82_FR_36238 82 FR 36090 - Cyclaniliprole; Pesticide Tolerances and Exemption From the Requirement of a Tolerance

82 FR 36090 - Cyclaniliprole; Pesticide Tolerances and Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 148 (August 3, 2017)

Page Range36090-36095
FR Document2017-16375

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 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.

Federal Register, Volume 82 Issue 148 (Thursday, August 3, 2017)
[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Rules and Regulations]
[Pages 36090-36095]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                             36090             Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Rules and Regulations

                                             procedures to derive the recommended                    U.S.C. 3501 et seq.), nor does it require             Agricultural commodities, Pesticides
                                             levels. For crop groups, and per EPA’s                  any special considerations under                      and pests, Reporting and recordkeeping
                                             current policy, a tolerance level for each              Executive Order 12898, entitled                       requirements.
                                             representative commodity was                            ‘‘Federal Actions to Address                             Dated: June 29, 2017.
                                             calculated separately, and then the                     Environmental Justice in Minority                     Donna Davis,
                                             maximum value within each crop group                    Populations and Low-Income
                                                                                                                                                           Acting Director, Registration Division, Office
                                             was selected as the tolerance level.                    Populations’’ (59 FR 7629, February 16,
                                                                                                                                                           of Pesticide Programs.
                                                All of EPA’s tolerance levels are                    1994).
                                             expressed to provide sufficient                            Since tolerances and exemptions that                 Therefore, 40 CFR chapter I is
                                             precision for enforcement purposes.                     are established on the basis of a petition            amended as follows:
                                             This may include the addition of                        under FFDCA section 408(d), such as
                                             trailing zeros, as was the case for                     the tolerance in this final rule, do not              PART 180—[AMENDED]
                                             Vegetable, cucurbit, group 9 for which                  require the issuance of a proposed rule,              ■ 1. The authority citation for part 180
                                             a tolerance of 0.3 ppm was proposed                     the requirements of the Regulatory                    continues to read as follows:
                                             and a tolerance at 0.30 ppm is being                    Flexibility Act (RFA) (5 U.S.C. 601 et
                                             established.                                            seq.), do not apply.                                      Authority: 21 U.S.C. 321(q), 346a and 371.
                                                Finally, EPA is revising the tolerance                  This action directly regulates growers,            ■ 2. Section 180.622, paragraph (a) is
                                             expression to clarify (1) that, as                      food processors, food handlers, and food              revised to read as follows:
                                             provided in FFDCA section 408(a)(3),                    retailers, not States or tribes, nor does
                                             the tolerance covers metabolites and                    this action alter the relationships or                § 180.622 Ethaboxam; tolerances for
                                             degradates of ethaboxam not specifically                distribution of power and                             residues.
                                             mentioned; and (2) that compliance                      responsibilities established by Congress                 (a) General. Tolerances are
                                             with the specified tolerance levels is to               in the preemption provisions of FFDCA                 established for residues of ethaboxam,
                                             be determined by measuring only the                     section 408(n)(4). As such, the Agency                including its metabolites and
                                             specific compounds mentioned in the                     has determined that this action will not              degradates, in or on the commodities
                                             tolerance expression.                                   have a substantial direct effect on States            listed in the table below. Compliance
                                                                                                     or tribal governments, on the                         with the tolerance levels specified
                                             V. Conclusion                                                                                                 below is to be determined by measuring
                                                                                                     relationship between the national
                                               Therefore, tolerances are established                 government and the States or tribal                   only ethaboxam (N-(cyano-2-
                                             for residues of ethaboxam (N-(cyano-2-                  governments, or on the distribution of                thienylmethyl)-4-ethyl-2-(ethylamino)-
                                             thienylmethyl)-4-ethyl-2-(ethlyamino)-                  power and responsibilities among the                  5-thiazolecarboxamide) in or on the
                                             5-thiazolecarboxamide), including its                   various levels of government or between               commodity.
                                             metabolites and degradates, in or on                    the Federal Government and Indian
                                             Ginseng at 0.10 ppm; Pepper/eggplant,                   tribes. Thus, the Agency has determined                            Commodity                       Parts per
                                             subgroup 8–10B at 0.90 ppm; Vegetable,                                                                                                                      million
                                                                                                     that Executive Order 13132, entitled
                                             cucurbit, group 9 at 0.30 ppm; and                      ‘‘Federalism’’ (64 FR 43255, August 10,               Ginseng ................................            0.10
                                             Vegetable, tuberous and corm, subgroup                  1999) and Executive Order 13175,                      Grape 1 ..................................           6.0
                                             1C at 0.01 ppm. Compliance with the                     entitled ‘‘Consultation and Coordination              Pepper/eggplant subgroup
                                             tolerance levels specified above is to be               with Indian Tribal Governments’’ (65 FR                 8–10B ................................            0.90
                                             determined by measuring only                            67249, November 9, 2000) do not apply                 Vegetable, cucurbit, group 9                        0.30
                                             ethaboxam (N-(cyano-2-thienylmethyl)-                   to this action. In addition, this action              Vegetable, tuberous and
                                             4-ethyl-2-(ethlyamino)-5-                               does not impose any enforceable duty or                 corm, subgroup 1C ...........                     0.01
                                             thiazolecarboxamide).                                   contain any unfunded mandate as                           1 There
                                                                                                                                                                     is no U.S. registration as of Sep-
                                             VI. Statutory and Executive Order                       described under Title II of the Unfunded              tember 27, 2006.
                                             Reviews                                                 Mandates Reform Act (UMRA) (2 U.S.C.                  *        *        *        *        *
                                                                                                     1501 et seq.).                                        [FR Doc. 2017–16371 Filed 8–2–17; 8:45 am]
                                               This action establishes tolerances                       This action does not involve any
                                             under FFDCA section 408(d) in                           technical standards that would require
                                                                                                                                                           BILLING CODE 6560–50–P

