82_FR_31106 82 FR 30979 - Flubendiamide; Pesticide Tolerances

82 FR 30979 - Flubendiamide; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 127 (July 5, 2017)

Page Range30979-30982
FR Document2017-14108

This regulation establishes a tolerance for residues of flubendiamide in or on tea at 50 parts per million (ppm). Nichino America, Inc. requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 82 Issue 127 (Wednesday, July 5, 2017)
[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Rules and Regulations]
[Pages 30979-30982]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14108]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0099; FRL-9962-13]


Flubendiamide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of 
flubendiamide in or on tea at 50 parts per million (ppm). Nichino 
America, Inc. requested this tolerance under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 5, 2017. Objections and 
requests for hearings must be received on or before September 5, 2017, 
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-2007-0099, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, P.E., Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: [email protected].

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).

[[Page 30980]]

     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2007-0099 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 
September 5, 2017. 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-2007-0099, 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 August 12, 2016 (81 FR 53379) (FRL-9949-
53), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announced the filing of a pesticide petition (PP 
6E8463) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, 
Wilmington, DE 19808-2951. This petition requested that 40 CFR 180.639 
be amended by establishing an import tolerance for residues of 
flubendiamide, N\2\-[1,1-dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N\1\-
[2-methyl-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-
benzenedicarboxamide, in or on the processed commodity of dried tea at 
60 parts per million (ppm). This document referenced a summary of a 
petition prepared by Nichino America, Inc., the registrant, which is 
available in the docket, http://www.regulations.gov. This tolerance was 
requested to cover residues of flubendiamide in or on tea resulting 
from uses of this pesticide on tea outside the United States; there is 
no current U.S. registration for use of flubendiamide on tea. In order 
to harmonize with Codex, EPA is establishing a tolerance for residues 
of flubendiamide in or on tea at 50 ppm. The available residue data 
supports this tolerance level. A revised Section F was submitted by 
Nichino America, Inc. to support this change to the petitioned-for 
tolerance. There were no comments received in response to the notice of 
filing.

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 flubendiamide including 
exposure resulting from the tolerance established by this action.
    In the Federal Register of December 12, 2012 (77 FR 73940) (FRL-
9373-3), EPA amended tolerances for residues of flubendiamide in or on 
apple, wet pomace and fruit, pome, group 11. EPA is relying upon 
significant portions of those risk assessments and the corresponding 
findings made in the December 12, 2012 Federal Register document in 
support of this action for the following reasons. The toxicity profile 
of flubendiamide has not changed. Much of the exposure profiled remains 
the same as well because there is no U.S. registration associated with 
the tea use (i.e., the estimated drinking water exposures reported in 
2012 are not expected to change nor is there any need to conduct a 
residential exposure assessment due to the lack of proposed or existing 
residential uses for flubendiamide). The Agency did take into 
consideration the potential additional dietary exposure to 
flubendiamide as a result of residues in or on imported tea. 
Aggregating that exposure with the dietary exposure estimated in the 
December 2012 tolerance assessment resulted in no change to the acute 
dietary exposure (3.1% of the aPAD for the general U.S. population and 
5.5% of the aPAD for children 1-2 years old, the most highly exposed 
population subgroup) and only a 1% change in the chronic dietary risk 
(21% of the cPAD) for the general U.S. population and an increase of 9% 
in the chronic dietary risk (67% of the cPAD) for children 1-2 years 
old, the most highly exposed population subgroup. The Agency's findings 
concerning cumulative effects and the children's safety factor as 
reflected in the December 2012 tolerance rulemaking are also relied 
upon in this action.
    Based upon the risk assessments supporting the December 12, 2012 
Federal Register document, the findings therein, and the updated risk 
assessment accounting for the residues of flubendiamide on imported 
tea, EPA concludes that there is a reasonable certainty that no harm 
will result to the general population, or to infants and

[[Page 30981]]

children from aggregate exposure to flubendiamide residues.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for these tolerances, please refer to the 
December 12, 2012, Federal Register document and its supporting 
documents, available at http://www.regulations.gov in docket ID number 
EPA-HQ-OPP-2007-0099. Further information about EPA's determination 
that an updated risk assessment was not necessary may be found in the 
document, ``Flubendiamide: Human Health Risk Assessment for the 
Petition for a Tolerance Without U.S. Registration for Residues in/on 
Tea.'' in docket ID number EPA-HQ-OPP-2007-0099.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An independently validated liquid chromatography/tandem mass 
spectrometry (LC/MS/MS) method, Method 00816/M002, was previously 
submitted for the determination of residues of in/on samples of plant 
commodities. The validated limit of quantitation (LOQ) is 0.01 ppm for 
each analyte in each matrix.

