[Federal Register Volume 70, Number 138 (Wednesday, July 20, 2005)]
[Rules and Regulations]
[Pages 41619-41625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14284]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0170; FRL-7723-3]


Etoxazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
etoxazole in or on grapes and tree nuts, including pistachios. 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 July 20, 2005. Objections and 
requests for hearings must be received on or before September 19, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0170. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
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 either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., 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.

FOR FURTHER INFORMATION CONTACT: Kable Davis, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0415; e-mail address: [email protected].



[[Page 41620]]

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), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 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 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 Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of September 26, 2003 (68 FR 55485) (FRL-
7324-8), 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 
3F6739) by Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200, 
P.O. Box 8025, Walnut Creek, CA 94596. The petition requested that 40 
CFR 180.593 be amended by establishing a tolerance for residues of the 
insecticide etoxazole, [2-(2, 6-difluorophenyl)-4-[4-(1, 1-
dimethylethyl)-2-ethoxyphenyl]-4, 5-dihydrooxazole], in or on grapes at 
0.50 parts per million (ppm), raisins at 1.5 ppm, tree nuts (Crop Group 
14), including pistachios at 0.01 ppm, and almond, hulls at 2.0 ppm. 
That notice included a summary of the petition prepared by Valent 
U.S.A. Corporation, the registrant. A comment was received from a 
private citizen who challenged the value of using animal testing for 
evaluating pesticide toxicity. This commenter's objections have been 
addressed in prior rulemaking documents in the Federal Register of 
October 29, 2004 (69 FR 63083) (FRL-7681-9).
    Section 408(b)(2)(A)(i) of 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 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 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 FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances of November 26, 1997 (62 FR 62961) 
(FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of 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 FFDCA, for a tolerance for residues of etoxazole on grapes 
at 0.50 ppm, raisins at 1.5 ppm, tree nuts (Crop Group 14), including 
pistachios at 0.01 ppm, and almond, hulls at 2.0 ppm. EPA's assessment 
of exposures and risks associated with establishing the tolerance 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by etoxazole as well 
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies 
reviewed are discussed in the Federal Register of September 26, 2003 
(68 FR 55485) (FRL-7324-1).

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 of concern are 
identified 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.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors (UF);'' the ``special FQPA safety 
factor;'' and, the ``default FQPA safety factor.'' By the term 
``traditional UF,'' EPA is referring to those additional UFs used prior 
to FQPA passage to account for database deficiencies. These traditional 
UFs have been incorporated by the FQPA into the additional safety 
factor for the protection of infants and children. The term ``special 
FQPA safety factor'' refers to those safety factors that are deemed 
necessary for the protection of infants and children primarily as a 
result of the FQPA. The ``default FQPA safety factor'' is the 
additional 10X safety factor that is mandated by the statute unless it 
is decided that there are reliable data to choose a different 
additional factor

[[Page 41621]]

(potentially a traditional UF or a special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by an UF of 100 to account for 
interspecies and intraspecies differences and any traditional UFs 
deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor 
or the default FQPA safety factor is used, 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 safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-5), one in a million (1 X 10-6), or one in ten 
million (1 X 10-7). 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 discussed in Unit III.B. of the final rule 
published in the Federal Register of September 26, 2003 (68 FR 55485) 
(FRL-7324-8).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.593) for the residues of etoxazole in or on a 
variety of raw agricultural commodities. The tolerances include: Apple, 
wet pomace 0.50 ppm, cattle fat 0.02 ppm, cattle liver 0.01 ppm, cotton 
gin byproducts 1.0 ppm, cotton undelinted seed 0.05 ppm, pome fruit 
(group 11) 0.20 ppm, goat fat 0.02 ppm, goat liver 0.01 ppm, horse fat 
0.02 ppm, horse liver 0.01 ppm, milk fat 0.01 ppm, sheep fat 0.02 ppm, 
sheep liver 0.01 ppm, strawberry 0.50 ppm, tangerine 0.10 ppm. 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 
milligram/kilogram/day (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 the chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEMTM/FCID), which 
incorporates food consumption data as reported by respondents in the 
United States Department of Agriculture (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.
    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 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 FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/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 1 model) before 
using PRZM/EXAMS (a Tier 2 model). The FIRST model is a subset of the 
PRZM/EXAMS model that uses a specific high-end runoff scenario for 
pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir 
environment, and both models include 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 screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used 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 the aggregate risk sections in this Unit.

[[Page 41622]]

    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.''
    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 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 based on reliable data 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 UFs (safety) in calculating a dose level 
that poses no appreciable risk to humans. 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 safety factor value based on 
the use of traditional UFs and/or special FQPA safety factors, as 
appropriate.
    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 UFs 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 underestimate the 
potential risks for infants, 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 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 EPA's 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

[[Page 41623]]

drinking water as a part of the aggregate risk assessment process.
    1. Acute risk. 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, 4% of 
the cPAD for all infants (<1 year old), and 8% of the cPAD for children 
1-2 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 the following Table 1:

                                   Table 1.--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                  4               1.77              0.242                440
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                               0.046                  8               1.77              0.242                420
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (3-5 years old)                                               0.046                  5               1.77              0.242                440
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (6-12 years old)                                              0.046                  2               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 level of 
concern.
    4. 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 registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    5. Aggregate cancer risk for U.S. population. 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 (gas chromatography/mass-selective 
detector or nitrogen/phosphorus detector) 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: [email protected].

B. International Residue Limits

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

V. Conclusion

    Therefore, the tolerance is established for residues of etoxazole, 
[2-(2, 6-difluorophenyl)-4-[4-(1, 1-dimethylethyl)-2-ethoxyphenyl]-4, 
5-dihydrooxazole], in or on grapes at 0.50 ppm, raisins at 1.5 ppm, 
tree nuts (Crop Group 14), including pistachios at 0.01 ppm, and 
almond, hulls at 2.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of 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 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-2005-0170 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before September 
19, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in

[[Page 41624]]

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 (1900L), 
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 Suite 350,1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. 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 ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0170, 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 ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. 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 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 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 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

[[Page 41625]]

submit a rule report, which includes a copy of the rule, to each House 
of the Congress and to the Comptroller General of the United States. 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
this final rule in the Federal Register. This final rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: July 12, 2005.
Lois Ann Rossi,
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. Section 180.593 is amended by alphabetically adding commodities to 
the table in paragraph (a) to read as follows:


Sec.  180.593  Etoxazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Almond, hulls..................................                      2.0
                                * * * * *
Grape..........................................                 0.50 ppm
Grape, raisin..................................                  1.5 ppm
                                * * * * *
Nut, tree, group 14............................                 0.01 ppm
Pistachio......................................                 0.01 ppm
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 05-14284 Filed 7-19-05; 8:45 am]
BILLING CODE 6560-50-S