[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Rules and Regulations]
[Pages 56262-56269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24379]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0694; FRL-9985-32]


Cyantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyantraniliprole in or on multiple commodities which are identified and 
discussed later in this document. The Interregional Research Project 
No. 4 (IR-4) and DuPont Crop Protection requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 13, 2018. Objections and 
requests for hearings must be received on or before January 14, 2019, 
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-2017-0694, 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 Goodis, 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. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select ``Test Methods and Guidelines.''

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-2017-0694 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 
January 14, 2019. 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-2017-0694, 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    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 March 21, 2018 (83 FR 12311) (FRL-9974-
76), 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 
7E8631) by The Interregional Research Project No. 4 (IR-4), Rutgers, 
The State University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.672 be 
amended by establishing tolerances for residues of the insecticide, 
cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-
6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, in or on 
Berry, low growing, except strawberry, subgroup 13-07H, except 
blueberry, lowbush and lingonberry at 0.08 parts per million (ppm) 
(proposal to replace an existing tolerance at the same level that is 
only for imported Berry, low growing, except strawberry, subgroup 13-
07H, with a tolerance supporting both domestic production and imported 
low growing berries, except strawberries); Brassica, leafy greens, 
subgroup 4-16B at 30 ppm; Caneberry subgroup 13-07A at 4.0 ppm; Celtuce 
at 20 ppm; Coffee, green bean at 0.05 ppm (proposal to replace an 
existing tolerance at the same level that is only for imported Coffee, 
green bean with a tolerance supporting both domestic production and 
imported coffee); Florence fennel at 20 ppm; Kohlrabi at 3.0 ppm; Leafy 
greens subgroup 4-16A at 20 ppm; Leaf petiole vegetable subgroup 22B at 
20 ppm; and Vegetable,

[[Page 56263]]

Brassica, head and stem, group 5-16 at 3.0 ppm. Upon the establishment 
of the above tolerances, IR-4 proposed to remove existing tolerances in 
40 CFR part 180.672 in or on the following commodities: Brassica head 
and stem, subgroup 5A at 3.0 ppm; Brassica leafy vegetables, subgroup 
5B at 30 ppm; and Vegetable, leafy, except Brassica, group 4 at 20 ppm.
    In the Federal Register of April 11, 2018 (83 FR 15528) (FRL-9975-
57), 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 
7F8622) by DuPont Crop Protection, Stine-Haskell Research Center, P.O. 
Box 30, Newark, DE 19714-0030. The petition requested that 40 CFR 
180.672 be amended by establishing tolerances for residues of the 
insecticide cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-
cyano-2-methyl-6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-
carboxamide, in or on Rice, hulls at 0.05 ppm; Rice, straw at 0.015 
ppm; Soybean, forage at 15 ppm; Soybean, hay at 50 ppm; Soybean, hulls 
at 1 ppm; Soybean, seed at 0.4 ppm; and Aspirated grain fractions at 
200 ppm. Upon the approval of the proposed tolerances in soybean forage 
and hay, it is proposed that the existing tolerances for indirect or 
inadvertent residues in soybean forage and hay be cancelled. In 
addition, DuPont Crop Protection requests to amend the tolerances in 40 
CFR 180.672, in or on rice, grain at 0.02 ppm by replacing an existing 
tolerance at the same level that is only for imported grain with a 
tolerance supporting both domestic production and imported grain.
    These documents referenced summaries of the petitions prepared by 
DuPont Crop Protection, the registrant, which are available in the 
docket, http://www.regulations.gov. Three comments were received on the 
notices of filing. EPA's response to these comments is discussed in 
Unit IV.C.
    Based upon review of the data supporting the petition, EPA modified 
some of the tolerance levels to conform to EPA's rounding classes and 
revised the commodity terminology for two tolerances. 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 cyantraniliprole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with 
cyantraniliprole follows.

