[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
[Pages 78731-78738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30585]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0420; FRL-9903-92]


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 multiple commodities and removes previously 
established commodities that will be superseded by tolerances 
established in this action, which are identified and discussed later in 
this document. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective December 27, 2013. Objections and 
requests for hearings must be received on or before February 25, 2014, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0420, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 78732]]

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-2012-0420 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 25, 2014. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0420, 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 July 25, 2012 (77 FR 43562) (FRL-9353-
6), 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 
2E8029) by IR-4, 500 College Rd. East, Suite 201 W., Princeton, NJ 
08540. The petition requested that 40 CFR 180.564 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[1,2-
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 bean, dry, seed at 
0.07 parts per million (ppm); bean, forage at 37 ppm; bean, succulent 
at 0.64 ppm; berry, low growing, except strawberry, subgroup 13-07H at 
0.9 ppm; small fruit, vine climbing, except fuzzy kiwifruit, subgroup 
13-07F at 2.0 ppm. The petition additionally requested to remove 
established tolerances of indoxacarb in or on grape at 2.0 ppm and 
cranberry at 0.90 ppm, upon approval of the updated crop groups or 
subgroups. That document referenced a summary of the petition prepared 
on behalf of IR-4 by DuPont Crop Protection, 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 upon review of the data supporting the petition, EPA has 
revised several proposed tolerances, has corrected the commodity 
terminology for bean forage to cowpea forage, and has determined that a 
tolerance should be established on cowpea hay. The reasons for these 
changes are explained 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.
    Indoxacarb products are frequently formulated as a mixture of the 
insecticidally active S-enantiomer (DPX-KN128) and the insecticidally 
inactive R-enantiomer (DPX-MP062). DPX-MP062 is an formula mixture 
containing the indoxacarb S-enantiomer and its R-enantiomer at 
approximately a 75:25 ratio. DPX-JW062 is the racemic mixture of the 
enantiomers at a 50:50 ratio. EPA has determined that it is appropriate 
to use data from DPX-

[[Page 78733]]

JW062 (50:50) to satisfy the requirements for dietary subchronic, 
chronic, oncogenicity and reproductive studies and that toxicology data 
using DPX-JW062 and DPX-MP062 may be bridged to DPX-KN128 formulations.
    The toxicity profile for KN128, MP062, and JW062 in rats, mice, and 
dogs with both subchronic and chronic oral exposures were qualitatively 
similar. Dermal subchronic exposure in the rat also resulted in a 
similar profile. Signs of toxicity occurred at similar doses and with a 
similar magnitude of response (females generally being more sensitive 
than males), and included decreases in body weight, weight gain, food 
consumption, and food efficiency. These compounds also affected the 
hematopoietic system by decreasing the red blood cell count, 
hemoglobin, and hematocrit in rats, dogs, and mice. Exposure to 
indoxacarb was frequently accompanied by an increase in reticulocytes 
in all three species and an increase in Heinz bodies in dogs and mice 
only. These signs of toxicity did not appear to increase in severity 
over time.
    Neurotoxicity was observed in rats and mice, and was characterized 
by one or more of the following symptoms in both male and female rats 
and mice: Weakness, head tilting, and abnormal gait or mobility with 
inability to stand or ataxia. There was possible evidence of lung 
damage in the acute inhalation studies with both MP062 and JW062.
    The immunotoxicity study in mice did not indicate toxicity to the 
immune system at the highest dose tested. In the 28-day inhalation 
study in rats, increased spleen weights, pigmentation, and 
hematopoiesis in the spleen, and hematological changes were observed at 
the highest dose tested. Increased spleen weights were also observed in 
the 28-day dermal rat study. The increase in spleen weights are not 
considered immunological in origin but can be considered a result of 
the hemolytic effects, which is the mode of action of indoxacarb.
    There was no evidence of carcinogenicity in either the rat or mouse 
in acceptable studies (JW062). JW062 was not mutagenic in a complete 
battery of mutagenicity studies. There was also no evidence of 
mutagenicity with either KN128 or MP062. Therefore, all formulations 
(KN128, MP062, and JW062) were classified as not likely to be 
carcinogenic in humans by all relevant routes of exposure.
    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 document: ``Indoxacarb. Human Health Risk 
Assessment for the Proposed New Use on Dry Beans, Succulent Beans, 
Small Fruit Vine Climbing Subgroup (except kiwifruit) 13-07F and Low 
Growing Berry Subgroup (except strawberry) 13-07H'' at pp. 50-55 in 
docket ID number EPA-HQ-OPP-2012-0420.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://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
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for    Study and  toxicological  effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 12 mg/kg/day  Acute RfD = 0.12 mg/ Acute oral rat neurotoxicity
 including infants and children     UFA = 10x.            kg/day.              study. LOAEL = 50 mg/kg based on
 and females 13-49 years old).     UFH = 10x...........  aPAD = 0.12 mg/kg/    decreased body weight and body-
                                   FQPA SF = 1x........   day.                 weight gain in females (MP062).*
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 2.0 mg/kg/day  Chronic RfD = 0.02   Weight of evidence approach was
                                   UFA = 10x...........   mg/kg/day.           used from four studies:
                                   UFH = 10x...........  cPAD = 0.02 mg/kg/   1. Subchronic toxicity study--rat
                                   FQPA SF = 1x........   day.                 (MP062).
                                                                              2. Subchronic neurotoxicity study--
                                                                               rat (MP062).
                                                                              3. Chronic/carcinogenicity study--
                                                                               rat (JW062).
                                                                              4. 2-generation rat reproduction
                                                                               study (JW062).
                                                                              LOAEL = 3.3 mg/kg/day based on
                                                                               decreased body weight, body-
                                                                               weight gain, food consumption,
                                                                               and food efficiency; decreased
                                                                               hematocrit, hemoglobin, and red
                                                                               blood cells only at 6 months.
----------------------------------------------------------------------------------------------------------------