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. There is currently a 
Codex MRL for tea established at 50 ppm; therefore, the U.S. EPA is 
establishing a tolerance on tea at the same level to harmonize with 
Codex.

C. Revisions to Petitioned-For Tolerance

    If only dried tea data are submitted for imported tea (data in/on 
the RAC are not required for imported tea) and the tolerance level 
based on these data is also meant to cover for detectable residues in 
instant tea (may be demonstrated by data depicting detectable residues 
in brewed tea), then the correct commodity definition for tolerance 
setting should be ``tea'' to cover incurred residues in or on all tea 
commodities and eliminate any regulatory ambiguity. In order to 
harmonize with Codex, EPA is establishing a tolerance for residues of 
flubendiamide in or on tea at 50 ppm. The available residue data 
supports this tolerance level. A revised Section F was submitted by 
Nichino America, Inc. to support this change to the petitioned-for 
tolerance.

V. Conclusion

    Therefore, a tolerance is established for residues of 
flubendiamide, N\2\-[1,1-dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N\1\-
[2-methyl-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-
benzenedicarboxamide, in or on tea at 50 ppm. At this time, there is no 
U.S. registration for use of flubendiamide on tea.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 23, 2017.
Donna S. Davis,
Acting 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.


[[Page 30982]]



0
2. In Sec.  180.639, add alphabetically the entry ``Tea'' to the table 
in paragraph (a) to read as follows:


Sec.  180.639  Flubendiamide; tolerances for residues.

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

 
                                * * * * *
Tea \1\.................................................              50
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of July 5, 2017, for use of
  flubendiamide on tea.

* * * * *
[FR Doc. 2017-14108 Filed 7-3-17; 8:45 am]
BILLING CODE 6560-50-P



                                                                     Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Rules and Regulations                                                                                30979

                                                                                      EPA-APPROVED KENTUCKY NON-REGULATORY PROVISIONS—Continued
                                                                                                                                                                                            State
                                                  Name of non-regulatory SIP                                                                                                                                 EPA approval
                                                                                                      Applicable geographic or nonattainment area                                      submittal date/                             Explanations
                                                          provision                                                                                                                                             date
                                                                                                                                                                                        effective date

                                              2008 8-hour ozone base year                  Portions of Boone, Campbell and Kenton Counties in Ken-                                           8/26/2016       7/5/2017 .........   182(a)(1)
                                                emissions inventory for the                  tucky.                                                                                                          [Insert citation       base-year
                                                Kentucky portion of the Cin-                                                                                                                                    of publica-         emissions
                                                cinnati-Hamilton, OH-KY-IN                                                                                                                                      tion].              inventory
                                                Area.



                                              PART 81—DESIGNATION OF AREAS                                            Authority: 42 U.S.C. 7401 et seq.                                  by revising the entries for ‘‘Cincinnati,
                                              FOR AIR QUALITY PLANNING                                            ■  4. In § 81.318, the table entitled                                  OH-KY-IN’’ to read as follows:
                                              PURPOSES                                                            ‘‘Kentucky-2008 8-Hour Ozone NAAQS                                     § 81.318    Kentucky.
                                              ■ 3. The authority citation for part 81                             (Primary and secondary)’’ is amended
                                                                                                                                                                                         *      *        *        *        *
                                              continues to read as follows:

                                                                                                              KENTUCKY—2008 8-HOUR OZONE NAAQS
                                                                                                                                 [Primary and secondary]

                                                                                                                                                                           Designation                                 Classification
                                                                                        Designated area
                                                                                                                                                                   Date 1                    Type                 Date 1                 Type

                                              Cincinnati, OH-KY-IN: 2                                                                                                 7/5/2017         Attainment.
                                                  Boone County (part) ...................................................................................   ........................   Attainment.
                                                      2000 Census tracts: 702, 703.05, 703.06, 703.07, 703.08, 703.09,
                                                          704.01, 704.02, 705.01, 705.02, 706.01, 706.03, 706.04.
                                                  Campbell County (part) ..............................................................................     ........................   Attainment.
                                                      2000 Census tracts: 501, 502, 503, 504, 505, 506, 512, 513,
                                                          519.01, 519.03, 519.04, 520.01, 520.02, 521, 522, 523.01,
                                                          523.02, 524, 525, 526, 528, 529, 530, 531.
                                                  Kenton County (part) ..................................................................................   ........................   Attainment.
                                                      2000 Census tracts: 603, 607, 609, 610, 611, 612, 613, 614, 616,
                                                          636.03, 636.04, 636.05, 636.06, 638, 640, 641, 642, 643, 644,
                                                          645, 646, 647, 648, 649, 650, 651, 652, 653, 654, 655.01,
                                                          655.02, 656, 657, 658, 659, 668, 669, 670, 671.
                                                         *                     *                   *                   *                                                         *                           *                       *
                                                  1 This date is July 20, 2012, unless otherwise noted.
                                                  2 Excludes Indian country located in each area, unless otherwise noted.




