[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Rules and Regulations]
[Pages 14623-14631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05707]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0357; FRL-9958-53]


Cyantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
cyantraniliprole in or on multiple commodities which are identified and 
discussed later in this document. E.I. DuPont de Nemours & Company and 
Syngenta Crop Protection, LLC requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 22, 2017. Objections and 
requests for hearings must be received on or before May 22, 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-2014-0357 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.

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-2014-0357 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 
May 22, 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-

[[Page 14624]]

2014-0357, 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 January 28, 2015 (80 FR 4525) (FRL-9921-
55), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
4F8258 and 4F8320) by E.I. du Pont de Nemours & Company, 1007 Market 
St., Wilmington, DE 19898 and Syngenta Crop Protection LLC, P.O. Box 
18300, Greensboro, NC 27419, respectively. The petitions requested that 
40 CFR part 180 be amended by establishing tolerances for residues of 
the insecticide cyantraniliprole, in or on artichokes, globe (import 
tolerance) at 0.1 parts per million (ppm); berries, low growing, except 
strawberries (crop subgroup 13-07H) (import tolerance) at 0.08 ppm; 
coffee, bean, green (import tolerance) at 0.05 ppm; grapes (import 
tolerance) at 1.5 ppm; olives (import tolerance) at 1.5 ppm; peanuts at 
0.01 ppm; peanut hay at 3 ppm; pomegranates (import tolerance) at 0.01 
ppm; rice, grain (import tolerance) at 0.03 ppm; soybeans, seed at 0.4 
ppm; strawberries at 1.0 ppm; vegetables, foliage of legume (crop group 
7) at 50 ppm; vegetables, leaves of root and tuber (crop group 2) at 40 
ppm; vegetables, legume, dried shelled, except soybean (crop subgroup 
6C) at 0.9 ppm; vegetables, legume, edible podded (crop subgroup 6A) at 
2 ppm; vegetables, legume, succulent shelled (crop subgroup 6B) at 0.2 
ppm; vegetables, root, except sugar beet (crop subgroup 1B) at 0.4 ppm; 
and tea, dried (import tolerance) at 30 ppm (PP 4F8258) and corn, field 
and pop, forage at 0.04 ppm; corn, field and pop, grain at 0.01 ppm; 
corn, field and pop, stover at 0.015 ppm; corn, sweet, forage at 0.02 
ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; and 
corn, sweet, stover at 0.08 ppm (PP 4F8320). That document referenced a 
summary of the petitions prepared by E.I. du Pont de Nemours & Company 
and Syngenta Crop Protection LLC, the registrants, which is available 
in the dockets EPA-HQ-OPP-2014-0357 and EPA-HQ-OPP-2014-0890, 
respectively, at http://www.regulations.gov. Comments were received on 
the notice of filing. EPA's response to these comments is discussed in 
Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which and the commodities upon which tolerances 
are being established. 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 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 mammals 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 90 days due to enhanced metabolism of the 
thyroid hormones by the liver. However, cyantraniliprole does not act 
directly on the thyroid; the thyroid effects observed are secondary to 
the effects on the liver.
    Cyantraniliprole is classified as ``Not Likely to be Carcinogenic 
to Humans'' based on the absence of increased tumor incidence in 
carcinogenicity studies in rats and mice. In addition, there are no 
genotoxicity, mutagenicity, neurotoxicity, or immunotoxicity concerns. 
There are also no developmental or reproductive toxicity concerns and 
there is no evidence of an adverse effect attributable to a single 
dose.
    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 the document titled ``Cyantraniliprole. Human 
Health Risk Assessment for the Proposed Uses on Root Vegetables (except 
Sugar Beet) (Crop Subgroup 1B), Leaves of Root and Tuber Vegetables 
(Crop Group 2), Legume Vegetables (Crop Group 6 except soybean), Leaves 
of Legume Vegetables (Crop Group 7 except soybean), Peanuts, 
Strawberries, Tobacco and Seed Treatment Uses on Corn (Field, Pop, 
Seed, Sweet). Tolerance Requests without U.S. Registration for 
Artichokes, Coffee Green Bean, Wine Grapes, Low Growing Berries (except 
Strawberries) (Crop Subgroup 13-07H), Olives, Pomegranate, and Tea 
Dried. Amended Tolerance Requests for Cucurbit

[[Page 14625]]

Vegetables (Crop Group 9) due to New Use Pattern and Amended Uses for 
Tomatoes and Peppers'' on page 40 in docket ID number EPA-HQ-OPP-2014-
0357.

