Indoxacarb. May 21, 2003. Pesticide tolerances for Emergency Exemptions. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Indoxacarb. May 21, 2003. Pesticide Tolerances for Emergency Exemptions. Final Rule. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2003/May/Day-21/p12480.htm

[Federal Register: May 21, 2003 (Volume 68, Number 98)]
[Rules and Regulations]
[Page 27740-27746]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my03-4]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: Madden.Barbara@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are 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: residuemethods@epa.gov.

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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. 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 (59 FR 22951, 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.

¥ Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

¥ 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

¥ 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