
[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Rules and Regulations]
[Pages 30979-30982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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: RDFRNotices@epa.gov.

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
 
                                * * * * *
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\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


