Document ID: EPA-HQ-OPP-2011-0668-0054
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Cyantraniliprole
Posted Date: 2014-02-05T05:00Z

[Federal Register Volume 79, Number 24 (Wednesday, February 5, 2014)]
[Rules and Regulations]
[Pages 6826-6833]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02210]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0668; FRL-9388-7]

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 that are identified and 
discussed later in this document. E.I. du Pont de Nemours & Company 
(DuPont) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective February 5, 2014. Objections and 
requests for hearings must be received on or before April 7, 2014, 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-2011-0668, 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), EPA West 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 6827]]

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-2011-0668 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 
April 7, 2014. 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-2011-0668, 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 May 23, 2012 (77 FR 30481) (FRL-9347-8), 
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 1F7894) 
by E.I. du Pont de Nemours & Company (DuPont), 1007 Market St., 
Wilmington, DE 19898. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the insecticide 
cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-
6-[(methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, including 
its metabolites and degradates, in or on almond hulls at 30 parts per 
million (ppm); berries and small fruits, bushberries (subgroup 13-07B) 
at 4 ppm; Brassica (cole) leafy vegetables, head and stem Brassica 
(subgroup 5A) at 2 ppm; Brassica (cole) leafy vegetables, leafy 
Brassica greens (subgroup 5B) at 30 ppm; bulb vegetables, onion, bulb 
(subgroup 3-07A) at 0.04 ppm; bulb vegetables, onion, green (subgroup 
3-07B) at 8 ppm; cattle, fat at 0.01 ppm; cattle, liver at 0.04 ppm; 
cattle, meat at 0.01 ppm; cattle, meat byproducts, except liver at 0.01 
ppm; cherries at 6 ppm; citrus fruits (group 10-10) at 0.7 ppm; cotton 
gin byproduct at 10 ppm; cucurbit vegetables (group 9) at 0.3 ppm; 
fruiting vegetables (group 8-10) at 2 ppm; goat, fat at 0.01 ppm; goat, 
liver at 0.04 ppm; goat, meat at 0.01 ppm; goat, meat byproducts, 
except liver at 0.01 ppm; hog, fat at 0.01 ppm; hog, liver at 0.04 ppm; 
hog, meat at 0.01 ppm; hog, meat byproducts, except liver at 0.01 ppm; 
horse, fat at 0.01 ppm; horse, liver at 0.04 ppm; horse, meat at 0.01 
ppm; horse, meat byproducts, except liver at 0.01 ppm; leafy vegetables 
(except Brassica vegetables) (group 4) at 15 ppm; milk at 0.01 ppm; 
milk, fat at 0.04 ppm; oilseeds, except cotton gin byproduct (group 20) 
at 1 ppm; pome fruits (group 11-10) at 0.8 ppm; root and tuber 
vegetables, tuberous and corm vegetables (subgroup 1C) at 0.15 ppm; 
sheep, fat at 0.01 ppm; sheep, liver at 0.04 ppm; sheep, meat at 0.01 
ppm; sheep, meat byproducts, except liver at 0.01 ppm; stone fruits, 
except cherries (group 12) at 1.5 ppm; tree nuts, except almond hulls 
(group 14) at 0.06 ppm; citrus, oil at 6 ppm; citrus, raw peel at 2 
ppm; and potato, wet peel at 0.3 ppm.
    In addition, DuPont requested to amend 40 CFR part 180 to establish 
indirect or inadvertent 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 the following commodities: Foliage 
of legume vegetables (group 7), forage at 0.15 ppm; foliage of legume 
vegetables (group 7), hay at 0.6 ppm; forage, fodder and straw of 
cereal grains (group 16), forage at 0.06 ppm; forage, fodder and straw 
of cereal grains (group 16), hay and straw at 0.15 ppm; grass forage, 
fodder, and hay (group 17), forage at 0.06 ppm; grass forage, fodder, 
and hay (group 17), hay at 0.15 ppm; leaves of root and tuber 
vegetables (human food or animal feed) (group 2) at 0.04 ppm; nongrass 
animal feeds (forage, fodder, straw, and hay) (group 18), forage at 
0.06 ppm; nongrass animal feeds (forage, fodder, straw, and hay) (group 
18), hay at 0.15 ppm; peanut hay at 0.03 ppm; root and tuber 
vegetables, root vegetables (subgroup 1A) at 0.03 ppm.
    That document referenced a summary of the petition prepared by 
DuPont, the registrant, which is available in the docket, http://www.regulations.gov.
    Based upon review of the data supporting the petition, EPA is 
establishing several tolerances that vary from levels requested in the 
original petition. 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