                                              *       *        *        *        *                                accordance with the instructions                                       Registration Division (7505P), Office of
                                              [FR Doc. 2017–13994 Filed 7–3–17; 8:45 am]                          provided in 40 CFR part 178 (see also                                  Pesticide Programs, Environmental
                                              BILLING CODE 6560–50–P                                              Unit I.C. of the SUPPLEMENTARY                                         Protection Agency, 1200 Pennsylvania
                                                                                                                  INFORMATION).                                                          Ave. NW., Washington, DC 20460–0001;
                                                                                                                  ADDRESSES: The docket for this action,                                 main telephone number: (703) 305–
                                              ENVIRONMENTAL PROTECTION                                                                                                                   7090; email address: RDFRNotices@
                                                                                                                  identified by docket identification (ID)
                                              AGENCY                                                                                                                                     epa.gov.
                                                                                                                  number EPA–HQ–OPP–2007–0099, is
                                              40 CFR Part 180                                                     available at http://www.regulations.gov                                SUPPLEMENTARY INFORMATION:
                                                                                                                  or at the Office of Pesticide Programs
                                              [EPA–HQ–OPP–2007–0099; FRL–9962–13]                                 Regulatory Public Docket (OPP Docket)                                  I. General Information
                                                                                                                  in the Environmental Protection Agency                                 A. Does this action apply to me?
                                              Flubendiamide; Pesticide Tolerances                                 Docket Center (EPA/DC), West William
                                              AGENCY:  Environmental Protection                                   Jefferson Clinton Bldg., Rm. 3334, 1301                                   You may be potentially affected by
                                              Agency (EPA).                                                       Constitution Ave. NW., Washington, DC                                  this action if you are an agricultural
                                              ACTION: Final rule.                                                 20460–0001. The Public Reading Room                                    producer, food manufacturer, or
                                                                                                                  is open from 8:30 a.m. to 4:30 p.m.,                                   pesticide manufacturer. The following
                                              SUMMARY:   This regulation establishes a                            Monday through Friday, excluding legal                                 list of North American Industrial
                                              tolerance for residues of flubendiamide                             holidays. The telephone number for the                                 Classification System (NAICS) codes is
                                              in or on tea at 50 parts per million                                Public Reading Room is (202) 566–1744,                                 not intended to be exhaustive, but rather
sradovich on DSK3GMQ082PROD with RULES




                                              (ppm). Nichino America, Inc. requested                              and the telephone number for the OPP                                   provides a guide to help readers
                                              this tolerance under the Federal Food,                              Docket is (703) 305–5805. Please review                                determine whether this document
                                              Drug, and Cosmetic Act (FFDCA).                                     the visitor instructions and additional                                applies to them. Potentially affected
                                              DATES: This regulation is effective July                            information about the docket available                                 entities may include:
                                              5, 2017. Objections and requests for                                at http://www.epa.gov/dockets.                                            • Crop production (NAICS code 111).
                                              hearings must be received on or before                              FOR FURTHER INFORMATION CONTACT:                                          • Animal production (NAICS code
                                              September 5, 2017, and must be filed in                             Michael L. Goodis, P.E., Director,                                     112).


                                         VerDate Sep<11>2014       16:11 Jul 03, 2017     Jkt 241001     PO 00000      Frm 00033      Fmt 4700     Sfmt 4700      E:\FR\FM\05JYR1.SGM           05JYR1


                                              30980             Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Rules and Regulations

