[Federal Register Volume 68, Number 93 (Wednesday, May 14, 2003)]
[Rules and Regulations]
[Pages 25824-25831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11758]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0173; FRL-7307-6]


Indoxacarb; Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues/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] + 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 peaches. This action is 
in response to university extension specialists, DuPont, and EPA's 
combined efforts to generate the information necessary for registration 
of the reduced risk pesticide, Indoxacarb, on peaches for control of 
oriental fruit moth and plum cuculio. This temporary tolerance supports 
a non-crop destruct experimental use permit (EUP) under section 5 of 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of Indoxacarb on peaches in Georgia, Michigan, New 
Jersey, Pennsylvania, South Carolina, and West Virginia. This 
regulation establishes a maximum permissible level for residues of 
Indoxacarb in this food commodity pursuant to section 408(e) of Federal 
Food Drug and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA). The tolerance will expire on May 15, 
2006.

DATES: This regulation is effective May 14, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0173, 
must be received on or before July 14, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Rita Kumar, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8291; 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:
    [sbull] Crop production (NAICS code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0173. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

[[Page 25825]]

II. Background and Statutory Findings

    In the Federal Register of April 16, 2003 (68 FR 18582) (FRL-7302-
3), EPA issued a proposed rule pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a, as amended by the FQPA (Public Law 104-170), EPA, in 
cooperation with university extension specialists, and DuPont Pont Crop 
Protection, pursuant to sections 408(e) and (r) of FFDCA, proposed to 
establish a tolerance for combined residues of the reduced risk 
pesticide, Indoxacarb in or on peaches. This temporary tolerance 
supports a non-crop destruct EUP under section 5 of FIFRA authorizing 
use of Indoxacarb on peaches in Georgia, Michigan, New Jersey, 
Pennsylvania, South Carolina, and West Virginia. Section 5 of FIFRA 
authorizes EPA to issue an experimental use permit for a pesticide. 
This provision was not amended by FQPA. EPA has established regulations 
governing such experimental use permits in 40 CFR part 172. Section 
408(r) of FFDCA authorizes EPA to issue time-limited tolerances for 
pesticide residues from FIFRA experimental use permits.
    The proposed rule requested that 40 CFR 180.564 be amended by 
establishing a tolerance 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] + 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 
peaches at 10.0 parts per million (ppm). The tolerance will expire on 
May 15, 2006.
    Section 408(b)(2)(A)(i) of the 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 the 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 the 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. * * 
*''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the 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, consistent with section 
408(b)(2) of the FFDCA, for a tolerance for 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] + 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 on 
peaches at 10 ppm. EPA's assessment of exposures and risks associated 
with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by Indoxacarb are 
discussed in the proposed rule, as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.
    Refer to the April 16, 2003, Federal Register document (68 FR, 
18582) for a detailed discussion of the aggregate risk assessments and 
determination of safety. EPA relies upon that risk assessment and the 
findings made in the Federal Register document in support of this 
action. Below is a brief summary of the aggregate risk assessment, 
including this use on peaches.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.564) for the combined residues of Indoxacarb, 
in or on a variety of raw agricultural commodities. Including 
tolerances already established for: Apple at 1.0 ppm, apple, wet pomace 
at 3.0 ppm, brassica, head and stem, subgroup at 5.0 ppm, cattle, goat, 
horse, sheep, and hog fat at 0.75 ppm, cattle, goat, horse, sheep, and 
hog meat at 0.03 ppm, cattle, goat, horse, sheep, and hog meat 
byproducts at 0.02 ppm, corn, sweet, forage at 10 ppm, corn, sweet, 
kernel plus cob with husk removed at 0.02 ppm, corn, sweet stover at 15 
ppm, cotton gin byproducts at 15 ppm, cotton, undelinted seed at 2.0 
ppm, lettuce, head at 4.0 ppm, lettuce, leaf at 10.0 ppm, milk at 0.10 
ppm, and milk, fat at 3.0 ppm, pear at 0.20 ppm, and vegetables, 
fruiting, group at 0.50 ppm. Risk assessments were conducted by EPA to 
assess dietary exposures from Indoxacarb in food as follows:
    An acute dietary endpoint for females 13 years and older and for 
the general population, including infants and children has been 
identified. The acute population adjusted dose (aPAD) for females is 
0.02 milligrams/kilogram/day (mg/kg/day). The acute dietary endpoint 
for the general population including infants and children is 0.12 mg/
kg/day. The chronic population adjusted dose (cPAD) for all populations 
is 0.02 mg/kg/day. Indoxacarb has been classified as a ``not likely'' 
to be carcinogenic to humans. It has been determined that the FQPA 
safety factor could be reduced to 1X for Indoxacarb. There is no 
indication of quantitative or qualitative increased susceptibility of 
rats or rabbits to in utero and/or postnatal exposure. Currently, 
indoxacarb is not registered for use in residential settings.
    For the chronic exposure estimates, it was assumed that all 
commodities had tolerance level residues and 100% of all RACs were 
treated with indoxacarb. Refined processing factors were used in the 
chronic analysis for several commodities, in place of the Dietary 
Exposure Evaluation Model (DEEM[reg]) default processing factors. The 
Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) and 
Screening Concentration in Ground Water (SCI-GROW) models provided the 
estimated environmental concentrations (EECs) of indoxacarb. The EECs 
for acute exposures are estimated to be 13.7 parts per billion (ppb) 
for surface water and 0.02 ppb for ground water. The EECs for chronic 
exposures are estimated to be

