Document ID: EPA-HQ-OPP-2005-0149-0004
Agency: epa
Document Type: Rule
Title: Indoxacarb; Pesticide Tolerance
Posted Date: 2007-07-11T04:00Z

[Federal Register: July 11, 2007 (Volume 72, Number 132)]
[Rules and Regulations]               
[Page 37633-37641]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy07-5]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0149; FRL-8137-8]

 
Indoxacarb; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of indoxacarb and its R-enantiomer in or on cranberry; fruit, pome, 
except pear, group 11; fruit, stone, group 12; grape; grape, raisin; 
okra; pea, southern, seed; pear, oriental; peppermint, tops; spearmint, 
tops; turnip greens; vegetable, Brassica, leafy, group 5; vegetable, 
cucurbit, group 9; vegetable, leafy, except Brassica, group 4; and 
vegetable, tuberous and corm, subgroup 1-C. E.I. du Pont de Nemours and 
Company and the Interregional Research Project No. 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA). This regulation also removes existing

[[Page 37634]]

tolerances on apple; Brassica, head and stem, subgroup 5A; lettuce, 
head; lettuce, leaf; and potato, which are superseded by the new 
tolerances; and removes expired time-limited tolerances on cherry, 
sweet; cherry, tart; peach; and collards; and the time-limited 
tolerance on cranberry (set to expire December 31, 2007), which are no 
longer needed as a result of this action. Finally, this regulation 
corrects a typographical error in the spelling of the word 
``enantiomer'' in the tolerance expression for indoxacarb given in 40 
CFR 180.564(a)(1).

DATES: This regulation is effective July 11, 2007. Objections and 
requests for hearings must be received on or before September 10, 2007, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2005-0149. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov,or, if 

only available in hard copy, at the OPP Regulatory Public Docket in Rm. 
S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, 
VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: madden.barbara@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide 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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, any person may file an objection 
to any aspect of this regulation and may also request a hearing on 
those objections. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2005-0149 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 as required by 40 CFR part 178 on or 
before September 10, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2005-0149, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of July 2, 2003 (68 FR 39541) (FRL-7312-9), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 3F6576) 
by E.I. du Pont de Nemours and Company, Newark, DE 19711. The petition 
requested that 40 CFR 180.564 be amended by establishing a tolerance 
for combined residues of the insecticide indoxacarb, (S)-methyl 7-
chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4- 
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl) [4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in or on grape at 2.0 parts 
per million (ppm) and raisin at 6.0 ppm. That notice

[[Page 37635]]

included a summary of the petition prepared by E.I. du Pont de Nemours 
and Company, the registrant, which is available to the public in the 
docket EPA-HQ-OPP-2003-0212, http://www.regulations.gov. One comment 

was received on the notice of filing from a private citizen expressing 
support for the proposed tolerances.
    In the Federal Register of May 5, 2004 (69 FR 25104) (FRL-7354-9), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 2E6482) 
by the Interregional Research Project No. 4 (IR-4). The petition 
requested that 40 CFR 180.564 be amended by revoking Brassica, head and 
stem, subgroup at 5.0 ppm and establishing a tolerance for combined 
residues of the insecticide indoxacarb, (S)-methyl 7-chloro-2,5-
dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in or on vegetable, , leafy, 
group 5 at 12 ppm and turnip greens at 12 ppm. That notice included a 
summary of the petition prepared by E.I. du Pont de Nemours and 
Company, the registrant, which is available to the public in the docket 
EPA-HQ-OPP-2004-0064, http://www.regulations.gov. There were no 