                                             response to a petition submitted to the                 Agency consideration of voluntary
                                             Agency. The Office of Management and                    consensus standards pursuant to section
                                             Budget (OMB) has exempted these types                                                                         ENVIRONMENTAL PROTECTION
                                                                                                     12(d) of the National Technology                      AGENCY
                                             of actions from review under Executive                  Transfer and Advancement Act
                                             Order 12866, entitled ‘‘Regulatory                      (NTTAA) (15 U.S.C. 272 note).                         40 CFR Part 180
                                             Planning and Review’’ (58 FR 51735,
                                             October 4, 1993). Because this action                   VII. Congressional Review Act                         [EPA–HQ–OPP–2014–0679; FRL–9963–02]
                                             has been exempted from review under                       Pursuant to the Congressional Review
                                             Executive Order 12866, this action is                                                                         Cyclaniliprole; Pesticide Tolerances
                                                                                                     Act (5 U.S.C. 801 et seq.), EPA will
                                             not subject to Executive Order 13211,                                                                         and Exemption From the Requirement
                                                                                                     submit a report containing this rule and
                                             entitled ‘‘Actions Concerning                                                                                 of a Tolerance
                                                                                                     other required information to the U.S.
                                             Regulations That Significantly Affect                   Senate, the U.S. House of                             AGENCY:  Environmental Protection
                                             Energy Supply, Distribution, or Use’’ (66               Representatives, and the Comptroller                  Agency (EPA).
                                             FR 28355, May 22, 2001) or Executive                    General of the United States prior to                 ACTION: Final rule.
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                                             Order 13045, entitled ‘‘Protection of                   publication of the rule in the Federal
                                             Children from Environmental Health                      Register. This action is not a ‘‘major                SUMMARY:   This regulation establishes
                                             Risks and Safety Risks’’ (62 FR 19885,                  rule’’ as defined by 5 U.S.C. 804(2).                 tolerances for residues of cyclaniliprole
                                             April 23, 1997). This action does not                                                                         in or on multiple commodities that are
                                             contain any information collections                     List of Subjects in 40 CFR Part 180                   identified and discussed later in this
                                             subject to OMB approval under the                         Environmental protection,                           document. ISK Biosciences Corporation
                                             Paperwork Reduction Act (PRA) (44                       Administrative practice and procedure,                requested these tolerances under the


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                                                               Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Rules and Regulations                                        36091

                                             Federal Food, Drug, and Cosmetic Act                    B. How can I get electronic access to                 II. Summary of Petitioned-For
                                             (FFDCA). Additionally, this regulation                  other related information?                            Tolerance
                                             also establishes an exemption from the                                                                           In the Federal Register of April 6,
                                             requirement of a tolerance for indirect                    You may access a frequently updated
                                                                                                     electronic version of EPA’s tolerance                 2015 (80 FR 18327) (FRL–9924–00),
                                             or inadvertent residues of cyclaniliprole                                                                     EPA issued a document pursuant to
                                             on multiple commodities identified and                  regulations at 40 CFR part 180 through
                                                                                                     the Government Printing Office’s e-CFR                FFDCA section 408(d)(3), 21 U.S.C.
                                             discussed later in this document.                                                                             346a(d)(3), announcing the filing of a
                                                                                                     site at http://www.ecfr.gov/cgi-bin/text-
                                             DATES: This regulation is effective
                                                                                                     idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  pesticide petition (PP 4F8253) by ISK
                                             August 3, 2017. Objections and requests                 40tab_02.tpl.                                         Biosciences Corporation, 7470 Auburn
                                             for hearings must be received on or                                                                           Road, Suite A, Concord, OH 44077. The
                                             before October 2, 2017, and must be                     C. How can I file an objection or hearing             petition requested that 40 CFR part 180
                                             filed in accordance with the instructions               request?                                              be amended by establishing tolerances
                                             provided in 40 CFR part 178 (see also                                                                         for residues of the insecticide
                                             Unit I.C. of the SUPPLEMENTARY                            Under FFDCA section 408(g), 21                      cyclaniliprole, 3-bromo-N-[2-bromo-4-
                                             INFORMATION).
                                                                                                     U.S.C. 346a, any person may file an                   chloro-6-[[(1-cyclopropylethyl)
                                                                                                     objection to any aspect of this regulation            amino]carbonyl]phenyl]-1-(3-chloro-2-
                                             ADDRESSES:    The docket for this action,               and may also request a hearing on those               pyridinyl)-1H-pyrazole-5-carboxamide,
                                             identified by docket identification (ID)                objections. You must file your objection              in or on the following commodities:
                                             number EPA–HQ–OPP–2014–0679, is                         or request a hearing on this regulation               Pome Fruit (Crop Group 11–10) at 0.3
                                             available at http://www.regulations.gov                 in accordance with the instructions                   parts per million (ppm); Tree Nuts (Crop
                                             or at the Office of Pesticide Programs                  provided in 40 CFR part 178. To ensure                Group 14–12) at 0.02 ppm; Stone Fruit
                                             Regulatory Public Docket (OPP Docket)                   proper receipt by EPA, you must                       (Crop Group 12–12) at 0.7 ppm; Fruiting
                                             in the Environmental Protection Agency                  identify docket ID number EPA–HQ–                     Vegetables (Crop Group 8–10) at 0.2
