[Federal Register Volume 68, Number 73 (Wednesday, April 16, 2003)]
[Proposed Rules]
[Pages 18582-18592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9340]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0125; FRL-7302-3]


Indoxacarb; Proposed Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to establish a temporary tolerance for 
combined residues of Indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2-
[[(methoxy carbonyl) [4-(trifluor omethoxy)phenyl]amino]carbonyl] 
indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate + its R-enantiomer 
[(R)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoro 
methoxy)phenyl]amino]carbonyl]indeno [1,2-e][1,3,4]oxadiazine-4a(3H)-
carboxylate in or on peaches under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA). This action is in response to university extension specialists, 
DuPont Crop Protection, and EPA's combined efforts to generate the 
information necessary for use of the reduced risk pesticide, 
Indoxacarb, on peaches for control of oriental fruit moth and plum 
cuculio. This proposed temporary tolerance supports a non-crop destruct 
experimental use permit (EUP) under section 5 of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of 
Indoxacarb on peaches in Georgia, Michigan, New Jersey, Pennsylvania, 
South Carolina, and West Virginia. This regulation proposes to 
establish a maximum permissible level for residues of Indoxacarb in 
this food commodity pursuant to section 408(e) of FFDCA, as amended by 
FQPA.

DATES: Comments, identified by docket ID number OPP-2003-0125, must be 
received on or before May 1, 2003.

ADDRESSES:  Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Rita Kumar, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8291; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS Code 111)
    [sbull] Animal production (NAICS Code 112)
    [sbull] Food manufacturing (NAICS Code 311)
    [sbull] Pesticide manufacturing (NAICS Code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0125. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not

[[Page 18583]]

included in the official public docket, will not be available for 
public viewing in EPA's electronic public docket. EPA's policy is that 
copyrighted material will not be placed in EPA's electronic public 
docket but will be available only in printed, paper form in the 
official public docket. To the extent feasible, publicly available 
docket materials will be made available in EPA's electronic public 
docket. When a document is selected from the index list in EPA Dockets, 
the system will identify whether the document is available for viewing 
in EPA's electronic public docket. Although not all docket materials 
may be available electronically, you may still access any of the 
publicly available docket materials through the docket facility 
identified in Unit I.B. EPA intends to work towards providing 
electronic access to all of the publicly available docket materials 
through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the Docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and To Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e- mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2003-0125. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2003-0125. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0125.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA., Attention: 
Docket ID Number OPP-2003-0125. Such deliveries are only accepted 
during the docket's normal hours of operation as identified in Unit 
I.B.1.

D. How Should I Submit CBI To the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.

[[Page 18584]]

    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the proposed rule or 
collection activity.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. Background and Statutory Findings

    EPA, in cooperation with DuPont Crop Protection and university 
extension specialists, under section 408(e) of the FFDCA, 21 U.S.C. 
346a, is proposing to establish a tolerance for combined residues of 
the insecticide Indoxacarb, in or on peaches at 10.0 parts per million 
(ppm). This action is in response to university extension specialists, 
DuPont, and EPA's combined efforts to generate the information 
necessary for registration of the reduced risk pesticide, Indoxacarb, 
on peaches for control of oriental fruit moth and plum cuculio. This 
proposed temporary tolerance supports a non-crop destruct experimental 
use permit (EUP) under section 5 of FIFRA authorizing use of Indoxacarb 
on peaches in Georgia, Michigan, New Jersey, Pennsylvania, South 
Carolina, and West Virginia. Section 5 of FIFRA authorizes EPA to issue 
an experimental use permit for a pesticide. This provision was not 
amended by FQPA. EPA has established regulations governing such 
experimental use permits in 40 CFR part 172. Section 408(r) of FFDCA 
authorizes EPA to issue temporary tolerances for pesticide residues 
from FIFRA experimental use permits.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue * * 
*''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for a tolerance for combined residues of 
Indoxacarb on peaches at 10.0 ppm. EPA's assessment of exposures and 
risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by Indoxacarb are 
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies reviewed.