[[Page 25826]]

3.7 ppb for surface water and 0.02 ppb for ground water.
    i. Acute exposure. Acute dietary 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. The DEEM[reg] analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989--1992 
nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the acute exposure assessments: An acute Tier 
II (partially refined analysis) dietary assessment was performed with 
use of anticipated residues (ARs) from field trial data, processing 
factors (where applicable), assumed 100% crop treated (CT) for all 
crops other than peaches, and 1% CT for the peach EUP (300 acres). ARs 
for meat, milk, poultry, and eggs (MMPE) raw agricultural commodities 
(RACs) were calculated also.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM[reg] analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989--1992 
nationwide CSFII and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: Chronic exposure estimates are expressed in mg/kg body 
weight (bw)/day and as a percent of the cPAD. The chronic dietary 
assessment assumed tolerance level residues, DEEM[reg] default 
processing factors, assumed 100% CT for all crops other than peaches, 
and 1% CT for the peach EUP (300 acres) (Tier I).
    iii. Cancer. There is no evidence for mutagenicity and there is no 
evidence of carcinogenicity in either the rat or mouse. Indoxacarb has 
been classified as ``not likely to be carcinogenic in humans'' by the 
Agency; therefore, no carcinogenic dietary risk analysis was performed.
    Section 408(b)(2)(E) of the 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 chemicals that have 
been measured in food. If EPA relies on such information, EPA must 
require 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. Following the initial 
data submission, EPA is authorized to require similar data on a time 
frame it deems appropriate. As required by section 408(b)(2)(E) of the 
FFDCA, EPA will issue a data call-in for information relating to ARs to 
be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that 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 such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if 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 percent crop 
treated (PCT) as required by section 408(b)(2)(F) of the FFDCA, EPA may 
require registrants to submit data on PCT.
    Dietary exposure estimates were based on 1% PCT for peaches. This 
PCT of 1% was based on the fact that the 2-year experimental use permit 
was issued for only 300 acres of peaches to be treated annually, which 
amounts to 0.2% of the total peach acreage in the United States. The 
reason for using 1% instead of 0.2% is to allow for any uncertainties 
in the residue evaluation. Before making this tolerance permanent, 
reevaluation of dietary exposure will be performed using all available 
information. Other commodities were assumed to be 100% treated.
    The Agency believes that the three conditions previously discussed 
have been met. With respect to Condition 1, EPA finds that the PCT 
information described 1% for Indoxacarb used on peaches is reliable and 
has a valid basis. A 2-year EUP has been issued for this use, which 
will allow for use of Indoxacarb on 300 acres of peaches in some 
eastern states. Before the use can be expanded for treatment of greater 
than 300 acres per year, permission from the Agency must be obtained. 
As to Conditions 2 and 3, 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 
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 lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for Indoxacarb in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of Indoxacarb.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the PRZM/EXAMS to estimate pesticide concentrations in 
surface water and SCI-GROW, which predicts pesticide concentrations in 
ground water. In general, EPA will use GENEEC (a Tier I model) before 
using PRZM/EXAMS (a Tier II model) for a screening-level assessment for 
surface water. The GENEEC model is a subset of the PRZM/EXAMS model 
that uses a specific high-end runoff scenario for pesticides. GENEEC 
incorporates a farm pond scenario, while PRZM/EXAMS incorporate an 
index reservoir environment in place of the previous pond scenario. The 
PRZM/EXAMS model includes a percent crop area factor as an adjustment 
to account for the maximum percent crop coverage within a watershed or 
drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use EECs from these models 
to quantify drinking water exposure and risk as a %RfD or %PAD. Instead 
drinking water levels of comparison (DWLOCs) are calculated and used as 
a point of comparison against the model