comments received in response to the notice of filing.
    In the Federal Register of June 30, 2005 (70 FR 37852) (FRL-7718-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
5E6911 and 5E6926) by the Interregional Research Project No. 4 (IR-4). 
The petitions requested that 40 CFR 180.564 be amended by establishing 
a tolerance for combined residues of the insecticide indoxacarb, (S)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in or on leafy greens, except 
spinach, subgroup 4A at 10 ppm; spinach at 3.0 ppm; leaf petioles 
subgroup 4B at 1.5 ppm; fruit, pome, except pear, group 11 at 1.0 ppm; 
vegetable, tuberous and corm, subgroup 1C at 0.01 ppm; okra at 0.5 ppm 
(all requested in PP 5E6911); pea (Southern) at 0.1 ppm; and mint at 10 
ppm (both requested in PP 5E6926). That notice included a summary of 
the petition prepared by E.I. du Pont de Nemours and Company, the 
registrant, which is available to the public in the docket EPA-HQ-OPP-
2005-0149, http://www.regulations.gov. There were no comments received 

in response to the notice of filing.
    In the Federal Register of April 12, 2006 (71 FR 18738) (FRL-7772-
2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
5E6991) by the Interregional Research Project No. 4 (IR-4). The 
petition requested that 40 CFR 180.564 be amended by establishing a 
tolerance for combined residues of the insecticide indoxacarb, (S)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in or on vegetable, cucurbit, 
group 9 at 0.5 ppm; fruit, stone, group 12 at 1 ppm; and cranberry at 1 
ppm. That notice referenced a summary of the petition prepared by E.I. 
du Pont de Nemours and Company, the registrant, which is available to 
the public in the docket EPA-HQ-OPP-2005-0149, http://www.regulations.gov.
 There were no comments received in response to the 

notice of filing.
    Based upon review of the data supporting the petitions, EPA has 
modified the proposed tolerances. The reasons for these changes are 
explained in Unit V.

III. Aggregate Risk Assessment and Determination of Safety

    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....'' These provisions were added to the FFDCA by the Food 
Quality Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in 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 for the petitioned-for tolerances 
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 cranberry at 0.90 
ppm; fruit, pome, except pear, group 11 at 1.0 ppm; fruit, stone, group 
12 at 0.90 ppm; grape at 2.0 ppm; grape, raisin at 5.0 ppm; okra at 
0.50 ppm; pea, southern, seed at 0.10 ppm; pear, oriental at 0.20 ppm; 
peppermint, tops at 11 ppm; spearmint, tops at 11 ppm; turnip greens at 
12 ppm; vegetable, Brassica, leafy, group 5 at 12 ppm; vegetable, 
cucurbit, group 9 at 0.60 ppm; vegetable, leafy, except Brassica, group 
4 at 14 ppm; and vegetable, tuberous and corm, subgroup 1-C at 0.01 
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. Specific information on the studies received and the nature 
of the adverse effects caused by indoxacarb as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov.
 The referenced

[[Page 37636]]

