[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Rules and Regulations]
[Pages 36090-36095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16375]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0679; FRL-9963-02]


Cyclaniliprole; Pesticide Tolerances and Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyclaniliprole in or on multiple commodities that are identified and 
discussed later in this document. ISK Biosciences Corporation requested 
these tolerances under the

[[Page 36091]]

Federal Food, Drug, and Cosmetic Act (FFDCA). Additionally, this 
regulation also establishes an exemption from the requirement of a 
tolerance for indirect or inadvertent residues of cyclaniliprole on 
multiple commodities identified and discussed later in this document.

DATES: This regulation is effective August 3, 2017. Objections and 
requests for hearings must be received on or before October 2, 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-2014-0679, 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, 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).
     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-2014-0679 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 
October 2, 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-2014-0679, 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 April 6, 2015 (80 FR 18327) (FRL-9924-
00), 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 
4F8253) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, 
Concord, OH 44077. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the insecticide 
cyclaniliprole, 3-bromo-N-[2-bromo-4-chloro-6-[[(1-
cyclopropylethyl)amino]carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-
pyrazole-5-carboxamide, in or on the following commodities: Pome Fruit 
(Crop Group 11-10) at 0.3 parts per million (ppm); Tree Nuts (Crop 
Group 14-12) at 0.02 ppm; Stone Fruit (Crop Group 12-12) at 0.7 ppm; 
Fruiting Vegetables (Crop Group 8-10) at 0.2 ppm; Cucurbit Vegetables, 
(Crop Group 9) at 0.2 ppm; and Small Fruit Vine Climbing Subgroup, 
except Fuzzy Kiwifruit (Crop Group 13-07F) at 0.9 ppm. Additionally 
tolerances are requested for residues of cyclaniliprole in or on the 
crops in the proposed Crop Subgroup 4-14A, Leafy greens subgroup at 7.0 
ppm, including amaranth, Chinese; amaranth, leafy; aster, Indian; 
blackjack; cat's whiskers; chervil, fresh leaves; cham-chwi; cham-
namul; chipilin; chrysanthemum, garland; cilantro, fresh leaves; corn 
salad; cosmos; dandelion; dang-gwi; dillweed; dock; dol-nam-mul; ebolo; 
endive; escarole; fameflower; feather cockscomb; good king henry; 
huauzontle; jute, leaves; lettuce, bitter; lettuce, head; lettuce, 
leaf; orach; parsley, fresh leaves; plantain, buckhorn; primrose, 
English; purslane, garden; purslane, winter; radicchio; spinach; 
spinach, malabar; spinach, New Zealand; spinach, tanier; swiss chard; 
and violet, Chinese; crops in the proposed Crop Subgroup 4-14B, 
Brassica leafy greens subgroup at 15 ppm, including arugula; broccoli 
raab; broccoli, Chinese; cabbage, abyssinian; cabbage, seakale; Chinese 
cabbage, bok choy; collards; cress, garden; cress, upland; hanover 
salad; kale; maca; mizuna; mustard greens; radish, leaves; rape greens; 
rocket, wild; shepherd's purse; turnip greens; and watercress; crops in 
the proposed Crop Subgroup 22B, Leaf petiole vegetable subgroup at 7.0 
ppm, including Cardoon; celery; celery, Chinese; fuki; rhubarb; udo; 
zuiki; and the crops in the proposed Crop Group 5-14, Brassica Head and 
Stem Vegetable at 1.5 ppm, including broccoli; Brussels sprouts; 
cabbage; cabbage, Chinese, napa; and cauliflower.