                                             Docket Center (EPA/DC), West William                    OPP–2014–0679 in the subject line on                  ppm; Cucurbit Vegetables, (Crop Group
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                 the first page of your submission. All                9) at 0.2 ppm; and Small Fruit Vine
                                             Constitution Ave. NW., Washington, DC                   objections and requests for a hearing                 Climbing Subgroup, except Fuzzy
                                             20460–0001. The Public Reading Room                     must be in writing, and must be                       Kiwifruit (Crop Group 13–07F) at 0.9
                                             is open from 8:30 a.m. to 4:30 p.m.,                    received by the Hearing Clerk on or                   ppm. Additionally tolerances are
                                             Monday through Friday, excluding legal                  before October 2, 2017. Addresses for                 requested for residues of cyclaniliprole
                                             holidays. The telephone number for the                  mail and hand delivery of objections                  in or on the crops in the proposed Crop
                                             Public Reading Room is (202) 566–1744,                  and hearing requests are provided in 40               Subgroup 4–14A, Leafy greens subgroup
                                             and the telephone number for the OPP                    CFR 178.25(b).                                        at 7.0 ppm, including amaranth,
                                             Docket is (703) 305–5805. Please review                   In addition to filing an objection or               Chinese; amaranth, leafy; aster, Indian;
                                             the visitor instructions and additional                 hearing request with the Hearing Clerk                blackjack; cat’s whiskers; chervil, fresh
                                             information about the docket available                  as described in 40 CFR part 178, please               leaves; cham-chwi; cham-namul;
                                             at http://www.epa.gov/dockets.                          submit a copy of the filing (excluding                chipilin; chrysanthemum, garland;
                                             FOR FURTHER INFORMATION CONTACT:                        any Confidential Business Information                 cilantro, fresh leaves; corn salad;
                                             Michael L. Goodis, Director,                            (CBI)) for inclusion in the public docket.            cosmos; dandelion; dang-gwi; dillweed;
                                             Registration Division (7505P), Office of                Information not marked confidential                   dock; dol-nam-mul; ebolo; endive;
                                             Pesticide Programs, Environmental                       pursuant to 40 CFR part 2 may be                      escarole; fameflower; feather
                                             Protection Agency, 1200 Pennsylvania                    disclosed publicly by EPA without prior               cockscomb; good king henry;
                                             Ave. NW., Washington, DC 20460–0001;                    notice. Submit the non-CBI copy of your               huauzontle; jute, leaves; lettuce, bitter;
                                             main telephone number: (703) 305–                       objection or hearing request, identified              lettuce, head; lettuce, leaf; orach;
                                             7090; email address: RDFRNotices@                       by docket ID number EPA–HQ–OPP–                       parsley, fresh leaves; plantain,
                                             epa.gov.                                                2014–0679, by one of the following                    buckhorn; primrose, English; purslane,
                                             SUPPLEMENTARY INFORMATION:                              methods:                                              garden; purslane, winter; radicchio;
                                                                                                       • Federal eRulemaking Portal: http://               spinach; spinach, malabar; spinach,
                                             I. General Information                                  www.regulations.gov. Follow the online                New Zealand; spinach, tanier; swiss
                                             A. Does this action apply to me?                        instructions for submitting comments.                 chard; and violet, Chinese; crops in the
                                                                                                     Do not submit electronically any                      proposed Crop Subgroup 4–14B,
                                                You may be potentially affected by                   information you consider to be CBI or                 Brassica leafy greens subgroup at 15
                                             this action if you are an agricultural                  other information whose disclosure is                 ppm, including arugula; broccoli raab;
                                             producer, food manufacturer, or                         restricted by statute.                                broccoli, Chinese; cabbage, abyssinian;
                                             pesticide manufacturer. The following                                                                         cabbage, seakale; Chinese cabbage, bok
                                             list of North American Industrial                         • Mail: OPP Docket, Environmental
                                                                                                                                                           choy; collards; cress, garden; cress,
                                             Classification System (NAICS) codes is                  Protection Agency Docket Center (EPA/
                                                                                                                                                           upland; hanover salad; kale; maca;
                                             not intended to be exhaustive, but rather               DC), (28221T), 1200 Pennsylvania Ave.
                                                                                                                                                           mizuna; mustard greens; radish, leaves;
                                             provides a guide to help readers                        NW., Washington, DC 20460–0001.
                                                                                                                                                           rape greens; rocket, wild; shepherd’s
                                             determine whether this document                           • Hand Delivery: To make special                    purse; turnip greens; and watercress;
                                             applies to them. Potentially affected                   arrangements for hand delivery or                     crops in the proposed Crop Subgroup
                                             entities may include:                                   delivery of boxed information, please                 22B, Leaf petiole vegetable subgroup at
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                                                • Crop production (NAICS code 111).                  follow the instructions at http://                    7.0 ppm, including Cardoon; celery;
                                                • Animal production (NAICS code                      www.epa.gov/dockets/contacts.html.                    celery, Chinese; fuki; rhubarb; udo;
                                             112).                                                     Additional instructions on                          zuiki; and the crops in the proposed
                                                • Food manufacturing (NAICS code                     commenting or visiting the docket,                    Crop Group 5–14, Brassica Head and
                                             311).                                                   along with more information about                     Stem Vegetable at 1.5 ppm, including
                                                • Pesticide manufacturing (NAICS                     dockets generally, is available at http://            broccoli; Brussels sprouts; cabbage;
                                             code 32532).                                            www.epa.gov/dockets.                                  cabbage, Chinese, napa; and cauliflower.