document is available in the docket established by this action, which 
is described under ADDRESSES, and is identified as EPA-HQ-OPP-2005-0149 
in that docket.
    Indoxacarb is an isomeric compound containing two enantiomers, the 
S-enantiomer (DPX-KN128, the insecticidally active component) and its 
R-enantiomer (DPX-KN127, the insecticidally inactive component). DPX-
MP062 is an enantiomeric mixture containing the S-enantiomer and its R-
enantiomer at approximately a 75:25 ratio. DPX-JW062 is the racemic 
mixture of the enantiomers at a 50:50 ratio.
    DPX-KN128, DPX-MP062 and DPX-JW062 appear to be of similar toxicity 
acutely. DPX-KN128 and DPX-MP062 were moderately acutely toxic by the 
oral route (toxicity category II) while DPX-JW062 was practically non-
toxic (toxicity category IV) due to its poor solubility in the corn oil 
vehicle. However, it was equally toxic orally, when tested using a 
solvent where it had a higher solubility, such as polyethylene glycol 
(PEG). By the dermal route, they had low toxicity (toxicity category 
III and IV). DPX-MP062 and DPX-JW062 had low acute inhalation toxicity 
(IV). DPX-MP062 and DPX-JW062 had moderate to low ocular irritant 
properties (III and IV), while DPX-KN128 was practically non-irritating 
to the rabbit's eyes. By the maximization test, DPX-KN128 and DPX-MP062 
were considered dermal sensitizers, while DPX-JW062 was not a 
sensitizer.
    There was possible evidence of lung damage in the acute inhalation 
studies with both DPX-MP062 and DPX-JW062. ``Lung noise,'' observed 
with JW062 may indicate the development of acute lung injury and high 
permeability pulmonary edema. This was not unexpected since an oxidant 
was generated during indoxacarb metabolism. ``Hunched over back and 
gasping'' were also present and suggested arterial hypoxemia that 
accompanies alveolar flooding. The acute inhalation study report with 
indoxacarb 70% manufacturing use product, noted that a ``red nasal 
discharge'' was detected for 2 days after exposure. This may be 
indicative of a lung exudate, a sign of lung injury. Subchronic (28 
days) inhalation toxicity on indoxacarb in rats was characterized by 
increased spleen weights, increased pigmentation and hematopoiesis in 
the spleen, and hematological changes.
    The toxicity profiles for DPX-KN128, DPX-MP062 and DPX-JW062 in 
rats, mice and dogs with both subchronic and chronic oral exposures 
were similar. Dermal subchronic exposure in the rat also resulted in a 
similar profile. The toxic signs occurred at similar doses and with a 
similar magnitude of response, with females generally being more 
sensitive than males. The endpoints that most frequently defined the 
LOAEL were non-specific, and included decreased body weight, weight 
gain, food consumption and food efficiency. These compounds also 
affected the hematopoietic system by decreasing the red blood cell 
count, hemoglobin and hematocrit in rats, dogs and mice. It was 
frequently accompanied by an increase in reticulocytes in all three 
species and an increase in Heinz bodies (dogs and mice only). None of 
these signs of toxicity appeared to get worse over time. In one 
subchronic rat study, the parameters appeared to return to normal 
levels following a four-week recovery period. High doses in the rats 
and mice also sometimes caused mortality.
    There was no evidence of susceptibility from either in utero or 
neonatal exposure to both rat and rabbit young with either DPX-MP062 or 
DPX-JW062. There was no evidence of susceptibility from in utero 
exposure in rats with DPX-KN128. There was no evidence of increased 
susceptibility in the developmental neurotoxicity study in rats with 
DPX-KN128. No evidence of teratogenicity was observed in rats and 
rabbits with DPX-MP062 or DPX-JW062. No evidence of teratogenicity was 
observed in rats with DPX-KN128. There was no evidence of reproductive 
effects in the 2-generation reproduction study in rats.
    Neurotoxicity was present in both rats and mice; however, it did 
not occur in the absence of other signs of toxicity. Neurotoxicity was 
characterized by one or more of the following symptoms in both male and 
female rats and mice: Weakness, head tilting, and abnormal gait or 
mobility with inability to stand, ataxia. Acute and subchronic 
neurotoxicity screening batteries were performed using DPX-MP062 in 
rats. Neurotoxicity was characterized by clinical signs (depression, 
abnormal gait, head shake, salivation) and functional-observation 
battery (FOB) (circling behavior, incoordination, slow righting reflex, 
decreased forelimb grip strength, decreased foot splay, decreased motor 
activity). However, there was no evidence of neurohistopathology in any 
study. Learning and memory parameters were affected in the pups in the 
developmental neurotoxicity study in rats with DPX-KN128.
    There was no evidence of carcinogenicity in either the rat or mouse 
in acceptable studies using DPX-JW062. DPX-JW062 was not mutagenic in a 
complete battery of mutagenicity studies. There was also no evidence of 
mutagenicity with either DPX-KN128, or DPX-MP062.
    Both DPX-JW062 and DPX-MP062 were rapidly absorbed and eliminated 
following oral administration. The absorption of DPX-JW062 was dose 
dependent and appeared to be saturated at the high dose. Both urine and 
feces represented major routes of excretion (35-45% and 33-47%, 
respectively). The distribution pattern did not vary with dosing 
regimen and overall tissue burden was limited to only 3.4-12.9% of the 
administered dose. The red blood cells of rats dosed with the 
trifluoromethoxyphenyl label consistently contained much greater levels 
of radioactivity than did plasma. Fat tissue contained the greatest 
level of radioactivity (1.76-8.76% of the administered dose) and, for 
both compounds, was greater in female rats. The finding also 
demonstrates a greater propensity for accumulation by female rats than 
by male rats. Both DPX-MP062 and DPX-JW062 were extensively metabolized 
and the metabolites were eliminated in the urine, feces, and bile. With 
the exception of parent compound (DPX-JW062, which accounted for 19.2% 
of a single low dose in the feces of female rats), none of the 
metabolites from any source represented more than 12.3% of the 
administered dose. 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. All of the biliary metabolites appear to undergo 
further biotransformation in the gut.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which the NOAEL in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment. Uncertainty/safety factors (UF) are used in conjunction 
with the LOC to take into account 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. Safety is assessed for acute and chronic risks by 
comparing aggregate exposure to the pesticide to the acute population 
adjusted dose