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 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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    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 proposed crops (except sugar beet root), percent crop 
treated (PCT) where available, and percent crop treated for new uses 
(PCTn) for some crops. In addition, the estimated percentage of 
imported grapes was incorporated into the assessment. For processed 
commodities, input values included combined average residues of parent 
and the metabolite (IN-J9Z38) with relevant processing factors. The 
chronic assessment incorporated empirical processing factors, if 
available, or Dietary Exposure Evaluation Model (DEEM) Version 7.81 
default processing factors as appropriate. Empirical processing factors 
were used for potato flakes and chips, tomatoes (paste, puree, dried, 
and juice), orange juice, apple juice, cottonseed oil, citrus oil, and 
dried plums. The processing factors for these commodities were set at 1 
because the residue input values included combined residues of the 
parent and the metabolite with relevant processing factors. Crop field 
trial data depicting residues in/on citrus fruit peels (lemon and 
orange) were available and included into the assessment.
    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 PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    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: 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 area.

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 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%; and corn 56%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the

[[Page 14626]]

maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. 
The maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency estimated the PCT for new uses as follows:
    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%; vegetable 
crop group 6C: Dried bean and peas 6%. For the imported grapes (wine 
grapes) a 50% import estimate was used in the chronic dietary risk 
assessment.
    EPA estimates of the PCTn of cyantraniliprole represent the upper 
bound of use expected during the pesticide's initial five years of 
registration; that is, PCTn for cyantraniliprole is a threshold of use 
that EPA is reasonably certain will not be exceeded for each registered 
use site. The PCTn recommended for use in the chronic dietary 
assessment is calculated as the average PCT of the market leader or 
leaders (i.e., the currently registered pesticide(s) with the greatest 
PCT) on that site over the three most recent years of available data. 
Comparisons are only made among pesticides of the same pesticide type 
(e.g., the market leader for insecticides on the use site is selected 
for comparison with a new insecticide). The market leader included in 
the estimation may not be the same for each year since different 
pesticides may dominate at different times.
    Typically, EPA uses USDA/NASS as the source of data because it is 
publicly available and directly reports values for PCT. When a specific 
use site is not reported by USDA/NASS, EPA uses market survey data and 
calculates the PCT given reported data on acres treated and acres 
grown. If no data are available, EPA may extrapolate PCTn from other 
crops, if the production area and pest spectrum are substantially 
similar.
    A retrospective analysis to validate this approach shows few cases 
where the PCT for the overall market leaders were exceeded. Further 
review of these cases identified factors contributing to the 
exceptionally high use of a new pesticide. To evaluate whether the PCTn 
for cyantraniliprole could be exceeded, EPA considered whether there 
may be unusually high pest pressure, as indicated in emergency 
exemption requests for cyantraniliprole; how the pest spectrum of the 
new pesticide compares with the market leaders; and whether pest 
resistance issues with past market leaders provide cyantraniliprole 
with significant market potential. EPA also considered the potential 
for resistance to cyantraniliprole to develop as a limiting factor in 
its use. Given currently available information, EPA concludes that it 
is unlikely that actual PCT for cyantraniliprole will exceed the 
estimated PCT for new uses during the next five years.
    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 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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Pesticide in Water Calculator (PWC), the estimated drinking water 
concentrations (EDWCs) of cyantraniliprole for chronic exposures are 
estimated to be 24 ppb for surface water and 64 ppb for ground water, 
respectively.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. An acute dietary risk 
assessment was not conducted since no acute toxicological effects were 
found. For the 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: Turfgrass (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: Residential exposure may 
occur by the dermal, oral, and inhalation routes and is expected to be 
short-term in duration of exposures. However, since a 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). For adults, the oral and inhalation routes of 
exposure were not aggregated since the endpoints of concern are not 
common. The turf and ornamental labels indicate that a maximum of two 
applications are allowed per season. Thus, intermediate-term 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. Although intermediate-term incidental oral post-
application exposures are possible (i.e., from soil ingestion, due to 
the persistence of cyantraniliprole), the short-term incidental oral 
exposures are protective of the possible intermediate-term incidental 
oral exposures because the POD for both durations is the same. Further 
information regarding EPA standard assumptions and generic inputs for 
residential exposures may be found at http://www2.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

