[Federal Register Volume 69, Number 97 (Wednesday, May 19, 2004)]
[Rules and Regulations]
[Pages 28832-28842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11346]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0130; FRL-7359-1]


Indoxacarb; Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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, and its R-enantiomer, (R)-methyl 7-chloro-2,5-dihydro-2- 
[[(methoxycarbonyl)[4-(trifluoromethoxy) 
phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-
carboxylate, in or on cherry, sweet and cherry, tart. E.I. DuPont de 
Nemours and Company, DuPont Crop Protection requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act of 1996 (FQPA). The tolerance will 
expire on May 21, 2007.

DATES: This regulation is effective May 19, 2004. Objections and 
requests for hearings must be received on or before July 19, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2004-0130. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either electronically in 
EDOCKET or in hard copy at the Public Information and Records Integrity 
Branch (PIRIB), Rm.

[[Page 28833]]

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.

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:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), 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 E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of March 17, 2004 (69 FR 12664-12670) (FRL-
7345-2), EPA issued a notice pursuant to section 408(d)(3) of the 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 3G6797) by E.I. DuPont de Nemours and Company, DuPont Crop 
Protection, Wilmington, DE. This notice included a summary of the 
petition prepared by DuPont, the registrant.
    The petition 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, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl)[4-(trifluoromethoxy) 
phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-
carboxylate, in or on cherry, sweet and cherry, tart at 1.0 part per 
million (ppm). The tolerance will expire on May 21, 2007. One comment 
was received from a private citizen objecting to this tolerance. This 
commenter opposes all residues, tolerances, exemptions from tolerance, 
animal testing, or the Agency's risk assessment process, and has 
objected to numerous Agency actions over the past several months.
    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, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl)[4-(trifluoromethoxy) 
phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-
carboxylate, on cherry, sweet and cherry, tart at 1.0 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 Table 1 of this unit as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

[[Page 28834]]



                            Table 1.--Acute, Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        DPX-MP062
                                          rodents                    NOAEL = M 3.1 mg/kg/day, F 2.1 mg/kg/day
                                                                     LOAEL = M 6.0 mg/kg/day, F 3.8 mg/kg/day
                                                                      based on decreased body weight, body
                                                                      weight gain, food consumption and food
                                                                      efficiency
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     DPX-JW062
                                          nonrodents                 NOAEL = 5.0 mg/kg/day
                                                                     LOAEL = 19 mg/kg/day based on hemolytic
                                                                      anemia, as indicated by decrease in HGB,
                                                                      RBCs; increases in platelets, increased
                                                                      reticulocytes; and secondary
                                                                      histopathologic findings indicative of
                                                                      blood breakdown (pigment in Kupffer cells,
                                                                      renal tubular epithelium, and spleen and
                                                                      bone marrow macrophages); increase in
                                                                      splenic EMH; and RBC hyperplasia in bone
                                                                      marrow in dogs
----------------------------------------------------------------------------------------------------------------
870.3200                                 21/28-Day dermal toxicity   DPX-MP062
                                                                     NOAEL = 2,000 mg/kg/day
                                                                     LOAEL = >2,000 mg/kg/day in rats
                                                                     DPX-MP062
                                                                     NOAEL = 50 mg/kg/day
                                                                     LOAEL = 500 mg/kg/day based on decreased
                                                                      body weights, body weight gains, food
                                                                      consumption, and food efficiency in F, and
                                                                      changes in hematology parameters
                                                                      (increased reticulocytes), the spleen
                                                                      (increased absolute and relative weight M
                                                                      only, gross discoloration), clinical signs
                                                                      of toxicity in both sexes in rats
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   DPX-MP062
                                          rodents                    Maternal NOAEL = 2.0 mg/kg/day
                                                                     LOAEL = 4.0 mg/kg/day based on decreased
                                                                      mean body weights, body weight gains, food
                                                                      consumption
                                                                     Developmental NOAEL = 2.0 mg/kg/day
                                                                     LOAEL = 4.0 mg/kg/day based on decreased
                                                                      fetal weights
                                                                     DPX-JW062
                                                                     Maternal NOAEL = 10 mg/kg/day
                                                                     LOAEL = 100 mg/kg/day based on mortality,
                                                                      clinical signs, and decreased mean body
                                                                      weights, body weight gains, and food
                                                                      consumption
                                                                     Developmental NOAEL = 10 mg/kg/day
                                                                     LOAEL = 100 mg/kg/day based on decreased
                                                                      numbers of live fetuses/litter.
                                                                     DPX-JW062
                                                                     Maternal NOAEL = 1.1 mg/kg/day
                                                                     LOAEL = 2.2 mg/kg/day based on decreased
                                                                      mean body weights, body weight gains, food
                                                                      consumption, and food efficiency.
                                                                     Developmental NOAEL = 1.1 mg/kg/day
                                                                     LOAEL = 2.2 mg/kg/day based on decreased
                                                                      fetal body weights
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   DPX-JW062 - rabbits
                                          nonrodents                 Maternal NOAEL = 500 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on slight
                                                                      decreases in maternal body weight gain and
                                                                      food consumption.
                                                                     Developmental NOAEL = 500 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on decreased
                                                                      fetal body weights and reduced
                                                                      ossification of the sternebrae.
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  DPX-JW062
                                          effects                    Parental/Systemic
                                                                     NOAEL = 1.5 mg/kg/day
                                                                     LOAEL = 4.4 mg/kg/day based on decreased
                                                                      body weights, body weight gains, and food
                                                                      consumption of F0 females, and increased
                                                                      spleen weights in the F0 and F1 females
                                                                     Reproductive
                                                                     NOAEL = 6.4 mg/kg/day
                                                                     LOAEL = 6.4 mg/kg/day
                                                                     Offspring
                                                                     NOAEL = 1.5 mg/kg/day
                                                                     LOAEL = 4.4 mg/kg/day based on decrease in
                                                                      the body weights of the F1 pups during
                                                                      lactation.
----------------------------------------------------------------------------------------------------------------