[[Page 37637]]

(``aPAD'') and chronic population adjusted dose (``cPAD''). The aPAD 
and cPAD are calculated by dividing the LOC by all applicable 
uncertainty/safety factors. Short-term, intermediate-term, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the margin of exposure (``MOE'') called for by the product 
of all applicable uncertainty/safety factors is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for indoxacarb used for 
human risk assessment can be found at http://www.regulations.gov in document 

``PPs: 2E6482, 3F6576, 5E6911, 5E6926, and 5E6991. Indoxacarb. 
Health Effects Division (HED) Risk Assessment for Grapes; Vegetable, 
Brassica, Leafy, Group 5; Turnip Greens; Vegetable, Leafy, Except 
Brassica (Group 4); Pome Fruits (Group 11, except pear); Tuberous and 
Corm Vegetables (Subgroup 1C); Cucurbit Vegetables (Group 9); Stone 
Fruits (Group 12); Cranberry; Mint; Okra; Southern Pea; and Fire Ant 
Bait.'' at pages 23-24 in Docket ID EPA-HQ-OPP-2005-0149.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to indoxacarb, EPA considered exposure under the petitioned-
for tolerances as well as all existing indoxacarb tolerances in (40 CFR 
180.564). EPA assessed dietary exposures from indoxacarb in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. In estimating acute dietary 
exposure, EPA used food consumption information from the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA relied upon anticipated 
residues for most commodities and percent crop treated information for 
most currently registered commodities. EPA assumed 100 percent crop 
(PCT) treated for all of the new commodities. Anticipated residues for 
all registered and new food commodities were based on field trial data.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 Nationwide CSFII. As to residue levels in food, EPA relied 
upon anticipated residues for most commodities and PCT information for 
most currently registered commodities. EPA assumed 100 PCT for all of 
the new commodities. Anticipated residues for all registered and new 
food commodities were based on field trial data.
    iii. Cancer. EPA has classified indoxacarb as ``not likely'' to be 
carcinogenic to humans via relevant routes of exposure using the 
Guidelines for Carcinogen Risk Assessment. Therefore, a cancer exposure 
assessment was not conducted.
    iv. Anticipated residue and 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 residues that have been measured in food. If 
EPA relies on such information, EPA must pursuant to section 408(f)(1) 
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. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    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:
    a. 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;
    b. The exposure estimate does not underestimate exposure for any 
significant subpopulation group; and
    c. 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 FFDCA, EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows:
    For the acute assessment, maximum PCT estimates were used for the 
following commodities: apple (5%), broccoli (50%), cabbage (25%), 
cauliflower and the remaining Brassica head and stem vegetables (55%), 
sweet corn (2.5%), head lettuce (25%), leaf lettuce (11%), peanut 
(2.5%), pear (2.5%), peppers (15%), potato (2.5%), soybean (1%), 
spinach (5%) and tomato (25%).
    For the chronic assessment, average weighted PCT estimates were 
used for the following commodities: apple (1%), broccoli (40%), cabbage 
(15%), cauliflower and the remaining Brassica head and stem vegetables 
(35%), sweet corn (1%), head lettuce (18%), leaf lettuce (9%), peanut 
(1%), pear (1%), peppers (10%), potato (1%), soybean (1%), spinach (5%) 
and tomato (15%).
    EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available federal, state, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of five percent except for those situations in which 
the average PCT is less than one. In those cases < 1% is used as the 
average and < 2.5% is used as the maximum. EPA uses a maximum PCT for 
acute dietary risk analysis. The maximum PCT figure is the single 
maximum value reported overall from available federal, state, and 
private market survey data on the existing use, across all years, and 
rounded up to the nearest multiple of five percent. In most cases, EPA 
uses available data from United States Department of Agriculture/
National Agricultural Statistics Service (USDA/NASS), Proprietary 
Market Surveys, and the National Center for Food and Agriculture Policy 
(NCFAP) for the most recent six years.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. The Agency is reasonably certain that the percentage of 
the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's

