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Etoxazole (Valent). September 26, 2003. Pesticide Tolerances. Final Rule. Federal Register.


http://www.epa.gov/fedrgstr/EPA-PEST/2003/September/Day-26/p24368.htm


[Federal Register: September 26, 2003 (Volume 68, Number 187)]
[Rules and Regulations]
[Page 55485-55493]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-15]

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

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0289; FRL-7324-8]
 
Etoxazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
etoxazole in or on cotton, pome fruits, strawberries, and imported 
tangerines. Valent U.S.A. Corporation requested this tolerance under 
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the 
Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 26, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0289, 
must be received on or before November 25, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Daniel C. Kenny, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 305-7546; e-mail address: kenny.dan@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:
     Crop Production (NAICS 111)
     Animal Production (NAICS 112)
     Food Manufacturing (NAICS 311)
     Pesticide Manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. 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-2003-0289. 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/. http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, Exit Disclaimer 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. 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.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of August 13, 2003 (68 FR 48377) (FRL-7322-
6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide petition (PP 2F6420) by Valent U.S.A. Corporation, 1333 
North California Blvd., Suite 600, Walnut Creek, CA 94596. That notice 
included a summary of the petition prepared by Valent U.S.A. 
Corporation, the registrant. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the insecticide etoxazole, 2-
(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole, in or on cottonseed at 0.05 parts per million (ppm); 
cotton, gin byproducts (gin trash) at 1.0 ppm, pome fruit (Crop Group 
11) at 0.2 ppm, apple, wet pomace at 1.0 ppm, strawberry at 0.5 ppm, 
and oranges at 0.10 ppm (to support the importation of mandarin oranges 
into the U.S.). As residues in processed commodities fed to animals may 
be transferred to milk and edible tissue of ruminants, tolerances were 
also proposed for animal fat at 0.03 ppm and milk fat at 0.04 ppm.
    Based on EPA's review, the petition was revised by the petitioner 
to propose tolerances for residues of etoxazole on cotton, undelinted 
seed at 0.05 ppm; cotton, gin byproducts at 1.0 ppm; fruit, pome, group 
11 at 0.20 ppm; apple, wet pomace at 0.50 ppm; strawberry at 0.50 ppm; 
tangerine at 0.10 ppm; liver of cattle, goat, horse, and sheep at 0.01 
ppm; fat of cattle, goat, horse, and sheep at 0.02 ppm; and milk, fat 
at 0.01 ppm. Although EPA requested a number of changes to the initial 
petition, the nature of the changes (i.e., clarification and correction 
of commodity terms and adjustments in tolerance levels) are not 
considered significant. Therefore, EPA is issuing this as a final 
action.
    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

[[Page 55486]]