                               Table 1.-- Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        DPX-MP062
                                          rodents                    NOAEL = M 3.1 mg/kg/day
                                                                     F 2.1 mg/kg/day
                                                                     LOAEL = M 6.0 mg/kg/day, F 3.8 mg/kg/day
                                                                      based on decreased body weight, body
                                                                      weight gain, food consumption and food
                                                                      efficiency.
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     DPX-JW062
                                          nonrodents                 NOAEL = 5.0 mg/kg/day
                                                                     LOAEL = 19 mg/kg/day based on hemolytic
                                                                      anemia, as indicated by decrease in HGB,
                                                                      RBCs; increases in platelets, increased
                                                                      reticulocytes; and secondary
                                                                      histopathologic findings indicative of
                                                                      blood breakdown (pigment in Kupffer cells,
                                                                      renal tubular epithelium, and spleen and
                                                                      bone marrow macrophages); increase in
                                                                      splenic EMH; and RBC hyperplasia in bone
                                                                      marrow in dogs.
----------------------------------------------------------------------------------------------------------------
870.3200                                 21/28-Day dermal toxicity   DPX-MP062
                                                                     NOAEL = 2,000 mg/kg/day
                                                                     LOAEL = >2,000 mg/kg/day in rats.
                                                                     DPX-MP062
                                                                     NOAEL = 50 mg/kg/day
                                                                     LOAEL = 500 mg/kg/day based on decreased
                                                                      body weights, body weight gains, food
                                                                      consumption, and food efficiency in F*,
                                                                      and changes in hematology parameters
                                                                      (increased reticulocytes), the spleen
                                                                      (increased absolute and relative weight M*
                                                                      only, gross discoloration), clinical signs
                                                                      of toxicity in both sexes in rats.
----------------------------------------------------------------------------------------------------------------

[[Page 18585]]

 
870.3700                                 Prenatal developmental in   DPX-MP062
                                          rodents                    Maternal NOAEL = 2.0 mg/kg/day
                                                                     LOAEL = 4.0 mg/kg/day based on decreased
                                                                      mean body weights, body weight gains, food
                                                                      consumption.
                                                                     Developmental NOAEL = 2.0 mg/kg/day
                                                                     LOAEL = 4.0 mg/kg/day based on decreased
                                                                      fetal weights.
                                                                     DPX-JW062
                                                                     Maternal NOAEL = 10 mg/kg/day
                                                                     LOAEL = 100 mg/kg/day based on mortality,
                                                                      clinical signs, and decreased mean body
                                                                      weights, body weight gains, and food
                                                                      consumption.
                                                                     Developmental NOAEL = 10 mg/kg/day
                                                                     LOAEL = 100 mg/kg/day based on decreased
                                                                      numbers of live fetuses/litter.
                                                                     DPX-JW062
                                                                     Maternal NOAEL = 1.1 mg/kg/day
                                                                     LOAEL = 2.2 mg/kg/day based on decreased
                                                                      mean body weights, body weight gains, food
                                                                      consumption, and food efficiency.
                                                                     Developmental NOAEL = 1.1 kg/day
                                                                     LOAEL = 2.2 mg/kg/day based on decreased