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                                             36092             Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Rules and Regulations

                                             Tolerances are also requested for                       defines ‘‘safe’’ to mean that ‘‘there is a            mediated hepatic drug metabolizing
                                             residues of cyclaniliprole in or on the                 reasonable certainty that no harm will                enzyme induction; (2) no
                                             following animal feed commodities:                      result from aggregate exposure to the                 histopathological changes were seen at
                                             almond, hulls at 8.0 ppm; apple, wet                    pesticide chemical residue, including                 any dose level tested; (3) the liver effects
                                             pomace at 0.96 ppm; and in the                          all anticipated dietary exposures and all             showed no progression of toxicity or
                                             following animal tissues and meat                       other exposures for which there is                    increase in the number of parameters
                                             byproducts: Cattle, fat at 0.08 ppm;                    reliable information.’’ This includes                 affected in the chronic study (1-year)
                                             cattle, kidney at 0.08 ppm; cattle, liver               exposure through drinking water and in                relative to the subchronic study; and (4)
                                             at 0.1 ppm; cattle, meat at 0.02 ppm;                   residential settings, but does not include            no liver effects were seen in toxicity
                                             cattle, meat byproducts at 0.02 ppm;                    occupational exposure. Section                        studies in rats and mice at or above the
                                             goat, fat at 0.08 ppm; goat, kidney at                  408(b)(2)(C) of FFDCA requires EPA to                 limit dose (1,000 mg/kg/day). In
                                             0.08 ppm; goat, liver at 0.1 ppm; goat,                 give special consideration to exposure                addition, a structurally related
                                             meat at 0.02 ppm; goat, meat byproducts                 of infants and children to the pesticide              chemical, chlorantraniliprole, tested up
                                             at 0.02 ppm; horse, fat at 0.08 ppm;                    chemical residue in establishing a                    to the limit dose in dogs did not
                                             horse, kidney at 0.08 ppm; horse, liver                 tolerance and to ‘‘ensure that there is a             demonstrate liver effects.
                                             at 0.1 ppm; horse, meat at 0.02 ppm;                    reasonable certainty that no harm will                   No toxicity was seen in rat and rabbit
                                             horse, meat byproducts at 0.02 ppm;                     result to infants and children from                   developmental toxicity and in rat
                                             milk at 0.01 ppm; sheep, fat at 0.08                    aggregate exposure to the pesticide                   reproduction studies which were tested
                                             ppm; sheep, kidney at 0.08 ppm; sheep,                  chemical residue. . . .’’                             up to the limit dose (1,000 mg/kg/day).
                                             liver at 0.1 ppm; sheep, meat at 0.02                      Consistent with FFDCA section                      Therefore, there is no evidence that
                                             ppm; and sheep, meat byproducts at                      408(b)(2)(D), and the factors specified in            cyclaniliprole produces increased
                                             0.02 ppm. In addition, a tolerance was                  FFDCA section 408(b)(2)(D), EPA has                   susceptibility with prenatal or postnatal
                                             requested for imported Tea (dried and                   reviewed the available scientific data                exposures. Cyclaniliprole is classified as
                                             instant) at 40 ppm. That document                       and other relevant information in                     ‘‘Not likely to be Carcinogenic to
                                             referenced a summary of the petition                    support of this action. EPA has                       Humans’’ based on no increase in
                                             prepared by ISK Biosciences                             sufficient data to assess the hazards of              treatment-related tumor incidence in the
                                             Corporation, the petitioner, which is                   and to make a determination on                        chronic toxicity study in rats and in
                                             available in the docket, http://                        aggregate exposure for cyclaniliprole                 carcinogenicity studies in rats and mice.
                                             www.regulations.gov. There were no                      including exposure resulting from the                 Cyclaniliprole produced no
                                             comments received in response to the                    tolerances established by this action.                genotoxicity. A dermal toxicity study
                                             notice of filing.                                       EPA’s assessment of exposures and risks               tested at the limit dose did not produce
                                                In the Federal Register of November                  associated with cyclaniliprole follows.               any systemic toxicity, which was
                                             23, 2015 (80 FR 72941) (FRL–9936–73),                      EPA has evaluated the available                    consistent with the finding of low
                                             EPA issued a document pursuant to                       toxicity data and considered its validity,            dermal absorption.
                                             FFDCA section 408(d)(3), 21 U.S.C.                      completeness, and reliability as well as                 Specific information on the studies
                                             346a(d)(3), announcing ISK’s                            the relationship of the results of the                received for cyclaniliprole as well as the
                                             amendment to its pesticide petition (PP                 studies to human risk. EPA has also                   no-observed-adverse-effect-level
                                             4F8253). The amended petition                           considered available information                      (NOAEL) from the toxicity studies can
                                             requested, in addition to the tolerances                concerning the variability of the                     be found at http://www.regulations.gov
                                             requested in the original petition, an                  sensitivities of major identifiable                   in document ‘‘Cyclaniliprole: Human
                                             exemption from the requirement of a                     subgroups of consumers, including                     Health Risk Assessment for the
                                             tolerance for indirect or inadvertent                   infants and children.                                 Proposed New Insecticide Active
                                             residues of cyclaniliprole in or on all                    No single or repeated dose study                   Ingredient’’ dated September 12, 2015 in
                                             food commodities, not already covered                   performed by any route of exposure                    docket ID number EPA–HQ–OPP–2014–
                                             by a tolerance. That document                           produced an adverse effect following                  0679.
                                             referenced a summary of the petition                    cyclaniliprole exposure below, at, or                    Based on the analysis of the available
                                             prepared by ISK Biosciences                             above the limit dose (1,000 mg/kg/day).               cyclaniliprole toxicological studies,
                                             Corporation, the petitioner, which is                   In short- and long-term studies in rats               there is no adverse toxicity seen in any
                                             available in the docket, http://                        and mice, the most consistent finding                 of the required submitted toxicology
                                             www.regulations.gov. A comment was                      was adaptive liver effects, which often               studies, and no toxicity endpoint and
                                             received on the notice of filing. EPA’s                 consisted of slight increases in liver                point of departure are established for
                                             response to that comment is discussed                   weight without associated clinical                    human health risk assessment.
                                             in Unit IV.C.                                           chemistry and histopathological                          Cyclaniliprole is proposed for use on
                                                Based upon review of the data                        changes, and it was seen mostly at or                 a variety of crops. Humans could
                                             supporting the petition, EPA is                         above the limit dose (1,000 mg/kg/day).               potentially be exposed to cyclaniliprole
                                             establishing tolerances that vary from                  In dogs, both subchronic and chronic                  residues in food because cyclaniliprole
                                             what was requested by the petitioner for                studies showed increases in liver                     may be applied directly to growing
                                             multiple commodities. The reasons for                   weight, centrilobular hepatocellular                  crops. These applications can also result
                                             these changes are explained in Unit                     hypertrophy, and elevated levels of                   in cyclaniliprole reaching surface and
                                             IV.D.                                                   alkaline phosphatase (ALP) at sub-limit               ground water, both of which can serve
                                                                                                     dose levels. However, these findings                  as sources of drinking water. There are
                                             III. Aggregate Risk Assessment and                      were not considered as adverse because                no proposed uses in residential settings;
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                                             Determination of Safety                                 of the following: (1) ALP increase in                 therefore, there are no anticipated
                                                Section 408(b)(2)(A)(i) of FFDCA                     dogs is a common laboratory finding                   residential exposures.
                                             allows EPA to establish a tolerance (the                and could be attributed to many factors                  Based on the toxicological profile of
                                             legal limit for a pesticide chemical                    such as corticosterone release, young                 cyclaniliprole, EPA has concluded that
                                             residue in or on a food) only if EPA                    dogs often have high and variable ALP                 the FFDCA requirements to retain an
                                             determines that the tolerance is ‘‘safe.’’              values related to bone growth,                        additional safety factor for protection of
                                             Section 408(b)(2)(A)(ii) of FFDCA                       cholestasis, and pharmacologically                    infants and children and to consider


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                                                               Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Rules and Regulations                                         36093

