[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Rules and Regulations]
[Pages 57860-57866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26517]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0095; FRL-9970-39]


Indoxacarb; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
indoxacarb in or on corn, field, forage; corn, field, stover; corn, 
field, grain. E. I. du Pont de Nemours and Company requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 8, 2017. Objections and 
requests for hearings must be received on or before February 6, 2018, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0095, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, 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-2017-0095 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 
February 6, 2018. 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

[[Page 57861]]

by docket ID number EPA-HQ-OPP-2017-0095, 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 June 8, 2017 (82 FR 26641) (FRL-9961-
14), 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 
6F8536) by E. I. du Pont de Nemours and Company, 974 Centre Road, 
Wilmington, Delaware 19805. The petition requested that 40 CFR part 180 
be amended by establishing tolerances for residues of the insecticide 
indoxacarb, [(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)-phenyl] amino]carbonyl]indeno[1,2e] 
[1,3,4]oxadiazine-4a(3H)-carboxylate], and [(R)-methyl 7 chloro-2,5-
dihydro-2[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] 
amino]carbonyl]indeno[1,2-e][1,3,4] oxadiazine-4a(3H)-carboxylate], in 
or on corn, field, forage at 10 parts per million (ppm); corn, field, 
stover at 15 ppm; corn, field, aspirated grain fractions at 45 ppm; 
corn, field flour at 0.07 ppm; corn, field, meal at 0.03 ppm; corn, 
field, oil at 0.05 ppm; corn, field, grain at 0.02 ppm. That document 
referenced a summary of the petition prepared by E. I. du Pont de 
Nemours and Company, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based on available information, EPA is establishing some tolerances 
that vary from what the petitioner requested. The reasons for these 
changes are discussed in Unit IV.C.

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 indoxacarb including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with indoxacarb 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.
    The most common effects resulting from exposure to indoxacarb 
(defined by the lowest-observed-adverse-effect-level (LOAEL)) were non-
specific, and included decreases in body weight, food consumption, and 
food efficiency. Indoxacarb also affected the hematopoietic system by 
decreasing the red blood cell count, hemoglobin, and hematocrit in 
rats, dogs, and mice.
    There was no evidence of reproductive effects in rats resulting 
from exposure to indoxacarb. There was no evidence of increased 
susceptibility in developing fetuses or in offspring following prenatal 
and/or postnatal exposure to indoxacarb in rats or rabbits. There was 
no evidence of increased susceptibility in the young in the 
developmental neurotoxicity study in rats. Neurotoxicity was observed 
in rats and mice, but at doses much higher than those selected for 
points of departure (PoDs) (which are based on changes in body weight, 
food consumption and changes in hematology). There is no evidence 
indoxacarb is carcinogenic, teratogenic, mutagenic, or immunotoxic.
    Specific information on the studies received and the nature of the 
adverse effects caused by indoxacarb 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 documents, Indoxacarb: Human Health Risk 
Assessment for Indoxacarb to Support the Proposed New Uses on Corn 
(Field, Pop, and Grown for Seed) in docket ID number EPA-HQ-OPP-2017-
0095 and Indoxacarb: Human Health Draft Risk Assessment for Indoxacarb 
to Support Registration Review and the Proposed New Use for Controlling 
Ants at Ornamental Nurseries, Sod Farms, and Livestock Corrals of non-
Food Bearing Animals in docket ID number EPA-HQ-OPP-2013-0367.

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

[[Page 57862]]

assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for indoxacarb used for 
human risk assessment is shown in Table 1 of this unit.

