Document ID: EPA-HQ-OPP-2019-0186-0001
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances for Emergency Exemptions: Indoxacarb
Posted Date: 2019-07-05T04:00Z

[Federal Register Volume 84, Number 129 (Friday, July 5, 2019)]
[Rules and Regulations]
[Pages 32088-32094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14325]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0186; FRL-9994-37]

Indoxacarb; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of indoxacarb in or on grass forage and grass hay. This action 
is in response to EPA's granting of an emergency exemption under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing 
use of the pesticide on mixed stands of alfalfa and grasses. Tolerances 
are already established for residues of indoxacarb in/on alfalfa forage 
and alfalfa hay and this regulation establishes maximum permissible 
levels for residues of indoxacarb in or on grass forage and grass hay. 
The time-limited tolerances expire on December 31, 2022.

DATES: This regulation is effective July 5, 2019. Objections and 
requests for hearings must be received on or before September 3, 2019 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2019-0186, is available at 
https://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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

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 40 CFR 
part 180 through the Government Printing Office's e-CFR site at https://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 section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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

[[Page 32089]]

provided in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2019-0186 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 September 3, 2019. Addresses for mail and hand delivery of 
objections and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2019-0186, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-EPA-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing time-limited tolerances for residues of indoxacarb, (S)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (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/on grass, forage at 10 
parts per million (ppm) and in/on grass, hay at 50 ppm. These time-
limited tolerances expire on December 31, 2022.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    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 . . 
. .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Indoxacarb in Mixed Stands of Alfalfa and 
Grasses and FFDCA Tolerances

    The California Department of Pesticide Regulations (CDPR) notified 
EPA that an emergency condition exists with respect to control of 
alfalfa weevils in mixed stands of alfalfa and grasses in the 
Intermountain Region of California. According to CDPR, an urgent and 
nonroutine situation arose due to the weevils' developing resistance to 
the commonly relied-upon pyrethroids, and without a suitable pesticide 
control, significant losses were expected due to yield and quality 
decreases. Indoxacarb is registered for use in alfalfa but not for 
grasses and thus there was a need for an emergency exemption for use in 
mixed stands of alfalfa and grasses. After having reviewed the 
submission, EPA determined that an emergency condition exists for this 
State, and that the criteria for approval of an emergency exemption are 
met. EPA has authorized a specific exemption under FIFRA section 18 for 
the use of indoxacarb on mixed stands of alfalfa and grasses for 
control of alfalfa weevils in California.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of indoxacarb in 
or on grass, forage and grass, hay. In doing so, EPA considered the 
safety standard in FFDCA section 408(b)(2) and decided that the 
necessary tolerance under FFDCA section 408(l)(6) would be consistent 
with the safety standard and with FIFRA section 18. Consistent with the 
need to move quickly on the emergency exemption to address an urgent 
and non-routine situation and to ensure that the resulting food is safe 
and lawful, EPA is issuing these tolerances without notice and 
opportunity for public comment as provided in FFDCA section 408(l)(6). 
Although these time-limited tolerances expire on December 31, 2022, 
under FFDCA section 408(l)(5), residues of the pesticide not in excess 
of the amounts specified in the tolerances remaining in or on grass, 
forage and grass, hay after that date will not be unlawful, provided 
the pesticide was applied in a manner that was lawful under FIFRA, and 
the residues do not exceed the levels that were authorized by these 
time-limited tolerances at the time of that application. EPA will take 
action to revoke these time-limited tolerances earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
indoxacarb meets FIFRA's registration requirements for use on grasses 
or whether permanent tolerances for this use would be appropriate. 
Under these circumstances, EPA does not believe that these time-limited 
tolerance decisions serve as bases for registration of indoxacarb by a 
State for special local needs under FIFRA section 24(c). Nor do these 
tolerances by themselves serve as authority for persons in any State 
other than California to use this pesticide on the applicable crops 
under FIFRA

[[Page 32090]]

section 18 absent the issuance of an emergency exemption applicable 
within that State. For additional information regarding the emergency 
exemption for indoxacarb, contact the Agency's Registration Division at 
the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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 expected as a result of this emergency exemption use and the 
time-limited tolerances for combined residues of indoxacarb on grass, 
forage and grass, hay at 10 ppm and 50 ppm, respectively. There are 
existing tolerances for residues of indoxacarb in/on meat and milk 
commodities, and EPA has determined that the existing tolerances for 
meat and milk commodities will not be exceeded by additional residues 
in grass forage and hay. EPA's assessment of exposures and risks 
associated with establishing the time-limited tolerances follows.

A. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (PODs) and levels of 
concern (LOCs) 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 or level at which no adverse effects are observed 
(the NOAEL) and the lowest level at which adverse effects of concern 
are identified (the LOAEL). Uncertainty/safety factors are used in 
conjunction with the POD to calculate a safe exposure level--generally 
referred to as a population-adjusted dose (PAD) or a reference dose 
(RfD)--and a safe margin of exposure (MOE). For non-threshold risks, 
the Agency assumes that any amount of exposure will lead to some degree 
of risk. Thus, the Agency estimates risk in terms of the probability of 
an occurrence of the adverse effect expected in a lifetime. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for indoxacarb used for 
human risk assessment is discussed in Unit III of the final rule 
published in the Federal Register of December 8, 2017 (82 FR 57860) 
(FRL-9970-39).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to indoxacarb, EPA considered exposure under the time-limited 
tolerances established by this action 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. Acute effects were 
identified for indoxacarb. In estimating acute dietary exposure, EPA 
used food consumption information from the United States Department of 
Agriculture's (USDA's) 2003-2008 National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA used full distributions of residue levels 
from 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 the food consumption data from the EPA used food 
consumption information from the USDA's 2003-2008 NHANES/WWEIA. As to 
residue levels in food, 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 referenced in Unit IV.A., EPA has 
concluded that indoxacarb does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for assessing cancer risk is 
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, and the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the maximum and average PCT for the acute and 
chronic dietary assessments for existing uses 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

[[Page 32091]]

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 that the three conditions discussed in Unit 
IV.B.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    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 estimated to be 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 acute dietary risk 
assessment, a time series distribution of ground water modeled residues 
was used to assess the contribution to drinking water. For 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 and crack 
and crevice applications indoors, outdoor broadcast (i.e., turf), 
perimeter and foundations, spot outdoors (i.e., direct mound 
applications for fire ants), and crack and crevice outdoors. Based on 
these use scenarios, EPA assessed residential exposure using the 
following assumptions:
     Spot and crack and crevice exposures were not 
quantified due to formulation types that minimize the potential for 
handler and postapplication exposures (i.e., gels or bait stations). 
Risks from spot and crack and crevice were not quantified 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 quantified 
due to the lack of a dermal endpoint. Residential handler inhalation 
and dermal exposures are considered negligible for applying ready-to-
use materials (i.e., baits or stations).
     Residential post-application dermal and 
incidental oral exposure: Postapplication 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 quantified for gels or bait 
stations; exposure is considered negligible. A golfer assessment was 
not conducted, due to the lack of a dermal endpoint. Postapplication 
inhalation exposure is generally not assessed following application to 
pets and turf. The combination of low vapor pressure (1.9 x 
10-10 mm Hg at 25 [deg]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, for adults it would be inappropriate to aggregate inhalation 
exposures 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: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found indoxacarb to share a common mechanism of 
toxicity with any other substances, and

[[Page 32092]]

indoxacarb does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has 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 website at 
https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when 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 has determined that reliable data show that 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, as shown in unit IV.B.1.iv. 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 in the Monte Carlo analysis. For food 
commodities, Residue Distribution Files (RDFs) were constructed for the 
probabilistic acute dietary assessment as appropriate, and average 
residues were used for blended commodities. For the chronic dietary 
assessment, either average residue levels from field trial studies were 
used or for crops where no residues were found, a value of \1/2\ the 
limit of quantitation was assumed. 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.

D. 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 
adequate MOEs exist.
    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 <1 year old, the population group receiving the greatest 
exposure. EPA has concluded the combined long-term food, water, and 
residential exposures result in an aggregate MOE of 260 (food, water, 
and residential) for children aged 1-2. Because EPA's level of concern 
for indoxacarb is an MOE of 100 or below, this MOE 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 with chronic dietary because they are based on different 
effects than for oral exposures. Because chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess short-term risk) and 
inhalation risk has been assessed for adults, no further assessment of 
short-term risk is necessary for adults, and EPA relies on the findings 
from the chronic dietary risk assessment and inhalation assessment, as 
noted in unit IV.D.2 and IV.D.3, for evaluating short-term risk to 
adults for indoxacarb.
    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 an MOE of 100 or below, this MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). 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 ages 1-2 years through food and water with intermediate-term 
residential exposures to indoxacarb. For adults, residential inhalation 
exposures cannot be aggregated with chronic dietary because they are 
based on different effects than for oral exposures. Because chronic 
dietary exposure has already been assessed under the appropriately 
protective cPAD (which is at least as protective as the POD used to 
assess

[[Page 32093]]

intermediate-term risk), no further assessment of intermediate-term 
risk is necessary for adults, and EPA relies on the findings from the 
chronic dietary risk assessment, as noted in unit IV.D.2, for 
evaluating intermediate-term risk to adults for indoxacarb.
    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 an aggregate MOE of 260. Because EPA's level 
of concern for indoxacarb is an 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.

V. 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.
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

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.
    The Codex has not established MRLs for indoxacarb in/on grass 
forage or grass hay.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (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 grass, forage at 10 
ppm and grass, hay at 50 ppm. These tolerances expire on 12/31/2022.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and 
408(l)(6). 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 in accordance 
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. 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: June 28, 2019.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 32094]]

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 paragraph (b) to read as follows:

Sec.  180.564  Indoxacarb; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
indoxacarb, including its metabolites and degradates, in or on the 
specified agricultural commodities in the table below, resulting from 
use of the pesticide pursuant to FIFRA section 18 emergency exemptions. 
Compliance with the tolerance levels specified in the table below is to 
be determined by measuring only indoxacarb, (S)-methyl 7-chloro-2,5-
dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (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.
    The tolerances expire on the dates specified in the table.

------------------------------------------------------------------------
                                                 Parts per    Expiration
                   Commodity                      million        date
------------------------------------------------------------------------
Grass, forage.................................           10   12/31/2022
Grass, hay....................................           50   12/31/2022
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-14325 Filed 7-3-19; 8:45 am]
 BILLING CODE 6560-50-P