                                                                      fetal body weights.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   DPX-JW062 - rabbits
                                          nonrodents                 Maternal NOAEL = 500 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on slight
                                                                      decreases in maternal body weight gain and
                                                                      food consumption.
                                                                     Developmental NOAEL = 500 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on decreased
                                                                      fetal body weights and reduced
                                                                      ossification of the sternebrae.
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  DPX-JW062
                                          effects                    Parental/Systemic NOAEL = 1.5 mg/kg/day
                                                                     LOAEL = 4.4 mg/kg/day based on decreased
                                                                      body weights, body weight gains, and food
                                                                      consumption of F0 females, and increased
                                                                      spleen weights in the F0 and F1 females
                                                                     Reproductive NOAEL = 6.4 mg/kg/day
                                                                     LOAEL = 6.4 mg/kg/day
                                                                     Offspring NOAEL = 1.5 mg/kg/day
                                                                     LOAEL = 4.4 mg/kg/day based on decrease in
                                                                      the body weights of the F1 pups during
                                                                      lactation.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity rodents    DPX-JW062
                                                                     NOAEL = M 5, F 2.1 mg/kg/day
                                                                     LOAEL = M 10, F 3.6 mg/kg/day based on
                                                                      decr. body weight, body weight gain, and
                                                                      food consumption and food efficiency;
                                                                      decreased HCT, HGB and RBC at 6 months in
                                                                      F only.
                                                                     no evidence of carcinogenic potential
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity dogs       DPX-JW062
                                                                     NOAEL = M 2.3, F 2.4 mg/kg/day
                                                                     LOAEL = M 18, F 19 mg/kg/day based on decr.
                                                                      HCT, HGB and RBC; increased Heinz bodies
                                                                      and reticulocytes and associated secondary
                                                                      microscopic changes in the liver, kidneys,
                                                                      spleen, and bone marrow; increased
                                                                      absolute and relative liver weights.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity rats        DPX-JW062 see 870.4100. No evidence of
                                                                      carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice        DPX-JW062
                                                                     NOAEL = M 2.6, F4.0 mg/kg/day
                                                                     LOAEL = M 14, F 20 mg/kg/day based on
                                                                      decreased body weight, body weight gain,
                                                                      and food efficiency and clinical signs
                                                                      indicative of neurotoxicity.
                                                                     No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene Mutation               DPX-MP062 strains TA97a, TA98, TA100 and
                                                                      TA1535 of S. typhimurium and strain
                                                                      WP2(uvrA) of E. coli were negative for
                                                                      mutagenic activity both with and without
                                                                      S9 activation for the concentration range
                                                                      10-5,000 [mu]g/plate
                                                                     DPX-JW062 strains TA97a, TA98, TA100 and
                                                                      TA1535 of S. typhimurium and strain
                                                                      WP2(uvrA) of E. coli were negative for
                                                                      mutagenic activity both with and without
                                                                      S9 activation for the concentration range
                                                                      10-5,000 [mu]g/plate.
----------------------------------------------------------------------------------------------------------------

