[Federal Register Volume 67, Number 138 (Thursday, July 18, 2002)]
[Rules and Regulations]
[Pages 47299-47310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18173]


=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0105; FRL-7186-2]


Indoxacarb; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for combined residues 
of indoxacarb in or on alfalfa forage, alfalfa hay, peanut, peanut hay, 
potato, soybean seed, soybean aspirated grain fractions, and soybean 
hulls. Additionally, this regulation is increasing the tolerance levels 
for head lettuce, milk, milk fat, meat, fat, and meat by-products of 
cattle, goat, hog, horse, and sheep. E. I. Du Pont de Nemours and 
Company requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
(FQPA) of 1996.

DATES: This regulation is effective July 18, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0105, 
must be received on or before September 16, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0105 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Geri McCann, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 605-0716; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production

[[Page 47300]]

 
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet home page at http://www.epa.gov/. 
To access this document, on the home page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to 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. To access the OPPTS Harmonized Guidelines referenced 
in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0105. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of (67 FR 3700, January 25 2002) (FRL-6819-
2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by the FQPA of 1996 (Public Law 104-170), announcing 
the filing of a pesticide petition (PP 1F6301) by E. I. Du Pont de 
Nemours and Company. This notice included a summary of the petition 
prepared by E. I. Du Pont de Nemours and Company, the registrant. The 
Agency received one e-mail letter from consumers/growers that believe 
there should be zero pesticide levels on human and animal foods.
    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-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 alfalfa, forage at 10 
parts per million (ppm), alfalfa, hay at 50 ppm, peanut at 0.01 ppm, 
peanut, hay at 40 ppm, potato at 0.01 ppm, soybean, seed at 0.80 ppm, 
aspirated grain fractions at 45 ppm, and soybean, hulls at 4.0 ppm. 
Additionally, the petition requested an increase in tolerance levels 
for head lettuce, milk, milk fat, meat, fat, and meat by-products of 
cattle, goat, hog, horse, and sheep based on a proposed increase in the 
labeled use rate for head lettuce and on potential changes in residue 
levels in livestock diets. The proposed increases are for head lettuce 
at 5.0 ppm, meat of cattle, goat, hog, horse, and sheep at 0.05 ppm, 
fat of cattle, goat, hog, horse, and sheep at 1.5 ppm, meat by-products 
of cattle, goat, hog, horse, and sheep at 0.03 ppm, milk at 0.15 ppm, 
and milk, fat at 4.0 ppm.
    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) 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) 
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 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), 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), for a tolerance for combined residues of indoxacarb on 
alfalfa, forage at 10 ppm, alfalfa, hay at 50 ppm, peanut at 0.01 ppm, 
peanut, hay at 40 ppm, potato at 0.01 ppm, soybean, seed at 0.80 ppm, 
aspirated grain fractions at 45 ppm, soybean, hulls at 4.0 ppm, 
lettuce, head at 5.0 ppm, meat of cattle, goat, hog, horse, and sheep 
at 0.05 ppm, fat of cattle, goat, hog, horse, and sheep at 1.5 ppm, 
meat by-products of cattle, goat, hog, horse, and sheep at 0.03 ppm, 
milk at 0.15 ppm, and milk, fat at 4.0 ppm. EPA's assessment of 
exposures and risks associated with establishing the tolerance(s) 
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

[[Page 47301]]

toxic effects caused by indoxacarb are discussed in the following Table 
1 as well as the no observed adverse effect level (NOAEL) and the 
lowest observed adverse effect level (LOAEL) from the toxicity studies 
reviewed.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                         90-Day oral         DPX-MP062
                                  toxicity rodents   NOAEL = M 3.1
                                                      milligrams/
                                                      kilogram/day (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         DPX-JW062
                                  toxicity in        NOAEL = 5.0 mg/kg/
                                  nonrodents          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    DPX-MP062
                                  toxicity           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            DPX-MP062
                                  developmental in   Maternal
                                  rodents            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
------------------------------------------------------------------------

[[Page 47302]]

 
870.3700                         Prenatal            DPX-JW062 - rabbits
                                  developmental in   Maternal
                                  nonrodents         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    DPX-JW062
                                  fertility 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
------------------------------------------------------------------------
870.4100                         Chronic toxicity    DPX-JW062
                                  rodents            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    DPX-JW062
                                  dogs               NOAEL = M 2.3, F
                                                      2.4 mg/kg/day
                                                     LOAEL = M 18, F 19
                                                      mg/kg/day based on
                                                      decreased HCT, HGB
                                                      nd 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     DPX-JW062 (see
                                  rats                870.4100--Chronic
                                                      toxicity rodents
                                                      above)
                                                     No evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.4300                         Carcinogenicity     DPX-JW062
                                  mice               NOAEL = M 2.6, F
                                                      4.0 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
------------------------------------------------------------------------