[[Page 78734]]

 
Incidental oral short-term (1 to   NOAEL= 2.0 mg/kg/day  LOC for MOE = 100..  Weight of evidence approach was
 30 days), intermediate-term (1    UFA = 10x...........                        used from four studies:
 to 6 months), and long-term (> 6  UFH = 10x...........                       1. Subchronic toxicity study--rat
 months).                          FQPA SF = 1x........                        (MP062).
                                                                              2. Subchronic neurotoxicity study--
                                                                               rat (MP062).
                                                                              3. Chronic/carcinogenicity study--
                                                                               rat (JW062).
                                                                              4. Two generation rat reproduction
                                                                               study (JW062).
                                                                              LOAEL = 3.3 mg/kg/day based on
                                                                               decreased body weight, body-
                                                                               weight gain, food consumption,
                                                                               and food efficiency; decreased
                                                                               hematocrit, hemoglobin and red
                                                                               blood cells only at 6 months.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation study      LOC for MOE = 100..  28-day rat inhalation toxicity
 days).                             NOAEL= 6 mg/kg/day.                        study (MP062). The LOAEL of 75.69
                                   UFA = 10x...........                        mg/kg/day is based on increased
                                   UFH = 10x...........                        spleen weights, pigmentation, and
                                   FQPA SF = 1x........                        hematopoiesis in the spleen,
                                                                               hematological changes and
                                                                               mortality (females).
----------------------------------------------------------------------------------------------------------------
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. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFH = potential variation in sensitivity among members of the human population (intraspecies).
* The LOAEL of 50 mg/kg was based on a 7% body weight decrease in females only on day 8. No significant
  differences were noted for days 1, 2, or 15. Currently, a 10% decrease in adult body weight is the threshold
  for an adverse effect, thus this study NOAEL is considered to be conservative.