                                                • Food manufacturing (NAICS code                       available at http://www.epa.gov/                      result to infants and children from
                                              311).                                                    dockets.                                              aggregate exposure to the pesticide
                                                • Pesticide manufacturing (NAICS                                                                             chemical residue. . . .’’
                                                                                                       II. Summary of Petitioned-For
                                              code 32532).                                                                                                      Consistent with FFDCA section
                                                                                                       Tolerance
                                              B. How can I get electronic access to                                                                          408(b)(2)(D), and the factors specified in
                                                                                                          In the Federal Register of August 12,              FFDCA section 408(b)(2)(D), EPA has
                                              other related information?                               2016 (81 FR 53379) (FRL–9949–53),                     reviewed the available scientific data
                                                 You may access a frequently updated                   EPA issued a document pursuant to                     and other relevant information in
                                              electronic version of EPA’s tolerance                    FFDCA section 408(d)(3), 21 U.S.C.                    support of this action. EPA has
                                              regulations at 40 CFR part 180 through                   346a(d)(3), announced the filing of a                 sufficient data to assess the hazards of
                                              the Government Printing Office’s e-CFR                   pesticide petition (PP 6E8463) by                     and to make a determination on
                                              site at http://www.ecfr.gov/cgi-bin/text-                Nichino America, Inc., 4550 New                       aggregate exposure for flubendiamide
                                              idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                     Linden Hill Road, Suite 501,                          including exposure resulting from the
                                              40tab_02.tpl.                                            Wilmington, DE 19808–2951. This                       tolerance established by this action.
                                                                                                       petition requested that 40 CFR 180.639
                                              C. How can I file an objection or hearing                                                                         In the Federal Register of December
                                                                                                       be amended by establishing an import
                                              request?                                                                                                       12, 2012 (77 FR 73940) (FRL–9373–3),
                                                                                                       tolerance for residues of flubendiamide,
                                                Under FFDCA section 408(g), 21                                                                               EPA amended tolerances for residues of
                                                                                                       N2-[1,1-dimethyl-2-
                                              U.S.C. 346a, any person may file an                                                                            flubendiamide in or on apple, wet
                                                                                                       (methylsulfonyl)ethyl-3-iodo-N1-[2-
                                              objection to any aspect of this regulation                                                                     pomace and fruit, pome, group 11. EPA
                                                                                                       methyl-4-[1,2,2,2-tetrafluoro-1-
                                              and may also request a hearing on those                                                                        is relying upon significant portions of
                                                                                                       (trifluoromethyl)ethyl]phenyl]-1,2-
                                              objections. You must file your objection                                                                       those risk assessments and the
                                                                                                       benzenedicarboxamide, in or on the
                                              or request a hearing on this regulation                                                                        corresponding findings made in the
                                                                                                       processed commodity of dried tea at 60
                                              in accordance with the instructions                                                                            December 12, 2012 Federal Register
                                                                                                       parts per million (ppm). This document
                                              provided in 40 CFR part 178. To ensure                                                                         document in support of this action for
                                                                                                       referenced a summary of a petition
                                              proper receipt by EPA, you must                          prepared by Nichino America, Inc., the                the following reasons. The toxicity
                                              identify docket ID number EPA–HQ–                        registrant, which is available in the                 profile of flubendiamide has not
                                              OPP–2007–0099 in the subject line on                     docket, http://www.regulations.gov.                   changed. Much of the exposure profiled
                                              the first page of your submission. All                   This tolerance was requested to cover                 remains the same as well because there
                                              objections and requests for a hearing                    residues of flubendiamide in or on tea                is no U.S. registration associated with
                                              must be in writing, and must be                          resulting from uses of this pesticide on              the tea use (i.e., the estimated drinking
