[Federal Register Volume 74, Number 131 (Friday, July 10, 2009)]
[Rules and Regulations]
[Pages 33159-33165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16368]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0271; FRL-8424-9]


Indoxacarb; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of indoxacarb and its metabolites and degradates, to be determined by 
measuring only indoxacarb and its R-enantiomer, in or on beet, garden, 
roots; beet, garden, tops; and bushberry subgroup 13-07B. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 10, 2009. Objections and 
requests for hearings must be received on or before September 8, 2009, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0271. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of 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 provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0271 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before September 8, 2009.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0271, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.

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     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of May 16, 2008 (73 FR 28461) (FRL-8361-6), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 8E7324) 
by Interregional Research Project Number 4 (IR-4), 500 College Road 
East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 
CFR 180.564 be amended by establishing tolerances for combined 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 beet, garden, roots 
at 0.30 parts per million (ppm); beet, garden, tops at 6.0 ppm; and 
bushberry subgroup 13-07B at 1.5 ppm. That notice referenced a summary 
of the petition prepared on behalf of IR-4 by E.I. du Pont de Nemours 
and Company, the registrant, which is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.

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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for 
tolerances for combined residues of indoxacarb and its metabolites and 
degradates, to be determined by measuring only indoxacarb and its R-
enantiomer, on beet, garden, roots at 0.30 ppm; beet, garden, tops at 
6.0 ppm; and bushberry subgroup 13-07B at 1.5 ppm. EPA's assessment of 
exposures and risks associated with establishing these tolerances 
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 is the S-enantiomer of an isomeric compound containing 
two enantiomers, the S-enantiomer (DPX-KN128, the insecticidally active 
component) and its R-enantiomer (DPX-KN127, the insecticidally inactive 
component). DPX-MP062 is an enantiomeric mixture containing the 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.
    DPX-KN128, DPX-MP062 and DPX-JW062 appear to be of similar toxicity 
acutely. DPX-KN128 and DPX-MP062 were moderately acutely toxic by the 
oral route while DPX-JW062 was practically non-toxic due to its poor 
solubility in the corn oil vehicle. However, it was equally toxic 
orally, when tested using a solvent where it had a higher solubility, 
such as polyethylene glycol (PEG). By the dermal route, they had low 
toxicity. DPX-MP062 and DPX-JW062 had low acute inhalation toxicity. 
DPX-MP062 and DPX-JW062 had moderate to low ocular irritant properties, 
while DPX-KN128 was practically non-irritating to the rabbit's eyes. By 
the maximization test, DPX-KN128 and DPX-MP062 were considered dermal 
sensitizers, while DPX-JW062 was not a sensitizer.
    There was possible evidence of lung damage in the acute inhalation 
studies with both DPX-MP062 and DPX-JW062. ``Lung noise,'' observed 
with JW062, may indicate the development of acute lung injury and high 
permeability pulmonary edema. This was not unexpected since an oxidant 
was generated during indoxacarb metabolism. ``Hunched over back and 
gasping'' were also present and suggested arterial hypoxemia that 
accompanies alveolar flooding. The acute inhalation study report with 
indoxacarb 70% manufacturing use product noted that a ``red nasal 
discharge'' was detected for 2 days after exposure. This may be 
indicative of a lung exudate, a sign of lung injury. Subchronic (28 
days) inhalation toxicity of indoxacarb in rats was characterized by 
increased spleen weights, increased pigmentation and hematopoiesis in 
the spleen, and hematological changes.
    The toxicity profiles for DPX-KN128, DPX-MP062, and DPX-JW062 in 
rats, mice, and dogs with both subchronic and chronic oral exposures 
were similar. Dermal subchronic exposure in the rat also resulted in a 
similar profile. The toxic signs occurred at similar doses and with a 
similar magnitude of response, with females generally being more 
sensitive than males. The endpoints that most frequently defined the 
lowest-observed-adverse-effect-level (LOAEL) were non-specific, and 
included decreased 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. It was frequently accompanied by an increase in 
reticulocytes in all three species and an increase in Heinz bodies 
(dogs and mice only). None of these signs of toxicity appeared to get 
worse over time. In one subchronic rat study, the parameters appeared 
to return to normal levels following a four-week recovery period. High 
doses in the rats and mice also sometimes caused mortality.
    There was no evidence of increased susceptibility of fetuses or 
offspring from either in utero or neonatal exposure to DPX-MP062 or 
DPX-JW062. There was no evidence of increased susceptibility from in 
utero exposure of rats to DPX-KN128. There was no evidence of increased 
susceptibility in the developmental neurotoxicity study in rats with 
DPX-KN128. No evidence of teratogenicity was observed in rats and 
rabbits with