[[Page 36092]]

Tolerances are also requested for residues of cyclaniliprole in or on 
the following animal feed commodities: almond, hulls at 8.0 ppm; apple, 
wet pomace at 0.96 ppm; and in the following animal tissues and meat 
byproducts: Cattle, fat at 0.08 ppm; cattle, kidney at 0.08 ppm; 
cattle, liver at 0.1 ppm; cattle, meat at 0.02 ppm; cattle, meat 
byproducts at 0.02 ppm; goat, fat at 0.08 ppm; goat, kidney at 0.08 
ppm; goat, liver at 0.1 ppm; goat, meat at 0.02 ppm; goat, meat 
byproducts at 0.02 ppm; horse, fat at 0.08 ppm; horse, kidney at 0.08 
ppm; horse, liver at 0.1 ppm; horse, meat at 0.02 ppm; horse, meat 
byproducts at 0.02 ppm; milk at 0.01 ppm; sheep, fat at 0.08 ppm; 
sheep, kidney at 0.08 ppm; sheep, liver at 0.1 ppm; sheep, meat at 0.02 
ppm; and sheep, meat byproducts at 0.02 ppm. In addition, a tolerance 
was requested for imported Tea (dried and instant) at 40 ppm. That 
document referenced a summary of the petition prepared by ISK 
Biosciences Corporation, the petitioner, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    In the Federal Register of November 23, 2015 (80 FR 72941) (FRL-
9936-73), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing ISK's amendment to its pesticide petition 
(PP 4F8253). The amended petition requested, in addition to the 
tolerances requested in the original petition, an exemption from the 
requirement of a tolerance for indirect or inadvertent residues of 
cyclaniliprole in or on all food commodities, not already covered by a 
tolerance. That document referenced a summary of the petition prepared 
by ISK Biosciences Corporation, the petitioner, which is available in 
the docket, http://www.regulations.gov. A comment was received on the 
notice of filing. EPA's response to that comment is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that vary from what was requested by the 
petitioner for multiple commodities. The reasons for these changes are 
explained in Unit IV.D.

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 cyclaniliprole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with cyclaniliprole 
follows.
    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    No single or repeated dose study performed by any route of exposure 
produced an adverse effect following cyclaniliprole exposure below, at, 
or above the limit dose (1,000 mg/kg/day). In short- and long-term 
studies in rats and mice, the most consistent finding was adaptive 
liver effects, which often consisted of slight increases in liver 
weight without associated clinical chemistry and histopathological 
changes, and it was seen mostly at or above the limit dose (1,000 mg/
kg/day). In dogs, both subchronic and chronic studies showed increases 
in liver weight, centrilobular hepatocellular hypertrophy, and elevated 
levels of alkaline phosphatase (ALP) at sub-limit dose levels. However, 
these findings were not considered as adverse because of the following: 
(1) ALP increase in dogs is a common laboratory finding and could be 
attributed to many factors such as corticosterone release, young dogs 
often have high and variable ALP values related to bone growth, 
cholestasis, and pharmacologically mediated hepatic drug metabolizing 
enzyme induction; (2) no histopathological changes were seen at any 
dose level tested; (3) the liver effects showed no progression of 
toxicity or increase in the number of parameters affected in the 
chronic study (1-year) relative to the subchronic study; and (4) no 
liver effects were seen in toxicity studies in rats and mice at or 
above the limit dose (1,000 mg/kg/day). In addition, a structurally 
related chemical, chlorantraniliprole, tested up to the limit dose in 
dogs did not demonstrate liver effects.
    No toxicity was seen in rat and rabbit developmental toxicity and 
in rat reproduction studies which were tested up to the limit dose 
(1,000 mg/kg/day). Therefore, there is no evidence that cyclaniliprole 
produces increased susceptibility with prenatal or postnatal exposures. 
Cyclaniliprole is classified as ``Not likely to be Carcinogenic to 
Humans'' based on no increase in treatment-related tumor incidence in 
the chronic toxicity study in rats and in carcinogenicity studies in 
rats and mice. Cyclaniliprole produced no genotoxicity. A dermal 
toxicity study tested at the limit dose did not produce any systemic 
toxicity, which was consistent with the finding of low dermal 
absorption.
    Specific information on the studies received for cyclaniliprole as 
well as the no-observed-adverse-effect-level (NOAEL) from the toxicity 
studies can be found at http://www.regulations.gov in document 
``Cyclaniliprole: Human Health Risk Assessment for the Proposed New 
Insecticide Active Ingredient'' dated September 12, 2015 in docket ID 
number EPA-HQ-OPP-2014-0679.
    Based on the analysis of the available cyclaniliprole toxicological 
studies, there is no adverse toxicity seen in any of the required 
submitted toxicology studies, and no toxicity endpoint and point of 
departure are established for human health risk assessment.
    Cyclaniliprole is proposed for use on a variety of crops. Humans 
could potentially be exposed to cyclaniliprole residues in food because 
cyclaniliprole may be applied directly to growing crops. These 
applications can also result in cyclaniliprole reaching surface and 
ground water, both of which can serve as sources of drinking water. 
There are no proposed uses in residential settings; therefore, there 
are no anticipated residential exposures.
    Based on the toxicological profile of cyclaniliprole, EPA has 
concluded that the FFDCA requirements to retain an additional safety 
factor for protection of infants and children and to consider

