[Federal Register Volume 65, Number 190 (Friday, September 29, 2000)]
[Rules and Regulations]
[Pages 58415-58424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25052]



[[Page 58415]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301064; FRL-6747-8]
RIN 2070-AB78]


Indoxacarb; Pesticide Tolerance

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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

SUMMARY:  This regulation establishes permanent tolerances for the 
combined residues of Indoxacarb, [(S)-methyl 7-chloro-2,5-dihydro-2-
[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] 
amino]carbonyl]indeno[1,2-e][1,3,4] oxadiazine-4a(3H)- carboxylate] and 
its R-enantiomer [(R)-methyl 7-chloro-2,5-dihydro-2-
[[(methoxycarbonyl)[4-(trifluoromethoxy) phenyl]amino] carbonyl]indeno 
[1,2-e][1,3,4] oxadiazine-4a(3H)- carboxylate] in a 75:25 mixture (DPX-
MP062), respectively, in or on the raw agricultural commodities as 
follows: apples, pears, Brassica (head and stem subgroup), cotton, leaf 
lettuce, head lettuce, fruiting vegetable group, sweet corn, milk, and 
the meat, meat byproducts and fat of cattle, goats, horses, hogs and 
sheep. E. I. du Pont de Nemours and Company requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996.

DATES:  This regulation is effective September 29, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301064, 
must be received by EPA on or before November 28, 2000.

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 control number OPP-301064 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT  By mail: Jane Smith, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: 703 305-7378; 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            Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  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/. 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 control number OPP-301064. 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 April 16, 1998 (63 FR 18912-18919) (FRL-
5782-8), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the 
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
announcing the filing of a pesticide petition (PP) 8F4948, for 
tolerance by E. I. du Pont de Nemours and Company, P.O. Box 80038, 
Wilmington, DE 19880-0038. This notice included a summary of the 
petition prepared by DuPont, the registrant. There were three comments 
in response to the Notice of Filing from members of the cotton 
industry. They expressed concern for the use of terminology associated 
with cotton in the Notice of Filing. These cotton terminology comments 
were forwarded within the Agency to the evaluators of the cotton 
portion of the submission which ultimately did not impact the 
interpretation of the submission.
    The petition (8F4948) requested that 40 CFR 180.564 be amended by 
establishing permanent tolerances for residues of the insecticide DPX-
MP062 (75:25 enantiomeric mixture of indoxacarb and its R-enantiomer), 
[R,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] in/on the raw agricultural commodities 
as follows: pome fruit at 2.0 parts per million (ppm), apple pomace at 
6.0 ppm, Brassicas, head and stem at 10.0 ppm, cottonseed at 3.0 ppm, 
cotton gin trash at 15.0 ppm, leaf lettuce at 20.0 ppm, head lettuce at 
7.0 ppm, fruiting vegetables at 0.70 ppm, sweet corn kernel at 0.02 
ppm, sweet corn forage at 20.0 ppm, and sweet corn stover at 25.0 ppm, 
meat 0.02 ppm, milk at 0.10 ppm, cattle kidney at 0.05 ppm; and by 
establishing a tolerance for residues of the insecticide DPX-MP062, 
(R,S)-

[[Page 58416]]