[[Page 6828]]

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. Cyantraniliprole is a 2-generation ryanodine receptor (RyR) 
insecticide belonging to the diamide class of chemistry whose 
pesticidal mode of action (MOA) is through unregulated activation of 
insect RyR channels. This leads to internal calcium store depletion and 
impaired regulation of muscle contraction, causing paralysis and 
eventual death of the insect. Mammalian RyR are shown to be 350 to 
>2,500 times less sensitive than those of insects. 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 only as a result of the adverse effects on 
the liver. Cyantraniliprole is classified as ``Not Likely to be 
Carcinogenic to Humans'' based on the absence of increased tumor 
incidence in acceptable/guideline carcinogenicity studies in rats and 
mice. In addition, there are no genotoxicity, mutagenicity, 
neurotoxicity, or immunotoxicity concerns. There are also no 
developmental or reproductive toxicity concerns. 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 ``Cyantraniliprole. Aggregate Human 
Health Risk Assessment for the Proposed New Uses of the New Active 
Insecticide (March 7, 2013)'' at p.16 in docket ID number EPA-HQ-OPP-
2011-0668.

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 (LOC) 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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints and points of departure 
for cyantraniliprole used for human risk assessment is shown in Table 1 
of this unit.

     Table 1--Summary of Toxicological Doses and Endpoints for Cyantraniliprole for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                   POD and  uncertainty/  RfD, PAD, LOC for
        Exposure/scenario              safety factors      risk assessment      Study and toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (general             An effect attributed to a single dose was not identified in the toxicology
 population, including infants      database.
 and children and females 13-49
 years of age).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 1 mg/kg/day.  Chronic RfD = 0.01   Based on 1-year oral study in
                                   UFA = 10x...........   mg/kg/day.           dogs.
                                   UFH = 10x...........  cPAD = 0.01 mg/kg/   LOAEL = 6 mg/kg/day based on
                                   FQPA SF = 1x........   day..                effects indicative of liver
                                                                               toxicity (increased liver weights
                                                                               and alkaline phosphatase
                                                                               activity), and significant
                                                                               decreases in albumin level.
----------------------------------------------------------------------------------------------------------------

[[Page 6829]]