A. Toxicological Profile

    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.
    In general, cyantraniliprole administration in mammalian test 
species produces both adverse and adaptive changes in the liver, 
thyroid gland, and adrenal cortex. With repeated dosing, consistent 
findings of mild to moderate increases in liver weights across multiple 
species (rats, mice and dogs) are observed. Dogs appear to be more 
sensitive than rats and mice; cyantraniliprole produces adverse liver 
effects (increases in alkaline phosphatase, decreases in cholesterol, 
and decreases in albumin) in dogs at lower dose levels than in rats. In 
addition, the liver effects in the dog show progressive severity with 
increased duration of exposure. The available data also show thyroid 
hormone homeostasis is altered in rats following exposure to 
cyantraniliprole after 28 or 90 days; however, cyantraniliprole is not 
a direct thyroid toxicant.
    Cyantraniliprole is classified as ``not likely to be carcinogenic 
to humans'' based on the absence of increased tumor incidence in 
acceptable/guideline carcinogenicity studies in rats and mice, and 
there are no mutagenicity concerns. There are also no developmental or 
reproductive toxicity concerns and no offspring susceptibility 
concerns. Cyantraniliprole does not produce developmental toxicity in 
either rats or rabbits. The 2-generation reproduction study in rats 
shows that cyantraniliprole has no adverse effect on any reproductive 
parameters.
    Acute and subchronic neurotoxicity studies reveal no evidence of 
neurotoxicity. Similarly, cyantraniliprole does not adversely impact 
the immune system in rats and mice. Based on the results of a 28-day 
dermal study in rats (as well as the dermal LD50 study), 
cyantraniliprole does not demonstrate any appreciable toxicity via 
dermal exposure. The 28-day inhalation toxicity study in rats does not 
show any adverse systemic or portal of entry effect at the highest 
concentration tested (100 mg/m\3\, equivalent to 18 mg/kg/day).
    Cyantraniliprole has no significant acute toxicity via the oral, 
dermal, and inhalation routes of exposure. Cyantraniliprole is not an 
eye or skin irritant and does not cause skin sensitization.
    Specific information on the studies received and the nature of the 
adverse effects caused by cyantraniliprole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Cyantraniliprole. Human Health Risk 
Assessment for Proposed Uses and Tolerance Requests on Coffee; 
Caneberry Subgroup 13-07A; Low Growing Berry Subgroup 13-07H, Except 
Strawberry, Lowbush Blueberry and Lingonberry; Brassica Leafy Greens 
Subgroup 4-16A; Leafy Greens Subgroup 4-16B; Brassica Head and Stem 
Vegetable Group 5-16; Leaf Petiole Vegetable Subgroup 22B; Celtuce; 
Florence Fennel; Kohlrabi; Rice; Soybean; and Aspirated Grain 
Fractions'' on pages 36-45 in docket ID number EPA-HQ-OPP-2017-0694.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there

[[Page 56264]]

is no appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological endpoints for cyantraniliprole used 
for human risk assessment is discussed in Unit III.B of the final rule 
published in the Federal Register of February 5, 2014 (79 FR 6826) 
(FRL-9388-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyantraniliprole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing cyantraniliprole 
tolerances in 40 CFR 180.672. EPA assessed dietary exposures from 
cyantraniliprole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for cyantraniliprole; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the 2003-2008 United 
States Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, a refined chronic (food and drinking 
water) dietary assessment was conducted assuming average field trial 
residues for all crops (except crop subgroup 1A, for which tolerance 
level residues were assumed); percent crop treated (PCT) data; 
empirical processing factors; and default processing factors were used 
as appropriate.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that cyantraniliprole does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on 
the actual percent of food treated for assessing chronic dietary risk 
only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: If data are available on pesticide use and 
food consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such areas.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the average PCT for existing uses as follows: 
Citrus: oranges 62%, grapefruit 87%, and lemons 46%; pome fruit: apples 
61% and pears 76%; stone fruits: apricots 53%, cherries 48%, peaches 
41%, and plums/prunes 59%; tree nuts: almonds 72%, hazelnuts 65%, 
pecans 22%, pistachios 49%, and walnuts 53%; bushberries (subgroup 13-
07B): blueberries 45%; fruiting vegetables: peppers 45% and tomatoes 
54%; cucurbits: cantaloupes 50%, cucumbers 23%, pumpkins 18%, squash 
24%, and watermelons 29%; leafy vegetables: celery 70%, lettuce 78%, 
and spinach 53%; Brassica (cole) leafy vegetables: broccoli 81%, 
cabbage 50%, and cauliflower 83%; onion 58%; potato 50%; oilseeds: 
canola 15% and sunflower 35%; corn 56%, cotton 41%; peanuts 41%; 
carrots 23%; soybeans 21%; strawberries 59%; vegetable crop group 7: 
dry beans/peas 6%, soybeans 21%, beans (snap, bush, etc.) 49%, and peas 
fresh/green/sweet) 38%; vegetable crop group 2: sugar beets 40%; 
vegetable crop group 6A: soybeans 21%, beans (snap, bush, etc., string) 
49%; peas fresh/green/sweet) 38%; and vegetable crop group 6C: dried 
bean and peas 6%. 100 PCT was assumed for all other crops, including 
all proposed new use crops. For imported grapes (wine grapes), a 50% 
import estimate was used in the chronic dietary risk assessment.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and California Department of 
Pesticide Regulation (CDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic dietary risk analysis and a maximum PCT for 
acute dietary risk analysis. The average PCT figures for each existing 
use are derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding up 
to the nearest 5%, except for those situations in which the average PCT 
is less than 1% or less than 2.5%. In those cases, the Agency would use 
less than 1% or less than 2.5% as the average PCT value, respectively. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 10 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5%, except where the maximum PCT is less than 2.5%, in which case, 
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to

