82_FR_14677 82 FR 14623 - Cyantraniliprole; Pesticide Tolerances

82 FR 14623 - Cyantraniliprole; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 54 (March 22, 2017)

Page Range14623-14631
FR Document2017-05707

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).

Federal Register, Volume 82 Issue 54 (Wednesday, March 22, 2017)
[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Rules and Regulations]
[Pages 14623-14631]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05707]


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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.

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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. 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



                                                                       Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations                                                   14623

                                                publication of the rule in the Federal                                                                           Parts per   number: (703) 305–7090; email address:
                                                                                                                                   Commodity
                                                Register. This action is not a ‘‘major                                                                            million    RDFRNotices@epa.gov.
                                                rule’’ as defined by 5 U.S.C. 804(2).                                                                                        SUPPLEMENTARY INFORMATION:
                                                                                                                         *           *          *           *         *
                                                List of Subjects in 40 CFR Part 180                                                                                          I. General Information
                                                                                                                       1 There
                                                                                                                            are no U.S. registrations for use on
                                                  Environmental protection,                                        this commodity as of March 22, 2017.                      A. Does this action apply to me?
                                                Administrative practice and procedure,                             *          *      *      *       *
                                                Agricultural commodities, Pesticides                                                                                            You may be potentially affected by
                                                                                                                   [FR Doc. 2017–05705 Filed 3–21–17; 8:45 am]               this action if you are an agricultural
                                                and pests, Reporting and recordkeeping
                                                requirements.
                                                                                                                   BILLING CODE 6560–50–P                                    producer, food manufacturer, or
                                                                                                                                                                             pesticide manufacturer. The following
                                                  Dated: March 6, 2017.                                                                                                      list of North American Industrial
                                                Michael Goodis,                                                    ENVIRONMENTAL PROTECTION                                  Classification System (NAICS) codes is
                                                Director, Registration Division, Office of                         AGENCY                                                    not intended to be exhaustive, but rather
                                                Pesticide Programs.                                                                                                          provides a guide to help readers
                                                                                                                   40 CFR Part 180
                                                  Therefore, 40 CFR chapter I is                                                                                             determine whether this document
                                                amended as follows:                                                [EPA–HQ–OPP–2014–0357; FRL–9958–53]                       applies to them. Potentially affected
                                                                                                                                                                             entities may include:
                                                PART 180—[AMENDED]                                                 Cyantraniliprole; Pesticide Tolerances                       • Crop production (NAICS code 111).
                                                                                                                                                                                • Animal production (NAICS code
                                                ■ 1. The authority citation for part 180                           AGENCY:  Environmental Protection                         112).
                                                continues to read as follows:                                      Agency (EPA).                                                • Food manufacturing (NAICS code
                                                                                                                   ACTION: Final rule.                                       311).
                                                    Authority: 21 U.S.C. 321(q), 346a and 371.
                                                                                                                                                                                • Pesticide manufacturing (NAICS
                                                ■  2. In § 180.560:                                                SUMMARY:  This regulation establishes                     code 32532).
                                                ■  a. Revise paragraph (a) introductory                            tolerances for residues of
                                                                                                                   cyantraniliprole in or on multiple                        B. How can I get electronic access to
                                                text; and
                                                                                                                   commodities which are identified and                      other related information?
                                                ■ b. Add alphabetically entries for ‘‘teff,
                                                forage,’’ ‘‘teff, grain,’’ ‘‘teff, hay,’’ and                      discussed later in this document. E.I.                       You may access a frequently updated
                                                ‘‘teff, straw’’ to the table in paragraph                          DuPont de Nemours & Company and                           electronic version of EPA’s tolerance
                                                (a).                                                               Syngenta Crop Protection, LLC                             regulations at 40 CFR part 180 through
                                                   The revision and additions read as                              requested these tolerances under the                      the Government Printing Office’s e-CFR
                                                follows:                                                           Federal Food, Drug, and Cosmetic Act                      site at http://www.ecfr.gov/cgi-bin/text-
                                                                                                                   (FFDCA).                                                  idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                § 180.560 Cloquintocet-mexyl; pesticide                            DATES:  This regulation is effective                      40tab_02.tpl.
                                                tolerances.
                                                                                                                   March 22, 2017. Objections and requests                   C. How can I file an objection or hearing
                                                  (a) General. Tolerances are                                      for hearings must be received on or                       request?
                                                established for residues of the inert                              before May 22, 2017, and must be filed
                                                ingredient cloquintocet-mexyl,                                     in accordance with the instructions                         Under FFDCA section 408(g), 21
                                                including its metabolites and                                      provided in 40 CFR part 178 (see also                     U.S.C. 346a, any person may file an
                                                degradates, in or on the commodities in                            Unit I.C. of the SUPPLEMENTARY                            objection to any aspect of this regulation
                                                the following table when used as a                                 INFORMATION).                                             and may also request a hearing on those
                                                safener in pesticide formulations                                                                                            objections. You must file your objection
                                                containing the active ingredients                                  ADDRESSES:   The docket for this action,                  or request a hearing on this regulation
                                                clodinafop-propargyl (wheat only),                                identified by docket identification (ID)                   in accordance with the instructions
                                                dicamba (wheat only), flucarbazone-                               number EPA–HQ–OPP–2014–0357 is                             provided in 40 CFR part 178. To ensure
                                                sodium (wheat only), halauxifen-methyl                            available at http://www.regulations.gov                    proper receipt by EPA, you must
                                                (wheat or barley), pinoxaden (wheat or                            or at the Office of Pesticide Programs                     identify docket ID number EPA–HQ–
                                                barley), or pyroxsulam (wheat or teff).                           Regulatory Public Docket (OPP Docket)                      OPP–2014–0357 in the subject line on
                                                Compliance with the tolerance levels                              in the Environmental Protection Agency                     the first page of your submission. All
                                                specified is to be determined by                                  Docket Center (EPA/DC), West William                       objections and requests for a hearing
                                                measuring the combined residues of                                Jefferson Clinton Bldg., Rm. 3334, 1301                    must be in writing, and must be
                                                cloquintocet-mexyl, (acetic acid [(5-                             Constitution Ave. NW., Washington, DC                      received by the Hearing Clerk on or
                                                chloro-8-quinolinyl)oxy]-, 1-                                     20460–0001. The Public Reading Room                        before May 22, 2017. Addresses for mail
                                                methylhexyl ester; CAS Reg. No. 99607–                            is open from 8:30 a.m. to 4:30 p.m.,                       and hand delivery of objections and
                                                70–2) and its acid metabolite (5-chloro-                          Monday through Friday, excluding legal                     hearing requests are provided in 40 CFR
                                                8-quinolinoxyacetic acid), expressed as                           holidays. The telephone number for the                     178.25(b).
                                                cloquintocet-mexyl, in or on the                                  Public Reading Room is (202) 566–1744,                       In addition to filing an objection or
                                                following commodities:                                            and the telephone number for the OPP                       hearing request with the Hearing Clerk
                                                                                                                  Docket is (703) 305–5805. Please review                    as described in 40 CFR part 178, please
                                                                                                     Parts per    the visitor instructions and additional                    submit a copy of the filing (excluding
                                                                Commodity                                         information about the docket available
                                                                                                      million                                                                any Confidential Business Information
jstallworth on DSK7TPTVN1PROD with RULES




                                                                                                                  at http://www.epa.gov/dockets.                             (CBI)) for inclusion in the public docket.
                                                                                                                  FOR FURTHER INFORMATION CONTACT:                           Information not marked confidential
                                                   *              *              *               *          *
                                                Teff,   forage 1 ...............................              0.2
                                                                                                                  Michael Goodis, Registration Division                      pursuant to 40 CFR part 2 may be
                                                Teff,   grain 1 .................................             0.1 (7505P), Office of Pesticide Programs,                     disclosed publicly by EPA without prior
                                                Teff,   hay 1 ....................................            0.5 Environmental Protection Agency, 1200                      notice. Submit the non-CBI copy of your
                                                Teff,   straw 1 .................................             0.1 Pennsylvania Ave. NW., Washington,                         objection or hearing request, identified
                                                                                                                  DC 20460–0001; main telephone                              by docket ID number EPA–HQ–OPP–