                                              received by the Hearing Clerk on or                      tea outside the United States; there is no            water exposures reported in 2012 are
                                              before September 5, 2017. Addresses for                  current U.S. registration for use of                  not expected to change nor is there any
                                              mail and hand delivery of objections                     flubendiamide on tea. In order to                     need to conduct a residential exposure
                                              and hearing requests are provided in 40                  harmonize with Codex, EPA is                          assessment due to the lack of proposed
                                              CFR 178.25(b).                                           establishing a tolerance for residues of              or existing residential uses for
                                                In addition to filing an objection or                  flubendiamide in or on tea at 50 ppm.                 flubendiamide). The Agency did take
                                              hearing request with the Hearing Clerk                   The available residue data supports this              into consideration the potential
                                              as described in 40 CFR part 178, please                  tolerance level. A revised Section F was              additional dietary exposure to
                                              submit a copy of the filing (excluding                   submitted by Nichino America, Inc. to                 flubendiamide as a result of residues in
                                              any Confidential Business Information                    support this change to the petitioned-for             or on imported tea. Aggregating that
                                              (CBI)) for inclusion in the public docket.               tolerance. There were no comments                     exposure with the dietary exposure
                                              Information not marked confidential                      received in response to the notice of                 estimated in the December 2012
                                              pursuant to 40 CFR part 2 may be                         filing.                                               tolerance assessment resulted in no
                                              disclosed publicly by EPA without prior                                                                        change to the acute dietary exposure
                                                                                                       III. Aggregate Risk Assessment and                    (3.1% of the aPAD for the general U.S.
                                              notice. Submit the non-CBI copy of your                  Determination of Safety
                                              objection or hearing request, identified                                                                       population and 5.5% of the aPAD for
                                              by docket ID number EPA–HQ–OPP–                             Section 408(b)(2)(A)(i) of FFDCA                   children 1–2 years old, the most highly
                                              2007–0099, by one of the following                       allows EPA to establish a tolerance (the              exposed population subgroup) and only
                                              methods:                                                 legal limit for a pesticide chemical                  a 1% change in the chronic dietary risk
                                                • Federal eRulemaking Portal: http://                  residue in or on a food) only if EPA                  (21% of the cPAD) for the general U.S.
                                              www.regulations.gov. Follow the online                   determines that the tolerance is ‘‘safe.’’            population and an increase of 9% in the
                                              instructions for submitting comments.                    Section 408(b)(2)(A)(ii) of FFDCA                     chronic dietary risk (67% of the cPAD)
                                              Do not submit electronically any                         defines ‘‘safe’’ to mean that ‘‘there is a            for children 1–2 years old, the most
                                              information you consider to be CBI or                    reasonable certainty that no harm will                highly exposed population subgroup.
                                              other information whose disclosure is                    result from aggregate exposure to the                 The Agency’s findings concerning
                                              restricted by statute.                                   pesticide chemical residue, including                 cumulative effects and the children’s
                                                • Mail: OPP Docket, Environmental                      all anticipated dietary exposures and all             safety factor as reflected in the
                                              Protection Agency Docket Center (EPA/                    other exposures for which there is                    December 2012 tolerance rulemaking
                                              DC), (28221T), 1200 Pennsylvania Ave.                    reliable information.’’ This includes                 are also relied upon in this action.
                                              NW., Washington, DC 20460–0001.                          exposure through drinking water and in                   Based upon the risk assessments
                                                • Hand Delivery: To make special                       residential settings, but does not include            supporting the December 12, 2012
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                                              arrangements for hand delivery or                        occupational exposure. Section                        Federal Register document, the findings
                                              delivery of boxed information, please                    408(b)(2)(C) of FFDCA requires EPA to                 therein, and the updated risk
                                              follow the instructions at http://                       give special consideration to exposure                assessment accounting for the residues
                                              www.epa.gov/dockets/contacts.html.                       of infants and children to the pesticide              of flubendiamide on imported tea, EPA
                                              Additional instructions on commenting                    chemical residue in establishing a                    concludes that there is a reasonable
                                              or visiting the docket, along with more                  tolerance and to ‘‘ensure that there is a             certainty that no harm will result to the
                                              information about dockets generally, is                  reasonable certainty that no harm will                general population, or to infants and