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 estimating acute dietary exposure, EPA utilized 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID) Version 3.16, which uses food consumption 
data from the U.S. Department of Agriculture's National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA) 
from 2003 to 2008. Anticipated residues (ARs) for most registered and 
proposed food commodities were based on field trial data, and in some 
crops tolerance-level residues were used. Residue estimates for some 
current uses were further refined using percent crop treated (PCT) 
data, and 100 PCT estimates were assumed for the remaining uses.
    Available processing data for indoxacarb were used to refine ARs 
for apples/pears (juice), cotton (oil), grapes (raisin and juice), 
peanut (oil), potato (dry, chips), prunes (dried), mint (oil), soybean 
(oil), and tomato (paste and puree), and other commodities where 
translation was applicable. DEEM-FCIDTM (ver. 7.81) default 
processing factors were assumed for all other processed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the same assumptions as described in Unit 
III.C.1.i.
    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.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows for the 
acute dietary assessment: Apples, 10%; broccoli, 70%; cabbage, 35%; 
cauliflower, 60%; cherries, 2.5%;

[[Page 78735]]

lettuce, 40%; peaches, 2.5%; peanuts, 10%; pears, 2.5%; potatoes, 2.5%; 
soybeans, 2.5%; spinach, 5%; sweet corn, 10%; and tomatoes, 40%.
    The Agency estimated the PCT for existing uses as follows for the 
chronic dietary risk assessment: Apples, 5%; broccoli, 50%; cabbage, 
25%; cauliflower, 40%; celery, 5%; cherries, 1%; grapes, 1%; lettuce, 
10%; peaches, 2.5%; peanuts, 2.5%; pears, 1%; potatoes, 1%; soybeans, 
1%; spinach, 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 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. In cases where the average PCT is less than 2.5, 2.5% is used as 
the average PCT. Similarly, in cases where the maximum PCT is less than 
2.5, 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute 
dietary risk analysis. The maximum PCT figure is the highest observed 
maximum value reported within the recent 6 years of available public 
and private market survey data for the existing use and rounded up to 
the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which indoxacarb may be applied in a particular area.
    2. Dietary exposure from drinking water. A Total Toxic Residue 
(TTR) approach was used for the parent indoxacarb and the degradation 
products with toxicological concern (IN-JT333, IN-KG4333, IN-KT413, IN-
ML437-0H) for the drinking water assessment. Therefore, the Agency used 
screening level water exposure models in the dietary exposure analysis 
and risk assessment for indoxacarb and its metabolites 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 Provisional Cranberry Model and Screening 
Concentration in Ground Water (SCI-GROW) models, the estimated drinking 
water concentrations (EDWCs) of indoxacarb and its metabolites for 
surface water are expected to be 59.26 parts per billion (ppb) for 
acute exposures and 18.48 for chronic exposures. For ground water, the 
EDWC is estimated to be 0.33 ppb for acute and chronic exposures.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The water concentration values 
of 59.26 ppb and 18.48 ppb were used to assess the contribution to 
drinking water for the acute and chronic dietary risk assessments, 
respectively.
    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 several uses that could result in residential 
exposures:
     Ready-to-use (RTU) bait stations.
     Spot-on applications of gels (crack and crevices and 
indoor spot directed treatments) for household insect control (indoor 
treatments).
     Spot-on treatments for the control of fleas and ticks on 
dogs and cats.
     Broadcast, perimeter and ant mound treatment on 
ornamentals, trees, and lawns/turf, utilizing granular and liquid 
formulations (outdoor treatments).
     Indoor spray applications with granular and liquid 
formulations for insect control on households/domestic dwellings (crack 
and crevice and spot directed treatments).
    Adult handlers were assessed for potential short-term inhalation 
toxicity from mixing/loading/applying the following:
     Granular formulation for insect control on lawns/turf.
     Liquid flowable formulation for insect control on lawns/
turf.
     Water-soluble packaging formulation for indoor spray 
applications with manually pressurized hand wand (crack and crevice and 
spot directed treatments) for insect control in households/domestic 
dwellings.
     Liquid flowable formulation for indoor spray applications 
with manually pressurized hand wand (crack and crevice and spot 
directed treatments) for insect control on households/domestic 
dwellings. Residential handler exposure is expected to be short-term in 
duration only, as intermediate-term exposures are not likely because of 
the intermittent nature of applications by homeowners.
    Potential postapplication exposures to indoxacarb were considered 
for adults and children (1-<2 years old), based on the following 
scenarios:
     Treated pets (dogs and cats) to children from short-, 
intermediate-, and long-term incidental oral exposures.
     Physical activities on turf to children from short-term 
incidental oral exposures.
     Crack and crevice and indoor spot-directed spray 
applications, including short-term inhalation exposures to adults and 
both short-term inhalation and short-term incidental oral exposures to 
children.
    Since there is no expectation of non-dietary oral exposures to 
adults from contact with treated pets, that aggregate risk is not 
quantified.
    Since inhalation and incidental oral exposure routes share a common 
toxicological endpoint (i.e., hematological changes), risk estimates 
have been combined for those routes. Therefore, the postapplication 
exposure scenarios that were combined for children 1 < 2 years old are 
the inhalation and hand-to-mouth (the highest incidental oral exposure 
assessment) for the indoor surfaces directed spray applications. This 
combination is considered protective of children's exposure to 
indoxacarb from residential uses.
    Because of the preventative nature of pet products and the 
potential for extended use in more temperate parts of the country, the 
residential