[[Page 47303]]

 
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
------------------------------------------------------------------------
870.6200                         Acute               DPX-MP062
                                  neurotoxicity      NOAEL = M 100, F
                                  screening battery   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          DPX-MP062
                                  neurotoxicity      NOAEL = M 0.57, F
                                  screening battery   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
                                  pharmacokinetics    DPX-JW062 were
                                                      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
                                                      trifluoromethoxyph
                                                      enyl 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 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 
intraspecies differences.
    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

[[Page 47304]]

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.
    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 10-6 
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 the following Table 2:

      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                          NOAEL = 2.0 mg/kg/day    FQPA SF = 1              Developmental rat
Females 13-50 years of age...........  UF = 100...............  aPAD = acute RfD.......   toxicity study
                                       Acute RfD = 0.02 mg/kg.  FQPA SF = 0.02 mg/kg/    Developmental LOAEL =
                                                                 day.                     4.0 mg/kg/day based on
                                                                                          decreased fetal body
                                                                                          weight
----------------------------------------------------------------------------------------------------------------
Acute dietary general population       NOAEL = 12.5 mg/kg       FQPA SF = 1              Acute oral rat
 including infants and children        UF = 100...............  aPAD = acute RfD.......   neurotoxicity study
                                       Acute RfD = 0.12 mg/kg.   FQPA SF = 0.12 mg/kg/   LOAEL = 50 mg/kg based
                                                                 day.                     on decreased body
                                                                                          weight and body weight
                                                                                          gain in females
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL = 2.0 mg/kg/day    FQPA SF = 1              90-Day rat subchronic
                                       UF = 100...............  cPAD = chr RfD.........   toxicity study
                                       Chronic RfD = 0.02 mg/   FQPA SF = 0.02 mg/kg/    90-Day rat
                                        kg/day.                  day.                     neurotoxicity study,
                                                                                          chronic/
                                                                                          carcinogenicity rat
                                                                                          study
                                                                                         LOAEL = 3.3 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight, alopecia,
                                                                                          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 oral (1-7 days)             Oral study               LOC for MOE = 100        Developmental rat
(Residential)........................   NOAEL= 2.0 mg/kg/day..   (Residential, includes   toxicity study
                                                                 the FQPA SF)            Maternal
                                                                                         LOAEL = 4.0 mg/kg/day
                                                                                          based on decreased
                                                                                          mean maternal body
                                                                                          weights, body weight
                                                                                          gains, and food
                                                                                          consumption
----------------------------------------------------------------------------------------------------------------
Intermediate-term                      Oral study               LOC for MOE = 100        90-Day rat subchronic
Oral (1 week--several months)........  NOAEL= 2.0 mg/kg/day...   (Residential, includes   toxicity study
(Occupational/.......................                            the FQPA SF)            LOAEL = 3.8 mg/kg/day
Residential).........................                                                     based on decreased
                                                                                          body weight, body
                                                                                          weight gain, food
                                                                                          consumption and food
                                                                                          efficiency
----------------------------------------------------------------------------------------------------------------
Short-(1-7 days), intermediate (1      Dermal study             LOC for MOE = 100        28-Day rat dermal
 week--several months), and long       NOAEL= 50 mg/kg/day....   (Occupational)           toxicity study
 (several months--lifetime)                                     LOC for MOE = 100        LOAEL = 500 mg/kg/day
Term dermal..........................                            (Residential, includes   based on decreased
(Occupational/.......................                            the FQPA SF).            body weights, body
Residential).........................                                                     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               LOC for MOE = 100        Rat developmental
(Occupational/.......................  NOAEL= 2.0 mg/kg/day      (Occupational)           toxicity study.
Residential).........................   (inhalation absorption  LOC for MOE = 100        Maternal
                                        rate = 100%).            (Residential, includes  LOAEL = 4.0 mg/kg/day
                                                                 the FQPA SF).            based on decreased
                                                                                          mean maternal body
                                                                                          weights, body weight
                                                                                          gains, and food
                                                                                          consumption
----------------------------------------------------------------------------------------------------------------

[[Page 47305]]

