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http://www.epa.gov/fedrgstr/EPA-PEST/2005/April/Day-22/p8123.htm

[Federal Register: April 22, 2005 (Volume 70, Number 77)]
[Rules and Regulations]
[Page 20821-20831]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ap05-6]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0388; FRL-7702-4]

Tetraconazole; Time-Limited Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-
tetrafluoroethoxy)propyl]-1H-1,2,4-triazole in or on sugarbeet roots at
0.05 parts per million (ppm), sugarbeet top at 3.0 ppm, sugarbeet dried
pulp at 0.15 ppm, sugarbeet molasses at 0.15 ppm, meat of cattle, goat,
horse, and sheep at 0.05 ppm, liver of cattle, goat, horse, and sheep
at 4.0 ppm, fat of cattle, goat, horse, and sheep at 0.30 ppm, meat
byproducts except liver of cattle, goat, horse and sheep at 0.10 ppm
and milk at 0.05 ppm. Sipcam Agro USA, Inc. requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA). Registrations will be
limited to the following States: Colorado, Minnesota, Michigan,
Montana, North Dakota, Nebraska, and Wyoming where use has previously
occurred under section 18 of FIFRA. The tolerances will expire on
November 30, 2012.

DATES: This regulation is effective April 22, 2005. Objections and
requests for hearings must be received on or before June 21, 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-2004-0388. 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: Mary Waller, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9354; e-mail address: waller.mary@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 code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code 311),, e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be

[[Page 20822]]

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

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 ``FederalRegister'' 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.gov/opptsfrs/home/guidelin.htm.

II. Background and Statutory Findings

In the Federal Register of October 14, 1999 (64 FR 55714) (FRL-
6382-7), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of three pesticide
petitions (9F5066, 9F6023 and 7E4830) by Sipcam Agro, USA, Inc., 300
Colonial Center Parkway, Roswell, GA 30076, formerly of 70 Mansell
Court, Suite 230, Rosewell, GA 30076. The petitions requested that 40
CFR part 180 be amended by establishing tolerances for residues of the
fungicide tetraconazole, in or on the following raw agricultural
commodities: beets, sugar at 0.01 ppm, beets, sugar, roots at 0.1 ppm,
beets, sugar, tops at 7.0 ppm, beets, sugar, pulp, dried at 0.3 ppm,
and beets, sugar, molasses at 0.3 ppm, cattle, meat at 0.01 ppm, cattle
meat byproducts at 2.0 ppm, cattle fat at 0.1 ppm, and milk at 0.02 ppm
(9F5066); peanuts meat (hulls removed) at 0.03 ppm, peanuts meal at
0.03 ppm, and peanuts oil at 0.1 ppm (9F6023); and imported bananas at
0.2 ppm (7E4830). Petition 7E4830 was later withdrawn. Petition 9F6023
was placed in abeyance by the petitioner. There were no comments
received in response to the notice of filing. The tolerances will
expire on February 28, 2009.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances 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 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 tetraconazole 1-
[2-(2,4-dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy)propyl]-1H-1,2,4-
triazole in or on sugarbeet roots at 0.05 ppm; sugarbeet tops at 3.0
ppm; sugarbeet dried pulp at 0.15 ppm; sugarbeet molasses at 0.15 ppm;
meat of cattle, goat, horse, and sheep at 0.05 ppm; liver of cattle,
goat, horse, and sheep at 4.0 ppm; fat of cattle, goat, horse, and
sheep at 0.30 ppm; meat byproducts except liver of cattle, goat, horse
and sheep at 0.10 ppm; and milk at 0.05 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 tetraconazole are
discussed below. Table 1 of this unit presents the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.

1. Acute toxicity. Acute toxicity data were as follows: Acute oral
lethal dose (LD)50 = 1,031 milligrams/kilogram (mg/kg)
(toxicity category III); acute dermal LD50 < 2,000 mg/kg
(toxicity category III); acute inhalation lethal concentration
(LC)50 = 3.66 mg/liter (L) (toxicity category IV); primary
eye irritation - clear by 72 hours (toxicity category III); primary
skin irritation - slight irritation (toxicity category IV); and dermal
sensitization - negative.

2. Developmental toxicity in rats. A developmental toxicity study
was conducted using rats gavaged with doses of 0, 5, 22.5, 100 mg/kg/
day from days 2 through 15 of gestation. The maternal toxicity LOAEL is
100 mg/kg/day based on decreased body weight gain, and food consumption
and increased liver and kidney weights. The maternal toxicity NOAEL is
22.5 mg/kg/day. Developmental toxicity was noted at 100 mg/kg/day and
consisted of an increased incidence of small fetuses, and supernumerary
ribs. The LOAEL and NOAEL for developmental toxicity were 100 and 22.5
mg/kg/day, respectively.