[[Page 36093]]

cumulative effects do not apply. Section 408(b)(2)(C) requires an 
additional tenfold margin of safety in the case of threshold risks, 
which are not present in this case. Section 408(b)(2)(D)(v) requires 
consideration of information concerning cumulative effects of 
substances that have a common mechanism of toxicity, which 
cyclaniliprole does not have.
    Based on the available data indicating a lack of adverse effects 
from exposure to cyclaniliprole, 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 
cyclaniliprole.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Method JSM0269 was developed for plant commodities, and Method 
JSM0277 was developed for livestock commodities. Residues of 
cyclaniliprole are extracted from crops using acetonitrile and cleaned 
up by solid phase extraction. Extracted residue levels are determined 
by liquid chromatography with tandem mass spectrometry (LC-MS/MS). 
Residues of cyclaniliprole are extracted from livestock using 
acetonitrile and cleaned up by liquid-liquid partition with hexane 
followed by SPE. Extracted residue levels are determined by LC-MS/MS in 
positive ion spray mode.
    Multiresidue methods testing data have been submitted for 
cyclaniliprole and NK-1375. The data indicate that the multiresidue 
methods (Protocols A through G) are not suitable for the analysis of 
cyclaniliprole, so the multiresidue methods cannot serve as enforcement 
methods. The multiresidue data have been sent to FDA.
    Adequate enforcement methodology (LC-MS/MS) 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: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for cyclaniliprole.

C. Response to Comments

    A comment was received from an anonymous commenter objecting to EPA 
requesting denial of this petition and stating that ``food should not 
be contaminated with these chemicals.'' The existing legal framework 
provided by section 408 of the Federal Food, Drug, and Cosmetic Act 
(FFDCA) states that tolerances may be set when the pesticide meets the 
safety standard imposed by that statute. As required by that statute, 
EPA conducted a comprehensive assessment of cyclaniliprole, including 
its potential for carcinogenicity. Based on its assessment of the 
available data, the Agency believes that given the observed lack of 
toxicity of this chemical, no risks of concern are expected. Therefore, 
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 cyclaniliprole.