exposure through drinking water and in residential settings, but does 
not include occupational exposure. Section 408(b)(2)(C) of the FFDCA 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for tolerances for residues of etoxazole on 
cotton, undelinted seed at 0.05 ppm; cotton, gin byproducts at 1.0 ppm; 
fruit, pome, group 11 at 0.20 ppm; apple, wet pomace at 0.50 ppm; 
strawberry at 0.50 ppm; tangerine at 0.10 ppm; liver of cattle, goat, 
horse, and sheep at 0.01 ppm; fat of cattle, goat, horse, and sheep at 
0.02 ppm; and milk, fat at 0.01 ppm. EPA's assessment of exposures and 
risks associated with establishing the tolerances 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 etoxazole 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        NOAEL = 61.8/69.0
                                  toxicity rodents   milligrams/kilogram/
                                  (rat)              day (mg/kg/day)
                                                     Male/Female (M/F)
                                                    LOAEL = 183.7/204.8
                                                     mg/kg/day (M/F),
                                                     based upon
                                                     increases in
                                                     hepatic enzyme
                                                     levels, increased
                                                     liver weights and
                                                     centrilobular
                                                     hepatocellular
                                                     swelling in both
                                                     sexes and liver
                                                     enlargement in
                                                     females only
------------------------------------------------------------------------
870.3100                         90-Day oral        NOAEL = not
                                  toxicity rodents   determined
                                  (rat)             LOAEL = 300.4/336.6
                                                     mg/kg/day (M/F),
                                                     based upon clinical
                                                     signs, clinical
                                                     chemistry,
                                                     increased liver
                                                     weights, and
                                                     histopathology
------------------------------------------------------------------------
870.3100                         90-Day oral        NOAEL = 213.6/250.5
                                  toxicity rodents   mg/kg/day (M/F)
                                  (mouse)           LOAEL = 878.4/994.5
                                                     mg/kg/day (M/F),
                                                     based upon
                                                     periportal
                                                     hepatocellular
                                                     necrosis, increased
                                                     alkaline
                                                     phosphatase levels,
                                                     accompanied by
                                                     increased relative
                                                     liver weight, liver
                                                     enlargement, and
                                                     centrilobular
                                                     hepatocellular
                                                     swelling
------------------------------------------------------------------------
870.3150                         90-Day oral        NOAEL = 5.33/5.42 mg/
                                  toxicity in        kg/day (M/F)
                                  nonrodents (dog)  LOAEL = 53.7/55.9 mg/
                                                     kg/day (M/F), based
                                                     upon clinical signs
                                                     (vomiting foamy
                                                     fluid and mucous
                                                     stool), clinical
                                                     chemistry,
                                                     increased liver
                                                     weights, and
                                                     centrilobular
                                                     swelling in the
                                                     liver and acinar
                                                     cell atrophy in the
                                                     prostate
------------------------------------------------------------------------
870.3200                         21/28-Day dermal   NOAEL = 1,000 mg/kg/
                                  toxicity           day (M/F)
                                  (rabbit)          LOAEL = not
                                                     determined. No
                                                     systemic effects
                                                     noted
------------------------------------------------------------------------
870.3700                         Prenatal           Maternal NOAEL =
                                  developmental      1,000 mg/kg/day
                                  toxicity in       LOAEL = not
                                  rodents (rat)      determined
                                                    Developmental NOAEL
                                                     = 1,000 mg/kg/day
                                                    LOAEL = not
                                                     determined
------------------------------------------------------------------------
870.3700                         Prenatal           Maternal NOAEL = 200
                                  developmental      mg/kg/day
                                  toxicity in       LOAEL = 1,000 mg/kg/
                                  nonrodents         day based upon
                                  (rabbit)           liver enlargement
                                                     and decreased body
                                                     weight gains and
                                                     food consumption
                                                    Developmental NOAEL
                                                     = 200 mg/kg/day
                                                    LOAEL = 1,000 mg/kg/
                                                     day based upon
                                                     increased
                                                     incidences of 27
                                                     presacral vertebrae
                                                     and 27 presacral
                                                     vertebrae with 13th
                                                     ribs in the fetuses
------------------------------------------------------------------------

[[Page 55487]]