[[Page 37638]]

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 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 environmental fate characteristics of 
indoxacarb. Further information regarding EPA drinking water models 
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.

    Based on the EPA's Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS) and Screening Concentration in Ground 
Water (SCI-GROW) models, the estimated environmental concentrations 
(EECs) of indoxacarb for acute exposures are estimated to be 25.1 parts 
per billion (ppb) for surface water and 0.21 ppb for ground water. The 
EECs for chronic exposures are estimated to be 5.37 ppb for surface 
water and 0.21 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 25.1 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 5.37 ppb was used to 
assess the contribution to drinking 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 currently registered for the following residential 
non-dietary sites: as a fire ant bait for turf, which may be applied as 
a mound treatment or as a broadcast application by ``residential'' 
(i.e., private persons) applicators as well as by commercial handlers.
    EPA assessed residential exposure using the following assumptions: 
EPA has determined that residential handlers are likely to be exposed 
to indoxacarb residues via dermal and inhalation routes during handling 
and applying activities. Based on the current use pattern, EPA expects 
duration of exposure to be short-term (1-30 days). The broadcast 
treatment results in a higher handler exposure than the mound treatment 
and is, therefore, the scenario assessed by EPA. EPA assessed exposure 
of residential handlers applying indoxacarb with a push-type spreader 
using SOPs for Residential Exposure Assessments (DEC-1997) in 
conjunction with unit exposures developed by the Outdoor Residential 
Exposure Task Force (ORETF).
    There is also the potential for short-term and intermediate-term 
post-application exposure of adults and children from entering areas 
previously treated with indoxacarb (i.e., turf treated for fire ants). 
The post-application scenarios assessed from exposure to treated turf 
include: Dermal exposure from treated lawns due to high contact lawn 
activities (adult and toddler); Dermal exposure from treated turf due 
to golfing (adults and youths); Hand-to-mouth transfer of pesticide 
residues on lawns (toddler); Incidental ingestion of granules from 
pesticide-treated residential areas (toddler); and Incidental ingestion 
of soil from pesticide-treated residential areas (toddler).
    4. Cumulative effects from 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to indoxacarb and any other 
substances and 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 
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') 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 database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the FQPA safety factor. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional uncertainty/safety 
factors and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no quantitative or 
qualitative evidence of increased prenatal or postnatal sensitivity in 
the two developmental toxicity studies in rats with DPX-JW062, one 
developmental toxicity study in rats with DPX-MP062 and DPX-KN128, one 
developmental toxicity study in rabbits with DPX-JW062, one 2-
generation reproduction studies in rats with DPX-JW062 and a 
developmental neurotoxicity (DNT) study in rats with DPX-KN128. In 
these studies, developmental toxicity was observed in the presence of 
maternal toxicity.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for indoxacarb is complete.
    ii. Neurotoxicity was seen in animal studies in rats and mice but 
at higher doses than the hematologic effects on which EPA's risk 
assessments are based. To evaluate the potential for increased 
sensitivity of infants and children to neurotoxic effects, EPA required 
a rat developmental neurotoxicity (DNT) study. The study has been 
submitted and reviewed. There was no evidence of increased sensitivity 
of offspring in the submitted study. Clinical observations, motor 
activity, acoustic startle habituation, and learning and memory testing 
were all comparable between the control and treated groups. Mean brain 
weight, gross and microscopic examinations and morphometric 
measurements of the brain were also