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 metabolite (IN-JT333), 
methyl 7-chloro-2,5-dihydro-2-[[[4-(trifluoromethoxy)phenyl] 
amino]carbonyl]indeno[1,2-e][1,3,4]oxadi azine- 4a(3H)-carboxylate, in/
on milk fat at 0.75 ppm and cattle fat at 0.75 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 the combined residues of indoxacarb and 
its R-enantiomer in/on the following: apple at 1.0 ppm; apple, wet 
pomace at 3.0 ppm; Brassica, head and stem, subgroup at 5.0 ppm; 
cattle, goat, horse, sheep and hog fat at 0.75 ppm; cattle, goat, 
horse, sheep and hog meat at 0.03 ppm; cattle, goat, horse, sheep and 
hog meat byproducts at 0.02 ppm; corn, sweet, forage at 10 ppm; corn, 
sweet, kernel plus cob with husk removed at 0.02 ppm; corn, sweet, 
stover at 15 ppm; cotton gin byproducts at 15 ppm; cotton, undelinted 
seed at 2.0 ppm; lettuce, head at 4.0 ppm; lettuce, leaf at 10 ppm; 
milk at 0.10 ppm; milk fat at 3.0 ppm; pear at 0.20 ppm; vegetables, 
fruiting, group at 0.50 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by indoxacarb and its 
R-enantiomer 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. DPX-MP062 is a 
75:25 mixture of the two enantiomers: indoxacarb which is 
insecticidally active, and its R-enantiomer, which is insecticidally 
inactive. DPX-JW062 is a mixture of these same two enantiomers; 
however, they are in a 50:50 ratio. Toxicology data submitted on DPX-
JW062 were considered relevant and included in the evaluation.
    The technical DPX-MP062 (75:25) is toxicity category I for acute 
oral (rat); IV for acute dermal (rat), inhalation (rats) and primary 
dermal irritation (rabbit); and III for primary eye irritation 
(rabbit). The technical is considered a dermal sensitizer (guinea pig).

           Table 1. -- Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                         90-Day oral         DPX--MP062 (75%
                                  toxicity rodents    indoxacarb / 25%
                                  -- rats             enantiomer) NOAEL
                                                      = Male (M) 3.1 mg/
                                                      kg/day, Female (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.
------------------------------------------------------------------------
870.3100                         90-Day oral         DPX--JW062 (50%
                                  toxicity rodents--  indoxacarb / 50%
                                  rats                enantiomer) /
                                                      NOAEL = M 8.0, F
                                                      4.6 mg/kg/day
                                                      LOAEL = M 16, F
                                                      9.5 mg/kg/day
                                                      based on mortality
                                                      (F only),
                                                      decreased. body
                                                      weight, body
                                                      weight gain, food
                                                      consumption and
                                                      food efficiency in
                                                      rats.
------------------------------------------------------------------------
870.3100                         90-Day oral         DPX--JW062 / NOAEL
                                  toxicity rodents--  = M 3.7, F 4.9 mg/
                                   rats               kg/day LOAEL = M
                                                      7.5, F 12 mg/kg/
                                                      day based on
                                                      decreased in
                                                      absolute body
                                                      weight, body
                                                      weight gain and
                                                      food efficiency in
                                                      rats.
------------------------------------------------------------------------
870.3100                         90-Day oral         DPX--JW062 / NOAEL
                                  toxicity rodents--  = M23, F 16 mg/kg/
                                   mice               day LOAEL = M 44,
                                                      F 30 mg/kg/day
                                                      based on mortality
                                                      (M only);
                                                      increased
                                                      reticulocytes and
                                                      Heinz bodies and
                                                      decreased body
                                                      weight, weight
                                                      gain, food
                                                      consumption, food
                                                      efficiency; and
                                                      increased clinical
                                                      signs (leaning to
                                                      one side and/or
                                                      with abnormal gait
                                                      or mobility) (F
                                                      only) in mice.
------------------------------------------------------------------------
870.3150                         90-Day oral         DPX--JW062 / NOAEL
                                  toxicity in         = 5.0 mg/kg/day
                                  nonrodents--dogs    LOAEL = 19 mg/kg/
                                                      day based on
                                                      hemolytic anemia,
                                                      as indicated by
                                                      decreased 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);
                                                      increased in
                                                      splenic EMH; and
                                                      RBC hyperplasia in
                                                      bone marrow in
                                                      dogs.
------------------------------------------------------------------------

[[Page 58417]]