[[Page 78736]]

postapplication exposures to treated pets may be short-, intermediate-, 
or long-term in duration. Postapplication incidental oral exposures 
from treated golf courses were not quantified since youth old enough to 
play golf are not expected to exhibit significant hand-to-mouth 
behavior. Furthermore, the residential lawn assessment provides the 
highest estimate of potential exposure from turf applications and is 
protective of any exposures to children from indoxacarb turf treatment 
scenarios. Finally, the residential handler and postapplication 
assessments consider inhalation and/or oral exposures only, since a 
dermal toxicity endpoint has not been identified for indoxacarb.
    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, an oxadiazine class insecticide, 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 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 Web site 
at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There was no quantitative or 
qualitative evidence of increased prenatal or postnatal sensitivity in 
the two developmental toxicity studies in rats with DPX-JW062, one 
developmental toxicity study in rats with DPX-MP062 and DPX-KN128, one 
developmental toxicity study in rabbits with DPX-JW062, one 2-
generation reproduction studies in rats with DPX-JW062, and the 
developmental neurotoxicity (DNT) study in rats with DPX-KN128. In 
these studies, developmental toxicity was observed only in the presence 
of maternal toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for indoxacarb is complete.
    ii. EPA has determined that an additional uncertainty factor is not 
needed to account for neurotoxicity. Neurotoxicity was seen in animal 
studies in rats and mice, but at higher doses than the hematologic 
effects on which EPA's risk assessments are based. To evaluate the 
potential for increased sensitivity of infants and children to 
neurotoxic effects, EPA required a rat developmental neurotoxicity 
(DNT) study. There was no evidence of increased sensitivity of 
offspring in the submitted study. Clinical observations, motor 
activity, acoustic startle habituation, and learning and memory testing 
were all comparable between the control and treated groups. Mean brain 
weight, gross and microscopic examinations, and morphometric 
measurements of the brain were also comparable between the controls and 
treated groups.
    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 acute and chronic dietary food exposure assessments 
utilized anticipated residues that are based on reliable field trial, 
as well as PCT data. For the new uses, a conservative estimate of 100 
PCT is assumed. EPA made conservative (protective) assumptions in the 
ground and surface water modeling used to assess exposure to indoxacarb 
in drinking water. EPA used similarly conservative assumptions to 
assess postapplication 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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
indoxacarb will occupy 49% of the aPAD for all infants less than 1 year 
old, 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 12% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Long-term (chronic) aggregate risk for indoxacarb also 
includes the contribution from dietary (food and drinking water) 
exposure plus the long-term postapplication exposure to treated pets. 
EPA has concluded the combined long-term food, water, and residential 
exposures result in an aggregate MOE of 420 for children 1-<2 years 
old. Because EPA's level of concern for indoxacarb is a MOE of 100 or 
below, this MOE is not of concern.
    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 through food and water with 
short-term residential exposures to indoxacarb.
    Using the exposure assumptions described in this unit for short-
term