[[Page 37639]]

comparable between the controls and treated groups.
    iii. There is no evidence that indoxacarb results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the two-generation 
reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute and chronic dietary food exposure assessments 
utilize anticipated residues for most commodities that are based on 
reliable field trial data. They also utilize PCT data that have been 
verified by the Agency for most existing uses. For all new uses, 100 
PCT is assumed. The acute and chronic assessments are somewhat refined 
and based on reliable data and will not underestimate exposure/risk. 
Conservative ground and surface water modeling estimates were used. 
Similarly conservative Residential SOPs were used to assess post-
application exposure to children as well as incidental oral exposure of 
toddlers. These assessments will not underestimate the exposure and 
risks posed by indoxacarb.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the acute population adjusted 
dose (``aPAD'') and chronic population adjusted dose (``cPAD''). The 
aPAD and cPAD are calculated by dividing the LOC by all applicable 
uncertainty/safety factors. For linear cancer risks, EPA calculates the 
probability of additional cancer cases given aggregate exposure. Short-
term, intermediate-term, and long-term risks are evaluated by comparing 
aggregate exposure to the LOC to ensure that the margin of exposure 
(``MOE'') called for by the product of all applicable uncertainty/
safety factors is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to indoxacarb will occupy 84% of the aPAD for the population group 
(children, 3 to 5 years old) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
indoxacarb from food and water will utilize 53% of the cPAD for the 
population group (children, 1 to 2 years old) with greatest exposure. 
Based the use pattern, chronic residential exposure to residues of 
indoxacarb is not expected.
    Indoxacarb is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for indoxacarb.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential 
exposures aggregated result in aggregate MOEs of 620 for the general 
U.S. population and 190 for children, 1 to 2 years old. The aggregate 
MOE for the general U.S. population is based on the residential turf 
(fire ant control) scenario and includes combined residential 
applicator and post-application dermal exposures. EPA determined that 
it is not appropriate to include applicator inhalation exposure in the 
aggregate exposure assessment, since toxicological endpoints of concern 
for dermal and inhalation exposures are different. The aggregate MOE 
for children includes post-application dermal and incidental oral 
exposures from entering turf areas previously treated with indoxacarb 
for fire ants.
    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 currently registered for use(s) that could result in 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for indoxacarb.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food, water, and 
residential exposures aggregated result in aggregate MOEs of 620 for 
the general U.S. population and 190 for children, 1 to 2 years old. The 
aggregate MOE for the general U.S. population is based on the 
residential turf (fire ant control) scenario and includes combined 
residential applicator and post-application dermal exposures. EPA 
determined that it is not appropriate to include applicator inhalation 
exposure in the aggregate exposure assessment, since toxicological 
endpoints of concern for dermal and inhalation exposures are different. 
The aggregate MOE for children includes post-application dermal and 
incidental oral exposures from entering turf areas previously treated 
with indoxacarb for fire ants.
    5. Aggregate cancer risk for U.S. population. EPA has classified 
indoxacarb as ``not likely'' to be carcinogenic to humans via relevant 
routes of exposure using the Guidelines for Carcinogen Risk Assessment. 
Therefore, a cancer aggregate exposure assessment was not conducted. 
Indoxacarb is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to indoxacarb residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression (high-performance liquid chromatography (HPLC)/
column switching/ultraviolet (UV) methods AMR 2712-93 and Du Pont 11978 
with confirmation/specificity provided by gas chromatography (GC)/mass-
selective detector method AMR 3493-95, Supplement No. 4). These methods 
may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no established or proposed Codex maximum residue limits 
(MRLs) for indoxacarb.