                                           VerDate Sep<11>2014         14:52 Mar 21, 2017        Jkt 241001   PO 00000       Frm 00023   Fmt 4700   Sfmt 4700   E:\FR\FM\22MRR1.SGM   22MRR1


                                                14624            Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations

                                                2014–0357, by one of the following                      ppm; corn, sweet, kernel plus cob with                considered available information
                                                methods:                                                husks removed at 0.01 ppm; and corn,                  concerning the variability of the
                                                  • Federal eRulemaking Portal: http://                 sweet, stover at 0.08 ppm (PP 4F8320).                sensitivities of major identifiable
                                                www.regulations.gov. Follow the online                  That document referenced a summary of                 subgroups of consumers, including
                                                instructions for submitting comments.                   the petitions prepared by E.I. du Pont de             infants and children.
                                                Do not submit electronically any                        Nemours & Company and Syngenta                           In general, cyantraniliprole
                                                information you consider to be CBI or                   Crop Protection LLC, the registrants,                 administration in mammals produces
                                                other information whose disclosure is                   which is available in the dockets EPA–                both adverse and adaptive changes in
                                                restricted by statute.                                  HQ–OPP–2014–0357 and EPA–HQ–                          the liver, thyroid gland, and adrenal
                                                  • Mail: OPP Docket, Environmental                     OPP–2014–0890, respectively, at http://               cortex. With repeated dosing, consistent
                                                Protection Agency Docket Center (EPA/                   www.regulations.gov. Comments were                    findings of mild to moderate increases
                                                DC), (28221T), 1200 Pennsylvania Ave.                   received on the notice of filing. EPA’s               in liver weights across multiple species
                                                NW., Washington, DC 20460–0001.                         response to these comments is                         (rats, mice, and dogs) are observed. Dogs
                                                  • Hand Delivery: To make special                      discussed in Unit IV.C.                               appear to be more sensitive than rats
                                                arrangements for hand delivery or                         Based upon review of the data                       and mice; cyantraniliprole produces
                                                delivery of boxed information, please                   supporting the petition, EPA has                      adverse liver effects (increases in
                                                follow the instructions at http://                      modified the levels at which and the                  alkaline phosphatase, decreases in
                                                www.epa.gov/dockets/contacts.html.                      commodities upon which tolerances are                 cholesterol, and decreases in albumin)
                                                Additional instructions on commenting                   being established. The reasons for these              in dogs at lower dose levels than in rats.
                                                or visiting the docket, along with more                 changes are explained in Unit IV.D.                   In addition, the liver effects in the dog
                                                information about dockets generally, is                                                                       show progressive severity with
                                                                                                        III. Aggregate Risk Assessment and
                                                available at http://www.epa.gov/                                                                              increased duration of exposure. The
                                                                                                        Determination of Safety
                                                dockets.                                                                                                      available data also show thyroid
                                                                                                           Section 408(b)(2)(A)(i) of FFDCA                   hormone homeostasis is altered in rats
                                                II. Summary of Petitioned-For                           allows EPA to establish a tolerance (the              following exposure to cyantraniliprole
                                                Tolerance                                               legal limit for a pesticide chemical                  after 90 days due to enhanced
                                                   In the Federal Register of January 28,               residue in or on a food) only if EPA                  metabolism of the thyroid hormones by
                                                2015 (80 FR 4525) (FRL–9921–55), EPA                    determines that the tolerance is ‘‘safe.’’            the liver. However, cyantraniliprole
                                                issued a document pursuant to FFDCA                     Section 408(b)(2)(A)(ii) of FFDCA                     does not act directly on the thyroid; the
                                                section 408(d)(3), 21 U.S.C. 346a(d)(3),                defines ‘‘safe’’ to mean that ‘‘there is a            thyroid effects observed are secondary
                                                announcing the filing of pesticide                      reasonable certainty that no harm will                to the effects on the liver.
                                                petitions (PP 4F8258 and 4F8320) by                     result from aggregate exposure to the                    Cyantraniliprole is classified as ‘‘Not
                                                E.I. du Pont de Nemours & Company,                      pesticide chemical residue, including                 Likely to be Carcinogenic to Humans’’
                                                1007 Market St., Wilmington, DE 19898                   all anticipated dietary exposures and all             based on the absence of increased tumor
                                                and Syngenta Crop Protection LLC, P.O.                  other exposures for which there is                    incidence in carcinogenicity studies in
                                                Box 18300, Greensboro, NC 27419,                        reliable information.’’ This includes                 rats and mice. In addition, there are no
                                                respectively. The petitions requested                   exposure through drinking water and in                genotoxicity, mutagenicity,
                                                that 40 CFR part 180 be amended by                      residential settings, but does not include            neurotoxicity, or immunotoxicity
                                                establishing tolerances for residues of                 occupational exposure. Section                        concerns. There are also no
                                                the insecticide cyantraniliprole, in or on              408(b)(2)(C) of FFDCA requires EPA to                 developmental or reproductive toxicity
                                                artichokes, globe (import tolerance) at                 give special consideration to exposure                concerns and there is no evidence of an
                                                0.1 parts per million (ppm); berries, low               of infants and children to the pesticide              adverse effect attributable to a single
                                                growing, except strawberries (crop                      chemical residue in establishing a                    dose.
                                                subgroup 13–07H) (import tolerance) at                  tolerance and to ‘‘ensure that there is a                Specific information on the studies
                                                0.08 ppm; coffee, bean, green (import                   reasonable certainty that no harm will                received and the nature of the adverse
                                                tolerance) at 0.05 ppm; grapes (import                  result to infants and children from                   effects caused by cyantraniliprole as
                                                tolerance) at 1.5 ppm; olives (import                   aggregate exposure to the pesticide                   well as the no-observed-adverse-effect-
                                                tolerance) at 1.5 ppm; peanuts at 0.01                  chemical residue. . . .’’                             level (NOAEL) and the lowest-observed-
                                                ppm; peanut hay at 3 ppm;                                  Consistent with FFDCA section                      adverse-effect-level (LOAEL) from the
                                                pomegranates (import tolerance) at 0.01                 408(b)(2)(D), and the factors specified in            toxicity studies can be found at http://
                                                ppm; rice, grain (import tolerance) at                  FFDCA section 408(b)(2)(D), EPA has                   www.regulations.gov in the document
                                                0.03 ppm; soybeans, seed at 0.4 ppm;                    reviewed the available scientific data                titled ‘‘Cyantraniliprole. Human Health
                                                strawberries at 1.0 ppm; vegetables,                    and other relevant information in                     Risk Assessment for the Proposed Uses
                                                foliage of legume (crop group 7) at 50                  support of this action. EPA has                       on Root Vegetables (except Sugar Beet)
                                                ppm; vegetables, leaves of root and                     sufficient data to assess the hazards of              (Crop Subgroup 1B), Leaves of Root and
                                                tuber (crop group 2) at 40 ppm;                         and to make a determination on                        Tuber Vegetables (Crop Group 2),
                                                vegetables, legume, dried shelled,                      aggregate exposure for cyantraniliprole               Legume Vegetables (Crop Group 6
                                                except soybean (crop subgroup 6C) at                    including exposure resulting from the                 except soybean), Leaves of Legume
                                                0.9 ppm; vegetables, legume, edible                     tolerances established by this action.                Vegetables (Crop Group 7 except
                                                podded (crop subgroup 6A) at 2 ppm;                     EPA’s assessment of exposures and risks               soybean), Peanuts, Strawberries,
                                                vegetables, legume, succulent shelled                   associated with cyantraniliprole                      Tobacco and Seed Treatment Uses on
                                                (crop subgroup 6B) at 0.2 ppm;                          follows.                                              Corn (Field, Pop, Seed, Sweet).
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                                                vegetables, root, except sugar beet (crop                                                                     Tolerance Requests without U.S.
                                                subgroup 1B) at 0.4 ppm; and tea, dried                 A. Toxicological Profile                              Registration for Artichokes, Coffee
                                                (import tolerance) at 30 ppm (PP                          EPA has evaluated the available                     Green Bean, Wine Grapes, Low Growing
                                                4F8258) and corn, field and pop, forage                 toxicity data and considered its validity,            Berries (except Strawberries) (Crop
                                                at 0.04 ppm; corn, field and pop, grain                 completeness, and reliability as well as              Subgroup 13–07H), Olives,
                                                at 0.01 ppm; corn, field and pop, stover                the relationship of the results of the                Pomegranate, and Tea Dried. Amended
                                                at 0.015 ppm; corn, sweet, forage at 0.02               studies to human risk. EPA has also                   Tolerance Requests for Cucurbit