[[Page 18586]]

 
870.5300                                 Gene Mutation               DPX-MP062 negative for mutagenic activity
                                                                      for the following concentration ranges:
                                                                      3.1-250 [mu]g/mL (-S9); 3.1-250 [mu]g/mL
                                                                      (+S9)
                                                                     DPX-JW062
                                                                     negative for mutagenic activity for the
                                                                      following concentration ranges:
                                                                      Negative;100-1,000 [mu]g/mL (-S9); 100-
                                                                      1,000 [mu]g/mL (+S9), precipitate >=1,000
                                                                      [mu]g/mL
----------------------------------------------------------------------------------------------------------------
870.5375                                 Cytogenetics                DPX-MP062
                                                                     no evidence of chromosomal aberrations
                                                                      induced by the test article over
                                                                      background for the following concentration
                                                                      ranges: 15.7-1,000 [mu]g/mL (+/-S9)
                                                                     DPX-JW062
                                                                     no evidence of chromosomal aberrations
                                                                      induced by the test article over
                                                                      background for the following concentration
                                                                      ranges: 19-300 [mu]g/mL (- S9), 19-150
                                                                      [mu]g/mL (+S9); partial insoluble and
                                                                      cytotoxicity >=150 [mu]g/mL
----------------------------------------------------------------------------------------------------------------
870.5395                                 Cytogenetics                DPX-MP062
                                                                     no evidence of mutagenicity for the
                                                                      following dose ranges: 3,000-4,000 mg/kg -
                                                                      males; 1,000-2,000 mg/kg - females
                                                                     DPX-JW062
                                                                     no evidence of mutagenicity at 2,500 or
                                                                      5,000 mg/kg
----------------------------------------------------------------------------------------------------------------
870.5550                                 Other Effects               DPX-MP062
                                                                     no evidence of mutagenic activity at the
                                                                      following concentration range: 1.56-200
                                                                      [mu]g/mL; cytotoxicity was seen at
                                                                      concentrations of >=100 [mu]g/mL
                                                                     DPX-JW062
                                                                     No evidence of mutagenic activity at the
                                                                      following concentration range: 0.1-50
                                                                      [mu]g/mL, cytotoxicity observed at >=50
                                                                      [mu]g/mL
----------------------------------------------------------------------------------------------------------------
870.6200                                 Acute neurotoxicity         DPX-MP062
                                          screening battery          NOAEL = M 100, F 12.5 mg/kg
                                                                     LOAEL = M 200 mg/kg based on decreased body
                                                                      weight gain, decreased food consumption,
                                                                      decreased forelimb grip strength, and
                                                                      decreased foot splay. F 50 mg/kg based on
                                                                      decreased body weight, body weight gain,
                                                                      and food consumption
                                                                     DPX-JW062
                                                                     NOAEL= M > 2,000 mg/kg
                                                                     = F < 500 mg/kg
                                                                     LOAEL > M 2,000 mg/kg
                                                                     F < 500 mg/kg based on clinical signs,
                                                                      decreased body weight gains and food
                                                                      consumption, and FOB effects
----------------------------------------------------------------------------------------------------------------
870.6200                                 Subchronic neurotoxicity    DPX-MP062
                                          screening battery          NOAEL = M 0.57, F 0.68 mg/kg/day
                                                                     LOAEL = M 5.6, F 3.3 mg/kg/day based on
                                                                      decreased body weight and alopecia
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              Both DPX-MP062 and DPX-JW062 were
                                          pharmacokinetics            extensively metabolized and the
                                                                      metabolites were eliminated in urine,
                                                                      feces, and bile. The metabolite profile
                                                                      for DPX-JW062 was dose dependent and
                                                                      varied quantitatively between males and
                                                                      females. Differences in metabolite
                                                                      profiles were also observed for the
                                                                      different label positions (indanone and
                                                                      trifluoromethoxyphenyl rings). All biliary
                                                                      metabolites undergo further
                                                                      biotransformation in the gut. The proposed
                                                                      metabolic pathway for both DPX-MP062 and
                                                                      DPX-JW062 has multiple metabolites bearing
                                                                      one of the two ring structures (see 870-
                                                                      4100 chronic toxicity rodents above).
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor 
(SF).
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently

[[Page 18587]]

used by the Agency to quantify carcinogenic risk. The Q* approach 
assumes that any amount of exposure will lead to some degree of cancer 
risk. A Q* is calculated and used to estimate risk which represents a 
probability of occurrence of additional cancer cases (e.g., risk is 
expressed as 1 x 10-6 or one in a million). Under certain 
specific circumstances, MOE calculations will be used for the 
carcinogenic risk assessment. In this non-linear approach, a ``point of 
departure'' is identified below which carcinogenic effects are not 
expected. The point of departure is typically a NOAEL based on an 
endpoint related to cancer effects though it may be a different value 
derived from the dose response curve. To estimate risk, a ratio of the 
point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for Indoxacarb used for human risk assessment is shown in 
Table 2 of this unit:

     Table 2.-- Summary of Toxicological Dose and Endpoints for Indoxacarb for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (females 13-50 years of  NOAEL = 2.0 mg/kg/day    FQPA SF = 1              Developmental rat
 age)                                  UF = 100...............  aPAD = acute RfD/FQPA     toxicity study.
                                       Acute RfD = 0.02 mg/kg.   SF = 0.02 mg/kg/day.     developmental LOAEL =
                                                                                          4.0 mg/kg/day based on
                                                                                          decreased fetal body
                                                                                          weight.
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population       NOAEL = 12.5 mg/kg       FQPA SF = 1              Acute oral rat
 including infants and children        UF = 100...............  aPAD = acute RfD/FQPA     neurotoxicity study.
                                       Acute RfD = 0.12 mg/kg.   SF = 0.12 mg/kg/day.    LOAEL = 50 mg/kg based
                                                                                          on decreased body
                                                                                          weight and body weight
                                                                                          gain in females.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL = 2.0 mg/kg/day    FQPA SF = 1              90-day rat subchronic
                                       UF = 100...............  cPAD = chronic RfD/FQPA   toxicity study, 90-day
                                       Chronic RfD = 0.02 mg/    SF = 0.02 mg/kg/day.     rat neurotoxicity
                                        kg/day.                                           study, chronic/
                                                                                          carcinogenicity rat
                                                                                          study.
                                                                                         LOAEL = 3.3 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight, alopecia,
                                                                                          body weight gain, food
                                                                                          consumption and food
                                                                                          efficiency; decreased
                                                                                          hematocrit, hemoglobin
                                                                                          and red blood cells
                                                                                          only at 6 months. 3.3
                                                                                          mg/kg/day is the
                                                                                          lowest LOAEL of the
                                                                                          three studies.
----------------------------------------------------------------------------------------------------------------
Short-Term Oral (1-7 days)             oral study 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.
                                                                 the FQPA SF)            LOAEL = 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)           toxicity study.
 (several months - lifetime) Term                               LOC for MOE = 100        LOAEL = 500 mg/kg/day
 Dermal (Occupational/Residential)                               (Residential, includes   based on decreased
                                                                 the FQPA SF).            body weights, body
                                                                                          weight gains, food
                                                                                          consumption, and food
                                                                                          efficiency in females,
                                                                                          and changes in
                                                                                          hematology parameters
                                                                                          (increased
                                                                                          reticulocytes), the
                                                                                          spleen (increased
                                                                                          absolute and relative
                                                                                          weight males only,
                                                                                          gross discoloration),
                                                                                          and clinical signs of
                                                                                          toxicity in both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1-7 days)       oral study NOAEL= 2.0    LOC for MOE = 100        Rat developmental
 (Occupational/Residential)             mg/kg/day (inhalation    (Occupational)           toxicity study.
                                        absorption rate =       LOC for MOE = 100        Maternal LOAEL = 4.0 mg/
                                        100%)                    (Residential, includes   kg/day based on
                                                                 the FQPA SF).            decreased mean
                                                                                          maternal body weights,
                                                                                          body weight gains, and
                                                                                          food consumption.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week - oral study NOAEL= 2.0    LOC for MOE = 100        90-day rat subchronic
  several months) (Occupational/        mg/kg/day (inhalation    (Occupational)           toxicity study.
 Residential)                           absorption rate =       LOC for MOE = 100        LOAEL = 3.8 mg/kg/day
                                        100%)                    (Residential, includes   based on decreased
                                                                 the FQPA SF).            body weight, body
                                                                                          weight gain, food
                                                                                          consumption and food
                                                                                          efficiency.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months - oral study NOAEL= 2.0    LOC for MOE = 100        90-day rat subchronic
  lifetime) (Occupational/              mg/kg/day (inhalation    (Occupational)           toxicity study, 90-day
 Residential)                           absorption rate =100%)  LOC for 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.
----------------------------------------------------------------------------------------------------------------

[[Page 18588]]