[[Page 25827]]

estimates of a pesticide's concentration in water. DWLOCs are 
theoretical upper limits on a pesticide's concentration in drinking 
water in light of total aggregate exposure to a pesticide in food, and 
from residential uses. Since DWLOCs address total aggregate exposure to 
Indoxacarb they are further discussed in the aggregate risk sections 
below.
    Based on the PRZM/EXAMS and SCI-GROW models the estimated EECs of 
Indoxacarb for acute exposures are estimated to be 13.7 parts per 
billion (ppb) for surface water and 0.02 ppb for ground water. The EECs 
for chronic exposures are estimated to be 3.7 ppb for surface water and 
0.02 ppb for ground 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 not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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 does not have, at this time, available data to determine 
whether Indoxacarb has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
Indoxacarb does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that Indoxacarb has 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 the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) 
(FRL-5754-7).

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold 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 data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There is no evidence for 
either qualitative or quantitative susceptibility. In all developmental 
studies, the developmental endpoint occurs at the maternal LOAEL or 
above. Although there is no rabbit developmental toxicity study with 
indoxacarb, a study is not required since:
    i. Studies-both using methyl cellulose-comparing JW062 in the 
rabbit and rat demonstrate that the toxicity profiles for the rat and 
rabbit are similar and that the rat is the more sensitive species;
    ii. Range finding studies in the rat comparing indoxacarb and JW062 
indicate that the maternal and external developmental toxicity are 
comparable;
    iii. A dietary developmental toxicity study in the rat with JW062 
had comparable toxicity to the gavage indoxacarb rat developmental 
toxicity study. Developmental toxicity only occurred at levels at or 
above maternal toxicity.
The reproduction toxicity study with JW062 can be used to satisfy the 
requirement for an indoxacarb study because:
    iv. Systemic toxicity is at similar doses and of similar magnitude 
to that observed in subchronic feeding studies with both indoxacarb and 
JW062;
    v. based on the data base, the HIARC determined that there was 
support for using data from dietary studies conducted with JW062 to 
satisfy the data requirements for indoxacarb.
    The Agency has required a developmental neurotoxicity study as 
confirmatory data due to:
    [sbull] Clinical signs of neurotoxicity in several studies, males 
and females, mice and rats, at some doses that do not cause mortality;
    [sbull] Signs of neurotoxicity in the acute neurotoxicity study-rat 
with indoxacarb (males and females), no mortality in males at 
neurotoxic doses;
    [sbull] Clinical signs of neurotoxicity in the 90-day toxicity 
study-rat indoxacarb (females), mortality;
    [sbull] Clinical signs of neurotoxicity in the 90-day toxicity 
study-mouse with the racemic mixture, JW062 (males and females), no 
mortality in females at neurotoxic doses, mortality in males;
    [sbull] Clinical signs of neurotoxicity in the 18 month 
carcinogenicity study-mouse with JW062 (males and females) high and mid 
dose, mortality at the high but no mortality at the mid dose; and
    [sbull] Clinical signs of neurotoxicity in the developmental 
toxicity study-rat with JW062 (using methyl cellulose as the vehicle), 
at doses causing mortality.
    3. Conclusion. The Agency concluded that the FQPA safety factor 
could be reducecd to 1X for Indoxacarb because:
    [sbull] There is no indication of quantitative or qualitative 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure;
    [sbull] The requirement of a developmental neurotoxicity study is 
not based on the criteria reflecting special concern for the developing 
fetuses or young which are generally used for requiring a DNT study--
and a safety factor (e.g.: neuropathy in adult animals; CNS 
malformations following prenatal exposure; brain weight or sexual 
maturation changes in offspring; and/or functional changes in 
offspring)--and therefore does not warrant an FQPA safety factor; and
    [sbull] The dietary (food and drinking water) exposure assessments 
will not underestimate the potential exposures for infants and children
    [sbull] There are no registered residential uses at the current 
time.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by EPAs Office of Water are used to calculate DWLOCs: 2 
liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default