[[Page 14627]]

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 Web site at http://www2.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 Food Quality 
Protection Act (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 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 at 14 mg/kg/day) 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.
    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 of susceptibility in developmental 
toxicity studies in rats and rabbits. 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. However, for the 
reasons summarized in Unit III.D.2. these effects are not of concern.
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic dietary food exposure assessment was a refined 
assessment which assumed average field trial residues for all crops 
(except sugar beet root), PCT where available, and PCTn data. 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 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 98% of the cPAD for 
children 1-2 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 1-2 years old. For adults, the oral and inhalation routes of 
exposure were not 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.

[[Page 14628]]

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.
    For the commodities discussed in this action, there are only Codex 
MRLs established for residues of cyantraniliprole on coffee beans (0.03 
ppm), cucurbit fruiting vegetables (0.3 ppm), legume animal feeds (in 
the U.S. identified as Foliage of legume vegetables) (0.8 ppm), and 
root and tuber vegetables (0.05 ppm). There are also Codex MRLs for 
residues of cyantraniliprole in/on ruminants at (0.01-0.05 ppm), milk 
(0.02 ppm), and poultry commodities at (0.01 ppm).
    The EPA has not harmonized the tolerances for these commodities 
with the existing Codex MRLs. The petitioner requested a tolerance on 
coffee without a U.S. registration be established at 0.05 ppm to be 
line with the existing MRL for coffee in Canada. The Codex MRLs 
established for residues of cyantraniliprole on cucurbit fruiting 
vegetables at 0.3 ppm, root and tuber vegetables at 0.05 ppm, and 
legume animal feeds at 0.8 ppm are lower than the U.S. tolerances of 
0.7 ppm, 0.15 ppm and 40 ppm, respectively. The U.S. tolerances cannot 
be harmonized because following the label use directions could result 
in residues above the established Codex MRLs. The Codex MRLs for 
residues of cyantraniliprole in/on ruminants at (0.01-0.05 ppm), milk 
(0.02 ppm), and poultry commodities at (0.01 ppm) are lower than the 
U.S. tolerances. The U.S. and Codex livestock MRLs are not harmonized 
due to different animal diets and tolerances (MRLs) established for 
different animal feed commodities. The U.S. tolerances cannot be 
harmonized (lowered) because following the label use directions could 
result in residues above the Codex MRLs.

C. Response to Comments

    A comment was submitted on behalf of the Center for Biological 
Diversity and the Center for Food Safety and was primarily concerned 
about EPA's consideration of the impacts of cyantraniliprole on the 
environment, pollinators, and endangered species. This comment is not 
relevant to the Agency's evaluation of safety of the cyantraniliprole 
tolerances under section 408 of the FFDCA, which requires the Agency to 
evaluate the potential harms to human health, not effects on the 
environment.
    EPA received two other comments to the Notices of Filing noting 
general concerns about the toxicity of this chemical and stating, in 
part, that ``this product represents a clear and present danger'' and 
``should not be approved to be sold.'' The Agency understands the 
commenter's concerns and recognizes that some individuals believe that 
pesticides should be banned on agricultural crops. However, the 
existing legal framework provided by section 408 of the 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. EPA has assessed the effects of this 
chemical on human health and determined that aggregate exposure to it 
will be safe.