 
Cancer (oral, dermal, inhalation)      ``not likely'' to be     N/A                      no evidence of
                                        carcinogenic to humans                            carcinogenicity in
                                                                                          either the rat or
                                                                                          mouse in acceptable
                                                                                          carcinogenicity
                                                                                          studies and no
                                                                                          evidence of
                                                                                          mutagenicity.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.564) for the combined residues of Indoxacarb, 
in or on a variety of raw agricultural commodities. Including 
tolerances already established for: alfalfa, forage at 10 ppm; alfalfa, 
hay at 50 ppm; 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 1.5 ppm; cattle, goat, horse, sheep, and hog meat 
at 0.05 ppm; cattle, goat, horse, sheep , and hog meat byproducts at 
0.03 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, head at 5.0 ppm; lettuce, leaf at 10.0 ppm; milk 
at 0.15 ppm; and milk, fat at 4.0 ppm; peanut at 0.01 ppm; peanut, hay 
at 40 ppm; pear at 0.20 ppm; potato at 0.01 ppm; soybean, seed at 0.8 
ppm; soybean, aspirated grain fractions at 45 ppm; and vegetables, 
fruiting, group at 0.50 ppm. Risk assessments were conducted by EPA to 
assess dietary exposures from Indoxacarb in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. The Dietary Exposure Evaluation Model (DEEM[reg]) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments: An acute Tier 2 (partially refined analysis) 
dietary assessment was performed with use of anticipated residues (ARs) 
from field trial data, processing factors (where applicable), and 
assumed 100% crop treated (CT) for all crops. ARs for meat, milk, 
poultry, and eggs (MMPE) raw agricultural commodities (RACs) were 
calculated also.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM[reg] analysis evaluated the individual food 
consumption as reported by respondents in the USDA1989-1992 nationwide 
CSFII and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the chronic exposure assessments: 
Chronic exposure estimates are expressed in mg/kg bw/day and as a 
percent of the cPAD. The chronic dietary assessment assumed tolerance 
level residues, DEEM[reg] default processing factors, assumed 100% CT 
for all crops other than peaches, and 1% CT for the peach EUP (300 
acres)(Tier 1).
    iii. Cancer. There is no evidence for mutagenicity and there is no 
evidence of carcinogenicity in either the rat or mouse. Indoxacarb has 
been classified as ``not likely to be carcinogenic in humans'' by the 
Agency; therefore, no carcinogenic dietary risk analysis was performed.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E) of the FFDCA, 
EPA will issue a data call-in for information relating to anticipated 
residues to be submitted no later than 5 years from the date of 
issuance of this tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency used PCT information as follows:
    Dietary exposure estimates were based on 1% PCT for peaches. This 
PCT of 1% was based on the fact that the 2-year experimental use permit 
was issued for only 300 acres of peaches to be treated annually, which 
amounts to 0.2% of the total peach acreage in the United States. The 
reason for using 1% instead of 0.2% is to allow for any uncertainties 
in the residue evaluation. Before making this tolerance permanent, 
reevaluation of dietary exposure will be performed using all available 
information. Other commodities were assumed to be 100% treated.
    The Agency believes that the three conditions previously discussed 
have been met. With respect to Condition 1, EPA finds that the PCT 
information described 1% for Indoxacarb used on peaches is reliable and 
has a valid basis. A 2-year EUP has been issued for this use, which 
will allow for use of Indoxacarb on 300 acres of peaches in some 
eastern states. Before the use can be expanded for treatment of greater 
than 300 acres per year, permission from the Agency must be obtained. 
As to Conditions 2 and 3, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk

[[Page 18589]]