                                             cumulative effects do not apply. Section                United Nations Food and Agriculture                   with one exception. EPA is not
                                             408(b)(2)(C) requires an additional                     Organization/World Health                             establishing a tolerance for subgroup
                                             tenfold margin of safety in the case of                 Organization food standards program,                  22B since residue field trial data (celery)
                                             threshold risks, which are not present in               and it is recognized as an international              were not provided to support the
                                             this case. Section 408(b)(2)(D)(v)                      food safety standards-setting                         establishing a tolerance for the
                                             requires consideration of information                   organization in trade agreements to                   commodities in subgroup 22B.
                                             concerning cumulative effects of                        which the United States is a party. EPA                  Additionally, the EPA is establishing
                                             substances that have a common                           may establish a tolerance that is                     a tolerance for Vegetable, leafy, group 4–
                                             mechanism of toxicity, which                            different from a Codex MRL; however,                  16 at 15 ppm instead of the requested
                                             cyclaniliprole does not have.                           FFDCA section 408(b)(4) requires that                 tolerance for residues in or on the leafy
                                                Based on the available data indicating               EPA explain the reasons for departing                 greens subgroup 4–16A at 7.0 ppm and
                                             a lack of adverse effects from exposure                 from the Codex level.                                 Brassica leafy greens subgroup 4–16B at
                                             to cyclaniliprole, EPA concludes that                     The Codex has not established a MRL                 15 ppm. Based on the Organization for
                                             there is a reasonable certainty that no                 for cyclaniliprole.                                   Economic Cooperation and
                                             harm will result to the general                                                                               Development (OECD) tolerance
                                                                                                     C. Response to Comments
                                             population, or to infants and children                                                                        calculation procedures and residue data
                                             from aggregate exposure to                                A comment was received from an                      for head lettuce, leaf lettuce, and
                                             cyclaniliprole.                                         anonymous commenter objecting to EPA                  spinach, the tolerance level would be
                                                                                                     requesting denial of this petition and                8.0 ppm for leafy greens subgroup 4–
                                             IV. Other Considerations                                stating that ‘‘food should not be                     16A. However, instead of establishing
                                             A. Analytical Enforcement Methodology                   contaminated with these chemicals.’’                  the two subgroup tolerances, in order to
                                                                                                     The existing legal framework provided                 harmonize with Canada which has
                                                Method JSM0269 was developed for                     by section 408 of the Federal Food,                   established a crop group, Leafy
                                             plant commodities, and Method                           Drug, and Cosmetic Act (FFDCA) states                 Vegetables (CG 4–13) maximum residue
                                             JSM0277 was developed for livestock                     that tolerances may be set when the                   level (MRL) at 15 ppm, EPA is
                                             commodities. Residues of cyclaniliprole                 pesticide meets the safety standard                   establishing a tolerance for Vegetable,
                                             are extracted from crops using                          imposed by that statute. As required by               leafy, group 4–16 at 15 ppm.
                                             acetonitrile and cleaned up by solid                    that statute, EPA conducted a                            The EPA is also establishing lower
                                             phase extraction. Extracted residue                     comprehensive assessment of                           tolerance levels than requested for the
                                             levels are determined by liquid                         cyclaniliprole, including its potential               following commodities because the
                                             chromatography with tandem mass                         for carcinogenicity. Based on its                     residue of concern is parent only
                                             spectrometry (LC–MS/MS). Residues of                    assessment of the available data, the                 instead of parent and its metabolite NK–
                                             cyclaniliprole are extracted from                       Agency believes that given the observed               1375: Almond hulls, reduced from 8 to
                                             livestock using acetonitrile and cleaned                lack of toxicity of this chemical, no risks           6.0 ppm; wet apple pomace, reduced
                                             up by liquid-liquid partition with                      of concern are expected. Therefore, EPA               from 0.96 to 0.50 ppm; Vegetable,
                                             hexane followed by SPE. Extracted                       concludes that there is a reasonable                  Brassica, head and stem, group 5–16
                                             residue levels are determined by LC–                    certainty that no harm will result to the             reduced from 1.5 to 1.0 ppm; cucurbit
                                             MS/MS in positive ion spray mode.                       general population, or to infants and                 vegetables, crop group 9, reduced from
                                                Multiresidue methods testing data                    children, from aggregate exposure to                  0.2 to 0.15 ppm; small vine climbing
                                             have been submitted for cyclaniliprole                  cyclaniliprole.                                       fruit, except fuzzy kiwifruit, crop group
                                             and NK–1375. The data indicate that the                                                                       13–07F, reduced from 0.9 to 0.80 ppm;
                                                                                                     D. Revisions to Petitioned-For
                                             multiresidue methods (Protocols A                                                                             and for the following commodities for
                                                                                                     Tolerances
                                             through G) are not suitable for the                                                                           each animal (cattle, goat, horse, and
                                             analysis of cyclaniliprole, so the                         Tolerances were requested for                      sheep)—fat, reduced from 0.08 to 0.015
                                             multiresidue methods cannot serve as                    individual crops in the proposed Crop                 ppm; kidney (now included in meat
                                             enforcement methods. The multiresidue                   Subgroup 4–14A, Leafy greens subgroup                 byproducts), reduced from 0.08 to 0.015
                                             data have been sent to FDA.                             at 7.0 ppm; crops in the proposed Crop                ppm; meat, reduced from 0.02 to 0.01
                                                Adequate enforcement methodology                     Subgroup 4–14B, Brassica leafy greens                 ppm; meat byproducts, reduced from
                                             (LC–MS/MS) is available to enforce the                  subgroup at 15 ppm; crops in the                      0.02 to 0.015 ppm; and liver, reduced
                                             tolerance expression. The method may                    proposed Crop Subgroup 22B, Leaf                      from 0.1 to 0.015 ppm.
                                             be requested from: Chief, Analytical                    petiole vegetable subgroup at 7.0 ppm                    Based on OECD tolerance calculation
                                             Chemistry Branch, Environmental                         and the crops in the proposed Crop                    procedures, EPA is also establishing
                                             Science Center, 701 Mapes Rd., Ft.                      Group 5–14: Brassica Head and Stem                    higher tolerance levels than requested
                                             Meade, MD 20755–5350; telephone                         Vegetable at 1.5 ppm. These crop groups               for the following commodities: The
                                             number: (410) 305–2905; email address:                  were proposed in a Proposed Rule that                 stone fruit crop group 12–12, increased
                                             residuemethods@epa.gov.                                 published in the Federal Register of                  from 0.7 to 1.0 ppm; the tree nuts crop
                                                                                                     November 14, 2014 (79 FR 68153). In                   group 14–12, increased from 0.02 to
                                             B. International Residue Limits                         the time since the petition was initially             0.03 ppm, and tea, dried leaves,
                                               In making its tolerance decisions, EPA                filed, these crop group/subgroups have                increased from 40 to 50 ppm. No
                                             seeks to harmonize U.S. tolerances with                 been established, although with a                     tolerance is needed for tea, instant (dry
                                             international standards whenever                        slightly different numbering based on                 form) since residues are covered by the
                                             possible, consistent with U.S. food                     the year in which the crop groups were                tolerance on tea, dried.
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                                             safety standards and agricultural                       finalized, i.e., since the rule was                      EPA is establishing an increased
                                             practices. EPA considers the                            published in 2016, the groups end in a                tolerance on milk from 0.01 ppm to
                                             international maximum residue limits                    –16, instead of –14 when they were                    0.015 ppm to harmonize with Canada.
                                             (MRLs) established by the Codex                         proposed. See May 3, 2016 (85 FR                         Finally, tolerances were requested for
                                             Alimentarius Commission (Codex), as                     26471). Therefore, EPA is establishing                residues in/on kidney and liver of cattle,
                                             required by FFDCA section 408(b)(4).                    the subgroup/group tolerances as                      goat, horse, and sheep. According to
                                             The Codex Alimentarius is a joint                       requested but with the updated names                  current EPA policy, residues for liver