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                                                                 Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations                                        14625

                                                Vegetables (Crop Group 9) due to New                       No such effects were identified in the             408(b)(2)(E) and authorized under
                                                Use Pattern and Amended Uses for                        toxicological studies for                             FFDCA section 408(f)(1). Data will be
                                                Tomatoes and Peppers’’ on page 40 in                    cyantraniliprole; therefore, a                        required to be submitted no later than
                                                docket ID number EPA–HQ–OPP–2014–                       quantitative acute dietary exposure                   5 years from the date of issuance of
                                                0357.                                                   assessment is unnecessary.                            these tolerances.
                                                                                                           ii. Chronic exposure. In conducting                  Section 408(b)(2)(F) of FFDCA states
                                                B. Toxicological Points of Departure/                   the chronic dietary exposure assessment               that the Agency may use data on the
                                                Levels of Concern                                       EPA used the food consumption data                    actual percent of food treated for
                                                   Once a pesticide’s toxicological                     from the 2003–2008 United States                      assessing chronic dietary risk only if:
                                                profile is determined, EPA identifies                   Department of Agriculture’s (USDA’s)                    • Condition a: The data used are
                                                toxicological points of departure (POD)                 National Health and Nutrition                         reliable and provide a valid basis to
                                                and levels of concern to use in                         Examination Survey, What We Eat in                    show what percentage of the food
                                                evaluating the risk posed by human                      America, (NHANES/WWEIA). As to                        derived from such crop is likely to
                                                exposure to the pesticide. For hazards                  residue levels in food, a refined chronic             contain the pesticide residue.
                                                that have a threshold below which there                 (food and drinking water) dietary                       • Condition b: The exposure estimate
                                                is no appreciable risk, the toxicological               assessment was conducted assuming                     does not underestimate exposure for any
                                                POD is used as the basis for derivation                 average field trial residues for all                  significant subpopulation group.
                                                of reference values for risk assessment.                proposed crops (except sugar beet root),                • Condition c: Data are available on
                                                PODs are developed based on a careful                   percent crop treated (PCT) where                      pesticide use and food consumption in
                                                analysis of the doses in each                           available, and percent crop treated for               a particular area, the exposure estimate
                                                toxicological study to determine the                    new uses (PCTn) for some crops. In                    does not understate exposure for the
                                                dose at which no adverse effects are                    addition, the estimated percentage of                 population in such area.
                                                observed (the NOAEL) and the lowest                     imported grapes was incorporated into
                                                                                                                                                              In addition, the Agency must provide
                                                dose at which adverse effects of concern                the assessment. For processed
                                                                                                                                                              for periodic evaluation of any estimates
                                                are identified (the LOAEL). Uncertainty/                commodities, input values included
                                                                                                                                                              used. To provide for the periodic
                                                safety factors are used in conjunction                  combined average residues of parent
                                                                                                                                                              evaluation of the estimate of PCT as
                                                with the POD to calculate a safe                        and the metabolite (IN–J9Z38) with
                                                                                                                                                              required by FFDCA section 408(b)(2)(F),
                                                exposure level—generally referred to as                 relevant processing factors. The chronic
                                                                                                                                                              EPA may require registrants to submit
                                                a population-adjusted dose (PAD) or a                   assessment incorporated empirical
                                                                                                        processing factors, if available, or                  data on PCT.
                                                reference dose (RfD)—and a safe margin                                                                          The Agency estimated the PCT for
                                                of exposure (MOE). For non-threshold                    Dietary Exposure Evaluation Model
                                                                                                        (DEEM) Version 7.81 default processing                existing uses as follows:
                                                risks, the Agency assumes that any                                                                              Citrus: Oranges 62%, grapefruit 87%,
                                                amount of exposure will lead to some                    factors as appropriate. Empirical
                                                                                                        processing factors were used for potato               and lemons 46%; pome fruit: Apples
                                                degree of risk. Thus, the Agency                                                                              61% and pears 76%; stone fruits:
                                                estimates risk in terms of the probability              flakes and chips, tomatoes (paste, puree,
                                                                                                        dried, and juice), orange juice, apple                Apricots 53%, cherries 48%, peaches
                                                of an occurrence of the adverse effect                                                                        41%, and plums/prunes 59%; tree nuts:
                                                expected in a lifetime. For more                        juice, cottonseed oil, citrus oil, and
                                                                                                        dried plums. The processing factors for               Almonds 72%, hazelnuts 65%, pecans
                                                information on the general principles                                                                         22%, pistachios 49%, and walnuts 53%;
                                                                                                        these commodities were set at 1 because
                                                EPA uses in risk characterization and a                                                                       bushberries (subgroup 13–07B):
                                                                                                        the residue input values included
                                                complete description of the risk                                                                              Blueberries 45%; fruiting vegetables:
                                                                                                        combined residues of the parent and the
                                                assessment process, see http://                                                                               Peppers 45% and tomatoes 54%;
                                                                                                        metabolite with relevant processing
                                                www2.epa.gov/pesticide-science-and-                                                                           cucurbits: Cantaloupes 50%, cucumbers
                                                                                                        factors. Crop field trial data depicting
                                                assessing-pesticide-risks/assessing-                                                                          23%, pumpkins 18%, squash 24%, and
                                                                                                        residues in/on citrus fruit peels (lemon
                                                human-health-risk-pesticides.                                                                                 watermelons 29%; leafy vegetables:
                                                                                                        and orange) were available and included
                                                   A summary of the toxicological                       into the assessment.                                  Celery 70%, lettuce 78%, and spinach
                                                endpoints for cyantraniliprole used for                    iii. Cancer. Based on the data                     53%; Brassica (cole) leafy vegetables:
                                                human risk assessment is discussed in                   summarized in Unit III.A., EPA has                    Broccoli 81%, cabbage 50%, and
                                                Unit III.B. of the final rule published in              concluded that cyantraniliprole does                  cauliflower 83%; onion 58%; potato
                                                the Federal Register of February 5, 2014                not pose a cancer risk to humans.                     50%; oilseeds: Canola 15% and
                                                (79 FR 6826) (FRL–9388–7).                              Therefore, a dietary exposure                         sunflower 35%; and corn 56%.
                                                C. Exposure Assessment                                  assessment for the purpose of assessing                  In most cases, EPA uses available data
                                                                                                        cancer risk is unnecessary.                           from United States Department of
                                                   1. Dietary exposure from food and                       iv. Anticipated residue and PCT                    Agriculture/National Agricultural
                                                feed uses. In evaluating dietary                        information. Section 408(b)(2)(E) of                  Statistics Service (USDA/NASS),
                                                exposure to cyantraniliprole, EPA                       FFDCA authorizes EPA to use available                 proprietary market surveys, and the
                                                considered exposure under the                           data and information on the anticipated               National Pesticide Use Database for the
                                                petitioned-for tolerances as well as all                residue levels of pesticide residues in               chemical/crop combination for the most
                                                existing cyantraniliprole tolerances in                 food and the actual levels of pesticide               recent 6–7 years. EPA uses an average
                                                40 CFR 180.672. EPA assessed dietary                    residues that have been measured in                   PCT for chronic dietary risk analysis.
                                                exposures from cyantraniliprole in food                 food. If EPA relies on such information,              The average PCT figure for each existing
                                                as follows:                                             EPA must require pursuant to FFDCA                    use is derived by combining available
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                                                   i. Acute exposure. Quantitative acute                section 408(f)(1) that data be provided 5             public and private market survey data
                                                dietary exposure and risk assessments                   years after the tolerance is established,             for that use, averaging across all
                                                are performed for a food-use pesticide,                 modified, or left in effect, demonstrating            observations, and rounding to the
                                                if a toxicological study has indicated the              that the levels in food are not above the             nearest 5%, except for those situations
                                                possibility of an effect of concern                     levels anticipated. For the present                   in which the average PCT is less than
                                                occurring as a result of a 1-day or single              action, EPA will issue such data call-ins             one. In those cases, 1% is used as the
                                                exposure.                                               as are required by FFDCA section                      average PCT and 2.5% is used as the