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                                                                Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Rules and Regulations                                               30981

                                              children from aggregate exposure to                      demonstrated by data depicting                           This action directly regulates growers,
                                              flubendiamide residues.                                  detectable residues in brewed tea), then              food processors, food handlers, and food
                                                 For a detailed discussion of the                      the correct commodity definition for                  retailers, not States or tribes, nor does
                                              aggregate risk assessments and                           tolerance setting should be ‘‘tea’’ to                this action alter the relationships or
                                              determination of safety for these                        cover incurred residues in or on all tea              distribution of power and
                                              tolerances, please refer to the December                 commodities and eliminate any                         responsibilities established by Congress
                                              12, 2012, Federal Register document                      regulatory ambiguity. In order to                     in the preemption provisions of FFDCA
                                              and its supporting documents, available                  harmonize with Codex, EPA is                          section 408(n)(4). As such, the Agency
                                              at http://www.regulations.gov in docket                  establishing a tolerance for residues of              has determined that this action will not
                                              ID number EPA–HQ–OPP–2007–0099.                          flubendiamide in or on tea at 50 ppm.                 have a substantial direct effect on States
                                              Further information about EPA’s                          The available residue data supports this              or tribal governments, on the
                                              determination that an updated risk                       tolerance level. A revised Section F was              relationship between the national
                                              assessment was not necessary may be                      submitted by Nichino America, Inc. to                 government and the States or tribal
                                              found in the document,                                   support this change to the petitioned-for             governments, or on the distribution of
                                              ‘‘Flubendiamide: Human Health Risk                       tolerance.                                            power and responsibilities among the
                                              Assessment for the Petition for a                                                                              various levels of government or between
                                                                                                       V. Conclusion
                                              Tolerance Without U.S. Registration for                                                                        the Federal Government and Indian
                                              Residues in/on Tea.’’ in docket ID                         Therefore, a tolerance is established               tribes. Thus, the Agency has determined
                                              number EPA–HQ–OPP–2007–0099.                             for residues of flubendiamide, N2-[1,1-               that Executive Order 13132, entitled
                                                                                                       dimethyl-2-(methylsulfonyl)ethyl-3-                   ‘‘Federalism’’ (64 FR 43255, August 10,
                                              IV. Other Considerations
                                                                                                       iodo-N1-[2-methyl-4-[1,2,2,2-tetrafluoro-             1999) and Executive Order 13175,
                                              A. Analytical Enforcement Methodology                    1-(trifluoromethyl)ethyl]phenyl]-1,2-                 entitled ‘‘Consultation and Coordination
                                                An independently validated liquid                      benzenedicarboxamide, in or on tea at                 with Indian Tribal Governments’’ (65 FR
                                              chromatography/tandem mass                               50 ppm. At this time, there is no U.S.                67249, November 9, 2000) do not apply
                                              spectrometry (LC/MS/MS) method,                          registration for use of flubendiamide on              to this action. In addition, this action
                                              Method 00816/M002, was previously                        tea.                                                  does not impose any enforceable duty or
                                              submitted for the determination of                                                                             contain any unfunded mandate as
                                                                                                       VI. Statutory and Executive Order
                                              residues of in/on samples of plant                                                                             described under Title II of the Unfunded
                                                                                                       Reviews
                                              commodities. The validated limit of                                                                            Mandates Reform Act (UMRA) (2 U.S.C.
                                              quantitation (LOQ) is 0.01 ppm for each                     This action establishes a tolerance                1501 et seq.).
                                              analyte in each matrix.                                  under FFDCA section 408(d) in                            This action does not involve any
                                                                                                       response to a petition submitted to the               technical standards that would require
                                              B. International Residue Limits                          Agency. The Office of Management and                  Agency consideration of voluntary
                                                 In making its tolerance decisions, EPA                Budget (OMB) has exempted these types                 consensus standards pursuant to section
                                              seeks to harmonize U.S. tolerances with                  of actions from review under Executive                12(d) of the National Technology
                                              international standards whenever                         Order 12866, entitled ‘‘Regulatory                    Transfer and Advancement Act
                                              possible, consistent with U.S. food                      Planning and Review’’ (58 FR 51735,                   (NTTAA) (15 U.S.C. 272 note).
                                              safety standards and agricultural                        October 4, 1993). Because this action                 VII. Congressional Review Act
                                              practices. EPA considers the                             has been exempted from review under
                                                                                                       Executive Order 12866, this action is                   Pursuant to the Congressional Review
                                              international maximum residue limits
                                                                                                       not subject to Executive Order 13211,                 Act (5 U.S.C. 801 et seq.), EPA will
                                              (MRLs) established by the Codex
                                                                                                       entitled ‘‘Actions Concerning                         submit a report containing this rule and
                                              Alimentarius Commission (Codex), as
                                                                                                       Regulations That Significantly Affect                 other required information to the U.S.
                                              required by FFDCA section 408(b)(4).
                                                                                                       Energy Supply, Distribution, or Use’’ (66             Senate, the U.S. House of
                                              The Codex Alimentarius is a joint
                                                                                                       FR 28355, May 22, 2001) or Executive                  Representatives, and the Comptroller
                                              United Nations Food and Agriculture
                                                                                                       Order 13045, entitled ‘‘Protection of                 General of the United States prior to
                                              Organization/World Health
                                                                                                       Children from Environmental Health                    publication of the rule in the Federal
                                              Organization food standards program,
                                                                                                       Risks and Safety Risks’’ (62 FR 19885,                Register. This action is not a ‘‘major
                                              and it is recognized as an international
                                                                                                       April 23, 1997). This action does not                 rule’’ as defined by 5 U.S.C. 804(2).
                                              food safety standards-setting
                                              organization in trade agreements to                      contain any information collections                   List of Subjects in 40 CFR Part 180
                                              which the United States is a party. EPA                  subject to OMB approval under the
                                                                                                       Paperwork Reduction Act (PRA) (44                       Environmental protection,
                                              may establish a tolerance that is                                                                              Administrative practice and procedure,
                                              different from a Codex MRL; however,                     U.S.C. 3501 et seq.), nor does it require
                                                                                                       any special considerations under                      Agricultural commodities, Pesticides
                                              FFDCA section 408(b)(4) requires that                                                                          and pests, Reporting and recordkeeping
                                              EPA explain the reasons for departing                    Executive Order 12898, entitled
                                                                                                       ‘‘Federal Actions to Address                          requirements.
                                              from the Codex level. There is currently
                                              a Codex MRL for tea established at 50                    Environmental Justice in Minority                        Dated: May 23, 2017.
                                              ppm; therefore, the U.S. EPA is                          Populations and Low-Income                            Donna S. Davis,
                                              establishing a tolerance on tea at the                   Populations’’ (59 FR 7629, February 16,               Acting Director, Registration Division, Office
                                              same level to harmonize with Codex.                      1994).                                                of Pesticide Programs.
                                                                                                          Since tolerances and exemptions that                 Therefore, 40 CFR chapter I is
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                                              C. Revisions to Petitioned-For Tolerance                 are established on the basis of a petition            amended as follows:
                                                If only dried tea data are submitted for               under FFDCA section 408(d), such as
                                              imported tea (data in/on the RAC are                     the tolerance in this final rule, do not              PART 180—[AMENDED]
                                              not required for imported tea) and the                   require the issuance of a proposed rule,
                                              tolerance level based on these data is                   the requirements of the Regulatory                    ■ 1. The authority citation for part 180
                                              also meant to cover for detectable                       Flexibility Act (RFA) (5 U.S.C. 601 et                continues to read as follows:
                                              residues in instant tea (may be                          seq.), do not apply.                                      Authority: 21 U.S.C. 321(q), 346a and 371.