[[Page 56265]]

which cyantraniliprole may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for cyantraniliprole in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of cyantraniliprole. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticides in Water Calculator (PWC; version 1.52) and 
Pesticide Root Zone Model Ground Water (PRZM GW) for ground water and 
FQPA Index Reservoir Screening Tool (FIRST) for surface water, the 
estimated drinking water concentrations (EDWCs) of cyantraniliprole for 
chronic exposures for non-cancer assessments are estimated to be 24 ppb 
for surface water and 64 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration value of 64 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Cyantraniliprole is currently registered for the following uses 
that could result in residential exposures: Turf grass (including 
residential, recreational, and golf course turf), ornamentals, and 
structural buildings (including indoor crack/crevice and outdoor 
broadcast). EPA assessed residential exposure using the following 
assumptions: EPA determined that residential exposures may occur by the 
dermal, oral, and inhalation routes of exposures. However, since dermal 
hazard has not been identified for cyantraniliprole, the only exposures 
of concern are handler inhalation (for adults), and post-application 
incidental oral (for children). Residential handler exposure is 
expected to be short-term in duration. The turf and ornamental labels 
indicate that a maximum of two applications are allowed per season. 
Thus, intermediate-term handler exposures are not likely because of the 
intermittent nature of applications by homeowners. Post-application 
incidental oral exposures for children may occur for short- and 
intermediate-term durations due to the persistence of cyantraniliprole. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has not found 
cyantraniliprole to share a common mechanism of toxicity with any other 
substances, and cyantraniliprole does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that cyantraniliprole does 
not have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
susceptibility in developmental toxicity studies in rats and rabbits. 
The developmental toxicity study in rats is tested up to the limit dose 
(1,000 mg/kg/day). In the rabbit developmental toxicity study, 
decreases in fetal body weight are seen at a dose higher than that 
resulting in maternal effects. In the reproductive toxicity study, 
increased incidence of thyroid follicular epithelium hypertrophy/
hyperplasia occurs in F1 parental animals at a dose lower 
than that for the parental (P) generation. A clear NOAEL (1.4 mg/kg/
day) is established for F1 parental animals, and the PODs 
selected for risk assessment from the dog studies (1 or 3 mg/kg/day) 
are protective of the effect (thyroid effect) seen in the F1 
parental animals. In addition, the submitted data support the 
conclusion that the effects on the thyroid are secondary to effects on 
the liver. As such, a comparative thyroid study is not required at this 
time.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for cyantraniliprole is complete.
    ii. There is no indication that cyantraniliprole is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that cyantraniliprole results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The exposure databases are complete or are estimated based 
on data that reasonably account for potential exposures. The chronic 
dietary food exposure assessment was a refined assessment which assumed 
average field trial residues for all crops (except crop subgroup 1A); 
PCT when available; empirical processing factors, if available, or 
default processing factors, as appropriate. The 2012 Residential 
standard operating procedures (SOPs) were previously used to assess 
post-application exposure to children including incidental oral 
exposure, and the residential post-application assessment assumed that 
maximum application rates are applied and that hand-to-mouth activities 
occur on the day of application. All of the exposure estimates are 
based on conservative, health-protective assumptions and are not likely 
to underestimate risk. EPA made conservative (protective) assumptions 
in the ground and surface water modeling used to assess exposure to 
cyantraniliprole in drinking water. EPA used similarly conservative 
assumptions to assess post application exposure of children as well as