D. Revisions to Petitioned-For Tolerances

    The Agency is not establishing the proposed tolerances for corn, 
field and pop, forage; corn, field and pop stover; corn, sweet, forage; 
and corn, sweet stover because the proposed uses are seed treatment 
only, not a foliar use, so no residues will be present on these feed 
commodities. Therefore, these tolerances are not necessary.
    The proposed tolerance for residues of cyantraniliprole in/on rice, 
grain of 0.03 ppm is being modified to 0.02 ppm based on the OECD 
statistical calculation applied to the field trial residue data.
    The proposed wine grape tolerance is being modified from 1.5 ppm to 
2.0 ppm and a tolerance is being established on olive oil at 2.0 ppm 
due to concentration demonstrated in the processing studies.
    The proposed tolerance for residues in/on legume vegetables, 
subgroup 6C of 0.9 ppm is being modified to 1.0 ppm based on the OECD 
statistical calculation applied to the field trial residue data.
    The proposed tolerance for residues in/on soybean seed including 
the foliage (forage and hay) is not being established since processing 
studies were not submitted for soybean processed commodities (hulls, 
meal, oil). Therefore, the proposed tolerance for residues of 
cyantraniliprole in/on vegetables, foliage of legume (crop group 7) is 
being revised to ``Vegetable, foliage of legume, except soybean, group 
7A.''
    Numerous ruminant commodity tolerances are already established. 
These ruminant (cattle, goats, horses, and sheep) commodity tolerances 
are being increased to reflect the new dietary burdens from the 
tolerances established by this document.

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, including 
its metabolites and degradates, in or on Artichoke, globe at 0.10 ppm; 
Berry, low growing, except strawberry, subgroup 13-07H at 0.08 ppm; 
Coffee, green bean at 0.05 ppm; Corn, field, grain at 0.01 ppm; Corn, 
pop, grain at 0.01 ppm; Corn, sweet, kernel plus cob with husks removed 
at 0.01 ppm; Grape, wine at 2.0 ppm; Olive at 1.5 ppm; Olive, oil at 
2.0 ppm; Peanut at 0.01 ppm; Pomegranate at 0.01 ppm; Rice, grain at 
0.02 ppm; Strawberry at 1.0 ppm; Tea at 30 ppm; Vegetable, foliage of 
legume, except soybean, group 7A at 40 ppm; Vegetable, leaves of root 
and tuber, group 2 at 40 ppm; Vegetable, legume, dried shelled, except 
soybean, subgroup 6C at 1.0 ppm; Vegetable, legume, edible podded, 
subgroup 6A at 2.0 ppm; Vegetable, legume, succulent shelled, subgroup 
6B at 0.20 ppm; and Vegetable, root, except sugar beet, subgroup 1B at 
0.40 ppm.
    In addition, the following tolerances are modified as follows: 
Peanut, hay from 0.01 ppm to 3.0 ppm and Vegetable, cucurbit, group 9 
from 0.40 ppm to 0.70 ppm.

[[Page 14629]]

    Also, due to the tolerances being established the following 
tolerances are modified as follows: Cattle, fat from 0.01 ppm to 0.10 
ppm; Cattle, meat from 0.01 ppm to 0.10 ppm; Cattle, meat byproducts 
from 0.01 ppm to 0.40 ppm; Goat, fat from 0.01 ppm to 0.10 ppm; Goat, 
meat from 0.01 ppm to 0.10 ppm; Goat, meat byproducts from 0.01 ppm to 
0.40 ppm; Horse, fat from 0.01 ppm to 0.10 ppm; Horse, meat from 0.01 
to 0.10 ppm; Horse, meat byproducts from 0.01 ppm to 0.40 ppm; Milk 
from 0.01 ppm to 0.20 ppm; Sheep, fat from 0.01 ppm to 0.10 ppm; Sheep, 
meat from 0.01 ppm to 0.10 ppm; and Sheep, meat byproducts from 0.01 to 
0.40 ppm.
    Lastly, due to the tolerances being established above, the indirect 
or inadvertent tolerances under 40 CFR 180.672 (d) for Peanut, hay; 
Vegetable, foliage of legume (group 7); Vegetable, leaves of root and 
tuber vegetables (group 2); and Vegetable, root (subgroup 1A) are 
removed as unnecessary, and new tolerances are established under 
180.672 (d) for Beet, sugar, roots at 0.02 ppm; Soybean, forage at 0.70 
ppm; and Soybean, hay at 0.70 ppm.