 
Incidental oral short-term (1 to   NOAEL = 3 mg/kg/day.  LOC for MOE = 100..  Based on both 28-day and 90-day
 30 days) and incidental oral      UFA = 10x...........                        oral study in dogs.
 intermediate-term (1 to 6         UFH = 10x...........                       28-Day LOAEL = 35 mg/kg/day
 months).                          FQPA SF = 1x........                        (lowest dose tested) based on
                                                                               decreases in body weight, food
                                                                               consumption, food efficiency, and
                                                                               changes in clinical chemistry
                                                                               (increased alkaline phosphatase,
                                                                               decreased cholesterol and
                                                                               decreased albumin).
                                                                              90-Day LOAEL = 32 mg/kg/day based
                                                                               on a collection of treatment-
                                                                               related effects indicative of
                                                                               liver toxicity. The effects
                                                                               included decreases in total
                                                                               protein, albumin, and cholesterol
                                                                               in males and females; increases
                                                                               in alkaline phosphatase in males
                                                                               and females; increases in alanine
                                                                               aminotransferase in females; and
                                                                               increases in liver weights in
                                                                               males and females.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).  A toxicity endpoint was not identified.
                                   Systemic toxicity was not seen in 28-day dermal toxicity in rats at the limit
                                    dose (1,000 mg/kg/day). There are no concerns for developmental or
                                    reproductive toxicity or neurotoxicity.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation study      LOC for MOE = 30...  Based on 28-day inhalation
 days).                             NOAEL = 0.1 mg/kg/                         toxicity study in rats.
                                    day.                                      A LOAEL was not established
                                   UFA = 3x.\a\........                        because the highest concentration
                                   UFH = 10x...........                        tested (0.1 mg/L) did not
                                   FQPA SF = 1x........                        demonstrate any adverse portal of
                                   HEC = 0.05 mg/L.....                        entry or systemic effects.
                                   HED = 7.2 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Classification: ``Not likely to be Carcinogenic to Humans'' based on data
                                    showing lack of treatment-related increase in tumor incidence in the rat and
                                    mouse carcinogenicity studies. Mutagenic concern was not reported in the
                                    mutagenicity studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. HEC = human equivalent concentration. HED = human
  equivalent dose. LOAEL = lowest observed adverse effect level. LOC = level of concern. mg/kg/day = milligram/
  kilogram/day.
mg/L = milligram/Liter. MOE = margin of exposure. NOAEL = no observed adverse effect level. PAD = population-
  adjusted dose. POD = point of departure. RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies).
\a\ The magnitude of the UFs applied is dependent on the methodology used to calculate risk. The reference
  concentration (RfC) methodology takes into consideration the pharmacokinetic (PK) differences, but not the
  pharmacodynamic (PD) differences. Consequently, the UF for interspecies extrapolation may be reduced to 3x (to
  account for the PD differences).

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. 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 food 
consumption data from the U.S. 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, EPA conducted a 
somewhat refined chronic (food and drinking water) dietary assessment 
assuming average field trial residues for all crops (except crop 
subgroup 1A which used tolerance levels). Tolerance-level residues were 
used to cover residues in all livestock commodities except liver and 
meat byproducts for which higher anticipated residue calculations were 
used. For processed commodities, input values included combined average 
residues of parent and the metabolite with relevant processing factors. 
It was assumed that 100% crop treated (PCT) for all crops.
    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 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.
    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,

[[Page 6830]]