[[Page 56266]]

incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by cyantraniliprole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
cyantraniliprole is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
cyantraniliprole from food and water will utilize 99% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
cyantraniliprole is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). 
Cyantraniliprole is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to cyantraniliprole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in an aggregate MOE of 149 for 
children 1 to 2 years old. For adults, the oral and inhalation routes 
of exposure are not appropriate to be aggregated since the endpoints of 
concern are not common. Because EPA's level of concern for 
cyantraniliprole is a MOE of 100 or below, this MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Cyantraniliprole is currently registered for uses that could 
result in intermediate-term residential exposure, however, the short-
term aggregate risk estimate described above is protective of potential 
intermediate-term exposures and risks in children.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, cyantraniliprole is not expected to pose a cancer risk to 
humans.
    6. Determination of safety. Based on these risk assessments, 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 cyantraniliprole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem 
mass spectroscopy (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.
    There are no established Codex MRLs on the caneberry subgroup 13-
07A, soybean, aspirated grain fractions, celtuce, Florence fennel and 
rice. The U.S. tolerances being established for coffee and Brassica, 
leafy greens subgroup 4-16A are harmonized with Codex. The U.S. 
tolerances being established for the low growing berry subgroup 13-07H; 
leaf petiole vegetable subgroup 22B; Brassica head and stem vegetable 
group 5-16; leafy greens subgroup 4-16B; and kohlrabi are not 
harmonized with Codex MRLs. The Codex MRLs established for residues of 
cyantraniliprole on these commodities are lower than the recommended 
U.S. tolerances. The U.S. tolerances cannot be harmonized because 
following the label use directions could result in residues above the 
established Codex MRLs.

C. Response to Comments

    EPA received three comments in response to the Notices of Filing. 
The first comment indicated IR-4 and Rutgers University are 
profiteering by registering pesticides. The content of this comment is 
not material to the safety of the tolerances that are the subject of 
this action; pesticide registration occurs under the provisions of the 
Federal Insecticide, Fungicide, and Rodenticide Act. The FFDCA allows 
any person to file a petition proposing the establishment of a 
tolerance, and financial benefit from associated registration of 
pesticides is not a factor EPA considers when determining whether a 
tolerance is safe.
    The second comment stated, in part, that no residues should be 
allowed. The Agency recognizes that some individuals believe that 
pesticides should be banned on agricultural crops. However, the 
existing legal framework provided by section 408 of the Federal Food, 
Drug and Cosmetic Act (FFDCA) states that tolerances may be set when 
persons seeking such tolerances or exemptions have demonstrated that 
the pesticide meets the safety standard imposed by that statute. This 
citizen's comment appears to be directed at the underlying statute and 
not EPA's implementation of it; the citizen has made no contention that 
EPA has acted in violation of the statutory framework.
    The last comment expressed concern about pollutant loadings and 
relatively high costs of regulations. The commenter also mentioned the 
Shelby Amendment, the Freedom of Information Act and the 
Intergovernmental Panel on Climate Change. The comment did not raise 
any issue related to the Agency's safety determination for 
cyantraniliprole tolerances. The receipt of this comment

[[Page 56267]]

is acknowledged; however, this comment is not relevant to this action.

D. Revisions to Petitioned-For Tolerances

    EPA modified the proposed tolerance levels for soybean, hulls and 
soybean, seed to conform to the Agency's rounding classes. The Agency 
also revised the commodity terminology to use the correct commodity 
definitions for Florence fennel (Fennel, Florence, fresh leaves and 
stalk) and Aspirated grain fractions (Grain, aspirated grain 
fractions).