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                                                14626            Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations

                                                maximum PCT. EPA uses a maximum                         indicated in emergency exemption                      surface water and 64 ppb for ground
                                                PCT for acute dietary risk analysis. The                requests for cyantraniliprole; how the                water, respectively.
                                                maximum PCT figure is the highest                       pest spectrum of the new pesticide                       Modeled estimates of drinking water
                                                observed maximum value reported                         compares with the market leaders; and                 concentrations were directly entered
                                                within the recent 6 years of available                  whether pest resistance issues with past              into the dietary exposure model. An
                                                public and private market survey data                   market leaders provide cyantraniliprole               acute dietary risk assessment was not
                                                for the existing use and rounded up to                  with significant market potential. EPA                conducted since no acute toxicological
                                                the nearest multiple of 5%.                             also considered the potential for                     effects were found. For the chronic
                                                   The Agency estimated the PCT for                     resistance to cyantraniliprole to develop             dietary risk assessment, the water
                                                new uses as follows:                                    as a limiting factor in its use. Given                concentration value of 64 ppb was used
                                                   Cotton 41%; peanuts 41%; carrots                     currently available information, EPA                  to assess the contribution to drinking
                                                23%; soybeans 21%; strawberries 59%;                    concludes that it is unlikely that actual             water.
                                                vegetable crop group 7: Dry beans/peas                  PCT for cyantraniliprole will exceed the                 3. From non-dietary exposure. The
                                                6%, soybeans 21%, beans (snap, bush,                    estimated PCT for new uses during the                 term ‘‘residential exposure’’ is used in
                                                etc.) 49%, and peas fresh/green/sweet)                  next five years.                                      this document to refer to non-
                                                38%; vegetable crop group 2: Sugar                         The Agency believes that the three                 occupational, non-dietary exposure
                                                beets 40%; vegetable crop group 6A:                     conditions discussed in Unit III.C.1.iv.              (e.g., for lawn and garden pest control,
                                                Soybeans 21%, beans (snap, bush, etc.,                  have been met. With respect to                        indoor pest control, termiticides, and
                                                string) 49%; peas fresh/green/sweet)                    Condition a, PCT estimates are derived                flea and tick control on pets).
                                                38%; vegetable crop group 6C: Dried                     from Federal and private market survey                Cyantraniliprole is currently registered
                                                bean and peas 6%. For the imported                      data, which are reliable and have a valid             for the following uses that could result
                                                grapes (wine grapes) a 50% import                       basis. The Agency is reasonably certain               in residential exposures: Turfgrass
                                                estimate was used in the chronic dietary                that the percentage of the food treated               (including residential, recreational, and
                                                risk assessment.                                        is not likely to be an underestimation.               golf course turf), ornamentals, and
                                                   EPA estimates of the PCTn of                                                                               structural buildings (including indoor
                                                                                                        As to Conditions b and c, regional
                                                cyantraniliprole represent the upper                                                                          crack/crevice and outdoor broadcast).
                                                                                                        consumption information and
                                                bound of use expected during the                                                                              EPA assessed residential exposure using
                                                                                                        consumption information for significant
                                                pesticide’s initial five years of                                                                             the following assumptions: Residential
                                                registration; that is, PCTn for                         subpopulations is taken into account
                                                                                                                                                              exposure may occur by the dermal, oral,
                                                cyantraniliprole is a threshold of use                  through EPA’s computer-based model
                                                                                                                                                              and inhalation routes and is expected to
                                                that EPA is reasonably certain will not                 for evaluating the exposure of
                                                                                                                                                              be short-term in duration of exposures.
                                                be exceeded for each registered use site.               significant subpopulations including
                                                                                                                                                              However, since a dermal hazard has not
                                                The PCTn recommended for use in the                     several regional groups. Use of this
                                                                                                                                                              been identified for cyantraniliprole, the
                                                chronic dietary assessment is calculated                consumption information in EPA’s risk
                                                                                                                                                              only exposures of concern are handler
                                                as the average PCT of the market leader                 assessment process ensures that EPA’s                 inhalation (for adults), and post-
                                                or leaders (i.e., the currently registered              exposure estimate does not understate                 application incidental oral (for
                                                pesticide(s) with the greatest PCT) on                  exposure for any significant                          children). For adults, the oral and
                                                that site over the three most recent years              subpopulation group and allows the                    inhalation routes of exposure were not
                                                of available data. Comparisons are only                 Agency to be reasonably certain that no               aggregated since the endpoints of
                                                made among pesticides of the same                       regional population is exposed to                     concern are not common. The turf and
                                                pesticide type (e.g., the market leader                 residue levels higher than those                      ornamental labels indicate that a
                                                for insecticides on the use site is                     estimated by the Agency. Other than the               maximum of two applications are
                                                selected for comparison with a new                      data available through national food                  allowed per season. Thus, intermediate-
                                                insecticide). The market leader included                consumption surveys, EPA does not                     term exposures are not likely because of
                                                in the estimation may not be the same                   have available reliable information on                the intermittent nature of applications
                                                for each year since different pesticides                the regional consumption of food to                   by homeowners. Post-application
                                                may dominate at different times.                        which cyantraniliprole may be applied                 incidental oral exposures for children
                                                   Typically, EPA uses USDA/NASS as                     in a particular area.                                 may occur for short- and intermediate-
                                                the source of data because it is publicly                  2. Dietary exposure from drinking                  term durations due to the persistence of
                                                available and directly reports values for               water. The Agency used screening level                cyantraniliprole. Although
                                                PCT. When a specific use site is not                    water exposure models in the dietary                  intermediate-term incidental oral post-
                                                reported by USDA/NASS, EPA uses                         exposure analysis and risk assessment                 application exposures are possible (i.e.,
                                                market survey data and calculates the                   for cyantraniliprole in drinking water.               from soil ingestion, due to the
                                                PCT given reported data on acres treated                These simulation models take into                     persistence of cyantraniliprole), the
                                                and acres grown. If no data are                         account data on the physical, chemical,               short-term incidental oral exposures are
                                                available, EPA may extrapolate PCTn                     and fate/transport characteristics of                 protective of the possible intermediate-
                                                from other crops, if the production area                cyantraniliprole. Further information                 term incidental oral exposures because
                                                and pest spectrum are substantially                     regarding EPA drinking water models                   the POD for both durations is the same.
                                                similar.                                                used in pesticide exposure assessment                 Further information regarding EPA
                                                   A retrospective analysis to validate                 can be found at http://www2.epa.gov/                  standard assumptions and generic
                                                this approach shows few cases where                     pesticide-science-and-assessing-                      inputs for residential exposures may be
                                                the PCT for the overall market leaders                  pesticide-risks/about-water-exposure-                 found at http://www2.epa.gov/pesticide-
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                                                were exceeded. Further review of these                  models-used-pesticide.                                science-and-assessing-pesticide-risks/
                                                cases identified factors contributing to                   Based on the First Index Reservoir                 standard-operating-procedures-
                                                the exceptionally high use of a new                     Screening Tool (FIRST) and Pesticide in               residential-pesticide.
                                                pesticide. To evaluate whether the PCTn                 Water Calculator (PWC), the estimated                    4. Cumulative effects from substances
                                                for cyantraniliprole could be exceeded,                 drinking water concentrations (EDWCs)                 with a common mechanism of toxicity.
                                                EPA considered whether there may be                     of cyantraniliprole for chronic                       Section 408(b)(2)(D)(v) of FFDCA
                                                unusually high pest pressure, as                        exposures are estimated to be 24 ppb for              requires that, when considering whether