[[Page 33161]]

DPX-MP062 or DPX-JW062. No evidence of teratogenicity was observed in 
rats with DPX-KN128. There was no evidence of reproductive effects in 
the 2-generation reproduction study in rats.
    Neurotoxicity was observed in both rats and mice; however, it did 
not occur in the absence of other signs of toxicity. Neurotoxicity 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 and ataxia. Acute and subchronic 
neurotoxicity screening batteries were performed using DPX-MP062 in 
rats. Neurotoxicity was characterized by clinical signs (depression, 
abnormal gait, head shake, salivation) and functional-observation 
battery (FOB) effects (circling behavior, incoordination, slow righting 
reflex, decreased forelimb grip strength, decreased foot splay, 
decreased motor activity). However, there was no evidence of 
neurohistopathology in any study. Learning and memory parameters were 
affected in the pups in the developmental neurotoxicity study in rats 
with DPX-KN128.
    There was no evidence of carcinogenicity in either the rat or mouse 
in acceptable studies using DPX-JW062. DPX-JW062 was not mutagenic in a 
complete battery of mutagenicity studies. There was also no evidence of 
mutagenicity with either DPX-KN128, or DPX-MP062.
    Both DPX-JW062 and DPX-MP062 were rapidly absorbed and eliminated 
following oral administration. The absorption of DPX-JW062 was dose 
dependent and appeared to be saturated at the high dose. Both urine and 
feces represented major routes of excretion (35-45% and 33-47%, 
respectively). The distribution pattern did not vary with dosing 
regimen and overall tissue burden was limited to only 3.4-12.9% of the 
administered dose. The red blood cells of rats dosed with the 
trifluoromethoxyphenyl label consistently contained much greater levels 
of radioactivity than did plasma. Fat tissue contained the greatest 
level of radioactivity (1.76-8.76% of the administered dose) and, for 
both compounds, was greater in female rats. The finding also 
demonstrates a greater propensity for accumulation by female rats than 
by male rats. Both DPX-MP062 and DPX-JW062 were extensively metabolized 
and the metabolites were eliminated in the urine, feces, and bile. With 
the exception of parent compound (DPX-JW062, which accounted for 19.2% 
of a single low dose in the feces of female rats), none of the 
metabolites from any source represented more than 12.3% of the 
administered dose. The metabolite profile for DPX-JW062 was dose 
dependent and varied quantitatively between males and females. 
Differences in metabolite profiles were also observed for the different 
label positions. All of the biliary metabolites appear to undergo 
further biotransformation in the gut.
    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 LOAEL from the toxicity studies 
can be found at http://www.regulations.gov in the document Indoxacarb. 
Health Effects Division (HED) Human Health Risk Assessment for 
Bushberry Crop Subgroup 13-07B and Beets (Garden), page 13 in docket ID 
number EPA-HQ-OPP-2008-0271.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which the 
NOAEL in the toxicology study identified as appropriate for use in risk 
assessment. However, if a NOAEL cannot be determined, the LOAEL or a 
Benchmark Dose (BMD) approach is sometimes used for risk assessment. 
Uncertainty/safety factors (UFs) are used in conjunction with the POD 
to take into account uncertainties inherent in the extrapolation from 
laboratory animal data to humans and in the variations in sensitivity 
among members of the human population as well as other unknowns. Safety 
is assessed for acute and chronic dietary risks by comparing aggregate 
food and water exposure to the pesticide to the acute population 
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The 
aPAD and cPAD are calculated by dividing the POD by all applicable UFs. 
Aggregate short-, intermediate-, and chronic-term risks are evaluated 
by comparing food, water, and residential exposure to the POD to ensure 
that the margin of exposure (MOE) called for by the product of all 
applicable UFs is not exceeded. This latter value is referred to as the 
Level of Concern (LOC).
    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 
greater than that 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 can be found at http://www.regulations.gov in the 
document Indoxacarb. Health Effects Division (HED) Human Health Risk 
Assessment for Bushberry Crop Subgroup 13-07B and Beets (Garden), page 
18 in docket ID number EPA-HQ-OPP-2008-0271.