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                                              30982                    Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Rules and Regulations

                                              ■ 2. In § 180.639, add alphabetically the                            FOR FURTHER INFORMATION CONTACT:                    Information not marked confidential
                                              entry ‘‘Tea’’ to the table in paragraph (a)                          Michael Goodis, Registration Division               pursuant to 40 CFR part 2 may be
                                              to read as follows:                                                  (7505P), Office of Pesticide Programs,              disclosed publicly by EPA without prior
                                                                                                                   Environmental Protection Agency, 1200               notice. Submit the non-CBI copy of your
                                              § 180.639 Flubendiamide; tolerances for                              Pennsylvania Ave. NW., Washington,                  objection or hearing request, identified
                                              residues.
                                                                                                                   DC 20460–0001; main telephone                       by docket ID number EPA–HQ–OPP–
                                                  (a) * * *                                                        number: (703) 305–7090; email address:              2016–0166, by one of the following
                                                  (1) * * *                                                        RDFRNotices@epa.gov.                                methods:
                                                                                                                   SUPPLEMENTARY INFORMATION:                            • Federal eRulemaking Portal: http://
                                                 *              *              *             *            *                                                            www.regulations.gov. Follow the online
                                              Tea 1 ......................................                    50   I. General Information                              instructions for submitting comments.
                                                                                                                   A. Does this action apply to me?                    Do not submit electronically any
                                                  *              *              *            *            *                                                            information you consider to be CBI or
                                                                                                                      You may be potentially affected by               other information whose disclosure is
                                                1 There are no U.S. registrations as of July
                                                                                                                   this action if you are an agricultural              restricted by statute.
                                              5, 2017, for use of flubendiamide on tea.
                                                                                                                   producer, food manufacturer, or                       • Mail: OPP Docket, Environmental
                                              *        *        *         *         *                              pesticide manufacturer. The following               Protection Agency Docket Center (EPA/
                                              [FR Doc. 2017–14108 Filed 7–3–17; 8:45 am]                           list of North American Industrial                   DC), (28221T), 1200 Pennsylvania Ave.
                                              BILLING CODE 6560–50–P                                               Classification System (NAICS) codes is              NW., Washington, DC 20460–0001.
                                                                                                                   not intended to be exhaustive, but rather             • Hand Delivery: To make special
                                                                                                                   provides a guide to help readers                    arrangements for hand delivery or
                                              ENVIRONMENTAL PROTECTION                                             determine whether this document                     delivery of boxed information, please
                                              AGENCY                                                               applies to them. Potentially affected               follow the instructions at http://
                                                                                                                   entities may include:                               www.epa.gov/dockets/contacts.html.
                                              40 CFR Part 180                                                         • Crop production (NAICS code 111).                Additional instructions on
                                              [EPA–HQ–OPP–2016–0166; FRL–9962–61]                                     • Animal production (NAICS code                  commenting or visiting the docket,
                                                                                                                   112).                                               along with more information about
                                              Indaziflam; Pesticide Tolerances                                        • Food manufacturing (NAICS code                 dockets generally, is available at http://
                                                                                                                   311).                                               www.epa.gov/dockets.
                                              AGENCY:  Environmental Protection
                                              Agency (EPA).                                                           • Pesticide manufacturing (NAICS
                                                                                                                                                                       II. Summary of Petitioned-For
                                                                                                                   code 32532).                                        Tolerance
                                              ACTION: Final rule.
                                                                                                                   B. How can I get electronic access to                  In the Federal Register of May 19,
                                              SUMMARY:   This regulation establishes                               other related information?                          2016 (81 FR 31581) (FRL–9946–02),
                                              tolerances for residues of indaziflam in
                                                                                                                      You may access a frequently updated              EPA issued a document pursuant to
                                              or on multiple commodities which are
                                                                                                                   electronic version of EPA’s tolerance               FFDCA section 408(d)(3), 21 U.S.C.