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                                                                 Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations                                        14627

                                                to establish, modify, or revoke a                       conclusion that the effects on the                    and no acute dietary endpoint was
                                                tolerance, the Agency consider                          thyroid are secondary to effects on the               selected. Therefore, cyantraniliprole is
                                                ‘‘available information’’ concerning the                liver.                                                not expected to pose an acute risk.
                                                cumulative effects of a particular                         3. Conclusion. EPA has determined                     2. Chronic risk. Using the exposure
                                                pesticide’s residues and ‘‘other                        that reliable data show the safety of                 assumptions described in this unit for
                                                substances that have a common                           infants and children would be                         chronic exposure, EPA has concluded
                                                mechanism of toxicity.’’                                adequately protected if the FQPA SF                   that chronic exposure to
                                                   EPA has not found cyantraniliprole to                were reduced to 1X. That decision is                  cyantraniliprole from food and water
                                                share a common mechanism of toxicity                    based on the following findings:                      will utilize 98% of the cPAD for
                                                with any other substances, and                             i. The toxicity database for                       children 1–2 years old, the population
                                                cyantraniliprole does not appear to                     cyantraniliprole is complete.                         group receiving the greatest exposure.
                                                produce a toxic metabolite produced by                     ii. There is no indication that                    Based on the explanation in Unit
                                                other substances. For the purposes of                   cyantraniliprole is a neurotoxic                      III.C.3., regarding residential use
                                                this tolerance action, therefore, EPA has               chemical and there is no need for a                   patterns, chronic residential exposure to
                                                assumed that cyantraniliprole does not                  developmental neurotoxicity study or                  residues of cyantraniliprole is not
                                                have a common mechanism of toxicity                     additional UFs to account for                         expected.
                                                with other substances. For information                  neurotoxicity.                                           3. Short-term risk. Short-term
                                                regarding EPA’s efforts to determine                       iii. There is no evidence of                       aggregate exposure takes into account
                                                which chemicals have a common                           susceptibility in developmental toxicity              short-term residential exposure plus
                                                mechanism of toxicity and to evaluate                   studies in rats and rabbits. In the                   chronic exposure to food and water
                                                the cumulative effects of such                          reproductive toxicity study, increased                (considered to be a background
                                                chemicals, see EPA’s Web site at http://                incidence of thyroid follicular                       exposure level).
                                                www2.epa.gov/pesticide-science-and-                     epithelium hypertrophy/hyperplasia                       Cyantraniliprole is currently
                                                assessing-pesticide-risks/cumulative-                   occurs in F1 parental animals at a dose               registered for uses that could result in
                                                assessment-risk-pesticides.                             lower than that for the parental (P)                  short-term residential exposure, and the
                                                                                                        generation. However, for the reasons                  Agency has determined that it is
                                                D. Safety Factor for Infants and                        summarized in Unit III.D.2. these effects             appropriate to aggregate chronic
                                                Children                                                are not of concern.                                   exposure through food and water with
                                                   1. In general. Section 408(b)(2)(C) of                  iv. There are no residual uncertainties            short-term residential exposures to
                                                FFDCA provides that EPA shall apply                     identified in the exposure databases.                 cyantraniliprole.
                                                an additional tenfold (10X) margin of                   The chronic dietary food exposure                        Using the exposure assumptions
                                                safety for infants and children in the                  assessment was a refined assessment                   described in this unit for short-term
                                                case of threshold effects to account for                which assumed average field trial                     exposures, EPA has concluded the
                                                prenatal and postnatal toxicity and the                 residues for all crops (except sugar beet             combined short-term food, water, and
                                                completeness of the database on toxicity                root), PCT where available, and PCTn                  residential exposures result in an
                                                and exposure unless EPA determines                      data. EPA made conservative                           aggregate MOE of 149 for children 1–2
                                                based on reliable data that a different                 (protective) assumptions in the ground                years old. For adults, the oral and
                                                margin of safety will be safe for infants               and surface water modeling used to                    inhalation routes of exposure were not
                                                and children. This additional margin of                 assess exposure to cyantraniliprole in                aggregated since the endpoints of
                                                safety is commonly referred to as the                   drinking water. EPA used similarly                    concern are not common. Because EPA’s
                                                Food Quality Protection Act (FQPA)                      conservative assumptions to assess post-              level of concern for cyantraniliprole is
                                                Safety Factor (SF). In applying this                    application exposure of children as well              a MOE of 100 or below, this MOE is not
                                                provision, EPA either retains the default               as incidental oral exposure of toddlers.              of concern.
                                                value of 10X, or uses a different                       These assessments will not                               4. Intermediate-term risk.
                                                additional safety factor when reliable                  underestimate the exposure and risks                  Intermediate-term aggregate exposure
                                                data available to EPA support the choice                posed by cyantraniliprole.                            takes into account intermediate-term
                                                of a different factor.                                                                                        residential exposure plus chronic
                                                   2. Prenatal and postnatal sensitivity.               E. Aggregate Risks and Determination of
                                                                                                                                                              exposure to food and water (considered
                                                There is no evidence of susceptibility in               Safety
                                                                                                                                                              to be a background exposure level).
                                                developmental toxicity studies in rats                     EPA determines whether acute and                      Cyantraniliprole is currently
                                                and rabbits. The developmental toxicity                 chronic dietary pesticide exposures are               registered for uses that could result in
                                                study in rats tested up to the limit dose               safe by comparing aggregate exposure                  intermediate-term residential exposure,
                                                (1,000 mg/kg/day). In the rabbit                        estimates to the acute PAD (aPAD) and                 however, the short-term aggregate risk
                                                developmental toxicity study decreases                  chronic PAD (cPAD). For linear cancer                 estimate described above is protective of
                                                in fetal body weight are seen at a dose                 risks, EPA calculates the lifetime                    potential intermediate-term exposures
                                                higher than that resulting in maternal                  probability of acquiring cancer given the             and risks in children.
                                                effects. In the reproductive toxicity                   estimated aggregate exposure. Short-,                    5. Aggregate cancer risk for U.S.
                                                study, increased incidence of thyroid                   intermediate-, and chronic-term risks                 population. Based on the lack of
                                                follicular epithelium hypertrophy/                      are evaluated by comparing the                        evidence of carcinogenicity in two
                                                hyperplasia occurs in F1 parental                       estimated aggregate food, water, and                  adequate rodent carcinogenicity studies,
                                                animals at a dose lower than that for the               residential exposure to the appropriate               cyantraniliprole is not expected to pose
                                                parental (P) generation. A clear NOAEL                  PODs to ensure that an adequate MOE                   a cancer risk to humans.
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                                                (1.4 mg/kg/day) is established for F1                   exists.                                                  6. Determination of safety. Based on
                                                parental animals, and the PODs selected                    1. Acute risk. An acute aggregate risk             these risk assessments, EPA concludes
                                                for risk assessment from the dog studies                assessment takes into account acute                   that there is a reasonable certainty that
                                                (1 or 3 mg/kg/day) are protective of the                exposure estimates from dietary                       no harm will result to the general
                                                effect (thyroid effect at 14 mg/kg/day)                 consumption of food and drinking                      population, or to infants and children
                                                seen in the F1 parental animals. In                     water. No adverse effect resulting from               from aggregate exposure to
                                                addition, the submitted data support the                a single oral exposure was identified                 cyantraniliprole residues.