V. Conclusion

    Therefore, tolerances are established for residues of 
cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-
6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, in or on 
Berry, low growing, except strawberry, subgroup 13-07H, except 
blueberry, lowbush and lingonberry at 0.08 parts per million (ppm); 
Brassica, leafy greens, subgroup 4-16B at 30 ppm; Caneberry subgroup 
13-07A at 4.0 ppm; Celtuce at 20 ppm; Fennel, Florence, fresh leaves 
and stalk at 20 ppm; Grain, aspirated grain fractions at 200 ppm; 
Kohlrabi at 3.0 ppm; Leaf petiole vegetable subgroup 22B at 20 ppm; 
Leafy greens subgroup 4-16A at 20 ppm; Rice hulls at 0.05 ppm; Rice, 
straw at 0.015 ppm; Soybean, forage at 15 ppm; Soybean, hay at 50 ppm; 
Soybean, hulls at 1.0 ppm; Soybean, seed at 0.40 ppm; and Vegetable, 
Brassica, head and stem, group 5-16 at 3.0 ppm. In addition, EPA is 
removing the following tolerances as they are superseded by the new 
tolerances being established in this rulemaking: from paragraph (a) 
(Berry, low growing, except strawberry, subgroup 13-07H at 0.08 ppm; 
Brassica head and stem, subgroup 5A at 3.0 ppm; Brassica leafy 
vegetables, subgroup 5B at 30 ppm; and Vegetable, leafy, except 
Brassica, group 4 at 20 ppm) and from paragraph (d) (soybean, forage at 
0.70 ppm and soybean, hay at 0.70 ppm). Finally, EPA is removing the 
footnote noting the lack of US registrations for the tolerances for 
coffee, green bean and rice, grain.

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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: October 24, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.672:
0
a. In the table to paragraph (a):
0
i. Remove the entry ``Berry, low growing, except strawberry, subgroup 
13-07H\1\''.
0
ii. Add alphabetically the entry ``Berry, low growing, except 
strawberry, subgroup 13-07H, except blueberry, lowbush and 
lingonberry''.
0
iii. Remove the entry ``Brassica head and stem, subgroup 5A''.
0
iv. Add alphabetically the entry ``Brassica, leafy greens, subgroup 4-
16B.
0
v. Remove the entry ``Brassica leafy vegetables, subgroup 5B''.
0
vi. Add alphabetically the entries: ``Caneberry subgroup 13-07A'' and 
``Celtuce''.
0
vii. Revise the entry ``Coffee, green bean''.
0
viii. Add alphabetically the entries: ``Fennel, Florence, fresh leaves 
and stalk''; ``Grain, aspirated grain fractions''; ``Kohlrabi''; ``Leaf 
petiole vegetable subgroup 22B''; ``Leafy greens subgroup 4-16A'';
0
ix. Revise the entry ``Rice, grain''.
0
x. Add alphabetically the entries: ``Rice hulls''; ``Rice, straw''; 
``Soybean, forage''; ``Soybean, hay''; ``Soybean, hulls''; ``Soybean, 
seed''; and ``Vegetable, Brassica, head and stem, group 5-16''.
0
xi. Remove the entry ``Vegetable, leafy, except Brassica, group 4''.

[[Page 56268]]

0
b. Remove from the table in paragraph (d) the entries: ``Soybean, 
forage''; and ``Soybean, hay''.
    The additions and revisions read as follows:


Sec.  180.672   Cyantraniliprole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Berry, low growing, except strawberry, subgroup 13-07H,             0.08
 except blueberry, lowbush and lingonberry..............
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Brassica, leafy greens, subgroup 4-16B..................              30
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Caneberry subgroup 13-07A...............................             4.0
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Celtuce.................................................              20
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Coffee, green bean......................................            0.05
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Fennel, Florence, fresh leaves and stalk................              20
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Grain, aspirated grain fractions........................             200
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Kohlrabi................................................             3.0
------------------------------------------------------------------------
Leaf petiole vegetable subgroup 22B.....................              20
Leafy greens subgroup 4-16A.............................              20
 
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
Rice, grain.............................................            0.02
------------------------------------------------------------------------
Rice, hulls.............................................            0.05
Rice, straw.............................................           0.015
 
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
Soybean, forage.........................................              15
Soybean, hay............................................              50
Soybean, hulls..........................................             1.0
Soybean, seed...........................................            0.40
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Vegetable, Brassica, head and stem, group 5-16..........             3.0
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 56269]]

* * * * *
[FR Doc. 2018-24379 Filed 11-9-18; 8:45 am]
 BILLING CODE 6560-50-P