V. Conclusion

    Based upon review of the data supporting the petitions, EPA has 
modified the proposed tolerances as follows:
    (1) PP 3F6576: Revised the commodity term and tolerance for 
``raisin'' to read ``grape, raisin'' at 5.0 ppm;
    (2) PP 5E6911: Replaced the proposed tolerances for ``leafy greens, 
except spinach, subgroup 4A'', ``leaf petioles subgroup 4B'' and 
``spinach'' with a single tolerance in or on ``vegetable, leafy, except 
Brassica, group 4'' at 14 ppm; and added a tolerance for ``pear, 
oriental'' at 0.20 ppm;
    (3) PP 5E 6926: Revised the commodity term ``pea (southern'') to 
read ``pea, southern, seed''; and revised the commodity term and 
tolerance level for ``mint'' to read ``peppermint, tops'' at 11 ppm and 
``spearmint, tops'' at 11 ppm; and
    (4) PP 5E6991: Revised the tolerances for ``vegetable, cucurbit, 
group 9'', ``fruit, stone, group 12'' and ``cranberry'' to 0.60 ppm, 
0.90 ppm and 0.90 ppm, respectively. The reasons for these changes are 
discussed below.

[[Page 37640]]

    EPA revised the commodity terms ``raisin'', mint'' and ``pea 
(southern)'' to agree with recommended commodity terms in the Office of 
Pesticide Program's Food and Feed Commodity Vocabulary. Based on data 
submitted with PP 5E6911 and data previously submitted to support the 
existing tolerances on leaf and head lettuce, EPA determined that it 
was appropriate to establish a tolerance for the crop group 
``vegetable, leafy, except Brassica, group 4'' instead of the proposed 
separate tolerances on ``leafy greens, except spinach, subgroup 4A'', 
``spinach'' and ``leaf petioles subgroup 4B''. The crop group tolerance 
of 14 ppm is based on data for the crop with the highest field trial 
residues (spinach). EPA is establishing a tolerance for ``pear, 
oriental'' at 0.20 ppm. A tolerance for ``pear'' currently exists at 
this level. Although residue field trial data for pear may be 
translated to oriental pear, a separate tolerance must be established 
under current regulations. EPA is taking this action to clarify 
tolerances for all members of the pome fruit crop group. Based on the 
submitted grape processing data showing a maximum concentration in 
raisins of 2.7x and the highest average field trial (HAFT) residue on 
grapes of 1.52 ppm, EPA has determined that the proposed raisin 
tolerance of 6.0 ppm should be revised to 5.0 ppm. EPA also determined 
that the proposed tolerance levels for ``peppermint, tops'', 
``spearmint, tops'', ``vegetable, cucurbit, group 9'', ``fruit, stone, 
group 12'' and ``cranberry'' were inappropriate and should be revised 
as specified above based on analyses of the residue field trial data 
using the Agency's Tolerance Spreadsheet in accordance with the 
Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial 
Data Standard Operating Procedure (SOP).
    Therefore, tolerances are established for combined residues of 
indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-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 cranberry at 0.90 
ppm; fruit, pome, except pear, group 11 at 1.0 ppm; fruit, stone, group 
12 at 0.90 ppm; grape at 2.0 ppm; grape, raisin at 5.0 ppm; okra at 
0.50 ppm; pea, southern, seed at 0.10 ppm; pear, oriental at 0.20 ppm; 
peppermint, tops at 11 ppm; spearmint, tops at 11 ppm; turnip greens at 
12 ppm; vegetable, Brassica, leafy, group 5 at 12 ppm; vegetable, 
cucurbit, group 9 at 0.60 ppm; vegetable, leafy, except Brassica, group 
4 at 14 ppm; and vegetable, tuberous and corm, subgroup 1-C at 0.01 
ppm. Existing tolerances on apple; Brassica, head and stem, subgroup 
5A; lettuce, head; lettuce, leaf; and potato, which are superseded by 
the new tolerances, are revoked.
    Time-limited tolerances were established for combined residues of 
indoxacarb and its R-enantiomer in or on cherry, sweet; cherry, tart; 
and peach in connection with a FIFRA section 5 experimental use permit 
granted by EPA. Time-limited tolerances were established for combined 
residues of indoxacarb and its R-enantiomer in or on collards and 
cranberry in connection with FIFRA section 18 emergency exemptions 
granted by EPA. All of these time-limited tolerances have expired, 
except the time-limited tolerance on cranberry, which is set to expire 
on December 31, 2007. Because EPA is establishing tolerances on stone 
fruit, Brassica leafy vegetables and cranberry, these time-limited 
tolerances, most of which have already expired, are not needed. 
Therefore, the time-limited tolerances for residues of indoxacarb and 
its R-enantiomer under 40 CFR 180.564(a)(2) and 40 CFR 180.564(b) are 
revoked.
    Finally, the word ``enantiomer'' is incorrectly spelled 
(``enantimomer'') in the tolerance expression for indoxacarb in 40 CFR 
180.564(a)(1) and is being corrected in this regulation.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers and food retailers, not States or tribes, nor does this action 
alter the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of section 
408(n)(4) of FFDCA. As such, the Agency has determined that this action 
will not have a substantial direct effect on States or tribal 
governments, on the relationship between the national government and 
the States or tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, the Agency has determined 
that Executive Order 13132, entitled Federalism (64 FR 43255, August 
10, 1999) and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000) do not apply to this rule. In addition, This rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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).

