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[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)]
[Rules and Regulations]
[Pages 38601-38604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13910]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0235; FRL-9946-75]

Chlorantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
chlorantraniliprole in or on multiple commodities which are identified 
and discussed later in this document. Interregional Research Project 
Number 4 (IR-4) requested the tolerances associated with pesticide 
petition number (PP) 5E8371, under the Federal Food, Drug, and Cosmetic 
Act (FFDCA). Additionally, the Agency is amending the existing 
tolerance for egg that was inadvertently omitted in a previous action.

DATES: This regulation is effective June 14, 2016. Objections and 
requests for hearings must be received on or before August 15, 2016, 
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-2013-0235, 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: Susan Lewis, 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).
     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

[[Page 38602]]

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-2013-0235 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
August 15, 2016. 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-2013-0235, 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 26, 2015 (80 FR 51759) (FRL-9931-
74), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP) 
5E8371 by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Princeton, NJ 08540. The petition requested that 40 CFR part 
180 be amended by establishing tolerances for residues of the 
insecticide chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)-carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide, in or on nut, tree, group 14-12 at 0.02 parts per million 
(ppm); and fruit, stone, group 12-12 at 2.5 ppm. This petition 
additionally requested that 40 CFR 180.628 be amended by revising the 
existing tolerance in or on artichoke, globe from 4.0 ppm to 2.0 ppm; 
and hop, dried cones from 90 ppm to 40 ppm. Upon establishment of the 
tolerances associated with (PP) 5E8371, IR-4 requests to remove the 
following existing tolerances in 40 CFR 180.628: Nut, tree, group 14 at 
0.04 ppm; pistachio at 0.04 ppm; fruit, stone, group 12-12, except 
cherry, chickasaw plum, and damson plum at 4.0 ppm; cherry, sweet at 
2.0 ppm; cherry, tart at 2.0 ppm; plum, chickasaw at 2.0 ppm; and plum, 
damson at 2.0 ppm. That document referenced a summary of the petition 
prepared on behalf of IR-4 by DuPont Crop Protection, the registrant, 
which is available in the docket EPA-HQ-OPP-2013-0235 at http://www.regulations.gov.
    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), 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 chlorantraniliprole, 
consistent with FFDCA section 408(b)(2).
    In the Federal Register of February 7, 2014 (79 FR 7397) (FRL-9905-
56), EPA established tolerances for residues of chlorantraniliprole in 
or on fruit, stone, group 12-12, except cherry, chickasaw plum, and 
damson plum at 4.0 ppm; onion, green subgroup 3-07B at 3.0 ppm; peanut, 
hay at 90 ppm; and peanut at 0.06 ppm. EPA is relying upon those risk 
assessments and the findings made in the February 7, 2014 Federal 
Register document in support of this action. The toxicity profile of 
chlorantraniliprole has not changed. Moreover, because EPA is simply 
lowering the previously assessed tolerance levels (where the EPA 
assumed tolerance-level residues for all crops and including the tree 
nut group 14-12 at 0.02 ppm), the previous dietary estimates also do 
not change as a result of this action. Therefore, the previously 
published risk assessments that supported the establishment of those 
tolerances remain valid.
    The petitioner requested to lower currently established tolerances 
for residues of chlorantraniliprole in/on hops dried cones from 90 ppm 
to 40 ppm and globe artichoke from 4.0 ppm to 2.0 ppm in order to 
harmonize with the Codex maximum residue limits (MRLs). Crop field 
trial studies were submitted for hops and globe artichoke that indicate 
lowering these tolerances are appropriate and will support the existing 
U.S. registrations. The petitioner also requested to lower the existing 
tolerance of 4.0 ppm for stone fruit group 12-12, except cherry, 
chickasaw plum, and damson plum and remove the cherry, sweet; cherry, 
tart; plum, chickasaw; and plum, damson tolerances established at 2.0 
ppm and establish a tolerance for stone fruit crop group 12-12 at 2.5 
ppm to align with the Canadian MRL. EPA has determined that the 
existing residue chemistry data support this new tolerance level, which 
is lower than the current tolerances for some commodities and higher 
for others. Further, the petitioner requested to convert the tree nut 
crop group 14 to tree nut crop group 14-12 and to remove the tolerance 
for pistachio to lower the tolerance for the group (and for the now-
included pistachio commodity) from 0.40 ppm to 0.02 ppm to harmonize 
the U.S. tolerance with the Codex and Canadian MRLs. EPA has determined 
that the existing residue chemistry data support the request for crop 
group conversion and for lowering the tolerance level.

[[Page 38603]]

    Furthermore, EPA issued a final rule in the Federal Register of 
September 18, 2013, concerning the addition of certain commodities to 
the 40 CFR 180.628. The EPA determined that the tolerance level for egg 
should be increased from 0.2 ppm to 1.0 ppm, and EPA assessed egg using 
the tolerance of 1.0 ppm in 2013 as well as in February 2014. This was 
inadvertently omitted from the table in the 2013 Final Rule. Therefore, 
this document corrects that omission.
    Therefore, EPA relies upon the findings made in the February 7, 
2014, Federal Register document, as well as the review of the 
additional globe artichoke and dried cones hop field trial data and 
existing residue chemistry data in support of this rule. EPA concludes 
that there is a reasonable certainty that no harm will result to the 
general population, or to infants and children from aggregate exposure 
to chlorantraniliprole residues.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for these tolerances, please refer to the 
February 7, 2014, Federal Register document and its supporting 
documents, available at http://www.regulations.gov in docket ID number 
EPA-HQ-OPP-2013-0235. Further information about EPA's determination 
that an updated risk assessment was not necessary may be found in the 
document, ``Chlorantraniliprole (DPX-E2Y45): Petition for Updating Crop 
Group Tolerances for Nut Tree Group 14-12 and Fruit Stone Group 12-12, 
and Amending Established Tolerances for Chlorantraniliprole in/on 
Artichoke Globe and Hop Dried Cones.'' in docket ID number EPA-HQ-OPP-
2013-0235.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, liquid chromatography mass 
spectrometry/mass spectrometry (LC/MS/MS); Method uPont-11374, is 
available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

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.
    Based on the data supporting the petition, EPA has harmonized 
chlorantraniliprole tolerances in or on artichoke, globe at 2.0 ppm; 
hop, dried cones at 40 ppm; and nut, tree, group 14-12 at 0.02 ppm with 
established Codex MRLs.