and fate/transport characteristics of cyantraniliprole. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of cyantraniliprole for 
acute exposures are estimated to be 43.14 parts per billion (ppb) for 
surface water and 6.33 ppb for ground water. For chronic exposures for 
non-cancer assessments EDWCs are also estimated to be 24.45 ppb for 
surface water and 6.33 for ground water.
    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 chronic dietary risk assessment, the water concentration of 
value 24.45 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 
proposed for use on the following sites that could result in 
residential exposures: indoor crack/crevice application, turfgrass, 
golf courses, and ornamentals including both outdoors and in interior 
plantscapes. EPA assessed residential exposure using the following 
assumptions: Residential exposure may occur by the dermal, oral, and 
inhalation routes of exposures. However, since dermal hazard has not 
been identified for cyantraniliprole, the only exposures of concern are 
handler inhalation (for adults), and post-application incidental oral 
(for children). Residential handler exposure is expected to be short-
term in duration. The turf and ornamental labels indicate that a 
maximum of two applications are allowed per season. Thus, intermediate-
term exposures are not likely because of the intermittent nature of 
applications by homeowners. Post-application incidental oral exposures 
for children may occur for short- and intermediate-term durations due 
to the persistence of cyantraniliprole. Further information regarding 
EPA standard assumptions and generic inputs for residential exposures 
may be found at http://www.epa.gov/opp00001/science/residential-exposure-sop.html.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has not found 
cyantraniliprole to share a common mechanism of toxicity with any other 
substances, and cyantraniliprole does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that cyantraniliprole does 
not have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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 Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10x, or uses a different additional 
SF when reliable data available to EPA support the choice of a 
different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
susceptibility in developmental toxicity studies in rats and rabbits. 
The developmental toxicity study in rats is tested up to the limit dose 
(1,000 mg/kg/day). In the rabbit developmental toxicity study decrease 
in fetal body weight is 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 (offspring of P0 
generation) at 14 mg/kg/day which is lower than that for the parental 
(P0) generation (110 mg/kg/day). A clear NOAEL (1.4 mg/kg/
day) is established for F1 parental animals, and the PODs 
selected for risk assessment from the dog studies (1 or 3 mg/kg/day) 
are protective of the effect (thyroid effect) seen in the F1 
parental animals. In addition, the submitted data support the 
conclusion that the effects on the thyroid are secondary to effects on 
the liver.
    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 1. 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. As discussed in Unit III.D.2., there is no evidence that 
cyantraniliprole results in increased susceptibility in in utero rats 
or rabbits in the prenatal developmental studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and average field trial residues. The field trial data were 
validated against the appropriate guideline criteria and found 
acceptable. The field trial data reflect the maximum residues that are 
likely to occur on food commodities when cyantraniliprole is used 
according to label directions at the maximum allowed application rate 
and minimum allowed interval from treatment to harvest. These are farm 
gate residues and do not reflect decreases in residues that may occur 
during transport and storage prior to consumption. No corrections were 
made for the percentage of crops treated, that is, it was assumed that 
100% of all crops for which there is a cyantraniliprole tolerance will 
be treated. Therefore, the data are considered unlikely to 
underestimate actual dietary exposure to cyantraniliprole. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to cyantraniliprole in drinking water. 
In addition, the residential exposure assessment is based on the 
updated 2012 Residential Standard Operating Procedures (SOPs) employing 
surrogate study data, including conservative exposure assumptions based 
on day 0 dermal/oral contact to turf and surfaces treated at the 
maximum application rate. These data are reliable and are not expected 
to underestimate risks to adults or children. The Residential SOPs are 
based upon reasonable ``worst-case'' assumptions are not expected to 
underestimate risk.

[[Page 6831]]

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 50% of the cPAD for 
children 1-2 years old (the population group receiving the greatest 
exposure) and 22% of the general U.S. population.
    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 proposed 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. Residential 
exposure estimates of all possible scenarios are not of concern. Short-
term inhalation MOEs range from 22,000 to 220,000,000. Furthermore, 
these calculated risk estimates are highly conservative because the 
inhalation exposure POD is based on an exposure duration of 24 hours 
per day.
    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 aggregate MOEs of 290 for children 
1-2 years old (the population group receiving the greatest exposure) 
and 22,000 for adults. Because EPA's LOC for cyantraniliprole is a MOE 
of 100 or below, these MOEs are 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). For adults, intermediate-term exposure is not expected for the 
residential exposure pathway. Therefore, the intermediate-term 
aggregate risk would be equivalent to the chronic dietary exposure 
estimate. For children 1 to <2 years old, the short-term aggregate risk 
is protective of the intermediate-term duration.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, cyantraniliprole is not expected to pose a cancer risk to 
humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to cyantraniliprole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate residue analytical method data have been submitted. 
Validation data have been provided for the proposed enforcement 
methods. Methods for measuring cyantraniliprole include the European 
Union (EU) multi-residue method DFG S19 (LC/MS/MS module, Dupont-21328) 
and the North American Free Trade Association (NAFTA) LC/MS/MS 1187 and 
1552 methods. These methods utilize two mass ion transitions so 
confirmatory methods are not required. EU Method DFG S19 has been 
independently validated with a limit of quantification (LOQ) of 0.01 
ppm for parent cyantraniliprole in cereals and dry products, matrices 
with high water content, acidic matrices, and fatty products. NAFTA 
method 1187 has been independently validated with an LOQ of 0.01 ppm 
for parent cyantraniliprole in almonds, onions, tomato paste, and sun 
dried tomatoes. NAFTA method 1552 has been independently validated with 
an LOQ of 0.01 ppm for parent cyantraniliprole in milk, muscle, and 
kidney. Note that cyantraniliprole is not recovered using the Food and 
Drug Administration (FDA) multi-residue methods.

