[Federal Register Volume 68, Number 98 (Wednesday, May 21, 2003)]
[Rules and Regulations]
[Pages 27740-27746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12480]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0151; FRL-7305-2]


Indoxacarb; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
combined residues of indoxacarb and its R-enantimomer in or on 
collards. This action is in response to EPA's granting of an emergency 
exemption under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) authorizing use of the pesticide on collards. 
This regulation establishes a maximum permissible level for residues of 
indoxacarb in this food commodity. The tolerance will expire and is 
revoked on June 30, 2006.

DATES: This regulation is effective May 21, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0151, 
must be received on or before July 21, 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 VII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; 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 a federal 
or state government agency (NAICS 9241) involved in administration of 
environmental quality programs (i.e., Departments of Agriculture, 
Environment, etc).
    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-2003-0151. 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.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is 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] and its R-enantimomer 
[(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 collards at 3.0 parts 
per million (ppm). This tolerance will expire and is revoked on June 
30, 2006. EPA will publish a document in the Federal Register to remove 
the revoked tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18-related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of 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. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State

[[Page 27741]]

agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by the Food Quality Protection Act of 1996 (FQPA). EPA has 
established regulations governing such emergency exemptions in 40 CFR 
part 166.

III. Emergency Exemption for Indoxacarb on Collards and FFDCA 
Tolerances

    The State of Georgia requested an emergency exemption use for 
indoxacarb (Avaunt[reg]) for control of the diamondback moth in 
collards, since this pest appears to have developed resistance to 
almost all available chemical alternatives. Although spinosad has 
provided satisfactory diamondback moth control until recently, field 
failures were detected in 2002, suggesting that resistance may be 
involved. According to the State, potential yield losses tend to be 
either 0% or 100%, since in affected fields the damage level may be 
considered either acceptable or a cause for rejection, in which case 
the crop would not be harvested. The State estimated an overall 10% 
decrease in yield in the absence of effective insecticides and a 
doubling of insecticide costs from $24.50 to $49.00 because of a lack 
of efficacy leading to repeated applications. The 10% estimate 
represents anticipated total losses in a few fields and minor losses in 
fields with manageable moth populations. EPA has authorized under FIFRA 
section 18 the use of indoxacarb on collards for control of diamond 
back moth in Georgia. After having reviewed the submission, EPA concurs 
that emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of indoxacarb in or on 
collards. In doing so, EPA considered the safety standard in section 
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance 
under section 408(l)(6) of the FFDCA would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in section 408(l)(6) of the FFDCA. 
Although this tolerance will expire and is revoked on June 30, 2006, 
under section 408(l)(5) of the FFDCA, residues of the pesticide not in 
excess of the amounts specified in the tolerance remaining in or on 
collards after that date will not be unlawful, provided the pesticide 
is applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by this tolerance at the time of 
that application. EPA will take action to revoke this tolerance earlier 
if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether indoxacarb 
meets EPA's registration requirements for use on collards or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of indoxacarb by a State for special local needs 
under FIFRA section 24(c). Nor does this tolerance serve as the basis 
for any State other than Georgia to use this pesticide on this crop 
under section 18 of FIFRA without following all provisions of EPA's 
regulations implementing FIFRA section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemption for 
indoxacarb, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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).
    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 
indoxacarb and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for a time-limited 
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] and its R-
enantimomer [(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 collards at 3.0 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Endpoints

    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 and the 
endpoints used in risk assessment are discussed in Unit III.A. and B. 
of the final rule on indoxacarb pesticide tolerances published in the 
Federal Register of July 18, 2002 (67 FR 47299) (FRL-7186-2). Please 
refer to that document should you desire detailed toxicological 
information on indoxacarb.
    The Agency has identified an acute dietary endpoint for females 13 
years and older and for the general population, including infants and 
children. 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 ``not likely'' to be 
carcinogenic to humans.

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 alfalfa, 
head lettuce, peanuts, potatoes, and soybeans. Additionally, there are 
tolerances for milk, milk fat, meat, fat and meat by-products of 
cattle, goat, hog, horse, and sheep. Risk assessments were conducted by 
EPA to assess dietary exposures from indoxacarb in food as follows:
    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 Dietary Exposure Evaluation Model (DEEM[reg] 
version 7.76) analysis evaluated the individual food consumption as 
reported by respondents in the U.S. Department of Agriculture (USDA) 
1989-1992 nationwide Continuing

[[Page 27742]]

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: Acute Tier II assessment, a 
partially refined analysis with use of anticipated residues (ARs) from 
field trial data, refined processing factors, and 100% crop treated.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM[reg] (version 7.76) 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 chronic exposure 
assessments: Tolerance level residues for all commodities and assumed 
all raw agricultural commodities were 100% treated with indoxacarb. 
Refined processing factors were used in the chronic analysis for 
several commodities, in place of the DEEM[reg] default processing 
factors.
    iii. Cancer. Indoxacarb has been classified as ``not likely'' to be 
carcinogenic to humans. Therefore, cancer risk was not assessed.
    iv. Anticipated residue information. 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 anticipated residues to be 
submitted no later than 5 years from the date of issuance of this 
tolerance.
    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 Pesticide Root Zone/Exposure Analysis Modeling System 
(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 estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a percent reference dose (%RfD) or 
percent population adjusted dose (%PAD). Instead drinking water levels 
of comparison (DWLOCs) are calculated and used as a point of comparison 
against the model 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 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).