                 Table 1--Summary of Toxicological Doses and Endpoints for Indoxacarb for Use in
                                          Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure  and                                      Study and
        Exposure/scenario              uncertainty/  safety       RfD, PAD, LOC for  risk       toxicological
                                             factors                     assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..  NOAEL = 12 mg/kg/day.......  Acute RfD = 0.12 mg/kg/day.  Acute oral rate
                                   UFA = 10x..................  aPAD = 0.12mg/kg/day.......   neurotoxicity
                                   UFH = 10x..................                                study LOAEL = 50
                                   FQPA SF = 1x...............                                mg/kg/day based on
                                                                                              decreased body
                                                                                              weight and body-
                                                                                              weight gain in
                                                                                              females (MP062).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 2.0 mg/kg/day.......  Chronic RfD = 0.02 mg/kg/    Weight of evidence
                                                                 day.                         approach was used
                                                                                              from four studies:
                                   UFA = 10x                    cPAD = 0.02 mg/kg/day......  (1) Subchronic
                                   UFH = 10x..................                                toxicity study--
                                   FQPA SF = 1x...............                                rat (MP062). MRID
                                                                                              44477129. LOAEL =
                                                                                              6.0 (M), 3.8 (F)
                                                                                              mg/kg/day based on
                                                                                              decreased body
                                                                                              weight, body-
                                                                                              weight gain, food
                                                                                              consumption and
                                                                                              food efficiency.
----------------------------------------------------------------------------------------------------------------
                                                                                             (2) Subchronic
                                                                                              neurotoxicity
                                                                                              study--rat
                                                                                              (MP062). MRID
                                                                                              44477135. LOAEL =
                                                                                              5.6 (M), 3.3 (F)
                                                                                              mg/kg/day based on
                                                                                              decreased body
                                                                                              weight and
                                                                                              alopecia.
                                                                                             (3) Chronic/
                                                                                              carcinogenicity
                                                                                              study--rat
                                                                                              (JW062). MRID
                                                                                              44477145. LOAEL =
                                                                                              10 (M), 3.6 (F) mg/
                                                                                              kg/day based on
                                                                                              decreased body
                                                                                              weight, body-
                                                                                              weight gain, and
                                                                                              food consumption
                                                                                              and food
                                                                                              efficiency;
                                                                                              decreased HCT, HGB
                                                                                              and RBC at 6
                                                                                              months in F only.
                                                                                             (4) Two-generation
                                                                                              rat reproduction
                                                                                              study (JW062).
                                                                                              MRID 44477144.
                                                                                             LOAEL = 4.4 mg/kg/
                                                                                              day based on
                                                                                              decreased body
                                                                                              weights, body-
                                                                                              weight gain, food
                                                                                              consumption and
                                                                                              food efficiency
                                                                                              and increased
                                                                                              spleen weights in
                                                                                              the F0 and F1
                                                                                              females.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL= 2.0 mg/kg/day.......  LOC for MOE = 100..........  Weight of evidence
 30 days).                         UFA = 10x..................                                approach was used
                                   UFH = 10x..................                                from four studies:
                                   FQPA SF = 1x...............                               (1) Subchronic
                                                                                              toxicity study--
                                                                                              rat (MP062). MRID
                                                                                              44477129. LOAEL =
                                                                                              6.0 (M), 3.8 (F)
                                                                                              mg/kg/day based on
                                                                                              decreased body
                                                                                              weight, body-
                                                                                              weight gain, food
                                                                                              consumption and
                                                                                              food efficiency.
----------------------------------------------------------------------------------------------------------------
                                                                                             (2) Subchronic
                                                                                              neurotoxicity
                                                                                              study--rat
                                                                                              (MP062). MRID
                                                                                              44477135. LOAEL =
                                                                                              5.6 (M), 3.3 (F)
                                                                                              mg/kg/day based on
                                                                                              decreased body
                                                                                              weight and
                                                                                              alopecia.
                                                                                             (3) Chronic/
                                                                                              carcinogenicity
                                                                                              study--rat
                                                                                              (JW062). MRID
                                                                                              44477145. LOAEL =
                                                                                              10 (M), 3.6 (F) mg/
                                                                                              kg/day based on
                                                                                              decreased body
                                                                                              weight, body-
                                                                                              weight gain, and
                                                                                              food consumption
                                                                                              and food
                                                                                              efficiency;
                                                                                              decreased HCT, HGB
                                                                                              and RBC at 6
                                                                                              months in F only.
                                                                                             (4) Two-generation
                                                                                              rat reproduction
                                                                                              study (JW062).
                                                                                              MRID 44477144.
                                                                                             LOAEL = 4.4 mg/kg/
                                                                                              day based on
                                                                                              decreased body
                                                                                              weights, body-
                                                                                              weight gain, food
                                                                                              consumption and
                                                                                              food efficiency
                                                                                              and increased
                                                                                              spleen weights in
                                                                                              the F0 and F1
                                                                                              females.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 30 days).  A quantitative dermal assessment is not required for indoxacarb, since the
Intermediate-Term Dermal (1-6       calculated human dermal LOAEL exceeds the limit dose of 1,000 mg/kg/day.
 months).
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation NOAEL= 23         LOC for MOE = 30...........  28-day rat
 days).                             [micro]g/L/day.                                           inhalation
                                   UFA = 3x...................                                toxicity study
                                   UFH = 10x..................                                (MP062). MRID
                                   FQPA SF = 1x...............                                45870001.
----------------------------------------------------------------------------------------------------------------
Inhalation (1-6 months)..........                                                            The LOAEL of 290
                                                                                              [micro]g/L/day is
                                                                                              based on increased
                                                                                              spleen weights,
                                                                                              pigmentation and
                                                                                              hematopoiesis in
                                                                                              the spleen,
                                                                                              hematological
                                                                                              changes, mortality
                                                                                              (females), and
                                                                                              nasal ulceration
                                                                                              and inflammation.
----------------------------------------------------------------------------------------------------------------