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                                                14628            Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations

                                                IV. Other Considerations                                directions could result in residues above             calculation applied to the field trial
                                                                                                        the established Codex MRLs. The Codex                 residue data.
                                                A. Analytical Enforcement Methodology                                                                            The proposed wine grape tolerance is
                                                                                                        MRLs for residues of cyantraniliprole
                                                   Adequate enforcement methodology                     in/on ruminants at (0.01–0.05 ppm),                   being modified from 1.5 ppm to 2.0 ppm
                                                (liquid chromatography with tandem                      milk (0.02 ppm), and poultry                          and a tolerance is being established on
                                                mass spectroscopy (LC/MS/MS)) is                        commodities at (0.01 ppm) are lower                   olive oil at 2.0 ppm due to
                                                available to enforce the tolerance                      than the U.S. tolerances. The U.S. and                concentration demonstrated in the
                                                expression.                                             Codex livestock MRLs are not                          processing studies.
                                                   The method may be requested from:                    harmonized due to different animal                       The proposed tolerance for residues
                                                Chief, Analytical Chemistry Branch,                     diets and tolerances (MRLs) established               in/on legume vegetables, subgroup 6C of
                                                Environmental Science Center, 701                       for different animal feed commodities.                0.9 ppm is being modified to 1.0 ppm
                                                Mapes Rd., Ft. Meade, MD 20755–5350;                    The U.S. tolerances cannot be                         based on the OECD statistical
                                                telephone number: (410) 305–2905;                       harmonized (lowered) because                          calculation applied to the field trial
                                                email address: residuemethods@                          following the label use directions could              residue data.
                                                epa.gov.                                                result in residues above the Codex                       The proposed tolerance for residues
                                                                                                        MRLs.                                                 in/on soybean seed including the foliage
                                                B. International Residue Limits
                                                                                                                                                              (forage and hay) is not being established
                                                   In making its tolerance decisions, EPA               C. Response to Comments                               since processing studies were not
                                                seeks to harmonize U.S. tolerances with                    A comment was submitted on behalf                  submitted for soybean processed
                                                international standards whenever                        of the Center for Biological Diversity                commodities (hulls, meal, oil).
                                                possible, consistent with U.S. food                     and the Center for Food Safety and was                Therefore, the proposed tolerance for
                                                safety standards and agricultural                       primarily concerned about EPA’s                       residues of cyantraniliprole in/on
                                                practices. EPA considers the                            consideration of the impacts of                       vegetables, foliage of legume (crop
                                                international maximum residue limits                    cyantraniliprole on the environment,                  group 7) is being revised to ‘‘Vegetable,
                                                (MRLs) established by the Codex                         pollinators, and endangered species.                  foliage of legume, except soybean, group
                                                Alimentarius Commission (Codex), as                     This comment is not relevant to the                   7A.’’
                                                required by FFDCA section 408(b)(4).                    Agency’s evaluation of safety of the                     Numerous ruminant commodity
                                                The Codex Alimentarius is a joint                       cyantraniliprole tolerances under                     tolerances are already established.
                                                United Nations Food and Agriculture                     section 408 of the FFDCA, which                       These ruminant (cattle, goats, horses,
                                                Organization/World Health                               requires the Agency to evaluate the                   and sheep) commodity tolerances are
                                                Organization food standards program,                    potential harms to human health, not                  being increased to reflect the new
                                                and it is recognized as an international                effects on the environment.                           dietary burdens from the tolerances
                                                food safety standards-setting                              EPA received two other comments to                 established by this document.
                                                organization in trade agreements to                     the Notices of Filing noting general
                                                which the United States is a party. EPA                                                                       V. Conclusion
                                                                                                        concerns about the toxicity of this
                                                may establish a tolerance that is                       chemical and stating, in part, that ‘‘this               Therefore, tolerances are established
                                                different from a Codex MRL; however,                    product represents a clear and present                for residues of cyantraniliprole, 3-
                                                FFDCA section 408(b)(4) requires that                   danger’’ and ‘‘should not be approved to              bromo-1-(3-chloro-2-pyridinyl)-N-[4-
                                                EPA explain the reasons for departing                   be sold.’’ The Agency understands the                 cyano-2-methyl-6-
                                                from the Codex level.                                   commenter’s concerns and recognizes                   [(methylamino)carbonyl]phenyl]-1H-
                                                   For the commodities discussed in this                that some individuals believe that                    pyrazole-5-carboxamide, including its
                                                action, there are only Codex MRLs                       pesticides should be banned on                        metabolites and degradates, in or on
                                                established for residues of                             agricultural crops. However, the existing             Artichoke, globe at 0.10 ppm; Berry, low
                                                cyantraniliprole on coffee beans (0.03                  legal framework provided by section                   growing, except strawberry, subgroup
                                                ppm), cucurbit fruiting vegetables (0.3                 408 of the FFDCA states that tolerances               13–07H at 0.08 ppm; Coffee, green bean
                                                ppm), legume animal feeds (in the U.S.                  may be set when persons seeking such                  at 0.05 ppm; Corn, field, grain at 0.01
                                                identified as Foliage of legume                         tolerances or exemptions have                         ppm; Corn, pop, grain at 0.01 ppm;
                                                vegetables) (0.8 ppm), and root and                     demonstrated that the pesticide meets                 Corn, sweet, kernel plus cob with husks
                                                tuber vegetables (0.05 ppm). There are                  the safety standard imposed by that                   removed at 0.01 ppm; Grape, wine at 2.0
                                                also Codex MRLs for residues of                         statute. EPA has assessed the effects of              ppm; Olive at 1.5 ppm; Olive, oil at 2.0
                                                cyantraniliprole in/on ruminants at                     this chemical on human health and                     ppm; Peanut at 0.01 ppm; Pomegranate
                                                (0.01–0.05 ppm), milk (0.02 ppm), and                   determined that aggregate exposure to it              at 0.01 ppm; Rice, grain at 0.02 ppm;
                                                poultry commodities at (0.01 ppm).                      will be safe.                                         Strawberry at 1.0 ppm; Tea at 30 ppm;
                                                   The EPA has not harmonized the                                                                             Vegetable, foliage of legume, except
                                                tolerances for these commodities with                   D. Revisions to Petitioned-For                        soybean, group 7A at 40 ppm;
                                                the existing Codex MRLs. The petitioner                 Tolerances                                            Vegetable, leaves of root and tuber,
                                                requested a tolerance on coffee without                   The Agency is not establishing the                  group 2 at 40 ppm; Vegetable, legume,
                                                a U.S. registration be established at 0.05              proposed tolerances for corn, field and               dried shelled, except soybean, subgroup
                                                ppm to be line with the existing MRL                    pop, forage; corn, field and pop stover;              6C at 1.0 ppm; Vegetable, legume, edible
                                                for coffee in Canada. The Codex MRLs                    corn, sweet, forage; and corn, sweet                  podded, subgroup 6A at 2.0 ppm;
                                                established for residues of                             stover because the proposed uses are                  Vegetable, legume, succulent shelled,
                                                cyantraniliprole on cucurbit fruiting                   seed treatment only, not a foliar use, so             subgroup 6B at 0.20 ppm; and
jstallworth on DSK7TPTVN1PROD with RULES




                                                vegetables at 0.3 ppm, root and tuber                   no residues will be present on these                  Vegetable, root, except sugar beet,
                                                vegetables at 0.05 ppm, and legume                      feed commodities. Therefore, these                    subgroup 1B at 0.40 ppm.
                                                animal feeds at 0.8 ppm are lower than                  tolerances are not necessary.                            In addition, the following tolerances
                                                the U.S. tolerances of 0.7 ppm, 0.15                      The proposed tolerance for residues of              are modified as follows: Peanut, hay
                                                ppm and 40 ppm, respectively. The U.S.                  cyantraniliprole in/on rice, grain of 0.03            from 0.01 ppm to 3.0 ppm and
                                                tolerances cannot be harmonized                         ppm is being modified to 0.02 ppm                     Vegetable, cucurbit, group 9 from 0.40
                                                because following the label use                         based on the OECD statistical                         ppm to 0.70 ppm.