[[Page 37641]]

List of Subjects in 40 CFR Part 180

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

    Dated: July 2, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.564, paragraph (a) is revised and paragraph (b) is 
removed and reserved 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-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:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Apple, wet pomace....................................                3.0
Alfalfa, forage......................................                 10
Alfalfa, hay.........................................                 50
Cattle, fat..........................................                1.5
Cattle, meat.........................................               0.05
Cattle, meat byproducts..............................               0.03
Corn, sweet, forage..................................                 10
Corn, sweet, kernel plus cob with husk removed.......               0.02
Corn, sweet, stover..................................                 15
Cotton, gin byproducts...............................                 15
Cotton, undelinted seed..............................                2.0
Cranberry............................................               0.90
Fruit, pome, except pear, group 11...................                1.0
Fruit, stone, group 12...............................               0.90
Goat, fat............................................                1.5
Goat, meat...........................................               0.05
Goat, meat byproducts................................               0.03
Grape................................................                2.0
Grape, raisin........................................                5.0
Hog, fat.............................................                1.5
Hog, meat............................................               0.05
Hog, meat byproducts.................................               0.03
Horse, fat...........................................                1.5
Horse, meat..........................................               0.05
Horse, meat byproducts...............................               0.03
Milk.................................................               0.15
Milk, fat............................................                4.0
Okra.................................................               0.50
Pea, southern, seed..................................               0.10
Peanut...............................................               0.01
Peanut, hay..........................................                 40
Pear.................................................               0.20
Pear, oriental.......................................               0.20
Peppermint, tops.....................................                 11
Sheep, fat...........................................                1.5
Sheep, meat..........................................               0.05
Sheep, meat byproducts...............................               0.03
Soybean, aspirated grain fractions...................                 45
Soybean, hulls.......................................                4.0
Soybean, seed........................................               0.80
Spearmint, tops......................................                 11
Turnip, greens.......................................                 12
Vegetable, Brassica, leafy, group 5..................                 12
Vegetable, cucurbit, group 9.........................               0.60
Vegetable, fruiting, group 8.........................               0.50
Vegetable, leafy, except Brassica, group 4...........                 14
Vegetable, tuberous and corm, subgroup 1-C...........               0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. E7-13339 Filed 7-10-07; 8:45 am]

BILLING CODE 6560-50-S