[[Page 57863]]

 
Cancer (Oral, dermal, inhalation)  ``Not likely'' to be carcinogenic to humans since no evidence of
                                    carcinogenicity in either the rat or mouse studies, and no evidence of
                                    mutagenicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. [micro]g/L/day = microgram/liter/day. MOE = margin of
  exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic).
  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).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to indoxacarb, EPA considered exposure under the petitioned-
for tolerances as well as all existing indoxacarb tolerances in 40 CFR 
180.564. EPA assessed dietary exposures from indoxacarb 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. Such effects were identified 
for indoxacarb. In conducting the acute dietary exposure assessment EPA 
used food consumption information 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). In estimating acute dietary exposure, EPA used maximum residue 
levels based on the results of field trials reflecting maximum use 
patterns in all commodities and used maximum Percent Crop Treated (PCT) 
estimates.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used food consumption information 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). In estimating chronic dietary exposure, EPA 
used average residue levels based on the results of field trials 
reflecting maximum use patterns in all commodities and used average PCT 
estimates.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that indoxacarb 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. Average or maximum 
residues and PCT values were used for food commodities.
    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 maximum and average PCT values for the acute 
and chronic dietary assessments, as follows:
     For acute dietary assessment: Apples: 10%; apricots: 15%; 
blueberries: 5%; broccoli: 70%, cabbage: 35%; cantaloupe: 10%; 
cauliflower: 60%; celery: 5%; cherries: 2.5%; cotton: 2.5%; cucumbers: 
10%; grapes: 5%; lettuce: 15%; nectarines: 15%; peaches: 10%; peanuts: 
10%; pears: 2.5%; peppers: 30%; plums/prunes: 5%; potatoes: 2.5%; 
soybeans: 2.5%; spinach: 5%; squash: 5%; sweet corn: 10%; and tomatoes: 
40%.
     For chronic dietary assessment: Apples: 5%; apricots: 5%; 
blueberries: 5% broccoli: 45%, cabbage: 20%; cantaloupe: 5%; 
cauliflower: 35%; celery: 5%; cherries: 2.5%; cotton: 2.5%; cucumbers: 
2.5%; grapes: 2.5%; lettuce: 5%; nectarines: 15%; peaches: 2.5%; 
peanuts: 5%; pears: 1%; peppers: 15%; plums/prunes: 5%; potatoes: 2.5%; 
soybeans: 1%; spinach: 2.5%; squash: 2.5%; sweet corn: 2.5%; and 
tomatoes: 20%.
    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 to 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 2.5%. In those 
cases, estimates of average PCT between 1% and 2.5% are rounded to 2.5% 
and estimates of average PCT less than 1% are rounded to 1%. 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%, except for those 
situations in which the maximum PCT is less than 2.5%. In those cases, 
EPA uses a maximum PCT value of 2.5%.
    The Agency believes the three conditions discussed in Unit 
III.C.1.iv.