C. International Trade Considerations

    In this rulemaking, EPA is reducing the tolerances for hops, dried 
cones from 90 ppm to 40 ppm; globe artichoke from 4.0 ppm to 2.0 ppm; 
lowering the existing tolerance of 4.0 ppm for stone fruit group 12-12, 
except cherry, chickasaw plum, and damson plum and establishing a lower 
tolerance for stone fruit crop group 12-12 at 2.5 ppm; and converting 
and lowering the tree nut crop group 14 and pistachio tolerances to 
tree nut crop group 14-12 at 0.40 ppm to 0.02 ppm. The petitioner 
requested these reductions in order to harmonize with Codex and 
Canadian MRLs. The reduction is appropriate based on available data and 
residue levels resulting from registered use patterns.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures Agreement, EPA notified the WTO of the 
request to revise these tolerances on September 14, 2015 as WTO 
notification G/SPS/N/USA/2778. In this action, EPA is allowing the 
existing higher tolerances to remain in effect for 6 months following 
the publication of this rule in order to allow a reasonable interval 
for producers in the exporting countries to adapt to the requirements 
of these modified tolerances. On December 14, 2016, those existing 
higher tolerances will expire, and the new reduced tolerances for 
artichoke, globe; fruit, stone, group 12-12; hop, dried cones; and nut, 
tree, group 14-12 will remain to cover residues of chlorantraniliprole 
on those commodities. Before that date, residues of chlorantraniliprole 
on those commodities would be permitted up to the higher tolerance 
levels; after that date, residues of chlorantraniliprole on artichoke, 
globe; the commodities contained in stone fruit group 12-12 and tree 
nut group 14-12; and hop, dried cones will need to comply with the new 
lower tolerance levels. This reduction in tolerance is not 
discriminatory; the same food safety standard contained in the FFDCA 
applies equally to domestically produced and imported foods.

V. Conclusion

    Therefore, tolerances are established for residues of 
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)-
carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in 
or on in or on artichoke, globe at 2.0 ppm; fruit, stone, group 12-12 
at 2.5 ppm; hop, dried cones at 40 ppm; and nut, tree, group 14-12 at 
0.02 ppm. Upon establishment of the aforementioned tolerances, the 
Agency is removing the tolerances for cherry, sweet at 2.0 ppm; cherry, 
tart at 2.0 ppm; plum, chickasaw at 2.0 ppm; and plum, damson at 2.0 
ppm as they are subsumed within the newly established group 12-12 
tolerances. The Agency is adding an expiration date of December 14, 
2016 to the existing tolerances for artichoke, globe at 4.0 ppm; nut, 
tree, group 14 at 0.04 ppm; pistachio at 0.04 ppm; fruit, stone, group 
12-12, except cherry, chickasaw plum, and damson plum at 4.0 ppm; and 
hop, dried cones at 90 ppm. Residues of chlorantraniliprole will be 
covered by these higher tolerances until the expiration date, after 
which time, they will need to comply with the lower tolerances being 
established today. Finally, the Agency is amending the existing 
tolerance for egg (increasing the tolerance level from 0.2 ppm to 1.0 
ppm) to finalize its efforts to establish that tolerance in the Federal 
Register of September 18, 2013.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of

[[Page 38604]]

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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 31, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.628, in the table in paragraph (a):
0
a. Remove the entries for ``Cherry, sweet,'' ``Cherry, tart,'' ``Plum, 
chickasaw,'' and ``Plum, damson;''
0
b. Revise the entry for ``Egg;''
0
c. Amend the existing entries by adding a footnote for ``Artichoke, 
globe,'' ``Fruit, stone, group 12-12, except cherry, chickasaw plum, 
and damson plum,'' ``Hop, dried cones,'' ``Nut, tree, group 14,'' and 
``Pistachio;'' and
0
d. Add alphabetically the entries for ``Artichoke, globe,'' ``Fruit, 
stone, group 12-12,'' ``Hop, dried cones,'' and ``Nut, tree, group 14-
12.''
    The additions and revisions read as follows:

Sec.  180.628  Chlorantraniliprole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Artichoke, globe \1\....................................             4.0
Artichoke, globe........................................             2.0
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Egg.....................................................             1.0
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                                * * * * *
------------------------------------------------------------------------
Fruit, stone, group 12-12...............................             2.5
Fruit, stone, group 12-12, except cherry, chickasaw                  4.0
 plum, and damson plum \1\..............................
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Hop, dried cones \1\....................................              90
Hop, dried cones........................................              40
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Nut, tree, group 14 \1\.................................            0.04
Nut, tree, group 14-12..................................            0.02
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Pistachio \1\...........................................            0.04
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
\1\ This tolerance expires on December 14, 2016.

* * * * *
[FR Doc. 2016-13910 Filed 6-13-16; 8:45 am]
BILLING CODE 6560-50-P
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