870.3800                         Reproduction and   Parental/Systemic
                                  fertility          NOAEL = 20 mg/kg/
                                  effects (rat)      day
                                                    LOAEL = 100 mg/kg/
                                                     day (M/F), based
                                                     upon increased
                                                     liver weights in
                                                     the P and F1 males
                                                     and increased
                                                     adrenal weights in
                                                     the P females
                                                    Offspring/Systemic
                                                     NOAEL = 20 mg/kg/
                                                     day
                                                    LOAEL = 100 mg/kg/
                                                     day (M/F), based
                                                     upon pup mortality
                                                    Reproductive NOAEL =
                                                     100 mg/kg/day
                                                    LOAEL = not
                                                     determined
------------------------------------------------------------------------
870.4300                         Combined chronic   NOAEL = 64 mg/kg/day
                                  toxicity/          (M/F)
                                  carcinogenicity   LOAEL = not
                                  rodents (rat)      determined
                                                    Equivocal evidence
                                                     of carcinogenicity
------------------------------------------------------------------------
870.4300                         2-Year feed/       NOAEL = 1.83/2.07 mg/
                                  carcinogenic       kg/day (M/F)
                                  (rat)             LOAEL = 187/216 (M/
                                                     F), based upon
                                                     effects on the
                                                     incisors including
                                                     abnormal
                                                     amelogenesis
                                                    No evidence of
                                                     carcinogenicity
------------------------------------------------------------------------
870.4100                         Chronic toxicity   NOAEL = 4.62/4.79 mg/
                                  nonrodents (dog)   kg/day (M/F)
                                                    LOAEL = 23.5/23.8 mg/
                                                     kg/day (M/F), based
                                                     upon increased
                                                     alkaline
                                                     phosphatase
                                                     activity, increased
                                                     liver weights,
                                                     liver enlargement
                                                     (females), and
                                                     incidences of
                                                     centrilobular
                                                     hepatocellular
                                                     swelling in the
                                                     liver
------------------------------------------------------------------------
                                 78-Week            NOAEL = 242/243 (M/
                                  carcinogenic       F)
                                  mouse             LOAEL = 484/482 (M/
                                                     F), based on a
                                                     slight increase in
                                                     the incidence of a
                                                     fatty change in the
                                                     centrilobular
                                                     hepatocytes in
                                                     males
------------------------------------------------------------------------
870.4200                         Carcinogenicity    NOAEL = 241/243 mg/
                                  mouse              kg/day (M/F)
                                                    LOAEL = not
                                                     determined
                                                    No evidence of
                                                     carcinogenicity
------------------------------------------------------------------------
Non-guideline                    13-Week study:     A toxic level of the
                                  Effect on          test substance did
                                  proliferative      not affect the
                                  activity of        proliferative
                                  testicular         activity of
                                  interstitial       testicular
                                  cells in rat       interstitial cells
------------------------------------------------------------------------
870.5100                         Gene mutation -    When tested up to
                                  reverse gene       cytotoxic levels,
                                  mutation assay     there was no
                                  in bacteria        evidence of induced
                                                     mutant colonies
                                                     over background
------------------------------------------------------------------------
Non-guideline                    Gene mutation -    When tested up to
                                  reverse gene       cytotoxic levels,
                                  mutation assay     there was no
                                  in bacteria        evidence of induced
                                                     mutant colonies
                                                     over background
------------------------------------------------------------------------
870.5300                         Gene mutation -    When tested up to
                                  in vitro forward   cytotoxic levels,
                                  gene mutation      mutagenic in the
                                  assay in mouse     presence of S9
                                  lymphoma cells     activation and
                                                     equivocal for
                                                     mutagenicity in the
                                                     absence of S9
                                                     activation
------------------------------------------------------------------------
870.5375                         Cytogenetics - in  When tested up to
                                  vitro mammalian    cytotoxic levels,
                                  cytogenetics       not clastogenic in
                                  assay              the presence or
                                                     absence of S9
                                                     activation
------------------------------------------------------------------------
870.5395                         Bone marrow        There was no
                                  micronucleus       significant
                                  assay              increase in the
                                                     frequency of
                                                     micronucleated
                                                     polychromatic
                                                     erythrocytes in
                                                     bone marrow after
                                                     any treatment time
------------------------------------------------------------------------
870.5550                         Unscheduled DNA    When tested up to
                                  synthesis (UDS)    cytotoxic levels,
                                  in primary rat     there was no
                                  hepatocytes/       evidence that UDS
                                  mammalian cell     was induced by the
                                  cultures           test substance
------------------------------------------------------------------------

B. Toxicological Endpoints

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

[[Page 55488]]

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 factors (SF) 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 SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 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 etoxazole used for human risk assessment is shown in 
Table 2 of this unit:

      Table 2.--Summary of Toxicological Dose and Endpoints for Etoxazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       Special FQPA SF* and   Study and Toxicological
          Exposure Scenario                 Assessment, UF      LOC for Risk Assessment          Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of  NOAEL = None mg/kg/day   FQPA SF = 1X             A dose and endpoint
 age)                                  UF = Not applicable (N/  aPAD = acute RfD / FQPA   attributable to a
                                        A).                      SF.                      single dose were not
                                       Acute RfD = None.......  = None.................   identified in the data
                                                                                          base including the
                                                                                          developmental toxicity
                                                                                          studies
-----------------------------------------------------------------------------------------
Acute dietary (general population      NOAEL = None mg/kg/day   FQPA SF = 1X             A dose and endpoint
 including infants and children)       UF = N/A...............  aPAD = acute RfD / FQPA   attributable to a
                                       Acute RfD = None.......   SF.                      single dose were not
                                                                = None.................   identified in the data
                                                                                          base including the
                                                                                          developmental toxicity
                                                                                          studies
-----------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 4.62 mg/kg/day   FQPA SF = 1X             Chronic oral toxicity
                                       UF = 100...............  cPAD = chronic RfD /      study - dog
                                       Chronic RfD = 0.046 mg/   FQPA SF.                LOAEL = 23.5 mg/kg/day
                                        kg/day.                 = 0.046 mg/kg/day......   based upon increased
                                                                                          alkaline phosphatase
                                                                                          activity, increased
                                                                                          liver weights, liver
                                                                                          enlargement (females),
                                                                                          and incidences of
                                                                                          centrilobular
                                                                                          hepatocellular
                                                                                          swelling in the liver
-----------------------------------------------------------------------------------------
Short-term incidental oral (1-30       NOAEL = 4.62 mg/kg/day   Residential LOC for MOE  Chronic oral toxicity
 days)                                                           = 100                    study - dog
                                                                Occupational = NA......  LOAEL = 23.5 mg/kg/day
                                                                                          based upon increased
                                                                                          alkaline phosphatase
                                                                                          activity, increased
                                                                                          liver weights, liver
                                                                                          enlargement (females),
                                                                                          and incidences of
                                                                                          centrilobular
                                                                                          hepatocellular
                                                                                          swelling in the liver
-----------------------------------------------------------------------------------------
Intermediate-term incidental oral (1-  NOAEL = 4.62 mg/kg/day   Residential LOC for MOE  Chronic oral toxicity
 6 months)                                                       = 100                    study - dog
                                                                Occupational = NA......  LOAEL = 23.5 mg/kg/day
                                                                                          based upon increased
                                                                                          alkaline phosphatase
                                                                                          activity, increased
                                                                                          liver weights, liver
                                                                                          enlargement (females),
                                                                                          and incidences of
                                                                                          centrilobular
                                                                                          hepatocellular
                                                                                          swelling in the liver
-----------------------------------------------------------------------------------------
Short-term dermal (1 to 30 days)       Dermal (or oral) study   Residential LOC for MOE  No hazard quantitation
                                        NOAEL = None             = N/A                    required for any
                                                                Occupational LOC for      duration. No systemic
                                                                 MOE = N/A.               effects noted up to
                                                                                          1,000 mg/kg/day in the
                                                                                          28-day dermal rat
                                                                                          study. There are no
                                                                                          developmental or
                                                                                          reproductive concerns
-----------------------------------------------------------------------------------------
Intermediate-term dermal (1 to 6       Dermal (or oral) study   Residential LOC for MOE  No hazard quantitation
 months)                                NOAEL = None             = N/A                    required for any
                                                                Occupational LOC for      duration. No systemic
                                                                 MOE = N/A.               effects noted up to
                                                                                          1,000 mg/kg/day in the
                                                                                          28-day dermal rat
                                                                                          study. There are no
                                                                                          developmental or
                                                                                          reproductive concerns
-----------------------------------------------------------------------------------------

[[Page 55489]]