 
Intermediate-term Inhalation (1 week-- Oral study               LOC for MOE = 100        90-Day rat subchronic
 several months)                       NOAEL= 2.0 mg/kg/day      (Occupational)           toxicity study
(Occupational/.......................   (inhalation absorption  LOC for MOE = 100        LOAEL = 3.8 mg/kg/day
Residential).........................   rate = 100%).            (Residential, includes   based on decreased
                                                                 the FQPA SF).            body weight, body
                                                                                          weight gain, food
                                                                                          consumption and food
                                                                                          efficiency
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (several months - Oral study               LOC for MOE = 100        90-Day rat subchronic
  lifetime)                            NOAEL= 2.0 mg/kg/day      (Occupational)           toxicity study,
(Occupational/.......................   (inhalation absorption  LOC for MOE = 100        90-day rat
Residential).........................   rate =100%).             (Residential, includes   neurotoxicity study,
                                                                 the FQPA SF).            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
----------------------------------------------------------------------------------------------------------------
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 Safety Factor 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 by-
products 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 by-products at 15 ppm, cotton, undelinted seed at 2.0 
ppm, lettuce, head at 4.0 ppm, lettuce, leaf at 10.0 ppm, milk at 0.10 
ppm, and milk, fat at 3.0 ppm, pear at 0.20 ppm, and vegetables, 
fruiting, group at 0.50 ppm. Risk assessments were conducted by EPA to 
assess dietary exposures from indoxacarb in food as follows:
    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 1989-1992 nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. The following assumptions were made 
for the acute exposure assessments: An acute Tier 2 (partially refined 
analysis) dietary assessment was performed with use of anticipated 
residues (ARs) from field trial data, processing factors (where 
applicable), and assumed 100% crop treated (CT). 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 Dietary Exposure Evaluation Model (DEEMTM 
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: Chronic exposure estimates are expressed in mg/kg 
bwt/day and as a percent of the cPAD. The chronic dietary assessment 
assumed tolerance level residues, DEEMTM default processing 
factors, and 100% CT (Tier 1).
    iii. Cancer. There is no evidence for mutagenicity and there is no 
evidence of carcinogenicity in either the rat or mouse. Indoxacarb has 
been classified as ``not likely to be carcinogenic in humans'' by the 
Agency; therefore, no carcinogenic dietary risk analysis was performed.
    iv. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(E) 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), 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, 
chemical, and environmental fate characteristics of indoxacarb.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) 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 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 meta-model of the PRZM/EXAMS model that uses a specific 
high-end runoff scenario

[[Page 47306]]

for pesticides. PRZM/EXAMS incorporate an index reservoir environment 
in place of the 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 
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 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.
    Based on the PRZM/EXAMS and SCI-GROW models, the estimated 
environmental concentrations (EECs) of indoxacarb for acute exposures 
are estimated to be 13.86 parts per billion (ppb) for surface water and 
0.02 ppb for ground water. The EECs for chronic exposures are estimated 
to be 2.47 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) 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).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 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 margin of exposure 
(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: 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; range finding studies in the rat 
comparing indoxacarb and JW062 indicate that the maternal and external 
developmental toxicity are comparable; 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: Systemic toxicity is 
at similar doses and of similar magnitude to that observed in 
subchronic feeding studies with both indoxacarb and JW062; based on the 
data base, the 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), 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.
      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; 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.

[[Page 47307]]

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 theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/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 7% of the aPAD for the U.S. population, 41% of 
the aPAD for females 13 years and older, 6% of the aPAD for all infants 
less than 1 year old and 12% of the aPAD for children 1 to 6 years old, 
the children population at greatest exposure. In addition, there is 
potential for acute dietary exposure to indoxacarb in drinking water. 
After calculating DWLOCs and comparing them to the EECs for surface 
water and ground water, EPA does not expect the aggregate exposure to 
exceed 100% of the aPAD, as shown in the following Table 3:

                                          Table 3.--Aggregate Risk Assessment for Acute Exposure to Indoxacarb
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface Water EEC       Ground Water EEC
        Population Subgroup               aPAD (mg/kg)            %aPAD (Food)               (ppb)                  (ppb)            Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                      0.12                    7                       13.86                  0.02                   3,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13 +                         0.12                    41                      13.86                  0.02                   350
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants less than 1 year         0.12                    6                       13.86                  0.02                   1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1 to 6                      0.12                    12                      13.86                  0.02                   1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 33% of the cPAD for the U.S. 
population, 48% of the cPAD for infants less than 1 year old and 85% of 
the cPAD for children 1 to 6 years old, the subpopulation at greatest 
exposure. There are no residential uses for indoxacarb that result in 
chronic residential exposure to indoxacarb. Based on the use pattern, 
chronic residential exposure to residues of indoxacarb is not expected. 
In addition, there is potential for chronic dietary exposure to 
indoxacarb in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface water and ground water, EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD, as shown in 
the following Table 4:

                                   Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Indoxacarb
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface Water EEC       Ground Water EEC
        Population Subgroup              cPAD mg/kg/day           %cPAD (Food)               (ppb)                  (ppb)           Chronic DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                      0.02                    33                      3.65                   0.02                   470
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants less than 1 year old     0.02                    48                      3.65                   0.02                   100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1 to 6                      0.02                    85                      3.65                   0.02                   30
--------------------------------------------------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Indoxacarb is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Indoxacarb is 
not

[[Page 47308]]

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 
the 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 a carcinogenic risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to indoxacarb residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (HPLC/UV Method AMR 2712-93) is 
available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

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

V. Conclusion

    Therefore, tolerances are established for combined residues of 
indoxacarb [(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl] amino]carbonyl]indeno[1,2-
e][1,3,4]oxadiazine-4a(3H)-carboxylate] 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 alfalfa, forage at 10 
ppm, alfalfa, hay at 50 ppm, peanut at 0.01 ppm, peanut, hay at 40 ppm, 
potato at 0.01 ppm, soybean, seed at 0.80 ppm, aspirated grain 
fractions at 45 ppm, soybean, hulls at 4.0 ppm. Additionally, the 
petition requested an increase in tolerance levels for head lettuce, 
milk, milk fat, meat, fat, and meat by-products of cattle, goat, hog, 
horse, and sheep based on a proposed increase in the labeled use rate 
for head lettuce and on potential changes in residue levels in 
livestock diets. The proposed increases are for head lettuce at 5.0 
ppm, meat of cattle, goat, hog, horse, and sheep at 0.05 ppm, fat of 
cattle, goat, hog, horse, and sheep at 1.5 ppm, meat by-products of 
cattle, goat, hog, horse, and sheep at 0.03 ppm, milk at 0.15 ppm, and 
milk, fat at 4.0 ppm.

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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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 FFDCA sections 408 and 409. 
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-2002-0105 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 September 
16, 2002.
    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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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) 260-4865.
    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.
    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.
    3. Copies for the docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket ID number OPP-2002-0105 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. 
In person or by courier, bring a copy to the location of

[[Page 47309]]

the PIRIB described in Unit I.B.2. 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. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: July 3, 2002.
Debra Edwards,
Acting 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 is revised to read as 
follows:

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

    2. Section 180.564 is amended by revising the table in paragraph 
(a) to read as follows:


Sec. 180.564  Indoxacarb, tolerances for residues.

    (a) *   *   *

[[Page 47310]]



------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Apple..........................................                      1.0
Apple, wet pomace..............................                      3.0
Brassica, head and stem, subgroup..............                      5.0
Alfalfa, forage................................                       10
Alfalfa, hay...................................                       50
Cattle, fat....................................                      1.5
Cattle, meat...................................                     0.05
Cattle, meat byproducts........................                     0.03
Corn, sweet, forage............................                       10
Corn, sweet, kernel plus cob with husk removed.                     0.02
Corn, sweet, stover............................                       15
Cotton gin byproducts..........................                       15
Cotton, undelinted seed........................                      2.0
Goat, fat......................................                      1.5
Goat, meat.....................................                     0.05
Goat, meat byproducts..........................                     0.03
Hog, fat.......................................                      1.5
Hog, meat......................................                     0.05
Hog, meat byproducts...........................                     0.03
Horse, fat.....................................                      1.5
Horse, meat....................................                     0.05
Horse, meat byproducts.........................                     0.03
Lettuce, head..................................                      5.0
Lettuce, leaf..................................                       10
Milk...........................................                     0.15
Milk, fat......................................                      4.0
Pear...........................................                     0.20
Peanut.........................................                     0.01
Peanut, hay....................................                       40
Potato.........................................                     0.01
Sheep, fat.....................................                      1.5
Sheep, meat....................................                     0.05
Sheep, meat byproducts.........................                     0.03
Soybean, aspirated grain fractions.............                       45
Soybean, hulls.................................                      4.0
Soybean, seed..................................                     0.80
Vegetable, fruiting, group.....................                     0.50
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-18173 Filed 7-17-02; 8:45 am]
BILLING CODE 6560-50-S