3. Development toxicity study in rabbits. A developmental toxicity
study was conducted using rabbits gavaged with doses of 0, 7.5, 15, and
30 mg/kg/day from days 6 through 18 of gestation. Compound-related
maternal toxicity was limited to depressed body weight gain during the
dosing period. No treatment-related effects occurred in maternal
mortality, clinical signs, food consumption, or cesarean parameters.
The maternal LOAEL is 30 mg/kg/day based on decreased body weight gain.
The maternal NOAEL is 15 mg/kg/day. No treatment-related effects in
developmental parameters were noted. The developmental LOAEL is greater
than 30 mg/kg/day. The developmental NOAEL is 30 mg/kg/day, the highest
dose tested (HDT).

4. Two-generation reproduction study. A two-generation reproduction
study was conducted using rats fed diets with dose levels of 0, 10, 70,
or 490 ppm (0, 0.7, 4.9, and 35.5 mg/kg/day for males or 0, 0.8, 5.9,
and 40.6 mg/kg/day for females). The LOAEL for parental toxicity was 70
ppm (4.9 mg/kg/day in males and 5.9 mg/kg/day in females) based on
increased mortality in P generation females. The NOAEL was 10 ppm (0.7
mg/kg/day in males and 0.8 mg/kg/day in females). The LOAEL for
offspring toxicity was 490 ppm (40.6

[[Page 20823]]

mg/kg/day from the P generation female intake) based on decreased
litter weight and mean pup weight in litters of all generations before
weaning and increased relative liver weights at weaning in both sexes
of all litters. The NOAEL was 70 ppm (5.9 mg/kg/day). The LOAEL for
reproductive toxicity was 70 ppm (4.9 mg/kg/day for males and 5.9 mg/
kg/day for females) based on increased mean gestation duration in P
generation parental females and related evidence of compound toxicity
in the parturition process. The NOAEL was 10 ppm (0.7 mg/kg/day for
males and 0.8 for females).

5. Chronic toxicity. A chronic toxicity study was conducted using
dogs fed diets containing 0, 22.5, 90, or 360 ppm for 52 weeks.
Treatment-related effects at the high dose included slight but
nonsignificant body weight reductions in both sexes from study week 3
to termination; significantly increased alkaline phosphatase, gamma-
glutamyltransferase, alanine aminotransferase and ornithine carbamoyl
transferase in both sexes from study week 13 to 52, increased absolute
and relative liver and kidney weights for both sexes, and
histopathological changes in both organs. In the mid-dose group,
effects were manifested as increased absolute and relative kidney
weights for males correlated with histopathological findings in the
males (apparent hypertrophy in cortical tubules of the kidneys in one
male). No adverse effects were seen at the low dose. The NOAEL is 22.5
ppm (equivalent to achieved intakes of 0.73 mg/kg/day for males or 0.82
mg/kg/day for females) and the LOAEL is 90 ppm (equivalent to achieved
intakes of 2.95 mg/kg/day for males or 3.33 mg/kg/day for females)
based on increased absolute and relative kidney weights and
histopathological changes in the male kidney.

6. Carcinogenicity study--i. Rats. A 2-year carcinogenicity study
was conducted using rats fed diets containing 0, 10, 80, 640 and 1,280
ppm for males and 0, 10, 80, and 640 ppm for females. The LOAEL is 640
ppm (27.7/39.4 mg/kg/day in male/female) based on histopathology of the
bone (osseous hypertrophy of the cranium/parietal bone), pale and
thickened incisors, and decreased absolute and relative adrenal and
pituitary weights in males; decreased body weight (at terminal
sacrifice) in females. The NOAEL is 80 ppm (3.4/4.4 mg/kg/day in male/
female). Under the conditions of this study, there was no evidence of a
treatment-related increase in tumor incidence when compared to
controls. Therefore, tetraconazole is not a carcinogen in this study.

ii. Mice. An 80-week carcinogenicity study was conducted using mice
fed diets containing 0, 10, 90, 800, or 1,250 ppm (0, 1.4, 12, 118, or
217 mg/kg/day for males; 0, 1.6, 14.8, 140, or 224 mg/kg/day for
females). The systemic toxicity LOAEL is 90 ppm (12 and 14.8 mg/kg/day
for males and females, respectively), based on increased liver weight
and hepatocyte vacuolation in both sexes and increased kidney weights
in males. The NOAEL is 10 ppm (1.4 and 1.6 mg/kg/day for males and
females, respectively). There was evidence of increased incidence of
combined benign and malignant liver tumors in mice of both sexes
treated with 95.05% tetraconazole at 800 ppm (48% for males and 22% for
females) and 1,250 ppm (84% for males and 64% for females) compared to
the control (20% for males and 0% for females). The doses were found to
be adequate to test the carcinogenic potential based on the reduction
of body weight gain and increased mortality at the highest dose.