[[Page 28835]]

 
870.4100                                 Chronic toxicity rodents    DPX-JW062
                                                                     NOAEL = M 5, F 2.1 mg/kg/day
                                                                     LOAEL = M 10, F 3.6 mg/kg/day based on
                                                                      decreased body weight, body weight gain,
                                                                      and food consumption and food efficiency;
                                                                      decreased HCT, HGB and RBC at 6 months in
                                                                      F only.
                                                                     No evidence of carcinogenic potential
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity dogs       DPX-JW062
                                                                     NOAEL = M 2.3, F 2.4 mg/kg/day
                                                                     LOAEL = M 18, F 19 mg/kg/day based on
                                                                      decreased HCT, HGB and RBC; increased
                                                                      Heinz bodies and reticulocytes and
                                                                      associated secondary microscopic changes
                                                                      in the liver, kidneys, spleen, and bone
                                                                      marrow; increased absolute and relative
                                                                      liver weights.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity rats        DPX-JW062 see 870.4100
                                                                     No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice        DPX-JW062
                                                                     NOAEL = M 2.6, F4.0 mg/kg/day
                                                                     LOAEL = M 14, F 20 mg/kg/day based on
                                                                      decreased body weight, body weight gain,
                                                                      and food efficiency and clinical signs
                                                                      indicative of neurotoxicity.
                                                                     No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation               DPX-MP062 strains TA97a, TA98, TA100 and
                                                                      TA1535 of S. typhimurium and strain
                                                                      WP2(uvrA) of E. coli were negative for
                                                                      mutagenic activity both with and without
                                                                      S9 activation for the concentration range
                                                                      10-5,000 [mu]g/plate
                                                                     DPX-JW062 strains TA97a, TA98, TA100 and
                                                                      TA1535 of S. typhimurium and strain
                                                                      WP2(uvrA) of E. coli were negative for
                                                                      mutagenic activity both with and without
                                                                      S9 activation for the concentration range
                                                                      10-5,000 [mu]g/plate.
----------------------------------------------------------------------------------------------------------------
870.5300                                 Gene mutation               DPX-MP062
                                                                     negative for mutagenic activity for the
                                                                      following concentration ranges: 3.1-250
                                                                      [mu]g/mL (-S9); 3.1-250 [mu]g/mL (+S9)
                                                                     DPX-JW062
                                                                     negative for mutagenic activity for the
                                                                      following concentration ranges:
                                                                      Negative;100-1,000 [mu]g/mL (-S9); 100-
                                                                      1,000 [mu]g/mL (+S9), precipitate >=1,000
                                                                      [mu]g/mL
----------------------------------------------------------------------------------------------------------------
870.5375                                 Cytogenetics                DPX-MP062
                                                                     No evidence of chromosomal aberrations
                                                                      induced by the test article over
                                                                      background for the following concentration
                                                                      ranges: 15.7-1,000 [mu]g/mL (+S9)
                                                                     DPX-JW062
                                                                     No evidence of chromosomal aberrations
                                                                      induced by the test article over
                                                                      background for the following concentration
                                                                      ranges: 19-300 [mu]g/mL (-S9), 19-150
                                                                      [mu]g/mL (+S9); partial insoluble and
                                                                      cytotoxicity >= 150 [mu]g/mL
----------------------------------------------------------------------------------------------------------------
870.5395                                 Cytogenetics                DPX-MP062
                                                                     No evidence of mutagenicity for the
                                                                      following dose ranges: 3,000-4,000 mg/kg -
                                                                      males; 1,000-2,000 mg/kg - females
                                                                     DPX-JW062
                                                                     No evidence of mutagenicity at 2,500 or
                                                                      5,000 mg/kg
----------------------------------------------------------------------------------------------------------------
870.5550                                 Other effects               DPX-MP062
                                                                     No evidence of mutagenic activity at the
                                                                      following concentration range: 1.56-200
                                                                      [mu]g/mL; cytotoxicity was seen at
                                                                      concentrations of >=100 [mu]g/mL
                                                                     DPX-JW062
                                                                     No evidence of mutagenic activity at the
                                                                      following concentration range: 0.1-50
                                                                      [mu]g/mL, cytotoxicity observed at >=50
                                                                      [mu]g/mL
----------------------------------------------------------------------------------------------------------------