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.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, for most currently 
registered commodities, EPA used anticipated residues derived from 
field trial data and maximum percent crop treated (PCT) estimates. EPA 
assumed tolerance-level residues and 100 PCT for the new commodities 
associated with this petition (garden beets and bushberries). Available 
processing data for indoxacarb were used to refine anticipated residues 
for apples/pears (juice), potato (dry, chips), cotton (oil), tomato 
(paste and puree), peanut (oil), soybean (oil), grapes (raisin and 
juice), prunes (dried), mint (oil), and other commodities where 
translation was appropriate. For all other processed commodities, DEEM-
FCID\TM\ (ver. 7.81) default processing factors were assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA relied upon 
anticipated residues derived from field trial data for most of the 
registered and new commodities and an anticipated residue value for 
milk derived from monitoring data collected by the United States 
Department of Agriculture's Pesticide Data Program

[[Page 33162]]

(PDP). Residue estimates were further refined using average PCT data 
and available processing data, as described in Unit III.C.i. EPA 
assumed 100 PCT for the new commodities, garden beets and bushberries.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA classified indoxacarb as ``not likely'' to be 
carcinogenic to humans via relevant routes of exposure. Therefore, an 
exposure assessment for evaluating 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, 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 used PCT information as follows:
    Acute dietary exposure assessment: Apple 5%, broccoli 50%, cabbage 
25%, cauliflower 55%, cherry 2.5%, corn (sweet) 2.5%, lettuce (head) 
25%, lettuce (leaf) 11%, peach 2.5%, peanut 2.5%, pear 2.5%, pepper 
15%, potato 2.5%, soybean 1%, spinach 5%, and tomato 25%.
    Chronic dietary exposure assessment: Apple 1%, broccoli 40%, 
cabbage 15%, cauliflower 35%, cherry 1%, lettuce (head) 18%, lettuce 
(leaf) 9%, peach 1%, peanut 1%, pear 1%, pepper 10%, potato 1%, soybean 
1%, spinach 5%, and tomato 15%.
    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 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. 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. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for indoxacarb in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of indoxacarb. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model /Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
indoxacarb for acute exposures are estimated to be 25.1 parts per 
billion (ppb) for surface water and 0.21 ppb for ground water. The 
EDWCs of indoxacarb for chronic exposures for non-cancer assessments 
are estimated to be 5.37 ppb for surface water and 0.21 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 25.1 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 5.37 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 several uses that could 
result in residential, non-dietary exposures. Indoxacarb is registered 
for use as a fire ant bait, which may be applied as a mound treatment 
or as a broadcast application to lawns, golf courses, and other 
recreational areas. Indoxacarb is also registered as a mole cricket 
bait applied as a broadcast treatment to lawns, golf courses, parks, 
recreational areas, and athletic fields. Finally, indoxacarb is 
registered as a foliar or broadcast spray to control lepidopterous 
larvae on landscape and recreational (including golf courses) turfgrass 
and ornamentals. EPA assessed residential exposure using the following 
assumptions:
    Based on the residential use patterns, commercial and private 
(i.e., grower/homeowner) pesticide handlers are expected to have short-
term (1-30 days) dermal and inhalation exposures to indoxacarb. 
Commercial handlers may also have intermediate-term exposures (1-6 
months). The short- and intermediate-term toxicological points of 
departure are the same; therefore, the

[[Page 33163]]

risk estimates for intermediate-term exposures are the same as those 
for short-term exposures.
    There is also the potential for short- and intermediate-term 
postapplication exposure of adults and children from entering areas 
previously treated with indoxacarb. The postapplication exposure 
scenarios assessed include: Dermal exposure from treated lawns due to 
high contact lawn activities (adult and toddler); Dermal exposure from 
treated turf due to golfing (adults and youths); Hand-to-mouth transfer 
of pesticide residues on lawns (toddler); Episodic incidental ingestion 
of granules from pesticide-treated residential areas (toddler); 
Incidental ingestion of soil from pesticide-treated residential areas 
(toddler); and Incidental oral object-to-mouth exposure from pesticide-
treated residential areas (toddler).
    Postapplication inhalation exposures are expected to be negligible 
and, therefore, were not assessed.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found indoxacarb to share a common mechanism of 
toxicity with any other substances, and indoxacarb does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA 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 http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 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 a 
developmental neurotoxicity (DNT) study in rats with DPX-KN128. In 
these studies, developmental toxicity was observed 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. With the exception of an immunotoxicity study, now mandatory 
under the 40 CFR part 158 Data Requirements for Pesticides, the 
toxicological database for indoxacarb is complete. The available data 
do not indicate that indoxacarb is immunotoxic. 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 (75.6 mg/kg/day). Increased spleen weights were 
also observed in the 28-day dermal rat study at 500 mg/kg/day. The 
increase in spleen weights is not considered immunological in origin 
but can be considered a result of the hemolytic effects, which is the 
mode of action of indoxacarb. Indoxacarb is currently regulated based 
on a NOAEL of 1.5 mg/kg/day for chronic dietary exposure (protective of 
hemolytic effects) and 9 mg/kg/day for acute dietary exposure. EPA does 
not believe that conducting a special series 870.7800 immunotoxicity 
study will result in NOAELs lower than those currently identified for 
indoxacarb, and an additional uncertainty factor is not needed to 
account for immunotoxicity.
    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. The study has been submitted and reviewed. 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 
utilize anticipated residues that are based on reliable field trial and 
monitoring data. They also utilize PCT data that have been verified by 
the Agency for most existing uses. 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 pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute 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