C. Safety Factor for Infants and Children

    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.
    The prenatal and postnatal toxicology data base for indoxacarb is 
complete with respect to FQPA considerations. The nature of the toxic 
effects caused by indoxacarb are discussed in Unit III.D. of the final 
rule on indoxacarb pesticide tolerances published in the Federal 
Register of July 18, 2002 (67 FR 47299) (FRL-7186-2). Please refer to 
that document should you desire detailed toxicological information on 
indoxacarb regarding FQPA considerations.

[[Page 27743]]

    The Agency concluded 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. EPA did require a developmental 
neurotoxicity study as confirmatory data. 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; central nervous system 
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 
the dietary (food and drinking water) exposure assessments will not 
underestimate the potential exposures for infants and children. 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 + chronic non-dietary, non-occupational 
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 the USEPA 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 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 indoxacarb 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 
indoxacarb on 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 all 
infants (<1 year old) and 79% of the aPAD for children 1-5 years old, 
the children subpopulations at greatest exposure. In addition, despite 
the potential for acute dietary exposure to indoxacarb in drinking 
water, after calculating DWLOCs and comparing them to conservative 
model EECs of indoxacarb in surface and ground water, EPA does not 
expect the aggregate exposure to exceed 100% of the aPAD, as shown in 
Table 1. below:

                      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
------------------------------------------------
All Infants (< 1year old)                               0.12           67         13.7         0.02          400
------------------------------------------------
Children (1-5 years old)                                0.12           79         13.7         0.02          760
------------------------------------------------
Females (13-40 years old)                               0.02           64         13.7         0.02          218
----------------------------------------------------------------------------------------------------------------

    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 all infants (<1 year old) and 79% of 
the cPAD for children (1-2 years old), the children subpopulation at 
greatest exposure. There are no residential uses for indoxacarb that 
result in chronic residential exposure to indoxacarb. In addition, 
despite the potential for chronic dietary exposure to indoxacarb in 
drinking water, after calculating DWLOCs and comparing them to 
conservative model EECs of indoxacarb in surface and ground water, EPA 
does not expect the aggregate exposure to exceed 100% of the cPAD, as 
shown in Table 2. below:

              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 (< 1 year old)                              0.02           29          3.7         0.02           65
------------------------------------------------

[[Page 27744]]

 
Children (1-2 years old)                                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 were previously addressed.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational 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 were previously addressed.
    5. Aggregate cancer risk for U.S. population. Indoxacarb has been 
classified as ``not likely'' to be carcinogenic to humans. Therefore, 
cancer risk was not assessed.
    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.

V. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has submitted a method for enforcing tolerances of 
indoxacarb in/on plant commodities, a high-performance liquid 
chromatography (HPLC)/column switching/ultraviolet (UV) detector method 
(AMR 2712-93). This method has been radiovalidated and undergone a 
successful independent laboratory validation (ILV) and a successful 
petition method validation (PMV) trial by the Analytical Chemistry 
Laboratory (ACL). The HPLC/UV Method AMR 2712-93 was forwarded to the 
Food and Drug Administration for inclusion in the Pesticide Analytical 
Manual (PAM), Vol. II). The Agency has determined that this method is 
suitable for enforcement of the tolerances associated with this 
petition.
    Adequate enforcement methodology 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 Mexican, Canadian or Codex Maximum Residue Limits 
(MRLs) established for indoxacarb on collards. Therefore, no 
compatibility problems exist for the proposed tolerance.

VI. Conclusion

    Therefore, the tolerance is established 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-enantimomer [(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 collards at 
3.0 ppm.

VII. 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) 
of the FFDCA, 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-2003-0151 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 21, 
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.''

[[Page 27745]]

    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 VII.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 the docket ID number OPP-2003-0151, 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).

VIII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. 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 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 FIFRA 
section 18 exemption under section 408 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.

IX. 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

[[Page 27746]]

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: May 9, 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 alphabetically adding the following 
commodity to the table in paragraph (b) to read as follows:


Sec.  180.564  Indoxacarb; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Collards..........................                3.0           06/30/06
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 03-12480 Filed 5-20-03; 8:45 am]
BILLING CODE 6560-50-S