[[Page 28836]]

 
870.6200                                 Acute neurotoxicity         DPX-MP062
                                          screening battery          NOAEL = M 100, F 12.5 mg/kg
                                                                     LOAEL = M 200 mg/kg based on decreased body
                                                                      weight gain, decreased food consumption,
                                                                      decreased forelimb grip strength, and
                                                                      decreased foot splay. F 50 mg/kg based on
                                                                      decreased body weight, body weight gain,
                                                                      and food consumption
                                                                     DPX-JW062
                                                                     NOAEL >= M 2,000 mg/kg = F < 500 mg/kg
                                                                     LOAEL > M 2,000 mg/kg F < 500 mg/kg based
                                                                      on clinical signs, decreased body weight
                                                                      gains and food consumption, and FOB
                                                                      effects
----------------------------------------------------------------------------------------------------------------
870.6200                                 Subchronic neurotoxicity    DPX-MP062
                                          screening battery          NOAEL = M 0.57, F 0.68 mg/kg/day
                                                                     LOAEL = M 5.6, F 3.3 mg/kg/day based on
                                                                      decreased body weight and alopecia
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              Both DPX-MP062 and DPX-JW062 were
                                          pharmacokinetics            extensively metabolized and the
                                                                      metabolites were eliminated in urine,
                                                                      feces, and bile. The metabolite profile
                                                                      for DPX-JW062 was dose dependent and
                                                                      varied quantitatively between males and
                                                                      females. Differences in metabolite
                                                                      profiles were also observed for the
                                                                      different label positions (indanone and
                                                                      trifluoromethoxyphenyl rings). All biliary
                                                                      metabolites undergo further
                                                                      biotransformation in the gut. The proposed
                                                                      metabolic pathway for both DPX-MP062 and
                                                                      DPX-JW062 has multiple metabolites bearing
                                                                      one of the two ring structures (see
                                                                      870.4100 chronic toxicity rodents above)
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intra species differences. Discuss 
any additional UFs (other than the FQPA SF) used in the assessment.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor 
(SF).
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 106 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for indoxacarb used for human risk assessment is shown in 
Table 2 of this unit:

      Table 2.--Summary of Toxicological Dose and Endpoints for Indoxacarb for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of  NOAEL = 2.0 mg/kg/day    FQPA SF = 1              Developmental rat
 age)                                   UF = 100                aPAD = acute RfD/FQPA     toxicity study
                                       Acute RfD = 0.02 mg/kg/   SF = 0.02 mg/kg/day.    LOAEL = 4.0 mg/kg/day
                                        day.                                              based on decreased
                                                                                          fetal body weight
-----------------------------------------------------------------------------------------