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                                                                        Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations                                                                                                  14629

                                                  Also, due to the tolerances being                                          subject to OMB approval under the                                             Transfer and Advancement Act
                                                established the following tolerances are                                     Paperwork Reduction Act (PRA) (44                                             (NTTAA) (15 U.S.C. 272 note).
                                                modified as follows: Cattle, fat from 0.01                                   U.S.C. 3501 et seq.), nor does it require
                                                                                                                                                                                                           VII. Congressional Review Act
                                                ppm to 0.10 ppm; Cattle, meat from 0.01                                      any special considerations under
                                                ppm to 0.10 ppm; Cattle, meat                                                Executive Order 12898, entitled                                                 Pursuant to the Congressional Review
                                                byproducts from 0.01 ppm to 0.40 ppm;                                        ‘‘Federal Actions to Address                                                  Act (5 U.S.C. 801 et seq.), EPA will
                                                Goat, fat from 0.01 ppm to 0.10 ppm;                                         Environmental Justice in Minority                                             submit a report containing this rule and
                                                Goat, meat from 0.01 ppm to 0.10 ppm;                                        Populations and Low-Income                                                    other required information to the U.S.
                                                Goat, meat byproducts from 0.01 ppm to                                       Populations’’ (59 FR 7629, February 16,                                       Senate, the U.S. House of
                                                0.40 ppm; Horse, fat from 0.01 ppm to                                        1994).                                                                        Representatives, and the Comptroller
                                                0.10 ppm; Horse, meat from 0.01 to 0.10                                         Since tolerances and exemptions that                                       General of the United States prior to
                                                ppm; Horse, meat byproducts from 0.01                                        are established on the basis of a petition                                    publication of the rule in the Federal
                                                ppm to 0.40 ppm; Milk from 0.01 ppm                                          under FFDCA section 408(d), such as                                           Register. This action is not a ‘‘major
                                                to 0.20 ppm; Sheep, fat from 0.01 ppm                                        the tolerance in this final rule, do not                                      rule’’ as defined by 5 U.S.C. 804(2).
                                                to 0.10 ppm; Sheep, meat from 0.01                                           require the issuance of a proposed rule,
                                                                                                                             the requirements of the Regulatory                                            List of Subjects in 40 CFR Part 180
                                                ppm to 0.10 ppm; and Sheep, meat
                                                byproducts from 0.01 to 0.40 ppm.                                            Flexibility Act (RFA) (5 U.S.C. 601 et                                          Environmental protection,
                                                  Lastly, due to the tolerances being                                        seq.), do not apply.                                                          Administrative practice and procedure,
                                                established above, the indirect or                                              This action directly regulates growers,                                    Agricultural commodities, Pesticides
                                                inadvertent tolerances under 40 CFR                                          food processors, food handlers, and food                                      and pests, Reporting and recordkeeping
                                                180.672 (d) for Peanut, hay; Vegetable,                                      retailers, not States or tribes, nor does                                     requirements.
                                                foliage of legume (group 7); Vegetable,                                      this action alter the relationships or                                           Dated: February 17, 2017.
                                                leaves of root and tuber vegetables                                          distribution of power and
                                                                                                                                                                                                           Daniel J. Rosenblatt,
                                                (group 2); and Vegetable, root (subgroup                                     responsibilities established by Congress
                                                                                                                             in the preemption provisions of FFDCA                                         Acting Director, Registration Division, Office
                                                1A) are removed as unnecessary, and                                                                                                                        of Pesticide Programs.
                                                new tolerances are established under                                         section 408(n)(4). As such, the Agency
                                                180.672 (d) for Beet, sugar, roots at 0.02                                   has determined that this action will not                                        Therefore, 40 CFR chapter I is
                                                ppm; Soybean, forage at 0.70 ppm; and                                        have a substantial direct effect on States                                    amended as follows:
                                                Soybean, hay at 0.70 ppm.                                                    or tribal governments, on the
                                                                                                                             relationship between the national                                             PART 180—[AMENDED]
                                                VI. Statutory and Executive Order                                            government and the States or tribal
                                                Reviews                                                                      governments, or on the distribution of                                        ■ 1. The authority citation for part 180
                                                  This action establishes tolerances                                         power and responsibilities among the                                          continues to read as follows:
                                                under FFDCA section 408(d) in                                                various levels of government or between                                           Authority: 21 U.S.C. 321(q), 346a and 371.
                                                response to a petition submitted to the                                      the Federal Government and Indian                                             ■ 2. In § 180.672, revise paragraphs (a)
                                                Agency. The Office of Management and                                         tribes. Thus, the Agency has determined                                       and (d) to read as follows:
                                                Budget (OMB) has exempted these types                                        that Executive Order 13132, entitled
                                                of actions from review under Executive                                       ‘‘Federalism’’ (64 FR 43255, August 10,                                       § 180.672 Cyantraniliprole; tolerances for
                                                Order 12866, entitled ‘‘Regulatory                                           1999) and Executive Order 13175,                                              residues.
                                                Planning and Review’’ (58 FR 51735,                                          entitled ‘‘Consultation and Coordination                                         (a) General. Tolerances are
                                                October 4, 1993). Because this action                                        with Indian Tribal Governments’’ (65 FR                                       established for the combined residues of
                                                has been exempted from review under                                          67249, November 9, 2000) do not apply                                         the insecticide cyantraniliprole, 3-
                                                Executive Order 12866, this action is                                        to this action. In addition, this action                                      bromo-1-(3-chloro-2-pyridinyl)-N-[4-
                                                not subject to Executive Order 13211,                                        does not impose any enforceable duty or                                       cyano-2-methyl-6-
                                                entitled ‘‘Actions Concerning                                                contain any unfunded mandate as                                               [((methylamino)carbonyl]phenyl]-1H-
                                                Regulations That Significantly Affect                                        described under Title II of the Unfunded                                      pyrazole-5-carboxamide, including its
                                                Energy Supply, Distribution, or Use’’ (66                                    Mandates Reform Act (UMRA) (2 U.S.C.                                          metabolites and degradates, in or on
                                                FR 28355, May 22, 2001) or Executive                                         1501 et seq.).                                                                commodities in the following table.
                                                Order 13045, entitled ‘‘Protection of                                           This action does not involve any                                           Compliance with the tolerance levels
                                                Children from Environmental Health                                           technical standards that would require                                        specified in the following table is to be
                                                Risks and Safety Risks’’ (62 FR 19885,                                       Agency consideration of voluntary                                             determined by measuring only
                                                April 23, 1997). This action does not                                        consensus standards pursuant to section                                       cyantraniliprole in or on the
                                                contain any information collections                                          12(d) of the National Technology                                              commodity.

                                                                                                                                                                                                                                                             Parts per
                                                                                                                                            Commodity                                                                                                         million

                                                Almond, hulls .......................................................................................................................................................................................                8.0
                                                Artichoke, globe 1 .................................................................................................................................................................................                0.10
                                                Berry, low growing, except strawberry, subgroup 13–07H 1 ...............................................................................................................                                            0.08
                                                Brassica head and stem, subgroup 5A ...............................................................................................................................................                                  3.0
                                                Brassica leafy vegetables, subgroup 5B .............................................................................................................................................                                  30
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                                                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



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                                                14630                   Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations

                                                                                                                                                                                                                                                               Parts per
                                                                                                                                            Commodity                                                                                                           million

                                                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, subgroup 6C .....................................................................................................                                                    1.0
                                                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.