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                                             36094             Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Rules and Regulations

                                             and kidney will be covered by                           Children from Environmental Health                    Register. This action is not a ‘‘major
                                             tolerances for residues in/on meat                      Risks and Safety Risks’’ (62 FR 19885,                rule’’ as defined by 5 U.S.C. 804(2).
                                             byproducts so separate tolerances are                   April 23, 1997). This action does not
                                                                                                                                                           List of Subjects in 40 CFR Part 180
                                             not needed.                                             contain any information collections
                                                                                                     subject to OMB approval under the                       Environmental protection,
                                             V. Conclusion                                                                                                 Administrative practice and procedure,
                                                                                                     Paperwork Reduction Act (PRA) (44
                                                Although the lack of toxicity supports               U.S.C. 3501 et seq.), nor does it require             Agricultural commodities, Pesticides
                                             a safety finding for an exemption from                  any special considerations under                      and pests, Reporting and recordkeeping
                                             the requirement of tolerance for all                    Executive Order 12898, entitled                       requirements.
                                             crops, EPA is establishing tolerances for               ‘‘Federal Actions to Address                            Dated: June 30, 2017.
                                             residues resulting from direct                          Environmental Justice in Minority                     Richard P. Keigwin, Jr.,
                                             applications to certain commodities                     Populations and Low-Income                            Director, Office of Pesticide Programs.
                                             because the petitioner requested them                   Populations’’ (59 FR 7629, February 16,
                                             for international trade purposes.                       1994).                                                  Therefore, 40 CFR chapter I is
                                             Tolerances are established for residues                    Since tolerances and exemptions that               amended as follows:
                                             of cyclaniliprole, 3-bromo-N-[2-bromo-                  are established on the basis of a petition
                                             4-chloro-6-[[(1-cyclopropylethyl)                                                                             PART 180—[AMENDED]
                                                                                                     under FFDCA section 408(d), such as
                                             amino]carbonyl]phenyl]-1-(3-chloro-2-                   the tolerance in this final rule, do not              ■ 1. The authority citation for part 180
                                             pyridinyl)-1H-pyrazole-5-carboxamide,                   require the issuance of a proposed rule,              continues to read as follows:
                                             in or on Pome Fruit (Crop Group 11–10)                  the requirements of the Regulatory
                                             at 0.30 parts per million (ppm); Nut, tree                                                                        Authority: 21 U.S.C. 321(q), 346a and 371.
                                                                                                     Flexibility Act (RFA) (5 U.S.C. 601 et
                                             (Crop Group 14–12) at 0.03 ppm; Stone                   seq.), do not apply.                                  ■ 2. Add § 180.694 to subpart C to read
                                             Fruit (Crop Group 12–12) at 1.0 ppm;                       This action directly regulates growers,            as follows:
                                             Fruiting Vegetables (Crop Group 8–10)                   food processors, food handlers, and food
                                             at 0.20 ppm; Cucurbit Vegetables, (Crop                                                                       § 180.694         Cyclaniliprole; tolerances for
                                                                                                     retailers, not States or tribes, nor does
                                                                                                                                                           residues.
                                             Group 9) at 0.15 ppm; Small Fruit Vine                  this action alter the relationships or
                                             Climbing Subgroup except Fuzzy                          distribution of power and                               (a) General. Tolerances are
                                             Kiwifruit (Crop Group 13–07F) at 0.80                   responsibilities established by Congress              established for residues of the
                                             ppm; Vegetable, leafy, group 4–16 at 15                 in the preemption provisions of FFDCA                 insecticide cyclaniliprole, including its
                                             ppm; Vegetable, Brassica, head and                      section 408(n)(4). As such, the Agency                metabolites and degradates, in or on the
                                             stem, group 5–16 at 1.0 ppm; Milk at                    has determined that this action will not              commodities in the table below.
                                             0.015 ppm; tea, dried leaves at 50 ppm;                 have a substantial direct effect on States            Compliance with the tolerance levels
                                             Almond, hulls at 6.0 ppm; Apple, wet                    or tribal governments, on the                         specified below is to be determined by
                                             pomace at 0.50 ppm; cattle, goat, horse,                relationship between the national                     measuring only cyclaniliprole, 3-bromo-
                                             and sheep fat at 0.015 ppm; cattle, goat,               government and the States or tribal                   N-[2-bromo-4-chloro-6-[[(1-
                                             horse, and sheep meat at 0.01 ppm; and                  governments, or on the distribution of                cyclopropylethyl)amino]carbonyl]
                                             cattle, goat, horse, and sheep meat                     power and responsibilities among the                  phenyl]-1-(3-chloro-2-pyridinyl)-1H-
                                             byproducts at 0.015 ppm.                                various levels of government or between               pyrazole-5-carboxamide, in or on the
                                                Additionally, an exemption from the                  the Federal Government and Indian                     commodity.
                                             requirement of a tolerance is established               tribes. Thus, the Agency has determined
                                             for indirect or inadvertent residues of                 that Executive Order 13132, entitled                                                                   Parts
                                                                                                                                                                        Commodity                         per million
                                             cyclaniliprole, 3-bromo-N-[2-bromo-4-                   ‘‘Federalism’’ (64 FR 43255, August 10,
                                             chloro-6-[[(1-cyclopropylethyl)                         1999) and Executive Order 13175,                      Almond, hulls ........................                  6.0
                                             amino]carbonyl]phenyl]-1-(3-chloro-2-                   entitled ‘‘Consultation and Coordination              Apple, wet pomace ...............                      0.50
                                             pyridinyl)-1H-pyrazole-5-carboxamide,                   with Indian Tribal Governments’’ (65 FR               Cattle, fat ..............................            0.015
                                             in or on all raw agricultural                           67249, November 9, 2000) do not apply                 Cattle, meat ..........................                0.01
                                             commodities, except for those                           to this action. In addition, this action              Cattle, meat byproducts .......                       0.015
                                             commodities with tolerances                                                                                   Fruit, pome, group 11–10 .....                         0.30
                                                                                                     does not impose any enforceable duty or
                                                                                                                                                           Fruit, small vine climbing, ex-
                                             established.                                            contain any unfunded mandate as                         cept fuzzy kiwifruit, sub-
                                             VI. Statutory and Executive Order                       described under Title II of the Unfunded                group 13–07F ....................                    0.80
                                             Reviews                                                 Mandates Reform Act (UMRA) (2 U.S.C.                  Fruit, stone, group 12–12 .....                          1.0
                                                                                                     1501 et seq.).                                        Goat, fat ................................            0.015
                                               This action establishes tolerances                       This action does not involve any                   Goat, meat ............................                0.01
                                             under FFDCA section 408(d) in                           technical standards that would require                Goat, meat byproducts .........                       0.015
                                             response to a petition submitted to the                 Agency consideration of voluntary                     Horse, fat ..............................             0.015
                                             Agency. The Office of Management and                    consensus standards pursuant to section               Horse, meat ..........................                 0.01
                                             Budget (OMB) has exempted these types                                                                         Horse, meat byproducts .......                        0.015
                                                                                                     12(d) of the National Technology
                                             of actions from review under Executive                                                                        Milk .......................................          0.015
                                                                                                     Transfer and Advancement Act                          Nut, tree, group 14–12 .........                       0.03
                                             Order 12866, entitled ‘‘Regulatory                      (NTTAA) (15 U.S.C. 272 note).                         Sheep, fat .............................              0.015
                                             Planning and Review’’ (58 FR 51735,                                                                           Sheep, meat .........................                  0.01
                                             October 4, 1993). Because this action                   VII. Congressional Review Act
                                                                                                                                                           Sheep, meat byproducts ......                         0.015
                                             has been exempted from review under                       Pursuant to the Congressional Review                Tea, dried 1 ...........................                 50
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                                             Executive Order 12866, this action is                   Act (5 U.S.C. 801 et seq.), EPA will                  Vegetable, Brassica, head
                                             not subject to Executive Order 13211,                   submit a report containing this rule and                and stem, group 5–16 .......                          1.0
                                             entitled ‘‘Actions Concerning                           other required information to the U.S.                Vegetable, cucurbit, group 9                           0.15
                                             Regulations That Significantly Affect                   Senate, the U.S. House of                             Vegetable, fruiting, group 8–
                                             Energy Supply, Distribution, or Use’’ (66               Representatives, and the Comptroller                    10 ......................................            0.20
                                                                                                                                                           Vegetable, leafy, group 4–16                             15
                                             FR 28355, May 22, 2001) or Executive                    General of the United States prior to
                                             Order 13045, entitled ‘‘Protection of                   publication of the rule in the Federal                    1 There    are no U.S. registrations for Tea.