[[Page 28837]]

 
Acute dietary (general population      NOAEL = 12 mg/kg/day UF  FQPA SF = 1              Acute oral rat
 including infants and children)        = 100                   aPAD = acute RfD/FQPA     neurotoxicity study
                                       Acute RfD = 0.12 mg/kg/   SF = 0.12 mg/kg/day.    LOAEL = 50 mg/kg/day
                                        day.                                              based on decreased
                                                                                          body weight and body
                                                                                          weight gain in females
-----------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL= 2.0 mg/kg/day UF  FQPA SF = 1 cPAD =       90-day rat subchronic
                                        = 100                    chronic RfD/FQPA SF =    toxicity study,
                                       Chronic RfD = 0.02 mg/    0.02 mg/kg/day          90-day rat
                                        kg/day.                                           neurotoxicity study,
                                                                                          chronic/
                                                                                          carcinogenicity rat
                                                                                          study
                                                                                         LOAEL = 3.3 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight, body
                                                                                          weight gain, food
                                                                                          consumption and food
                                                                                          efficiency; decreased
                                                                                          hematocrit, hemoglobin
                                                                                          and red blood cells
                                                                                          only at 6 months. 3.3
                                                                                          mg/kg/day is the
                                                                                          lowest LOAEL of the
                                                                                          three studies
-----------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days)        Dermal (or oral) study   LOC for MOE = 100        28-day rat dermal
(Occupational).......................   NOAEL= 50 mg/kg/day     (Occupational).........   toxicity study
                                                                                         LOAEL = 500 mg/kg/day
                                                                                          based on based on
                                                                                          decreased body
                                                                                          weights, body weight
                                                                                          gains, food
                                                                                          consumption, and food
                                                                                          efficiency in females,
                                                                                          and changes in
                                                                                          hematology parameters
                                                                                          (increased
                                                                                          reticulocytes), the
                                                                                          spleen (increased
                                                                                          absolute and relative
                                                                                          weight males only,
                                                                                          gross discoloration),
                                                                                          and clinical signs of
                                                                                          toxicity in both sexes
-----------------------------------------------------------------------------------------
Short-term inhalation (1-7 days)       oral study NOAEL =2.0    LOC for MOE = 100        Rat developmental
(Occupational).......................   mg/kg/day (inhalation   (Occupational).........   toxicity study.
                                        absorption rate = 100%                            Maternal LOAEL = 4.0
                                                                                          mg/kg/day based on
                                                                                          decreased mean
                                                                                          maternal body weights,
                                                                                          body weight gains, and
                                                                                          food consumption
-----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      ``Not likely'' to be     N/A                      No evidence of
                                        carcinogenic to humans                            carcinogenicity in
                                                                                          either the rat or
                                                                                          mouse in acceptable
                                                                                          carcinogenicity
                                                                                          studies and no
                                                                                          evidence of
                                                                                          mutagenicity
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional safety factor retained due to concerns unique to the
  FQPA.

C. 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, Vegetables, fruiting, 
group at 0.50 ppm, and a time-limited tolerance for peach at 10.0 ppm. 
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 
(DEEMTM) analysis evaluated the individual food consumption 
as reported by respondents in the USDA 1994-1996 and 1998 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: A partially 
refined, acute dietary exposure assessment was performed with use of 
some anticipated residues (ARs) from field trial data, processing 
factors (where applicable), and assuming 100% crop treated. 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 DEEMTM analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1994-1996 and 1998 
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 bw/day 
and as a pest percent of the cPAD. The chronic dietary assessment 
assumed tolerance level residues, DEEMTM default processing 
factors, assumed 100% CT for all crops other than cherries and peaches, 
and 1% CT for the peach EUP (300 acres) and cherry EUP (180) acres.
    iii. Cancer. There is no evidence for mutagenicity and there is no 
evidence of

[[Page 28838]]