 
870.3200                         28-Day dermal       DPX--MP062 / NOAEL
                                  toxicity -- rats    = 2,000 mg/kg/day
                                                      LOAEL = >2,000 mg/
                                                      kg/day in rats.
------------------------------------------------------------------------
870.3200                         28-Day dermal       DPX--MP062 / NOAEL
                                  toxicity -- rats    = 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.
------------------------------------------------------------------------
870.3700a                        Prenatal            DPX--MP062 /
                                  developmental in    Maternal NOAEL =
                                  rodents--rats       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.
------------------------------------------------------------------------
870.3700a                        Prenatal            DPX--JW062 /
                                  developmental in    Maternal NOAEL =
                                  rodents--rats       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.
------------------------------------------------------------------------
870.3700a                        Prenatal            DPX--JW062 /
                                  developmental in    Maternal NOAEL =
                                  rodents--rats       1.1 mg/kg/day
                                                      LOAEL = 2.2 mg/kg/
                                                      day based on
                                                      decreased mean
                                                      body weights, body
                                                      weight gains, food
                                                      consumption, and
                                                      food efficiency.
                                                      Developmental
                                                      NOAEL = 1.1 mg/kg/
                                                      day LOAEL = 2.2 mg/
                                                      kg/day based on
                                                      decreased fetal
                                                      body weights.
------------------------------------------------------------------------
870.3700b                        Prenatal            DPX--JW062 /
                                  developmental in    Maternal NOAEL =
                                  nonrodents--rabbi   500 mg/kg/day
                                  ts                  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
                                                      decr. fetal body
                                                      weights and
                                                      reduced
                                                      ossification of
                                                      the sternebrae.
------------------------------------------------------------------------
870.3800                         Reproduction and    DPX--JW062 /
                                  fertility           Parental/Systemic
                                  effects--rats       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
                                                      decreased in the
                                                      body weights of
                                                      the F1 pups during
                                                      lactation.
------------------------------------------------------------------------
870.4100a                        Chronic toxicity    DPX--JW062 / NOAEL
                                  rodents--rats       = 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
------------------------------------------------------------------------
870.4100b                        Chronic toxicity--  DPX--JW062 / NOAEL
                                  dogs                = M 2.3, F 2.4 mg/
                                                      kg/day LOAEL = M
                                                      18, F 19 mg/kg/day
                                                      based on
                                                      decreased. HCT,
                                                      HGB and RBC;
                                                      increased Heinz
                                                      bodies and
                                                      reticulocytes and
                                                      associated
                                                      secondary
                                                      microscopic
                                                      changes in the
                                                      liver, kidneys,
                                                      spleen, and bone
                                                      marrow; increased
                                                      absolute and
                                                      relative liver
                                                      weights.
------------------------------------------------------------------------
870.4200                         Carcinogenicity--r  DPX--JW062 / see
                                  ats                 870.4100a no
                                                      evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.4300                         Carcinogenicity--m  DPX--JW062 / NOAEL
                                  ice                 = M 2.6, F4.0 mg/
                                                      kg/day, LOAEL = M
                                                      14, F 20 mg/kg/day
                                                      based on decreased
                                                      body weight, body
                                                      weight gain, and
                                                      food efficiency
                                                      and clinical signs
                                                      indicative of
                                                      neurotoxicity. no
                                                      evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.5100                         Gene mutation       DPX--MP062 /
                                                      strains TA97a,
                                                      TA98, TA100 and
                                                      TA1535 of S.
                                                      typhimurium and
                                                      strain WP2(uvrA)
                                                      of E. coli were
                                                      negative for
                                                      mutagenic activity
                                                      both with and
                                                      without S9
                                                      activation for the
                                                      concentration
                                                      range 10-5000
                                                      g/plate
------------------------------------------------------------------------
870.5100                         Gene mutation       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 10-5000
                                                      g/plate.
------------------------------------------------------------------------

[[Page 58418]]