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                                                               Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Rules and Regulations                                           36095

                                               (b) Section 18 emergency exemptions.                  ADDRESSES:   Contact information for the              SUPPLEMENTARY INFORMATION:
                                             [Reserved]                                              EPA Headquarters:
                                                                                                        • Docket Coordinator, Headquarters;                Table of Contents
                                               (c) Tolerances with regional
                                             registrations. [Reserved]                               U.S. Environmental Protection Agency;                 I. Background
                                               (d) Indirect or inadvertent residues.                 CERCLA Docket Office; 1301                               A. What are CERCLA and SARA?
                                             [Reserved]                                              Constitution Avenue NW.; William                         B. What is the NCP?
                                                                                                     Jefferson Clinton Building West, Room                    C. What is the National Priorities List
                                             ■ 3. Add § 180.1344 to subpart D to read
                                                                                                                                                                 (NPL)?
                                             as follows:                                             3334, Washington, DC 20004, 202/566–                     D. How are sites listed on the NPL?
                                                                                                     0276.                                                    E. What happens to sites on the NPL?
                                             § 180.1344 Cyclaniliprole; exemption from                  The contact information for the                       F. Does the NPL define the boundaries of
                                             the requirement of a tolerance.                         regional dockets is as follows:                             sites?
                                                An exemption from the requirement                       • Holly Inglis, Region 1 (CT, ME, MA,                 G. How are sites removed from the NPL?
                                             of a tolerance is established for indirect              NH, RI, VT), U.S. EPA, Superfund                         H. May the EPA delete portions of sites
                                             and inadvertent residues of the                         Records and Information Center, 5 Post                      from the NPL as they are cleaned up?
                                             insecticide cyclaniliprole, including its               Office Square, Suite 100, Boston, MA                     I. What is the Construction Completion List
                                             metabolites and degradates, in or on all                02109–3912; 617/918–1413.                                   (CCL)?
                                             raw agricultural commodities not listed                    • Ildefonso Acosta, Region 2 (NJ, NY,                 J. What is the Sitewide Ready for
                                                                                                                                                                 Anticipated Use measure?
                                             in paragraph (a) of § 180.694, when                     PR, VI), U.S. EPA, 290 Broadway, New                     K. What is state/tribal correspondence
                                             residues are present therein as a result                York, NY 10007–1866; 212/637–4344.                          concerning NPL Listing?
                                             of subsequent uptake by crops rotated                      • Lorie Baker (ASRC), Region 3 (DE,                II. Availability of Information to the Public
                                             into fields where the crops in § 180.694                DC, MD, PA, VA, WV), U.S. EPA,                           A. May I review the documents relevant to
                                             (a) were treated with cyclaniliprole.                   Library, 1650 Arch Street, Mailcode                         this final rule?
                                             [FR Doc. 2017–16375 Filed 8–2–17; 8:45 am]              3HS12, Philadelphia, PA 19103; 215/                      B. What documents are available for review
                                                                                                     814–3355.                                                   at the EPA Headquarters docket?
                                             BILLING CODE 6560–50–P
                                                                                                        • Cathy Amoroso, Region 4 (AL, FL,                    C. What documents are available for review
                                                                                                     GA, KY, MS, NC, SC, TN), U.S. EPA, 61                       at the EPA regional dockets?
                                                                                                     Forsyth Street SW., Mailcode 9T25,                       D. How do I access the documents?
                                             ENVIRONMENTAL PROTECTION                                                                                         E. How may I obtain a current list of NPL
                                             AGENCY                                                  Atlanta, GA 30303; 404/562–8637.                            sites?
                                                                                                        • Todd Quesada, Region 5 (IL, IN, MI,              III. Contents of This Final Rule
                                             40 CFR Part 300                                         MN, OH, WI), U.S. EPA Superfund                          A. Additions to the NPL
                                                                                                     Division Librarian/SFD Records                           B. What did the EPA do with the public
                                             [EPA–HQ–OLEM–2016–0428, 0430, 0432,                     Manager SRC–7J, Metcalfe Federal                            comments it received?
                                             0434, 0435, 0436 and 0437; FRL–9965–31–
                                             OLEM]
                                                                                                     Building, 77 West Jackson Boulevard,                  IV. Statutory and Executive Order Reviews
                                                                                                     Chicago, IL 60604; 312/886–4465.                         A. Executive Order 12866: Regulatory