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. Currently there are no 
Codex MRLs for cyantraniliprole.

C. Response to Comments

    The Agency did not receive any public comments on the May 23, 2012 
Federal Register Notice of Filing.

D. Revisions to Petitioned-For Tolerances

    Based on the residue data provided and using the Organization of 
Economic Cooperation and Development (OECD) statistical calculation 
procedures, EPA is revising the tolerance levels for the following 
plant commodities: Almond hulls; Brassica head and stem vegetables 
(subgroup 5A); fruit, pome (group 11-10); fruit, stone; nut, tree 
(group 14-12); oilseed (group 20); vegetable, cucurbit (group 9); and 
vegetable, leafy (except Brassica) (group 4).
    The proposed tolerance for citrus oil was lowered from 4 ppm to 2.4 
ppm, consistent with the results from application of the median 
processing factor to the highest average field trials (HAFT) for 
oranges. EPA is not establishing tolerances for the processed 
commodities citrus raw peel and potato wet peel. The processing studies 
do not show a concentration of residue in these commodities relative to 
the raw agricultural commodities (RAC); therefore, the tolerances on 
RAC are sufficient to cover residues in these processed commodities.
    EPA is not establishing separate tolerances for liver of cattle, 
goat, horse, and sheep; hog fat, liver, meat, and meat byproducts; and 
milk fat. The livestock commodity tolerances are derived from 
consideration of the maximum reasonably balanced livestock diets and 
the livestock feeding studies. A tolerance value of 0.01 ppm is 
appropriate for liver (of cattle, goat, horse, and sheep), which is 
covered by the meat byproducts tolerance. The dietary exposures of hogs 
and poultry do not indicate a need for tolerances (residues are not 
anticipated), and there is no indication of significant

[[Page 6832]]

concentration of cyantraniliprole in milk fat relative to milk.
    With the exception of the proposed tolerance for leaves of root and 
tuber vegetables, EPA is revising all of the proposed tolerances for 
inadvertent residues (with a plantback interval (PBI) of 30 days) based 
on available residue data and use of the OECD statistical calculation 
procedures. For some crop groups, more than one tolerance was proposed 
for various components of the group (e.g., crop group 16 which includes 
forage, fodder, and straw of cereal grains); however, only one 
tolerance is possible per group, and the tolerance is based on the 
member commodity with the highest residue levels.
    EPA issued a final rule in the Federal Register of August 22, 2012 
(77 FR 50617) (FRL-9354-3) that revised some crop grouping regulations. 
As part of that action, EPA expanded and revised the previously 
existing tree nut crop group 14. Changes to crop group 14 included 
adding pistachios plus a number of other nuts, revising the taxonomic 
names for several commodities, and naming the new crop group tree nut 
group 14-12. The representative commodities remain the same as previous 
almond and pecan. That final rule became effective on October 22, 2012. 
EPA indicated in the August 22, 2012 final rule as well as the earlier 
proposed rule published in the Federal Register of November 9, 2011 (76 
FR 69693) (FRL-8887-8) that, for existing petitions for which a Notice 
of Filing had been published, the Agency would attempt to conform these 
petitions to the rule. Therefore, consistent with this rule, EPA has 
assessed and is establishing a tolerance for cyantraniliprole on tree 
nuts crop group 14-12.