                                              identified and discussed later in this
                                                                                                                   regulations at 40 CFR part 180 through              346a(d)(3), announcing the filing of a
                                              document. Interregional Research
                                                                                                                   the Government Printing Office’s e-CFR              pesticide petition (PP 6E8452) by IR–4,
                                              Project Number 4 (IR–4) requested these
                                                                                                                   site at http://www.ecfr.gov/cgi-bin/text-           Rutgers University, 500 College Rd.
                                              tolerances under the Federal Food,
                                                                                                                   idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                East, Suite 201 W, Princeton, NJ 08540.
                                              Drug, and Cosmetic Act (FFDCA).
                                                                                                                   40tab_02.tpl.                                       The petition requested that 40 CFR
                                              DATES: This regulation is effective July
                                                                                                                                                                       180.653 be amended by establishing
                                              5, 2017. Objections and requests for                                 C. How can I file an objection or hearing           tolerances for residues of the herbicide
                                              hearings must be received on or before                               request?                                            indaziflam (N-[(1R,2S)-2,3-dihydro-2,6-
                                              September 5, 2017, and must be filed in                                Under FFDCA section 408(g), 21                    dimethyl-1H-inden-1-yl]-6-(1-
                                              accordance with the instructions                                     U.S.C. 346a, any person may file an                 fluoroethyl)-1,3,5-triazine-2,4-diamine)
                                              provided in 40 CFR part 178 (see also                                objection to any aspect of this regulation          in or on bushberry, subgroup 13–07B at
                                              Unit I.C. of the SUPPLEMENTARY                                       and may also request a hearing on those             0.01 parts per million (ppm); caneberry,
                                              INFORMATION).
                                                                                                                   objections. You must file your objection            subgroup 13–07A at 0.01 ppm; coffee,
                                              ADDRESSES: The docket for this action,                               or request a hearing on this regulation             green bean at 0.01 ppm; fruit, small,
                                              identified by docket identification (ID)                             in accordance with the instructions                 vine climbing, except fuzzy kiwifruit,
                                              number EPA–HQ–OPP–2016–0166, is                                      provided in 40 CFR part 178. To ensure              subgroup 13–07F at 0.01 ppm; hop,
                                              available at http://www.regulations.gov                              proper receipt by EPA, you must                     dried cones at 0.03 ppm; fruit, stone,
                                              or at the Office of Pesticide Programs                               identify docket ID number EPA–HQ–                   group 12–12 at 0.01 ppm; and nut, tree,
                                              Regulatory Public Docket (OPP Docket)                                OPP–2016–0166 in the subject line on                group 14–12 at 0.01 ppm. Additionally,
                                              in the Environmental Protection Agency                               the first page of your submission. All              the petition requested that tolerances be
                                              Docket Center (EPA/DC), West William                                 objections and requests for a hearing               established for the crops in the
                                              Jefferson Clinton Bldg., Rm. 3334, 1301                              must be in writing, and must be                     proposed crop subgroup 23A (small
                                              Constitution Ave. NW., Washington, DC                                received by the Hearing Clerk on or                 fruit, edible peel subgroup) at 0.01 ppm,
                                              20460–0001. The Public Reading Room                                  before September 5, 2017. Addresses for             including acerola; African plum; agritos,
                                              is open from 8:30 a.m. to 4:30 p.m.,                                 mail and hand delivery of objections                almondette; appleberry; arbutus berry;
                                              Monday through Friday, excluding legal                               and hearing requests are provided in 40             bayberry, red; bignay; breadnut;
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                                              holidays. The telephone number for the                               CFR 178.25(b).                                      cabeluda; carandas-plum; Ceylon iron
                                              Public Reading Room is (202) 566–1744,                                 In addition to filing an objection or             wood; Ceylon olive; cherry-of-the-Rio-
                                              and the telephone number for the OPP                                 hearing request with the Hearing Clerk              Grande; Chinese olive, black; Chinese
                                              Docket is (703) 305–5805. Please review                              as described in 40 CFR part 178, please             olive, white; chirauli-nut; cocoplum;
                                              the visitor instructions and additional                              submit a copy of the filing (excluding              desert-date; false sandalwood; fragrant
                                              information about the docket available                               any Confidential Business Information               manjack; gooseberry, Abyssinian;
                                              at http://www.epa.gov/dockets.                                       (CBI)) for inclusion in the public docket.          gooseberry, Ceylon; gooseberry,


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Document Created: 2017-07-04 02:00:54
Document Modified: 2017-07-04 02:00:54
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective July 5, 2017. Objections and requests for hearings must be received on or before September 5, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactMichael L. Goodis, P.E., Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email
FR Citation82 FR 30979 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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