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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]
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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, 
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 |