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: February 17, 2017.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.672, revise paragraphs (a) and (d) to read as follows:


Sec.  180.672   Cyantraniliprole; tolerances for residues.

    (a) General. Tolerances are established for the combined 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, including its metabolites and degradates, in or on 
commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only cyantraniliprole in or on the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Almond, hulls...........................................             8.0
Artichoke, globe \1\....................................            0.10
Berry, low growing, except strawberry, subgroup 13-07H              0.08
 \1\....................................................
Brassica head and stem, subgroup 5A.....................             3.0
Brassica leafy vegetables, subgroup 5B..................              30
Bushberry, subgroup 13-07B..............................             4.0
Cattle, fat.............................................            0.10
Cattle, meat............................................            0.10
Cattle, meat byproducts.................................            0.40
Cherry, subgroup 12-12A.................................             6.0
Citrus, oil.............................................             2.4
Coffee, green bean \1\..................................            0.05
Corn, field, grain......................................            0.01

[[Page 14630]]

 
Corn, pop, grain........................................            0.01
Corn, sweet, kernel plus cob with husks removed.........            0.01
Cotton, gin byproducts..................................              10
Fruit, citrus, group 10-10..............................            0.70
Fruit, pome, group 11-10................................             1.5
Goat, fat...............................................            0.10
Goat, meat..............................................            0.10
Goat, meat byproducts...................................            0.40
Grape, wine \1\.........................................             2.0
Horse, fat..............................................            0.10
Horse, meat.............................................            0.10
Horse, meat byproducts..................................            0.40
Milk....................................................            0.20
Nut, tree, group 14-12..................................            0.04
Oilseed group 20........................................             1.5
Olive \1\...............................................             1.5
Olive, oil \1\..........................................             2.0
Onion, bulb, subgroup 3-07A.............................            0.04
Onion, green, subgroup 3-07B............................             8.0
Peach, subgroup 12-12B..................................             1.5
Peanut..................................................            0.01
Peanut hay..............................................             3.0
Plum, subgroup 12-12C...................................            0.50
Pomegranate \1\.........................................            0.01
Rice, grain \1\.........................................            0.02
Sheep, fat..............................................            0.10
Sheep, meat.............................................            0.10
Sheep, meat byproducts..................................            0.40
Strawberry..............................................             1.0
Tea \1\.................................................              30
Vegetable, cucurbit, group 9............................            0.70
Vegetable, foliage of legume, except soybean, group 7A..              40
Vegetable, fruiting, group 8-10.........................             2.0
Vegetable, leafy, except Brassica, group 4..............              20
Vegetable, leaves of root and tuber, group 2............              40
Vegetable, legume, dried shelled, except soybean,                    1.0
 subgroup 6C............................................
Vegetable, legume, edible podded, subgroup 6A...........             2.0
Vegetable, legume, succulent shelled, subgroup 6B.......            0.20
Vegetable, root, except sugar beet, subgroup 1B.........            0.40
Vegetable, tuberous and corm, subgroup 1C...............            0.15
------------------------------------------------------------------------
\1\ There are no U.S. registrations for these commodities.

* * * * *
    (d) Indirect or inadvertant residues. Tolerances are established 
for indirect or inadvertant tolerances for residues of 
cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-
6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, including 
its metabolites and degradates, in or on commodities in the following 
table. Compliance with the tolerance levels specified in the following 
table is to be determined by measuring only cyantraniliprole in or on 
the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18.........................            0.20
Beet, sugar, roots......................................            0.02
Grain, cereal, forage, fodder and straw, group 16.......            0.50
Grass forage, fodder and hay, group 17..................            0.50
Soybean, forage.........................................            0.70
Soybean, hay............................................            0.70
------------------------------------------------------------------------

[FR Doc. 2017-05707 Filed 3-21-17; 8:45 am]
 BILLING CODE 6560-50-P