                                                *     *     *     *    *                                                      pyridinyl)-N-[4-cyano-2-methyl-6-                                              Compliance with the tolerance levels
                                                  (d) Indirect or inadvertant residues.                                       [((methylamino)carbonyl]phenyl]-1H-                                            specified in the following table is to be
                                                Tolerances are established for indirect                                       pyrazole-5-carboxamide, including its                                          determined by measuring only
                                                or inadvertant tolerances for residues of                                     metabolites and degradates, in or on                                           cyantraniliprole in or on the
                                                cyantraniliprole, 3-bromo-1-(3-chloro-2-                                      commodities in the following table.                                            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
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                                                                 Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations                                         14631

                                                ENVIRONMENTAL PROTECTION                                number: (703) 305–7090; email address:                2016–0566, by one of the following
                                                AGENCY                                                  BPPDFRNotices@epa.gov.                                methods:
                                                                                                        SUPPLEMENTARY INFORMATION:                              • Federal eRulemaking Portal: http://
                                                40 CFR Part 180
                                                                                                        I. General Information                                www.regulations.gov. Follow the online
                                                                                                                                                              instructions for submitting comments.
                                                [EPA–HQ–OPP–2016–0566; FRL–9959–92]                     A. Does this action apply to me?                      Do not submit electronically any
                                                                                                           You may be potentially affected by                 information you consider to be CBI or
                                                Aspergillus flavus AF36; Amendment
                                                to an Exemption From the                                this action if you are an agricultural                other information whose disclosure is
                                                Requirement of a Tolerance                              producer, food manufacturer, or                       restricted by statute.
                                                                                                        pesticide manufacturer. The following                   • Mail: OPP Docket, Environmental
                                                AGENCY:  Environmental Protection                       list of North American Industrial                     Protection Agency Docket Center (EPA/
                                                Agency (EPA).                                           Classification System (NAICS) codes is                DC), (28221T), 1200 Pennsylvania Ave.
                                                ACTION: Final rule.                                     not intended to be exhaustive, but rather             NW., Washington, DC 20460–0001.
                                                                                                        provides a guide to help readers
                                                SUMMARY:   This regulation amends the                   determine whether this document                         • Hand Delivery: To make special
                                                existing tolerance exemption for                        applies to them. Potentially affected                 arrangements for hand delivery or
                                                Aspergillus flavus AF36 by establishing                 entities may include:                                 delivery of boxed information, please
                                                an exemption from the requirement of a                     • Crop production (NAICS code 111).                follow the instructions at http://
                                                tolerance for residues of Aspergillus                      • Animal production (NAICS code                    www.epa.gov/dockets/contacts.html.
                                                flavus AF36 in or on almond and fig                     112).                                                 Additional instructions on commenting
                                                when used in accordance with label                         • Food manufacturing (NAICS code                   or visiting the docket, along with more
                                                directions and good agricultural                        311).                                                 information about dockets generally, is
                                                practices. Interregional Research Project                  • Pesticide manufacturing (NAICS                   available at http://www.epa.gov/
                                                Number 4 submitted a petition to EPA                    code 32532).                                          dockets.
                                                under the Federal Food, Drug, and
                                                                                                        B. How can I get electronic access to                 II. Background
                                                Cosmetic Act (FFDCA), requesting that
                                                EPA amend the existing tolerance                        other related information?
                                                                                                                                                                 In the Federal Register of November
                                                exemption for Aspergillus flavus AF36.                    You may access a frequently updated                 30, 2016 (81 FR 86312) (FRL–9954–06),
                                                This regulation eliminates the need to                  electronic version of 40 CFR part 180                 EPA issued a document pursuant to
                                                establish a maximum permissible level                   through the Government Publishing                     FFDCA section 408(d)(3), 21 U.S.C.
                                                for residues of Aspergillus flavus AF36                 Office’s e-CFR site at http://                        346a(d)(3), announcing the filing of a
                                                under FFDCA.                                            www.ecfr.gov/cgi-bin/text-                            pesticide tolerance petition (PP 6E8471)
                                                DATES: This regulation is effective                     idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  by Interregional Research Project
                                                March 22, 2017. Objections and requests                 40tab_02.tpl.                                         Number 4 (IR–4), Rutgers University,
                                                for hearings must be received on or                     C. How can I file an objection or hearing             500 College Rd. East, Suite 201W,
                                                before May 22, 2017, and must be filed                  request?                                              Princeton, NJ 08540. The petition
                                                in accordance with the instructions                                                                           requested that 40 CFR 180.1206 be
                                                provided in 40 CFR part 178 (see also                     Under FFDCA section 408(g), 21
                                                                                                        U.S.C. 346a(g), any person may file an                amended by establishing an exemption
                                                Unit I.C. of the SUPPLEMENTARY                                                                                from the requirement of a tolerance for
                                                INFORMATION).
                                                                                                        objection to any aspect of this regulation
                                                                                                        and may also request a hearing on those               residues of Aspergillus flavus AF36 in
                                                ADDRESSES:    The docket for this action,               objections. You must file your objection              or on almond and fig. That document
                                                identified by docket identification (ID)                or request a hearing on this regulation               referenced a summary of the petition
                                                number EPA–HQ–OPP–2016–0566, is                         in accordance with the instructions                   prepared by the petitioner IR–4, which
                                                available at http://www.regulations.gov                 provided in 40 CFR part 178. To ensure                is available in the docket via http://
                                                or at the Office of Pesticide Programs                  proper receipt by EPA, you must                       www.regulations.gov. There were no
                                                Regulatory Public Docket (OPP Docket)                   identify docket ID number EPA–HQ–                     comments received in response to the
                                                in the Environmental Protection Agency                  OPP–2016–0566 in the subject line on                  notice of filing.
                                                Docket Center (EPA/DC), West William                    the first page of your submission. All
                                                Jefferson Clinton Bldg., Rm. 3334, 1301                                                                       III. Final Rule
                                                                                                        objections and requests for a hearing
                                                Constitution Ave. NW., Washington, DC                   must be in writing, and must be                       A. EPA’s Safety Determination
                                                20460–0001. The Public Reading Room                     received by the Hearing Clerk on or
                                                is open from 8:30 a.m. to 4:30 p.m.,                    before May 22, 2017. Addresses for mail                  Section 408(c)(2)(A)(i) of FFDCA
                                                Monday through Friday, excluding legal                  and hand delivery of objections and                   allows EPA to establish an exemption
                                                holidays. The telephone number for the                  hearing requests are provided in 40 CFR               from the requirement for a tolerance (the
                                                Public Reading Room is (202) 566–1744,                  178.25(b).                                            legal limit for a pesticide chemical
                                                and the telephone number for the OPP                      In addition to filing an objection or               residue in or on a food) only if EPA
                                                Docket is (703) 305–5805. Please review                 hearing request with the Hearing Clerk                determines that the exemption is ‘‘safe.’’
                                                the visitor instructions and additional                 as described in 40 CFR part 178, please               Section 408(c)(2)(A)(ii) of FFDCA
                                                information about the docket available                  submit a copy of the filing (excluding                defines ‘‘safe’’ to mean that ‘‘there is a
                                                at http://www.epa.gov/dockets.                          any Confidential Business Information                 reasonable certainty that no harm will
jstallworth on DSK7TPTVN1PROD with RULES




                                                FOR FURTHER INFORMATION CONTACT:                        (CBI)) for inclusion in the public docket.            result from aggregate exposure to the
                                                Robert McNally, Biopesticides and                       Information not marked confidential                   pesticide chemical residue, including
                                                Pollution Prevention Division (7511P),                  pursuant to 40 CFR part 2 may be                      all anticipated dietary exposures and all
                                                Office of Pesticide Programs,                           disclosed publicly by EPA without prior               other exposures for which there is
                                                Environmental Protection Agency, 1200                   notice. Submit the non-CBI copy of your               reliable information.’’ This includes
                                                Pennsylvania Ave. NW., Washington,                      objection or hearing request, identified              exposure through drinking water and in
                                                DC 20460–0001; main telephone                           by docket ID number EPA–HQ–OPP–                       residential settings but does not include


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Document Created: 2017-03-22 03:59:07
Document Modified: 2017-03-22 03:59:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective 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).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation82 FR 14623 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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