[[Page 25828]]

body weights and drinking water consumption values vary on an 
individual basis. This variation will be taken into account in more 
refined screening-level and quantitative drinking water exposure 
assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
Indoxacarb will occupy 12% of the aPAD for the U.S. population, 64% of 
the aPAD for females 13 years and older, 67% of the aPAD for infants 
less than 1 year old and 79% of the aPAD for children 1 to 2 years old. 
In addition, there is potential for acute dietary exposure to 
Indoxacarb in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in Table 1 of 
this Unit:

                      Table 1.--Aggregate Risk Assessment for Acute Exposure to Indoxacarb
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................         0.12           12         13.7         0.02        3,700
Females 13+....................................         0.12           64         13.7         0.02          218
All infants less than 1 year...................         0.12           67         13.7         0.02          400
Children 1 to 2................................         0.12           79         13.7         0.02          760
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
Indoxacarb from food will utilize 30% of the cPAD for the U.S. 
population, 29% of the cPAD for infants less than 1 year and 79% of the 
cPAD for children 1 to 2 years old. There are no residential uses for 
Indoxacarb that result in chronic residential exposure to Indoxacarb. 
Based on the use pattern, chronic residential exposure to residues of 
Indoxacarb is not expected. In addition, there is potential for chronic 
dietary exposure to Indoxacarb in drinking water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect the aggregate exposure to exceed 100% of the cPAD, as 
shown in Table 2 of this unit:

               Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Indoxacarb
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................         0.02           30          3.7         0.02          490
All infants less than 1 year old...............         0.02           29          3.7         0.02           65
Children 1 to 2................................         0.02           79          3.7         0.02           30
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Indoxacarb is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Indoxacarb is 
not registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. There is no evidence 
for mutagenicity and there is no evidence of carcinogenicity in either 
rat or mouse. Indoxacarb has been classified as ``not likely to be 
carcinogenic in humans'' by the Agency; therefore Indoxacarb is is not 
expected to pose carcinogenic risk when used as directed.
    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, and 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/UV Method AMR 2712-93) is available to enforce the 
tolerance expression. The method may be requested from: Calvin Furlow, 
PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Avenue., NW, Washington D.C. 
20460; Telephone Number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    There are no established or proposed Codex, Canadian, or Mexican 
maximum residue limits (MRLs) for residues of Indoxacarb; therefore, 
international

[[Page 25829]]

harmonization is not an issue at this time.

V. Conclusion

    Therefore, the time-limited tolerance is established for 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] + 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 peaches at 10 ppm. 
This tolerance will expire and is revoked on May 15, 2006.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d), 
as was provided in the old sections 408 and 409 of the FFDCA. However, 
the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0173 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 on or before July 14, 
2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0173, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected].
    Please use an ASCII file format and avoid the use of special 
characters and any form of encryption. Copies of electronic objections 
and hearing requests will also be accepted on disks in WordPerfect 6.1/
8.0 or ASCII file format. Do not include any CBI in your electronic 
copy. You may also submit an electronic copy of your request at many 
Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
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 rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). 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., or 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). Nor does it require any

[[Page 25830]]

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); or OMB review 
or any Agency action under Executive Order 13045, entitled Protection 
of Children from Environmental Health Risks and Safety Risks (62 FR 
19885, April 23, 1997). 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). Since tolerances and 
exemptions that are established on the basis of a petition under 
section 408(d) of the FFDCA, such as the tolerance in this final rule, 
do not require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. 
In addition, the Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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: April 30, 2003.
Debra Edwards
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), 346(a) and 371.

0
2. Section 180.564 is amended by redesignating the existing text in 
paragraph (a) following the heading ``General'' as paragraph (a)(1) and 
by adding a new paragraph (a)(2) to read as follows:


Sec.  180.564  Indoxacarb; tolerances for residues.

    (a) * * *
    (1) * * *
    (2) Time-limited tolerances are established for 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] + 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 connection with use of the pesticide under FIFRA 
section 5 experimental use permit granted by EPA. The tolerances are 
specified in the following table, and will expire and are revoked on 
the dates specified.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Peach.............................                 10       May 15, 2006
------------------------------------------------------------------------


[[Page 25831]]

[FR Doc. 03-11758 Filed 5-13-03; 8:45 am]
BILLING CODE 6560-50-S