[[Page 57864]]

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 
indoxacarb 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 indoxacarb in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of indoxacarb. 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 Surface Water Concentration Calculator (SWCC) model 
and the Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of indoxacarb for acute exposures 
are 39 parts per billion (ppb) for surface water and 131 ppb for ground 
water; for chronic exposures the EDWCs are 11 ppb for surface water and 
123 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, a time series distribution of ground water modeled residues 
was used to assess the contribution to drinking water. For the chronic 
dietary risk assessment, a single point water concentration value of 
123 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).
    Indoxacarb is currently registered for the following uses that 
could result in residential exposures: Pet spot-on uses, spot, crack 
and crevice applications indoors, outdoor broadcast (i.e., turf), 
perimeter and foundations, spot (i.e., direct mount applications for 
fire ants), and crack and crevice.
    Based on these use scenarios, EPA assessed residential exposure 
using the following assumptions:
     Spot and crack and crevice exposures were not assessed due 
to formulation types that minimize the potential for handler and post-
application exposures (i.e., gels or bait stations). Risks from spot 
and crack and crevice were not assessed because exposures from these 
formulation types are expected to be negligible.
     Residential handler exposure: There is a potential for 
dermal and inhalation exposure. Residential handler inhalation exposure 
is considered negligible for applying ready-to-use pet spot-ons. 
Residential handler dermal exposures are expected for ready-to-use pet 
spot-ons, however dermal exposures were not assessed due to the lack of 
a dermal endpoint. Residential handler inhalation and dermal exposures 
are considered negligible for applying ready-to-use arenas (i.e., baits 
or stations).
     Residential post-application dermal and incidental oral 
exposure: Post-application assessments were not conducted for ant mound 
uses, because these are considered perimeter/spot uses; residential 
exposure is expected to be negligible. Spot and crack and crevice 
exposures were not assessed for gels or bait stations; exposure is 
considered negligible. A golfer assessment was not conducted, due to 
the lack of a dermal endpoint. Post-application inhalation exposure is 
generally not assessed following application to pets and turf. The 
combination of low vapor pressure (1.9x10-10 mm Hg at 25 [ordm]C for 
indoxacarb) of active ingredients typically used in pet and turf 
pesticide products, and the small amounts of pesticide applied to pets 
is expected to result in only negligible inhalation exposure. Ingestion 
of granules is considered an episodic event and not a routine behavior. 
Because the Agency does not expect this to occur on a regular basis, 
concern for human health is related to acute poisoning rather than 
short-term residue exposure. For these reasons, the episodic ingestion 
scenario is not included in the aggregate assessment. The only route of 
residential exposure for inclusion in the adult aggregate assessment is 
inhalation. However, inhalation exposures cannot be aggregated with 
background dietary exposures because the toxicity endpoints for the 
inhalation and short-term oral routes are different. Therefore, the 
only residential exposures that were combined are for children 1 to <2 
years old in the short-term aggregate assessment that reflects hand-to-
mouth exposures from post-application exposure to spot treatment on 
carpets, and children 1 to <2 years old in the intermediate- and long-
term aggregate assessment that reflects exposures from treated pets.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 indoxacarb to share a common mechanism of 
toxicity with any other substances, and indoxacarb does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA assumed that 
indoxacarb 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 FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10 times;, or uses a different additional safety factor when

[[Page 57865]]

reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
reproductive effects in rats. There was no evidence of increased 
susceptibility in developing fetuses or in the offspring following 
prenatal and/or postnatal exposure to indoxacarb in rats or rabbits. 
There was no evidence of increased susceptibility in the young in the 
developmental neurotoxicity study in rats.
    3. Conclusion. EPA determined 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 indoxacarb is complete.
    ii. The acute neurotoxicity, subchronic toxicity, and developmental 
neurotoxicity studies for indoxacarb are available and all endpoints 
used in the risk assessment are protective of neurotoxic effects.
    iii. There is no evidence that indoxacarb results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The Agency estimated maximum and average PCT values for the 
acute and chronic dietary assessments, respectively, as shown in unit 
III.C.i., and unit III.C.ii.
    Food residues were taken from the results of supervised field trial 
studies reflecting maximum use patterns. Drinking water residues were 
included in the dietary assessments as follows: A point estimate of 123 
ppb was used for the chronic assessment and the time series 
distribution of ground water modeled residues was used in the acute 
assessment as a residue distribution file (RDF) in the Monte Carlo 
analysis. For food commodities, RDFs were constructed for the 
probabilistic acute dietary assessment as appropriate, and average 
residues were computed for blended commodities and for the chronic 
dietary assessment.
    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 indoxacarb.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to indoxacarb will occupy 56% of the aPAD for children ages 1-2, the 
population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
indoxacarb from food and water will utilize 35% of the cPAD for all 
infants less than 1-year old, the population group receiving the 
greatest exposure. EPA has concluded the combined long-term food, 
water, and residential exposures result in aggregate MOEs of 260 (food, 
water, and residential) for children aged 1-2. Because EPA's level of 
concern for indoxacarb is a MOE of 100 or below, this MOEs is not of 
concern. For adults, residential inhalation exposures cannot be 
aggregated because they are based on different effects than for oral 
exposures. Therefore, long-term aggregate risk for adults is equivalent 
to the chronic dietary risk noted in this unit.
    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). Indoxacarb 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 to children aged 1-2 years 
through food and water with short-term residential exposures to 
indoxacarb. For adults, residential inhalation exposures cannot be 
aggregated because they are based on different effects than for oral 
exposures. Therefore, short-term aggregate risk for adults is 
equivalent to the chronic risk noted in unit III.E.2.
    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 120 (food, water, 
and residential) for children aged 1-2. Because EPA's level of concern 
for indoxacarb is a MOE of 100 or below, this MOEs 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). Indoxacarb is currently registered for uses that could result 
in intermediate-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure to 
children aged 1-2 years through food and water with intermediate-term 
residential exposures to indoxacarb. For adults, residential inhalation 
exposures cannot be aggregated because they are based on different 
effects than for oral exposures. Therefore, intermediate-term aggregate 
risk for adults is equivalent to the chronic risk noted above in unit 
III.E.2.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures for children 
aged 1-2 years result in aggregate MOEs of 260. Because EPA's level of 
concern for indoxacarb is a MOE of 100 or below, this MOE is not of 
concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, indoxacarb 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 indoxacarb residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For the enforcement of tolerances established on crops, two High 
Performance Liquid Chromatograph/Ultraviolet Detection (HPLC/UV) 
methods, DuPont protocols AMR 2712-93 and DuPont-11978, are available 
for use. The limits of quantitation (LOQs) for these methods range from 
0.01 to 0.05 ppm for a variety of plant commodities. A third procedure, 
Gas Chromatograph/Mass-Selective Detection (GC/MSD), DuPont method AMR 
3493-95 Supplement No. 4, is also available for the confirmation of 
residues in plants.

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

[[Page 57866]]

safety standards and agricultural practices. EPA considers the 
international maximum residue limits (MRLs) established by the Codex 
Alimentarius Commission (Codex), as required by FFDCA section 
408(b)(4). The Codex Alimentarius is a joint United Nations Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established MRLs in field corn for indoxacarb.

C. Revisions to Petitioned-For Tolerances

    Based on available data and using the Organisation for Economic Co-
operation and Development (OECD) maximum residue limit (MRL) 
calculation procedures, EPA determined that the appropriate tolerance 
level for corn, field, forage is 6.0 ppm. Based on the corn processing 
studies, the Agency determined that there is a low level of residue 
concentration from processing; therefore, separate tolerances are not 
needed for the processed corn commodities of flour, meal, or oil 
because these commodities are covered by the tolerance for corn, field, 
grain. The ``grain, aspirated fractions'' tolerance does not need to be 
modified for field corn because 40 CFR 180.564(a) currently lists a 
tolerance level of 45 ppm for ``grain, aspirated fractions,'' and this 
tolerance covers potential indoxacarb residues in aspirated grain 
fractions derived from corn.

V. Conclusion

    Therefore, tolerances are established for residues of indoxacarb, 
[(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)-phenyl] amino]carbonyl] 
indeno[1,2e][1,3,4]oxadiazine-4a(3H)-carboxylate], and [(R)-methyl 7 
chloro-2,5-dihydro-2[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] 
amino]carbonyl] indeno [1,2-e][1,3,4] oxadiazine-4a(3H)-carboxylate], 
in or on corn, field, forage at 6.0 ppm; corn, field, stover at 15 ppm; 
and corn, field, grain at 0.02 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: November 22, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.564, add alphabetically the entries for ``Corn, field, 
forage'', ``Corn, field, grain'', and ``Corn, field, stover'' to the 
table in paragraph (a)(1) to read as follows:


Sec.  180.564   Indoxacarb; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Corn, field, forage.....................................             6.0
Corn, field, grain......................................            0.02
Corn, field, stover.....................................              15
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2017-26517 Filed 12-7-17; 8:45 am]
 BILLING CODE 6560-50-P