[[Page 33164]]

occupy 63% of the aPAD for children 3 to 5 years 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 6.6% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
indoxacarb is not expected.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposures take into account short- or intermediate-term 
residential exposure plus chronic exposure from food and water 
(considered to be a background exposure level). Indoxacarb is currently 
registered for uses that could result in short- and intermediate-term 
residential exposures and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short- and intermediate-term residential exposures to indoxacarb.
    Using the exposure assumptions described in this unit for short- 
and intermediate-term exposures, EPA has concluded the combined short-/
intermediate-term food, water, and residential exposures aggregated 
result in aggregate MOEs of 320 for adults and 102 for children 
(toddlers). The aggregate MOE for adults includes dietary exposures 
from food and drinking water, as well as dermal handler and 
postapplication exposures from the residential use of indoxacarb on 
turf for mole cricket control, the residential scenario resulting in 
the highest estimated exposures. Similarly, the aggregate MOE for 
toddlers includes dietary (food and drinking water) and residential 
exposures. The residential exposure estimate for toddlers is also based 
on the worst-case turf scenario (mole cricket control) and includes 
dermal and incidental oral postapplication exposures. The highest 
estimated incidental oral exposures for toddlers are from hand-to-mouth 
activities on treated turf; therefore, the oral hand-to-mouth exposures 
were used to calculate the aggregate MOE for toddlers.
    5. Aggregate cancer risk for U.S. population. EPA has classified 
indoxacarb as ``not likely'' to be carcinogenic to humans via relevant 
routes of exposure. Indoxacarb is not expected to pose a cancer risk.
    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; e-mail address: [email protected].

B. International Residue Limits

    There are no established or proposed Codex, Canadian or Mexican 
maximum residue limits (MRLs) for indoxacarb on bushberries or garden 
beets.

C. Changes to Proposed Tolerances

    Tolerances for indoxacarb are currently expressed in terms of 
``combined 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.'' EPA is revising the 
tolerance expression for existing tolerances and the proposed 
tolerances on garden beets and bushberries to clarify the chemical 
moieties that are covered by the tolerances and specify how compliance 
with the tolerances is to be measured. The revised tolerance expression 
makes clear that the tolerance covers ``residues of indoxacarb, 
including its metabolites and degradates,'' and that compliance with 
the tolerance levels will 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.
    EPA has determined that it is reasonable to make this change final 
without prior proposal and opportunity for comment, because public 
comment is not necessary, in that the change has no substantive effect 
on the tolerance, but rather is merely intended to clarify the existing 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of indoxacarb, 
including its metabolites and degradates, in or on beet, garden, roots 
at 0.30 ppm; beet, garden, tops at 6.0 ppm; and bushberry subgroup 13-
07B at 1.5 ppm. Compliance with these tolerance levels 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.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory

[[Page 33165]]

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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: July 1, 2009.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.564 is amended in paragraph (a) by revising the 
introductory text and by alphabetically adding the following 
commodities to the table to read as follows:


Sec. 180.564  Indoxacarb; tolerances for residues.

    (a) General. Tolerances are established for residues of indoxacarb, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified 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.

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Beet, garden, roots............................                     0.30
Beet, garden, tops.............................                      6.0
Bushberry subgroup 13-07B......................                      1.5
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-16368 Filed 7-9-09; 8:45 am]
BILLING CODE 6560-50-S