D. Revisions to Petitioned-For Tolerances

    Tolerances were requested for individual crops in the proposed Crop 
Subgroup 4-14A, Leafy greens subgroup at 7.0 ppm; crops in the proposed 
Crop Subgroup 4-14B, Brassica leafy greens subgroup at 15 ppm; crops in 
the proposed Crop Subgroup 22B, Leaf petiole vegetable subgroup at 7.0 
ppm and the crops in the proposed Crop Group 5-14: Brassica Head and 
Stem Vegetable at 1.5 ppm. These crop groups were proposed in a 
Proposed Rule that published in the Federal Register of November 14, 
2014 (79 FR 68153). In the time since the petition was initially filed, 
these crop group/subgroups have been established, although with a 
slightly different numbering based on the year in which the crop groups 
were finalized, i.e., since the rule was published in 2016, the groups 
end in a -16, instead of -14 when they were proposed. See May 3, 2016 
(85 FR 26471). Therefore, EPA is establishing the subgroup/group 
tolerances as requested but with the updated names with one exception. 
EPA is not establishing a tolerance for subgroup 22B since residue 
field trial data (celery) were not provided to support the establishing 
a tolerance for the commodities in subgroup 22B.
    Additionally, the EPA is establishing a tolerance for Vegetable, 
leafy, group 4-16 at 15 ppm instead of the requested tolerance for 
residues in or on the leafy greens subgroup 4-16A at 7.0 ppm and 
Brassica leafy greens subgroup 4-16B at 15 ppm. Based on the 
Organization for Economic Cooperation and Development (OECD) tolerance 
calculation procedures and residue data for head lettuce, leaf lettuce, 
and spinach, the tolerance level would be 8.0 ppm for leafy greens 
subgroup 4-16A. However, instead of establishing the two subgroup 
tolerances, in order to harmonize with Canada which has established a 
crop group, Leafy Vegetables (CG 4-13) maximum residue level (MRL) at 
15 ppm, EPA is establishing a tolerance for Vegetable, leafy, group 4-
16 at 15 ppm.
    The EPA is also establishing lower tolerance levels than requested 
for the following commodities because the residue of concern is parent 
only instead of parent and its metabolite NK-1375: Almond hulls, 
reduced from 8 to 6.0 ppm; wet apple pomace, reduced from 0.96 to 0.50 
ppm; Vegetable, Brassica, head and stem, group 5-16 reduced from 1.5 to 
1.0 ppm; cucurbit vegetables, crop group 9, reduced from 0.2 to 0.15 
ppm; small vine climbing fruit, except fuzzy kiwifruit, crop group 13-
07F, reduced from 0.9 to 0.80 ppm; and for the following commodities 
for each animal (cattle, goat, horse, and sheep)--fat, reduced from 
0.08 to 0.015 ppm; kidney (now included in meat byproducts), reduced 
from 0.08 to 0.015 ppm; meat, reduced from 0.02 to 0.01 ppm; meat 
byproducts, reduced from 0.02 to 0.015 ppm; and liver, reduced from 0.1 
to 0.015 ppm.
    Based on OECD tolerance calculation procedures, EPA is also 
establishing higher tolerance levels than requested for the following 
commodities: The stone fruit crop group 12-12, increased from 0.7 to 
1.0 ppm; the tree nuts crop group 14-12, increased from 0.02 to 0.03 
ppm, and tea, dried leaves, increased from 40 to 50 ppm. No tolerance 
is needed for tea, instant (dry form) since residues are covered by the 
tolerance on tea, dried.
    EPA is establishing an increased tolerance on milk from 0.01 ppm to 
0.015 ppm to harmonize with Canada.
    Finally, tolerances were requested for residues in/on kidney and 
liver of cattle, goat, horse, and sheep. According to current EPA 
policy, residues for liver

[[Page 36094]]

and kidney will be covered by tolerances for residues in/on meat 
byproducts so separate tolerances are not needed.

