (decreased body weight and food consumption and liver
toxicity).
    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 flutriafol is complete.
    ii. There is no concern for neurotoxicity with flutriafol. Signs of
neurotoxicity were reported in the acute and subchronic neurotoxicity
studies at the highest dose only; however, these effects were primarily
seen in animals that were agonal (at the point of death) and, thus, are
not indicative of neurotoxicity. In addition, there was no evidence of
neurotoxicity in any additional short-term studies in rats, mice, and
dogs, or in the long-term toxicity studies in rats, mice, and dogs. A
developmental neurotoxicity study is not needed given these results.
    iii. There are no concerns or residual uncertainties for prenatal
and/or postnatal toxicity. Though there is evidence for increased
susceptibility in the prenatal studies in rats and rabbits and the two-
generation reproduction study in rats, there are no concerns for the
offspring toxicity observed in the developmental and reproductive
toxicity studies for the following reasons:
     Clear NOAELs and LOAELs were established in the fetuses/
offspring for each of these studies;
     The dose-response for these effects is well defined and
characterized;
     Developmental endpoints are used for assessing acute
dietary risks to the most sensitive population (females 13-49 years
old) as well as all other short- and intermediate-term exposure
scenarios; and
     The chronic reference dose is greater than 300-fold lower
than the dose at which the offspring effects were observed in the two-
generation reproduction studies.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to flutriafol in drinking water. These assessments
will not underestimate the exposure and risks posed by flutriafol.

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 flutriafol will occupy 24% of the aPAD for females 13-49 years 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
flutriafol from food and water will utilize 42% of the cPAD for all
infants less than 1 year old, the population group receiving the
greatest exposure. There are no residential uses for flutriafol.
    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). Flutriafol is
not registered for any use patterns that would result in residential
exposure. Therefore, the short-term aggregate risk is the sum of the
risk from exposure to flutriafol through food and water and will not be
greater than the chronic aggregate risk.
    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). Flutriafol is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to flutriafol through food and water, which has already been addressed,
and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, flutriafol is not expected to pose a cancer risk to humans.
    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 flutriafol residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, (gas chromatography/Nitrogen/
Phosphorus detector (NPD) for tolerances and method ICIA AM00306 for
ruminant liver) 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
U.N. 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 flutriafol.

C. Revisions to Petitioned-For Tolerances

    Based on an analysis of residue levels from crop field trials, EPA
raised tolerance levels for direct application to grape; peanut; fruit,
stone, group 12-10; and rotational crop tolerances for corn, sweet,
forage. For the same reason, EPA lowered tolerance levels for direct
application to banana (import); grape, raisin; fruit, pome, group 11-
09; beet, sugar; and rotational crop tolerances for corn, sweet,
stover; corn, field, forage; and cotton, gin byproducts were lowered.
    Additional residue chemistry data are needed to support tolerances
for direction application to corn, field, forage; corn, field, stover;
corn, field, grain; corn, field, flour; corn, field, refined oil; corn,
field, meal; corn, pop; corn, pop, stover; wheat, forage; wheat, hay;
wheat, straw; wheat, grain; wheat, grain bran; wheat, grain, germ;
triticale, grain; barley, hay; barley, straw; barley, grain; barley,
grain, bran; buckwheat, grain; oat, forage; oat, hay; oat, straw; oat,
grain; oat, grain, bran; rye, forage; rye, straw; and rye, grain and
the proposed milk tolerance. Accordingly, EPA has not made a
determination with regard to these petitioned-for tolerances at this
time.
    EPA is not establishing a tolerance for sugar beet tops because the
Agency no longer considers sugar beet tops to be a feed item. EPA has
required a label prohibition on feeding of flutriafol-treated peanut
hay, and thus is not establishing a peanut hay tolerance. Based on
results of the sugar beet processing study, EPA has determined that
tolerances are unnecessary for beet, sugar, refined; beet sugar,
molasses; and beet, sugar dried pulp. These processed commodities are
adequately covered by the associated raw agricultural tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of flutriafol,
(()-[alpha]-(2-fluorophenyl)-[alpha]-(4-fluorophenyl)-1H-
1,2,4-triazole-1-ethanol, in or on banana (import) at 0.30 ppm; grape
at 1.5 ppm; grape, raisin at 2.4 ppm; peanut at 0.09 ppm; fruit, pome
(crop group 11-09) at 0.40 ppm; fruit, stone (crop group 12-10) at 1.5
ppm; beet, sugar at 0.08 ppm; and to the rotation to corn, sweet,
forage at 0.09 ppm; corn, sweet, stover at 0.07 ppm; corn, sweet,
kernels plus cob with husks removed at 0.01 ppm; corn, field, forage at
0.09 ppm; corn, field, stover at 0.07 ppm; corn, field, grain at 0.01
ppm; corn, field, refined oil at 0.02 ppm; corn, pop, stover at 0.07
ppm; corn, pop at 0.01 ppm; cotton, undelinted seed at 0.01 ppm; and
cotton, gin byproducts at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to petitions 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 section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: October 28, 2011.
Lois Rossi,
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. Section 180.629 is amended by alphabetically adding the following
commodities to the table in paragraph