 
870.5300                         Gene mutation       DPX--MP062 /
                                                      negative for
                                                      mutagenic activity
                                                      for the following
                                                      concentration
                                                      ranges: 3.1-250
                                                      g/mL (-
                                                      S9); 3.1-250
                                                      g/mL
                                                      (+S9)
------------------------------------------------------------------------
870.5300                         Gene mutation       DPX--JW062 /
                                                      negative for
                                                      mutagenic activity
                                                      for the following
                                                      concentration
                                                      ranges:
                                                      Negative;100-1,000
                                                      g/mL (-
                                                      S9); 100-1,000
                                                      g/mL
                                                      (+S9), precipitate
                                                      1,000
                                                      g/mL
------------------------------------------------------------------------
870.5375                         Cytogenetics        DPX--MP062 / no
                                                      evidence of
                                                      chromosomal
                                                      aberrations
                                                      induced by the
                                                      test article over
                                                      background for the
                                                      following
                                                      concentration
                                                      ranges: 15.7-1,000
                                                      g/mL
                                                      (+S9)
------------------------------------------------------------------------
870.5375                         Cytogenetics        DPX--JW062 / no
                                                      evidence of
                                                      chromosomal
                                                      aberrations
                                                      induced by the
                                                      test article over
                                                      background for the
                                                      following
                                                      concentration
                                                      ranges: 19-300
                                                      g/mL (-
                                                      S9), 19-150 g/mL (+S9);
                                                      partial insoluble
                                                      and cytotoxicity
                                                      150
                                                      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
------------------------------------------------------------------------
870.5395                         Cytogenetics        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
                                                      g/mL;
                                                      cytotoxicity was
                                                      seen at
                                                      concentrations of
                                                      100
                                                      g/mL
------------------------------------------------------------------------
870.5550                         Other effects       DPX--JW062 / No
                                                      evidence of
                                                      mutagenic activity
                                                      at the following
                                                      concentration
                                                      range: 0.1-50
                                                      g/mL,
                                                      cytotoxicity
                                                      observed at 50 g/mL
------------------------------------------------------------------------
870.6200a                        Acute               DPX--MP062 / NOAEL
                                  neurotoxicity       = M 100, F 12.5 mg/
                                  screening battery   kg LOAEL = M 200
                                  -- rat              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
------------------------------------------------------------------------
870.6200a                        Acute               DPX--JW062 / NOAEL
                                  neurotoxicity       >= M 2,000 mg/kg,
                                  screening battery   F < 500 mg/kg
                                  --rats              LOAEL > M 2,000 mg/
                                                      kg, F < 500 mg/kg
                                                      based on clinical
                                                      signs, decreased
                                                      body weight gains
                                                      and food
                                                      consumption, and
                                                      FOB effects
------------------------------------------------------------------------
870.6200b                        Subchronic          DPX--MP062 / NOAEL
                                  neurotoxicity       = M 0.57, F 0.68
                                  screening battery   mg/kg/day LOAEL =
                                  -- rats             M 5.6, F 3.3 mg/kg/
                                                      day based on
                                                      decreased body
                                                      weight and
                                                      alopecia.
------------------------------------------------------------------------
870.7485                         Metabolism and      Both DPX--MP062 and
                                  pharmacokinetic --  DPX--JW062 were
                                   rats               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.
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for 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 
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

[[Page 58419]]

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 and its R-enantiomer used for human risk 
assessment is shown in the following Table 2:

  Table 2. -- Summary of Toxicological Dose and Endpoints for Indoxacarb and its R-enantiomer for Use in Human
                                                 Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk        FQPA Safety Factor
          Exposure Scenario            Assessment, Uncertainty   (SF)* and Endpoint for  Study and Toxicological
                                             Factor (UF)            Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of   NOAEL = 2.0 mg/kg/day    FQPA SF = 1 aPAD =       Developmental rat
 age                                    UF = 100 Acute RfD =     acute RfD        toxicity study.
                                        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 UF =   FQPA SF = 1 aPAD =       Acute oral rat
 including infants and children         100 Acute RfD = 0.12     acute RfD        neurotoxicity study.
                                        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 UF  FQPA SF = 1 cPAD = chr   90-Day rat subchronic
                                        = 100 Chronic RfD =      RfD  FQPA SF =   toxicity study, 90-day
                                        0.02 mg/kg/day           0.02 mg/kg/day           rat 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 NOAEL/
                                                                                          LOAEL of the 3
                                                                                          studies.
----------------------------------------------------------------------------------------------------------------
Short-term oral (1-7 days)             Oral study NOAEL= 2.0    LOC for MOE = 100        Developmental rat
 (Residential)                          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 (1 week -     Oral study NOAEL= 2.0    LOC for MOE = 100        90-day rat subchronic
 several months) (Residential)          mg/kg/day                (Residential, includes   toxicity study. LOAEL
                                                                 the FQPA SF)             = 3.8 mg/kg/day based
                                                                                          on decreased body
                                                                                          weight, body weight
                                                                                          gain, food consumption
                                                                                          and food efficiency.
----------------------------------------------------------------------------------------------------------------
 Short- (1-7 days), intermediate- (1   Dermal study NOAEL= 50   LOC for MOE = 100        28-day rat dermal
 week--several months), and long-       mg/kg/day                (Occupational) LOC for   toxicity study. LOAEL
 (several months--lifetime) term                                 MOE = 100                = 500 mg/kg/day based
 dermal (Occupational/ Residential)                              (Residential, includes   on decreased body
                                                                 the FQPA SF)             weights, body weight
                                                                                          gains, food
                                                                                          consumption, and food
                                                                                          efficiency in females,
                                                                                          and changes in
                                                                                          hematology parameters
                                                                                          (increased
                                                                                          reticulocytes), the
                                                                                          spleen (increased
                                                                                          absolute and relative
                                                                                          weight males only,
                                                                                          gross discoloration),
                                                                                          and clinical signs of
                                                                                          toxicity in both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------
 Short-term inhalation (1-7 days)      Oral study NOAEL= 2.0    LOC for MOE = 100        Rat developmental
 (Occupational/ Residential)            mg/kg/day (inhalation    (Occupational) LOC for   toxicity study.
                                        absorption rate =        MOE = 100                maternal LOAEL = 4.0
                                        100%)                    (Residential, includes   mg/kg/day based on
                                                                 the FQPA SF)             decreased mean
                                                                                          maternal body weights,
                                                                                          body weight gains, and
                                                                                          food consumption.
----------------------------------------------------------------------------------------------------------------
Intermediate- term inhalation (1       Oral study NOAEL= 2.0    LOC for MOE = 100        90-day rat subchronic
 week--several months) (Occupational/   mg/kg/day (inhalation    (Occupational) LOC for   toxicity study. LOAEL
 Residential)                           absorption rate =        MOE = 100                = 3.8 mg/kg/day based
                                        100%)                    (Residential, includes   on decreased body
                                                                 the FQPA SF)             weight, body weight
                                                                                          gain, food consumption
                                                                                          and food efficiency.
----------------------------------------------------------------------------------------------------------------

[[Page 58420]]

 
 Long-term inhalation (several         Oral study NOAEL= 2.0    LOC for MOE = 100        90-day rat subchronic
 months--lifetime) (Occupational/       mg/kg/day (inhalation    (Occupational) LOC for   toxicity study, 90-day
 Residential)                           absorption rate =100%)   MOE = 100                rat neurotoxicity
                                                                 (Residential, includes   study, chronic/
                                                                 the FQPA SF)             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 or residues of 
indoxacarb and its R-enantiomer, in or on a variety of raw agricultural 
commodities including apples, pears, Brassica (head and stem subgroup), 
cotton, leaf lettuce, head lettuce, fruiting vegetable group, sweet 
corn, milk, and the meat, meat byproducts and fat of cattle, goats, 
horses, hogs and sheep. Risk assessments were conducted by EPA to 
assess dietary exposures from indoxacarb and its R-enantiomer 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 one day 
or single exposure. The Dietary Exposure Evaluation Model (DEEM) 
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: acute Tier 1 analysis assuming tolerance level 
residues and 100% crop treated (CT) information was performed; however, 
dietary risk estimates from residues in food exceeded Agency's level of 
concern (> 100% aPAD). 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 100% 
CT. Note that the Tier 2 assessment is deterministic in that point 
estimates were used for all residues and the conservative assumption of 
100% CT was made. Additional refinement using % CT data would result in 
even lower exposure estimates from residues in food.
     ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the DEEM analysis evaluated the individual food consumption 
as reported by respondents in the USDA 1989-1992 nationwide CSFII and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the chronic exposure assessments: tolerance 
level residues and 100% CT (Tier 1). Additional refinement using less 
than 100% CT data would result in even lower exposure estimates from 
residues in food.
     iii. 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 and its R-
enantiomer in drinking water. Because the Agency does not have 
comprehensive monitoring data, drinking water concentration estimates 
are made by reliance on simulation or modeling taking into account data 
on the physical characteristics of indoxacarb and its R-enantiomer.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
the Screening Concentration in Ground Water Model (SCI-GROW), which 
predicts pesticide concentrations in ground water. In general, EPA will 
use GENEEC (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model) 
for a screening-level assessment for surface water. The GENEEC model is 
a subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated

[[Page 58421]]

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 and its R-
enantiomer they are further discussed in the aggregate risk sections 
below.
    Based on the PRZM/EXAMS and SCI-GROW models the estimated 
environmental concentrations (EECs) of indoxacarb and its R-enantiomer 
for acute exposures are estimated to be 3.81 parts per billion (ppb) 
for surface water and 0.02 ppb for ground water. The EECs for chronic 
exposures are estimated to be 0.56 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 and its R-
enantiomer 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 and its R-enantiomer 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 and its R-enantiomer 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 and 
its R-enantiomer 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. Safety factor for infants and children--i. 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.
    ii. Prenatal and postnatal sensitivity. There is no evidence of 
susceptibility from either in utero or neonatal exposure to both rat 
and rabbit young with either DPX--MP062 or DPX--JW062.
    iii. Conclusion. There is a complete toxicity data base for 
indoxacarb and its R-enantiomer and exposure data are complete or are 
estimated based on data that reasonably accounts for potential 
exposures. The FQPA safety factor is 1X. EPA determined that the 10X 
safety factor to protect infants and children should be removed 
because, there is no indication of quantitative or qualitative 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure; the requirement of a developmental neurotoxicity 
study is not based on the criteria reflecting special concern for the 
developing fetuses or young which are generally used for requiring a 
DNT study--and a safety factor (e.g.: neuropathy in adult animals; CNS 
malformations following prenatal exposure; brain weight or sexual 
maturation changes in offspring; and/or functional changes in 
offspring)--and therefore does not warrant an FQPA SF; the dietary 
(food and drinking water) exposure assessments will not under estimate 
the potential exposures for infants and children; and there are no 
registered residential uses at the current time.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are 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 U S EPA 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, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP 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, OPP 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 only to 
indoxacarb and its R-enantiomer will occupy < or = 10% of the aPAD for 
the U.S. population, 33% of the aPAD for females 13 years and older, 6% 
of the aPAD for infants < 1 year and 10% of the aPAD for children 1-6 
years old. In addition, there is potential for acute dietary exposure 
to indoxacarb and its R-enantiomer in drinking water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect the aggregate exposure to exceed 100% of the aPAD as 
shown in the following Table 3:

[[Page 58422]]



          Table 3. -- Aggregate Risk Assessment for Acute Exposure to Indoxacarb and its R-enantiomer.
----------------------------------------------------------------------------------------------------------------
                                                                              Surface      Ground
         Scenario / Population Subgroup          aPAD (mg/kg/    % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     day)                     (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
 Females 13-50 years old                                0.02           33         3.81         0.02        3,400
----------------------------------------------------------------------------------------------------------------
 General U.S. Population                                0.12            6         3.81         0.02        4,000
----------------------------------------------------------------------------------------------------------------
 All Infants < 1 year old                               0.12            6         3.81         0.02        1,100
----------------------------------------------------------------------------------------------------------------
 Children 1-6 years old                                 0.12           10         3.81         0.02        1,100
----------------------------------------------------------------------------------------------------------------
 Children 7-12 years old                                0.12            7         3.81         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 and its R-enantiomer from food will utilize 28% of the cPAD 
for the U.S. population, 37% of the cPAD for infants <1 year old, and 
73% of the cPAD for children 1-6 years old. There are no residential 
uses for indoxacarb and its R-enantiomer that result in chronic 
residential exposure to indoxacarb and its R-enantiomer. In addition, 
there is potential for chronic dietary exposure to indoxacarb and its 
R-enantiomer in drinking water. After calculating the DWLOCs and 
comparing them to the EECs for surface and ground water, EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD, as shown in 
the following Table 4:

   Table 4. -- Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Indoxacarb and its R-enantiomer
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.12           28         0.56         0.02          500
----------------------------------------------------------------------------------------------------------------
All Infants <1 year old                                 0.12           37         0.56         0.02          130
----------------------------------------------------------------------------------------------------------------
 Children 1-6 years old                                 0.12           73         0.56         0.02           53
----------------------------------------------------------------------------------------------------------------
Children 7-12 years old                                 0.12           40         0.56         0.02          120
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old                                 0.12           22         0.56         0.02          540
----------------------------------------------------------------------------------------------------------------

    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 and its r- 
enantiomer 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 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 
and its R-enantiomer is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
     5. 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 and its R-enantiomer residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example: gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: 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

    No other international residue limits have been established at this 
time.

C. Conditions

    The following toxicology studies are required as confirmatory: a 
developmental neurotoxicity study in the rat (Guideline #870.6300) and 
a 90-day inhalation toxicity study in the rat (Guideline #870.3465).

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
indoxacarb [(S)-methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl] amino]carbonyl] indeno[1,2-
e][1,3,4]oxadiazine-4a(3H)-carboxylate] and its R-enantiomer [(R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl] amino]carbonyl] indeno[1,2-
e][1,3,4]oxadiazine- 4a(3H)-carboxylate] in or on the following raw 
agricultural commodities: at 1.0 ppm; apple, wet pomace at 3.0 ppm; 
Brassica, head and stem, subgroup at 5.0 ppm; cattle, goat, horse, 
sheep and hog fat at 0.75 ppm; cattle, goat, horse, sheep and hog meat 
at 0.03 ppm; cattle, goat, horse, sheep and hog meat byproducts at 0.02 
ppm; corn, sweet, forage at 10 ppm; corn, sweet, kernel plus cob with 
husk removed at 0.02 ppm; corn, sweet, stover at 15 ppm; cotton gin 
byproducts at 15 ppm; cotton, undelinted seed at 2.0 ppm; lettuce, head 
at 4.0 ppm;

[[Page 58423]]

lettuce, leaf at 10 ppm; milk at 0.10 ppm; milk fat at 3.0 ppm; pear at 
0.20 ppm; and vegetables, fruiting, group at 0.50 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 control number OPP-301064 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 November 
28, 2000.
    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 control number OPP-301064, 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 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 file format 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). 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 prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require 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

[[Page 58424]]

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).

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: September 21, 2000.
Susan B. Hazen,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


    2. Section 180.564 is added to read as follows:


Sec. 180.564  Indoxacarb; tolerances for residues.

    (a) General. Tolerances are established for the 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 
the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Apple......................................................          1.0
Apple, wet pomace..........................................          3.0
Brassica, head and stem, subgroup..........................          5.0
Cattle, goat, horse, sheep and hog fat.....................         0.75
Cattle, goat, horse, sheep and hog meat....................         0.03
Cattle, goat, horse, sheep and hog meat byproducts.........         0.02
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
Lettuce, head..............................................          4.0
Lettuce, leaf..............................................           10
Milk.......................................................         0.10
Milk fat...................................................          3.0
Pear.......................................................         0.20
Vegetables, fruiting, group................................         0.50
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 00-25052 Filed 9-28-00; 8:45 am]
BILLING CODE 6560-50-S