assessment process ensures that EPA's exposure estimate does not 
understate exposure for any significant subpopulation group and allows 
the Agency to be reasonably certain that no regional population is 
exposed to residue levels higher than those estimated by the Agency. 
Other than the data available through national food consumption 
surveys, EPA does not have available information on the regional 
consumption of food to which Indoxacarb may be applied in a particular 
area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for Indoxacarb in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of Indoxacarb.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW (screening concentration in ground water), which predicts 
pesticide concentrations in groundwater. 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 percent reference dose (%RfD) or 
percent population adjusted dose (%PAD). Instead, drinking water levels 
of comparison (DWLOCs) are calculated and used as a point of comparison 
against the model estimates of a pesticide's concentration in water. 
DWLOCs are theoretical upper limits on a pesticide's concentration in 
drinking water in light of total aggregate exposure to a pesticide in 
food, and from residential uses. Since DWLOCs address total aggregate 
exposure to Indoxacarb they are further discussed in the aggregate risk 
sections below.
    Based on the PRZM/EXAMS and SCI-GROW models the estimated 
environmental concentrations (EECs) of Indoxacarb for acute exposures 
are estimated to be 13.7 parts per billion (ppb) for surface water and 
0.02 ppb for ground water. The EECs for chronic exposures are estimated 
to be 3.7 ppb for surface water and 0.02 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Indoxacarb is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether Indoxacarb has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
Indoxacarb does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that Indoxacarb has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There is no evidence for 
either qualitative or quantitative susceptibility. In all developmental 
studies, the developmental endpoint occurs at the maternal LOAEL or 
above. Although there is no rabbit developmental toxicity study with 
indoxacarb, a study is not required since: (1) studies both using 
methyl cellulose comparing JW062 in the rabbit and rat demonstrate that 
the toxicity profiles for the rat and rabbit are similar and that the 
rat is the more sensitive species; (2) range finding studies in the rat 
comparing indoxacarb and JW062 indicate that the maternal and external 
developmental toxicity are comparable; (3) a dietary developmental 
toxicity study in the rat with JW062 had comparable toxicity to the 
gavage indoxacarb rat developmental toxicity study. Developmental 
toxicity only occurred at levels at or above maternal toxicity.
    The reproduction toxicity study with JW062 can be used to satisfy 
the requirement for an indoxacarb study because: 1) systemic toxicity 
is at similar doses and of similar magnitude to that observed in 
subchronic feeding studies with both indoxacarb and JW062; 2) based on 
the data base, the HIARC determined that there was support for using 
data from dietary studies conducted with JW062 to satisfy the data 
requirements for indoxacarb.
    The Agency has required a developmental neurotoxicity study as 
confirmatory data due to:
    [sbull] Clinical signs of neurotoxicity in several studies, males 
and females, mice and rats, at some doses that do not cause mortality;
    [sbull] Signs of neurotoxicity in the acute neurotoxicity study rat 
with indoxacarb (males and females), no mortality in males at 
neurotoxic doses;

[[Page 18590]]

    [sbull] Clinical signs of neurotoxicity in the 90-day toxicity 
study rat indoxacarb (females), mortality;
    [sbull] Clinical signs of neurotoxicity in the 90-day toxicity 
study mouse with the racemic mixture, JW062 (males and females), no 
mortality in females at neurotoxic doses, mortality in males;
    [sbull] Clinical signs of neurotoxicity in the 18 month 
carcinogenicity study mouse with JW062 (males and females) high and mid 
dose, mortality at the high but no mortality at the mid dose; and
    [sbull] Clinical signs of neurotoxicity in the developmental 
toxicity study rat with JW062 (using methyl cellulose as the vehicle), 
at doses causing mortality.
    3. Conclusion. The Agency concluded that the FQPA safety factor 
could be reducecd to 1X for Indoxacarb because:
    [sbull] There is no indication of quantitative or qualitative 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure;
    [sbull] The requirement of a developmental neurotoxicity study is 
not based on the criteria reflecting special concern for the developing 
fetuses or young which are generally used for requiring a DNT study - 
and a safety factor (e.g.: neuropathy in adult animals; CNS 
malformations following prenatal exposure; brain weight or sexual 
maturation changes in offspring; and/or functional changes in 
offspring) - and therefore does not warrant an FQPA safety factor; and
    [sbull] The dietary (food and drinking water) exposure assessments 
will not underestimate the potential exposures for infants and children
    [sbull] 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 drinking 
water level of comparison (DWLOCs) which are used as a point of 
comparison against the model estimates of a pesticide's concentration 
in water (EECs). DWLOC values are not regulatory standards for drinking 
water. DWLOCs are theoretical upper limits on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food and residential uses. In calculating a DWLOC, the 
Agency determines how much of the acceptable exposure (i.e., the PAD) 
is available for exposure through drinking water [e.g., allowable 
chronic water exposure (mg/kg/day) = cPAD - (average food + residential 
exposure)]. This allowable exposure through drinking water is used to 
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
Indoxacarb will occupy 12% of the aPAD for the U.S. population, 69% of 
the aPAD for females 13 years and older, 67% of the aPAD for infants 
less than 1 year old and 36% of the aPAD for children 1 to 2 years old. 
In addition, there is potential for acute dietary exposure to 
Indoxacarb in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPad, as shown in Table 3 of 
this unit:

                      Table 3.-- Aggregate Risk Assessment for Acute Exposure to Indoxacarb
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                  aPAD (mg/     % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
 U.S. Population                                        0.12            7         13.7         0.02        3,700
----------------------------------------------------------------------------------------------------------------
Females 13 +                                            0.02           69         13.7         0.02          180
----------------------------------------------------------------------------------------------------------------
All infants less than 1 year                            0.12           67         13.7         0.02          400
----------------------------------------------------------------------------------------------------------------
Children 1 to 2                                         0.12           36         13.7         0.02          760
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
Indoxacarb from food will utilize 30% of the cPAD for the U.S. 
population, 29% of the cPAD for infants less than 1 year old and 79% of 
the cPAD for children 1 to 2 years old. There are no residential uses 
for Indoxacarb that result in chronic residential exposure to 
Indoxacarb. Based the use pattern, chronic residential exposure to 
residues of Indoxacarb is not expected. In addition, there is potential 
for chronic dietary exposure to Indoxacarb in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in Table 4 of this unit:

[[Page 18591]]



              Table 4.-- Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Indoxacarb
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.02           30          3.7         0.02          490
---------------------------------------------------------------------------
All infants less than 1 year old                        0.02           29          3.7         0.02          140
---------------------------------------------------------------------------
Children 1 to 2                                         0.02           79          3.7         0.02           43
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Indoxacarb is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Indoxacarb is 
not registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. There is no evidence 
for mutagenicity and there is no evidence of carcinogenicity in either 
the rat or mouse. Indoxacarb has been classified as ``not likely to be 
carcinogenic in humans'' by the Agency; therefore, Indoxacarb is not 
expected to pose carcinogenic risk when used as directed.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to Indoxacarb residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

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

V. Conclusion

    A 15-day comment period is being allowed for this proposed rule 
because of the speed of growth and the pest pressure, and the Agency's 
desire to be suportive of efforts by peach growers and researchers to 
find alternatives to organophosphates for control of oriental fruit 
moth and plum curculio in peaches. Additionally, the Agency feels that 
there is strong evidence in support of the safety of this proposed 
action.
    Therefore, a temporary tolerance for 3 years is proposed for 
combined residues of Indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2-
[[(methoxy carbonyl) [4-(trifluoromethoxy)phenyl] amino]carbonyl] 
indeno[1,2-e][1,3,4]oxadiazine-4a(3H)- carboxylate + its R-enantiomer] 
(R)-methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl)[4-(trifluoro 
methoxy)phenyl]amino]carbonyl]indeno [1,2-e][1,3,4]oxadiazine-4a(3H)-
carboxylate in peaches at 10.0 ppm.

VI. Statutory and Executive Order Reviews

    This proposed rule is establishing a tolerance under section 408(d) 
of the FFDCA. EPA is proposing this regulation in cooperation with 
Research Extension Specialists at the University of Georgia, Rutgers 
University, Clemson University, Pennsylvania State University, Michigan 
State University, University of West Virginia, and DuPont de Nemours 
and Company. The Office of Management and Budget (OMB) has exempted 
these types of actions from review under Executive Order 12866, 
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 
Because this proposed rule has been exempted from review under 
Executive Order 12866 due to its lack of significance, this proposed 
rule is not subject to Executive Order 13211, Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001). This proposed rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the tolerance in 
this proposed 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

[[Page 18592]]

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 
proposed rule directly regulates growers, food processors, food 
handlers and food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this 
proposed rule does not have any ``tribal implications'' as described in 
Executive Order 13175, entitled Consultation and Coordination with 
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive 
Order 13175, requires EPA to develop an accountable process to ensure 
``meaningful and timely input by tribal officials in the development of 
regulatory policies that have tribal implications.'' ``Policies that 
have tribal implications'' is defined in the Executive order to include 
regulations that have ``substantial direct effects on one or more 
Indian tribes, on the relationship between the Federal Government and 
the Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.'' This proposed rule 
will not have substantial direct effects on tribal governments, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

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

    Dated: April 10, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 03-9340 Filed 4-15-03; 8:45 a.m.]
BILLING CODE 6560-50-S