(a), by adding a new footnote 1, and by revising paragraph (d) to read
as follows:

Sec.  180.629  Flutriafol; tolerances for residues.

    (a) * * *

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

                              * * * * * * *
Banana\1\......................................                     0.30
Beet, sugar....................................                     0.08

                              * * * * * * *
Fruit, pome, group 11-09.......................                     0.40
Fruit, stone, group 12-10......................                      1.5

                              * * * * * * *
Grape..........................................                      1.5
Grape, raisin..................................                      2.4

                              * * * * * * *
Peanut.........................................                     0.09

                              * * * * * * *
------------------------------------------------------------------------
\1\There are no U.S. registrations as of October 26, 2011.

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established
for the indirect or inadvertent residues of the fungicide flutriafol,
including its metabolites and degradates, in or on the commodities in
the table below when present therein as a result of the application of
flutriafol to the growing crops listed in the table to paragraph (a) of
this section. Compliance with the following tolerance levels specified
below is to be determined by measuring only flutriafol (()-
[alpha]-(2-fluorophenyl)-[alpha]-(4-fluorophenyl)-1H-1,2,4-triazole-1-
ethanol) in or on the following commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Corn, field, forage............................                     0.09
Corn, field, grain.............................                     0.01
Corn, field, refined oil.......................                     0.02
Corn, field, stover............................                     0.07
Corn, pop......................................                     0.01
Corn, pop, stover..............................                     0.07
Corn, sweet, forage............................                     0.09
Corn, sweet, kernel plus cob with husk removed.                     0.01
Corn, sweet, stover............................                     0.07
Cotton, gin byproducts.........................                     0.02
Cotton, undelinted seed........................                     0.01
------------------------------------------------------------------------

[FR Doc. 2011-28947 Filed 11-8-11; 8:45 am]
BILLING CODE P


[Federal Register: June 1, 2009 (Volume 74, Number 103)]
[Notices]
[Page 26250-26251]
[DOCID:fr01jn09-53]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Dermatologic and Ophthalmic Drugs Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 26, 2009, from 8
a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, Maryland Ballrooms,
8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301-
589-5200.
    Contact Person: Paul Tran, Center for Drug Evaluation and Research
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express
delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 301-827-
7001, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area), code<PHONE_NUMBER>. Please call the Information Line
for up-to-date information on this meeting. A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
agency's Web site and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the
meeting.
    Agenda: The committee will discuss new drug applications (NDAs) 22-
288, BEPREVE (bepotastine besilate) ophthalmic solution, 1.5%, ISTA
Pharmaceuticals, Inc., proposed for the treatment of ocular itching
associated with allergic conjunctivitis, and NDA 22-358, sodium
hyaluronate ophthalmic solution, 0.18%, River Plate Biotechnology,
Inc., proposed for the treatment of the signs and symptoms of dry eye
disease.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
17, 2009. Oral presentations from the public will be scheduled between
approximately 9:30 a.m. to 10 a.m., and 1:30 p.m. to 2 p.m. Those
desiring to make formal oral presentations should notify the contact
person and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses of
proposed

participants, and an indication of the approximate time requested to
make their presentation on or before June 11, 2009. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by June 12, 2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact John Lauttman at
301-827-7001, at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 20, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-12625 Filed 5-29-09; 8:45 am]

BILLING CODE 4160-01-S