V. Conclusion

    Although the lack of toxicity supports a safety finding for an 
exemption from the requirement of tolerance for all crops, EPA is 
establishing tolerances for residues resulting from direct applications 
to certain commodities because the petitioner requested them for 
international trade purposes. Tolerances are established for residues 
of cyclaniliprole, 3-bromo-N-[2-bromo-4-chloro-6-[[(1-
cyclopropylethyl)amino]carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-
pyrazole-5-carboxamide, in or on Pome Fruit (Crop Group 11-10) at 0.30 
parts per million (ppm); Nut, tree (Crop Group 14-12) at 0.03 ppm; 
Stone Fruit (Crop Group 12-12) at 1.0 ppm; Fruiting Vegetables (Crop 
Group 8-10) at 0.20 ppm; Cucurbit Vegetables, (Crop Group 9) at 0.15 
ppm; Small Fruit Vine Climbing Subgroup except Fuzzy Kiwifruit (Crop 
Group 13-07F) at 0.80 ppm; Vegetable, leafy, group 4-16 at 15 ppm; 
Vegetable, Brassica, head and stem, group 5-16 at 1.0 ppm; Milk at 
0.015 ppm; tea, dried leaves at 50 ppm; Almond, hulls at 6.0 ppm; 
Apple, wet pomace at 0.50 ppm; cattle, goat, horse, and sheep fat at 
0.015 ppm; cattle, goat, horse, and sheep meat at 0.01 ppm; and cattle, 
goat, horse, and sheep meat byproducts at 0.015 ppm.
    Additionally, an exemption from the requirement of a tolerance is 
established for indirect or inadvertent residues of cyclaniliprole, 3-
bromo-N-[2-bromo-4-chloro-6-[[(1-
cyclopropylethyl)amino]carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-
pyrazole-5-carboxamide, in or on all raw agricultural commodities, 
except for those commodities with tolerances established.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). 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: June 30, 2017.
Richard P. Keigwin, Jr.,
Director, 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. Add Sec.  180.694 to subpart C to read as follows:


Sec.  [emsp14]180.694  Cyclaniliprole; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide cyclaniliprole, including its metabolites and degradates, 
in or on the commodities in the table below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
cyclaniliprole, 3-bromo-N-[2-bromo-4-chloro-6-[[(1-
cyclopropylethyl)amino]carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-
pyrazole-5-carboxamide, in or on the commodity.

------------------------------------------------------------------------
                                                            Parts  per
                        Commodity                             million
------------------------------------------------------------------------
Almond, hulls...........................................             6.0
Apple, wet pomace.......................................            0.50
Cattle, fat.............................................           0.015
Cattle, meat............................................            0.01
Cattle, meat byproducts.................................           0.015
Fruit, pome, group 11-10................................            0.30
Fruit, small vine climbing, except fuzzy kiwifruit,                 0.80
 subgroup 13-07F........................................
Fruit, stone, group 12-12...............................             1.0
Goat, fat...............................................           0.015
Goat, meat..............................................            0.01
Goat, meat byproducts...................................           0.015
Horse, fat..............................................           0.015
Horse, meat.............................................            0.01
Horse, meat byproducts..................................           0.015
Milk....................................................           0.015
Nut, tree, group 14-12..................................            0.03
Sheep, fat..............................................           0.015
Sheep, meat.............................................            0.01
Sheep, meat byproducts..................................           0.015
Tea, dried \1\..........................................              50
Vegetable, Brassica, head and stem, group 5-16..........             1.0
Vegetable, cucurbit, group 9............................            0.15
Vegetable, fruiting, group 8-10.........................            0.20
Vegetable, leafy, group 4-16............................              15
------------------------------------------------------------------------
\1\ There are no U.S. registrations for Tea.


[[Page 36095]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

0
3. Add Sec.  180.1344 to subpart D to read as follows:


Sec.  [emsp14]180.1344  Cyclaniliprole; exemption from the requirement 
of a tolerance.

    An exemption from the requirement of a tolerance is established for 
indirect and inadvertent residues of the insecticide cyclaniliprole, 
including its metabolites and degradates, in or on all raw agricultural 
commodities not listed in paragraph (a) of Sec.  180.694, when residues 
are present therein as a result of subsequent uptake by crops rotated 
into fields where the crops in Sec.  180.694 (a) were treated with 
cyclaniliprole.

[FR Doc. 2017-16375 Filed 8-2-17; 8:45 am]
BILLING CODE 6560-50-P