 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 almond, hulls at 8.0 ppm; 
Brassica head and stem (subgroup 5A) at 3.0 ppm; Brassica leafy 
vegetables (subgroup 5B) at 30 ppm; bushberry (subgroup 13-07B) at 4.0 
ppm; cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm; cattle, meat 
byproducts at 0.01 ppm; cherry (subgroup 12-12A) at 6.0 ppm; citrus, 
oil at 2.4 ppm; cotton, gin byproducts at 10 ppm; fruit, citrus (group 
10-10) at 0.70 ppm; fruit, pome (group 11-10) at 1.5 ppm; goat, fat at 
0.01 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; 
horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat byproducts 
at 0.01 ppm; milk at 0.01 ppm; nut, tree (group 14-12) at 0.04 ppm; 
oilseed (group 20) at 1.5 ppm; onion, bulb (subgroup 3-07A) at 0.04 
ppm; onion, green (subgroup 3-07B) at 8.0 ppm; peach (subgroup 12-12B) 
at 1.5 ppm; plum (subgroup 12-12C) at 0.50 ppm; sheep, fat at 0.01 ppm; 
sheep, meat at 0.01 ppm; sheep, meat byproducts at 0.01 ppm; vegetable, 
cucurbit (group 9) at 0.40 ppm; vegetable, fruiting (group 8-10) at 2.0 
ppm; vegetable, leafy (except Brassica) (group 4) at 20 ppm; vegetable, 
tuberous and corm (subgroup 1C) at 0.15 ppm. In addition, indirect or 
inadvertent tolerances for 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 the following commodities: Animal feed, nongrass (group 18) at 
0.20 ppm; grain, cereal, forage, fodder and straw (group 16) at 0.50 
ppm; grass forage, fodder and hay (group 17) at 0.50 ppm; peanut, hay 
at 0.01 ppm; vegetable, foliage of legume (group 7) at 0.70 ppm; 
vegetable, leaves of root and tuber vegetables (group 2) at 0.04 ppm; 
vegetable, root (subgroup 1A) at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
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 final rule 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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: January 24, 2014.
Steven Bradbury,
Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

[[Page 6833]]

PART 180--[AMENDED]

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

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

0
2. Add new Sec.  180.672 to subpart C 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
Brassica head and stem (subgroup 5A).......................          3.0
Brassica leafy vegetables (subgroup 5B)....................           30
Bushberry (subgroup 13-07B)................................          4.0
Cattle, fat................................................         0.01
Cattle, meat...............................................         0.01
Cattle, meat byproducts....................................         0.01
Cherry (subgroup 12-12A)...................................          6.0
Citrus, oil................................................          2.4
Cotton, gin byproducts.....................................           10
Fruit, citrus (group 10-10)................................         0.70
Fruit, pome (group 11-10)..................................          1.5
Goat, fat..................................................         0.01
Goat, meat.................................................         0.01
Goat, meat byproducts......................................         0.01
Horse, fat.................................................         0.01
Horse, meat................................................         0.01
Horse, meat byproducts.....................................         0.01
Milk.......................................................         0.01
Nut, tree (group 14-12)....................................         0.04
Oilseed (group 20).........................................          1.5
Onion, bulb (subgroup 3-07A)...............................         0.04
Onion, green (subgroup 3-07B)..............................          8.0
Peach (subgroup 12-12B)....................................          1.5
Plum (subgroup 12-12C).....................................         0.50
Sheep, fat.................................................         0.01
Sheep, meat................................................         0.01
Sheep, meat byproducts.....................................         0.01
Vegetable, cucurbit (group 9)..............................         0.40
Vegetable, fruiting (group 8-10)...........................          2.0
Vegetable, leafy (except Brassica) (group 4)...............           20
Vegetable, tuberous and corm (subgroup 1C).................         0.15
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established 
for indirect or inadvertent 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
Grain, cereal, forage, fodder and straw (group 16).........         0.50
Grass forage, fodder and hay (group 17)....................         0.50
Peanut, hay................................................         0.01
Vegetable, foliage of legume (group 7).....................         0.70
Vegetable, leaves of root and tuber vegetables (group 2)...         0.04
Vegetable, root (subgroup 1A)..............................         0.02
------------------------------------------------------------------------

[FR Doc. 2014-02210 Filed 2-4-14; 8:45 am]
BILLING CODE 6560-50-P