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 
anticipated residues 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% CT for peaches and 
cherries. This PCT of 1% was based on the fact that the 2-year 
experimental use permit s were issued for only 300 acres of peaches, 
and 180 acres of cherries to be treated annually, which amounts to 0.2% 
of the total peach and cherry acreages 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 and cherries is 
reliable and has a valid basis. A 2-year EUP has been issued for both 
of these uses, which will allow for use of indoxacarb on 300 acres of 
peaches and 180 acres of cherries in some eastern states. Before these 
uses can be expanded for treatment of greater than 300 or 180 acres 
respectively 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 First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) 
to estimate pesticide concentrations in surface water and Screening 
Concentrations in Ground Water (SCI-GROW), which predicts pesticide 
concentrations in ground water. In general, EPA will use FIRST (a Tier 
1 model) before using PRZM/EXAMS (a Tier 2 model) for a screening-level 
assessment for surface water. The FIRST model is a subset of the PRZM/
EXAMS model that uses a specific high-end runoff scenario for 
pesticides. FIRST and PRZM/EXAMS incorporate an index reservoir 
environment. FIRST and PRZM/EXAMS models include 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 screen for sorting out pesticides for which it is 
highly unlikely that drinking water concentrations would 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 %RfD or %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 high-end to bounding estimates 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

[[Page 28839]]

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).

D. 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: (1) 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; (2) range finding studies in the rat 
comparing indoxacarb and JW062 indicate that the maternal and external 
developmental toxicity are comparable; (3) 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: (1) systemic toxicity 
is at similar doses and of similar magnitude to that observed in 
subchronic feeding studies with both indoxacarb and JW062; (2) based on 
the data base, EPA 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:
     Clinical signs of neurotoxicity in several studies, males 
and females, mice and rats, at some doses that do not cause mortality.
     Signs of neurotoxicity in the acute neurotoxicity study 
rat with indoxacarb (males and females), no mortality in males at 
neurotoxic doses.
     Clinical signs of neurotoxicity in the 90-day toxicity 
study rat indoxacarb (females), mortality.
     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.
     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.
     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 reduced to 1X for indoxacarb because:
     There is no indication of quantitative or qualitative 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure.
     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.
     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.

E. 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 high-end to 
bounding estimates 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 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 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 36 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

[[Page 28840]]

EECs for surface and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD, as shown in Table 3 of this unit:

                       Table 3.--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         3700
---------------------------------------------------------------------------
Females 13 +                                            0.12           64         13.7         0.02          220
---------------------------------------------------------------------------
All infants (less than 1 year)                          0.12           67         13.7         0.02          400
---------------------------------------------------------------------------
Children (1 to 2 years)                                 0.12           36         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 31% of the cPAD for the U.S. 
population, 29% of the cPAD for infants less than 1 year old and 80% 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. 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 water and ground water, EPA does 
not expect the aggregate exposure to exceed 100% of the cPAD, as shown 
in Table 4 if this unit:

               Table 4.--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           31          3.7         0.02          480
---------------------------------------------------------------------------
All infants (less than 1 year) old                      0.02           29          3.7         0.02          140
---------------------------------------------------------------------------
Children (1 to 2 years)                                 0.02           80          3.7         0.02           40
----------------------------------------------------------------------------------------------------------------

    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 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 (example--gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    There are no established or proposed Codex, Canadian, or Mexican 
maximum residue limits (MRLs) for residues of indoxacarb; therefore, 
international harmonization is not an issue at this time.

V. Conclusion

    Therefore, the 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, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl)[4-(trifluoromethoxy) 
phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-
carboxylate, in or on cherry, sweet and cherry, tart at 1.0 ppm. This 
tolerance will expire and is revoked on May 21, 2007.

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

[[Page 28841]]

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-2004-0130 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 19, 
2004.
    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 (1900L), 
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 Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. 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 (202) 564-6255.
    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 ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0130, 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 ADDRESSES. 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 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

[[Page 28842]]

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. 801et 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: May 6, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.564 is amended by alphabetically adding the following 
commodities to the table in paragraph (a)(2) to read as follows:


Sec.  180.564  Indoxacarb; tolerances for residues.

    (a) * * * P>(2) * * *

----------------------------------------------------------------------------------------------------------------
                                                                                         Expiration/revocation
               Commodity                              Parts per million                           date
----------------------------------------------------------------------------------------------------------------
Cherry, sweet.........................                                            1.0  May 21, 2007
Cherry, tart..........................                                            1.0  May 21, 2007
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 04-11346 Filed 5-18-04; 8:45 am]
BILLING CODE 6560-50-S