[[Page 78737]]

exposures, EPA has concluded the aggregate short-term exposure (food, 
water, and residential exposures) result in the lowest aggregate MOEs 
of 110 for children 1-<2 years old (resulting from the postapplication 
crack and crevice and spot directed treatment indoor spray) and 1,600 
for adults (resulting from the handler turf use). Because EPA's level 
of concern for indoxacarb is a MOE of 100 or below, these MOEs are not 
of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). 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 through 
food and water with intermediate-term residential exposures to 
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 (from pet 
treatments) result in an aggregate MOE of 420 for children 1-<2 years 
old 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

    Adequate enforcement methodology (high-performance liquid 
chromatography (HPLC)/column switching/ultraviolet (UV) method AMR 
2712-93 with confirmation/specificity provided by gas chromatography 
(GC)/mass-selective detector method AMR 3493-95, Supplement No. 4) is 
available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for indoxacarb in or on cranberries 
at 1 ppm, dry chickpea at 0.2 ppm, dry cowpea at 0.1 ppm, dry mung bean 
at 0.2 ppm, and grapes at 2 ppm, based on measurement of indoxacarb and 
its R-enantiomer. U.S. tolerances for subgroup 13-07F (represented by 
grape) at 2 ppm and subgroup 13-07H (represented by cranberry) at 1 ppm 
are harmonized with the corresponding Codex MRLs. Additionally, the 
U.S. tolerance level for dry bean is being established at 0.2 ppm, in 
order to harmonize with the Codex MRLs for dry chickpea and dry mung 
bean. The Codex has not established MRLs for the other commodities 
associated with this action.

C. Revisions to Petitioned-For Tolerances

    Based on the data submitted with the petition, EPA revised the 
proposed tolerances for several commodities, as follows: Succulent bean 
from 0.64 ppm to 0.9 ppm; and low growing berry, except strawberry, 
subgroup 13-07H from 0.9 ppm to 1 ppm. EPA also determined that the 
proposed tolerance in or on bean forage at 37 ppm should be revised to 
50 ppm, and the Agency determined that the commodity should be listed 
as cowpea forage because the cowpea forage and hay are the only 
significant feedstuffs associated with dry beans. Because of that 
reason, EPA also determined that a tolerance is necessary for cowpea 
hay at 100 ppm. Finally, EPA revised the tolerance on bean, dry, seed 
from 0.07 ppm to 0.2 ppm in order to harmonize with Codex MRLs. The 
Agency revised these tolerance levels based on analysis of the residue 
field trial data using the Organization of Economic Cooperation and 
Development (OECD) tolerance calculation procedures.

 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[1,2-
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 bean, dry seed at 0.2 
ppm; bean, succulent at 0.9 ppm; cowpea, forage at 50 ppm; cowpea, hay 
at 100 ppm; berry, low growing, except strawberry, subgroup 13-07H at 1 
ppm; and fruit, small vine climbing, except fuzzy kiwifruit, subgroup 
13-07F at 2 ppm. This regulation additionally removes the established 
tolerances in or on cranberry at 0.90 ppm and grape at 2.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule,

[[Page 78738]]

the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
et seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 16, 2013.
Lois Rossi,
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:
0
a. Remove the commodities ``Cranberry'' and ``Grape'' in the table in 
paragraph (a)(1).
0
b. Add alphabetically the following commodities to the table in 
paragraph (a)(1). The amendments read as follows:


Sec.  180.564  Indoxacarb; tolerances for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Bean, dry, seed............................................          0.2
Bean, succulent............................................          0.9
 
                                * * * * *
Berry, low growing, except strawberry, subgroup 13-07H.....            1
 
                                * * * * *
Cowpea, forage.............................................           50
Cowpea, hay................................................          100
 
                                * * * * *
Fruit, small vine climbing, except fuzzy kiwifruit,                    2
 subgroup 13-07F...........................................
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-30585 Filed 12-26-13; 8:45 am]
BILLING CODE 6560-50-P