Long-term dermal (>6 months)           Dermal (or oral) study   Residential LOC for MOE  No hazard quantitation
                                        NOAEL = None             = N/A                    required for any
                                                                Occupational LOC for      duration. No systemic
                                                                 MOE = N/A.               effects noted up to
                                                                                          1,000 mg/kg/day in the
                                                                                          28[dash]day dermal rat
                                                                                          study. The weight-of-
                                                                                          the-evidence from the
                                                                                          28-day, 90-day, 52-
                                                                                          week interim chronic
                                                                                          toxicity/
                                                                                          carcinogenicity and
                                                                                          the 2-year chronic
                                                                                          toxicity/
                                                                                          carcinogenicity rat
                                                                                          studies shows that the
                                                                                          systemic effects
                                                                                          (mainly in the liver)
                                                                                          occur around the same
                                                                                          dose levels from short-
                                                                                          term through long-term
                                                                                          exposure without
                                                                                          increasing in
                                                                                          severity. Therefore,
                                                                                          results of the 28-day
                                                                                          dermal toxicity study
                                                                                          can be applicable to
                                                                                          long-term exposure
-----------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days)   Oral study NOAEL = 4.62  Residential LOC for MOE  Chronic oral toxicity
                                        mg/kg/day                = 100                    study - dog
                                       (inhalation absorption   Occupational LOC for     LOAEL = 23.5 mg/kg/day
                                        rate = 100%).            MOE = 100.               based upon increased
                                                                                          alkaline phosphatase
                                                                                          activity, increased
                                                                                          liver weights, liver
                                                                                          enlargement (females),
                                                                                          and incidences of
                                                                                          centrilobular
                                                                                          hepatocellular
                                                                                          swelling in the liver
-----------------------------------------------------------------------------------------
Intermediate-term inhalation (1 to 6   Oral study NOAEL = 4.62  Residential LOC for MOE  Chronic oral toxicity
 months)                                mg/kg/day                = 100                    study - dog
                                       (inhalation absorption   Occupational LOC for     LOAEL = 23.5 mg/kg/day
                                        rate = 100%).            MOE = 100.               based upon increased
                                                                                          alkaline phosphatase
                                                                                          activity, increased
                                                                                          liver weights, liver
                                                                                          enlargement (females),
                                                                                          and incidences of
                                                                                          centrilobular
                                                                                          hepatocellular
                                                                                          swelling in the liver
-----------------------------------------------------------------------------------------
Long-term inhalation (>6 months)       Oral study NOAEL = 4.62  Residential LOC for MOE  Chronic oral toxicity
                                        mg/kg/day                = 100                    study - dog
                                       (inhalation absorption   Occupational LOC for     LOAEL = 23.5 mg/kg/day
                                        rate = 100%).            MOE = 100.               based upon increased
                                                                                          alkaline phosphatase
                                                                                          activity, increased
                                                                                          liver weights, liver
                                                                                          enlargement (females),
                                                                                          and incidences of
                                                                                          centrilobular
                                                                                          hepatocellular
                                                                                          swelling in the liver
-----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)              Classified as ``not likely to be carcinogenic to humans''
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. There are currently no 
food/feed uses or tolerances for etoxazole. Risk assessments were 
conducted by EPA to assess dietary exposures from etoxazole in food as 
follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. An endpoint of concern attributable to a single oral 
dose was not selected for either the general U.S. population (including 
infants and children) or the females 13-50 years old population 
subgroup for etoxazole; therefore, an acute dietary exposure analysis 
was not performed. EPA evaluated the suitability of the developmental 
toxicity study in rabbits in which the developmental NOAEL of 200 mg/
kg/day is based upon increased incidences of 27 presacral vertebrae and 
27 presacral vertebrae with 13th ribs (skeletal variations) in the 
fetuses at the LOAEL of 1,000 mg/kg/day (limit dose). Although these 
developmental effects may be attributed to a single dose, EPA concluded 
that these effects are minor in magnitude and were observed only at the 
limit dose (1,000 mg/kg/day). Therefore, quantitation of the acute risk 
was not performed.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM[reg]) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1994-1996 and 1998 nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. The following assumptions were made 
for the chronic exposure assessments: The assessment assumed that 100% 
of the proposed crops were treated and that all treated crops and 
livestock had residues of concern at the tolerance level. The general 
U.S. population and all population subgroups have exposure and risk 
estimates which are below EPA's LOC (i.e., the cPADs are all below 
100%). The most highly exposed subgroup is children 1 to 2 years of 
age, which utilizes 5% of the cPAD.
    iii. Cancer. EPA has determined that etoxazole is not likely to be 
a human carcinogen and EPA therefore, does not expect it to pose a 
cancer risk. As a