                                             National Priorities List                                   • Brenda Cook, Region 6 (AR, LA,                         Planning and Review and Executive
                                                                                                     NM, OK, TX), U.S. EPA, 1445 Ross                            Order 13563: Improving Regulation and
                                             AGENCY:  Environmental Protection                       Avenue, Suite 1200, Mailcode 6SFTS,                         Regulatory Review
                                             Agency (EPA).                                                                                                    B. Paperwork Reduction Act (PRA)
                                                                                                     Dallas, TX 75202–2733; 214/665–7436.                     C. Regulatory Flexibility Act (RFA)
                                             ACTION: Final rule.                                        • Kumud Pyakuryal, Region 7 (IA,                      D. Unfunded Mandates Reform Act
                                                                                                     KS, MO, NE), U.S. EPA, 11201 Renner                         (UMRA)
                                             SUMMARY:   The Comprehensive                            Blvd., Mailcode SUPRSTAR, Lenexa, KS                     E. Executive Order 13132: Federalism
                                             Environmental Response,                                 66219; 913/551–7956.                                     F. Executive Order 13175: Consultation
                                             Compensation, and Liability Act of 1980                    • Victor Ketellapper, Region 8 (CO,                      and Coordination With Indian Tribal
                                             (‘‘CERCLA’’ or ‘‘the Act’’), as amended,                MT, ND, SD, UT, WY), U.S. EPA, 1595                         Governments
                                             requires that the National Oil and                      Wynkoop Street, Mailcode 8EPR–B,                         G. Executive Order 13045: Protection of
                                             Hazardous Substances Pollution                          Denver, CO 80202–1129; 303/312–6578.                        Children From Environmental Health
                                             Contingency Plan (‘‘NCP’’) include a list                  • Sharon Murray, Region 9 (AZ, CA,                       and Safety Risks
                                             of national priorities among the known                  HI, NV, AS, GU, MP), U.S. EPA, 75                        H. Executive Order 13211: Actions That
                                             releases or threatened releases of                                                                                  Significantly Affect Energy Supply,
                                                                                                     Hawthorne Street, Mailcode SFD 6–1,                         Distribution, or Use
                                             hazardous substances, pollutants or                     San Francisco, CA 94105; 415/947–                        I. National Technology Transfer and
                                             contaminants throughout the United                      4250.                                                       Advancement Act (NTTAA)
                                             States. The National Priorities List                       • Ken Marcy, Region 10 (AK, ID, OR,                   J. Executive Order 12898: Federal Actions
                                             (‘‘NPL’’) constitutes this list. The NPL is             WA), U.S. EPA, 1200 6th Avenue,                             to Address Environmental Justice in
                                             intended primarily to guide the                         Mailcode ECL–112, Seattle, WA 98101;                        Minority Populations and Low-Income
                                             Environmental Protection Agency (‘‘the                  206/463–1349.                                               Populations
                                             EPA’’ or ‘‘the agency’’) in determining                 FOR FURTHER INFORMATION CONTACT:                         K. Congressional Review Act
                                             which sites warrant further                             Terry Jeng, phone: (703) 603–8852,                    I. Background
                                             investigation. These further                            email: jeng.terry@epa.gov. Site
                                             investigations will allow the EPA to                    Assessment and Remedy Decisions                       A. What are CERCLA and SARA?
                                             assess the nature and extent of public                  Branch, Assessment and Remediation                       In 1980, Congress enacted the
                                             health and environmental risks                          Division, Office of Superfund                         Comprehensive Environmental
                                             associated with the site and to                         Remediation and Technology                            Response, Compensation, and Liability
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                                             determine what CERCLA-financed                          Innovation (Mailcode 5204P), U.S.                     Act, 42 U.S.C. 9601–9675 (‘‘CERCLA’’ or
                                             remedial action(s), if any, may be                      Environmental Protection Agency; 1200                 ‘‘the Act’’), in response to the dangers of
                                             appropriate. This rule adds seven sites                 Pennsylvania Avenue NW., Washington,                  uncontrolled releases or threatened
                                             to the General Superfund section of the                 DC 20460; or the Superfund Hotline,                   releases of hazardous substances, and
                                             NPL.                                                    phone (800) 424–9346 or (703) 412–                    releases or substantial threats of releases
                                             DATES: The document is effective on                     9810 in the Washington, DC,                           into the environment of any pollutant or
                                             September 5, 2017.                                      metropolitan area.                                    contaminant that may present an


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Document Created: 2017-08-03 07:24:58
Document Modified: 2017-08-03 07:24:58
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 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).
ContactMichael 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
FR Citation82 FR 36090 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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