[[Page 55490]]

result, a quantitative cancer dietary exposure analysis was not 
performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for etoxazole 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 etoxazole.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW model is used to predict pesticide concentrations in 
shallow ground water. For a screening-level assessment for surface 
water EPA will use FIRST (a Tier I model) before using PRZM/EXAMS (a 
Tier II model). The FIRST model is a subset of the PRZM/EXAMS model 
that uses a specific high-end runoff scenario for pesticides. While 
both FIRST and PRZM/EXAMS incorporate an index reservoir environment, 
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 LOC.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to etoxazole they are further 
discussed in Unit III.E.
    Based on the FIRST and SCI-GROW models, the EECs of etoxazole for 
chronic exposures are estimated to be 1.77 parts per billion (ppb) for 
surface water and 0.242 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). Etoxazole is not 
registered for use on any sites that would result in residential 
exposure.
    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.''
    EPA does not have, at this time, available data to determine 
whether etoxazole has a common mechanism of toxicity with other 
substances. 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 etoxazole and 
any other substances and etoxazole 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 etoxazole 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 policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/
cumulative.

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 qualitative 
evidence of increased susceptibility following exposure to etoxazole in 
the rat reproduction study. Therefore, EPA performed a Degree of 
Concern Analysis to determine the LOC for the effects observed when 
considered in the context of all available toxicity data, and to 
identify any residual uncertainties after establishing toxicity 
endpoints and traditional UF to be used in the risk assessment of this 
chemical. If residual uncertainties are identified, EPA examines 
whether these residual uncertainties can be addressed by a special FQPA 
safety factor and, if so, the size of the factor needed.
    In performing the Degree of Concern Analysis, EPA noted that the 
effects in the pups in the rat reproduction study are well-
characterized with a clear NOAEL. In addition, the pup effects occur at 
the same dose as maternal toxicity. Furthermore, the doses selected for 
various risk assessment scenarios are lower than the doses that caused 
off spring toxicity. There are no residual uncertainties for prenatal/
postnatal toxicity in this study. Therefore, although there is evidence 
of increased qualitative susceptibility in the rat reproduction study, 
the concern is low.
    For the reasons stated above, EPA has concluded that there is low 
concern for prenatal and/or postnatal toxicity resulting from exposure 
to etoxazole.
    3. Conclusion. There is a complete toxicity data base for etoxazole 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. EPA determined that the 
10X SF to protect infants and children should be removed. The FQPA 
factor is removed for the following reasons. The toxicological data 
base is complete for FQPA assessment and there is low concern for 
prenatal and/or postnatal toxicity resulting from exposure to 
etoxazole. The chronic dietary food exposure assessment assumed that 
100% of the proposed crops were treated and that all treated crops and 
livestock had residues of concern at the tolerance level. By using 
these screening-level assumptions, actual exposures/risks will not be 
underestimated. In addition, the dietary drinking water assessment 
utilized modeling results which included conservative assumptions for 
the parent and all degradates of concern. Since conservative 
assumptions were used in the water models where environmental fate data 
are lacking, the water exposure assessment will not

[[Page 55491]]

underestimate the potential risks for infant, and children. Finally, 
there are no registered or proposed residential uses for etoxazole.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. As stated above, an endpoint of concern attributable 
to a single oral dose was not identified in the hazard data base for 
either the general U.S. population (including infants and children) or 
the females 13-50 years old population subgroup. Therefore, no acute 
risk is expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to etoxazole 
from food will utilize 1% of the cPAD for the U.S. population, 3% of 
the cPAD for all infants less than 1-year old and 5% of the cPAD for 
children 1 to 2 years old. There are no residential uses for etoxazole 
that result in chronic residential exposure to etoxazole. In addition, 
there is potential for chronic dietary exposure to etoxazole in 
drinking water. After calculating DWLOCs and comparing them to the EECs 
for surface water and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in Table 3 of this unit:

                                   Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Etoxazole
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Surface Water EEC   Ground Water EEC    Chronic DWLOC
                   Population Subgroup                       cPAD mg/kg/day      %cPAD (Food)          (ppb)              (ppb)              (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                        0.046                  1               1.77              0.242              1,600
-------------------------------------------------------------------------------------------------
All infants (< 1 year old)                                             0.046                  3               1.77              0.242                440
-------------------------------------------------------------------------------------------------
Children (1-2 years old)                                               0.046                  5               1.77              0.242                440
-------------------------------------------------------------------------------------------------
Children (3-5 years old)                                               0.046                  3               1.77              0.242                440
-------------------------------------------------------------------------------------------------
Children (6-12 years old)                                              0.046                  1               1.77              0.242                450
-------------------------------------------------------------------------------------------------
Youth (13-19 years old)                                                0.046                 <1               1.77              0.242              1,400
-------------------------------------------------------------------------------------------------
Adults (20-49 years old)                                               0.046                 <1               1.77              0.242              1,600
-------------------------------------------------------------------------------------------------
Females (13-49 years old)                                              0.046                 <1               1.77              0.242              1,400
-------------------------------------------------------------------------------------------------
Adults (50+ years old)                                                 0.046                 <1               1.77              0.242              1,600
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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). Etoxazole 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 LOC.
    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). Etoxazole is 
not

[[Page 55492]]

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 LOC.
    5. Aggregate cancer risk for U.S. population. Etoxazole has been 
classified as a ``not likely human carcinogen.'' Therefore, etoxazole 
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, and to infants and children from aggregate 
exposure to etoxazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    No Codex, Canadian or Mexican maximum residue limits have been 
established for residues of etoxazole.

V. Conclusion

    Therefore, the tolerances are established for residues of 
etoxazole, 2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-
ethoxyphenyl]-4,5-dihydrooxazole, in or on cotton, undelinted seed at 
0.05 ppm; cotton, gin byproducts at 1.0 ppm; fruit, pome, group 11 at 
0.20 ppm; apple, wet pomace at 0.50 ppm; strawberry at 0.50 ppm; 
tangerine at 0.10 ppm; liver of cattle, goat, horse, and sheep at 0.01 
ppm; fat of cattle, goat, horse, and sheep at 0.02 ppm; and milk, fat 
at 0.01 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0289 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
25, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0289, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual

[[Page 55493]]

issues(s) in the manner sought by the requestor would be adequate to 
justify the action requested (40 CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled 
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive Order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of section 408(n)(4) of the FFDCA. For these same reasons, 
the Agency has determined that this rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments 
(65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive Order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 16, 2003.
James Jones,
Director, Office of Pesticide Programs.

 Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

 2. Section 180.593 is added to read as follows:

Sec.  180.593  Etoxazole; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide etoxazole, 2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-
2-ethoxyphenyl]-4,5-dihydrooxazole, in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Apple, wet pomace....................................               0.50
Cattle, fat..........................................               0.02
Cattle, liver........................................               0.01
Cotton, gin byproducts...............................                1.0
Cotton, undelinted seed..............................               0.05
Fruit, pome, group 11................................               0.20
Goat, fat............................................               0.02
Goat, liver..........................................               0.01
Horse, fat...........................................               0.02
Horse, liver.........................................               0.01
Milk, fat............................................               0.01
Sheep, fat...........................................               0.02
Sheep, liver.........................................               0.01
Strawberry...........................................               0.50
Tangerine\1\.........................................              0.10
------------------------------------------------------------------------
\1\There are no U.S. registrations for use of etoxazole on tangerines as
  of September 26, 2003.

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

[FR Doc. 03-24368 Filed 9-25-03; 8:45am]
BILLING CODE 6560-50-S
NOTE FROM FAN:
Fruit, pome, group 11:
apple
apple, dried pomace
apple, juice
apple, wet pomace
crabapple
fruit, pome
loquat
mayhaw
pear
pear, oriental
quince