7. Mutagenicity studies. A battery of mutagenicity studies yielded
negative results in Salmonella typhimurium, cultured Chinese hamster
ovary (CHO) cells, and mouse lymphoma cells. There was no evidence of
clastogenicity in vitro or in vivo and tetraconazole did not induce
unscheduled DNA synthesis in human HeLa cells.

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 calculate an acute or chronic reference dose (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by the appropriate UF (RfD =
NOAEL/UF). Where an additional safety factor is retained due to
concerns unique to the FQPA, this additional factor is applied to the
RfD by dividing the RfD by such additional factor. The acute or chronic
population adjusted dose (aPAD or cPAD) is a modification of the RfD to
accommodate this type of FQPA Safety Factor (SF).

For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.

The linear default risk methodology (Q*) is the primary method
currently 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 tetraconazole used for human risk assessment is shown in
the following Table 1.

[[Page 20824]]

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Section 18 tolerances
have been established (40 CFR 180.557) for the residues of
tetraconazole, in or on the following raw agricultural commodities:
Sugarbeet roots, tops, molasses and dried pulp and cattle meat, meat
byproducts and milk. The tolerances proposed in this assessment are
numerically different from the current section 18 tolerance levels
which were based on higher use rates. Additionally, tolerances are
being proposed for goat, horse, and sheep commodities in addition to
cattle. Since section 18 registrations have been authorized for the use
of tetraconazole on soybeans to control soybean rust, this dietary
assessment for use of tetraconazole on sugarbeets assumes residues on
soybean products as well as poultry and swine commodities. Risk
assessments were conducted by EPA to assess dietary exposures from
tetraconazole in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model
(DEEMTM-FCIDTM) analysis evaluated the individual
food consumption as reported by respondents in the United States
Department of Agriculture (USDA)1994-1996 Nationwide Continuing Surveys
of Food Intake by Individuals (CSFII) and accumulated exposure to the
chemical for each commodity. The following assumptions were made for
the acute exposure assessments: Tolerance level residues were used for
all commodities and it was assumed that 100% of all crops were treated.

ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEMTM-FCIDTM analysis evaluated
the individual food consumption as reported by respondents in the USDA
1994-1996 Nationwide CSFII and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: Tolerance level residues were assumed for all
soybean commodities, poultry liver, poultry meat byproducts, and eggs.
Anticipated residues were assumed for poultry fat, poultry meat, milk,
and all sugarbeet, goat, horse, sheep, cattle, and swine commodities.
It was assumed that 100% of all crops were treated.

iii. Cancer. In conducting the cancer dietary risk assessment the
Dietary Exposure Evaluation Model (DEEMTM-FCIDTM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1994-1996 CSFII and accumulated exposure to the
chemical for each commodity. The following assumptions were made for
the cancer exposure assessments: Tolerance level residues were assumed
for poultry liver, poultry meat byproducts, and eggs. Anticipated
residues were assumed for poultry fat, poultry meat, milk, and all
soybean, sugarbeet, cattle, goat, sheep, horse and swine commodities.
For sugarbeets, 52 percent crop treated (PCT) was assumed and 67 PCT
was assumed for soybeans. Additionally, water was included as a dietary
commodity with a tetraconazole concentration of 0.00446 ppm, equal to
the 30-year average surface water concentration.

iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of the FFDCA authorizes EPA to use available data and information on
the anticipated residue levels of pesticide residues in food and the
actual levels of pesticide chemicals that have been measured in food.
If EPA relies on such information, EPA must require that data be
provided 5 years after the tolerance is established, modified, or left
in effect, demonstrating that the levels in food are not above the
levels anticipated. Following the initial data submission, EPA is
authorized to require similar data on a time frame it deems
appropriate. As required by section 408(b)(2)(E) of the FFDCA, EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.

Section 408(b)(2)(F) of the FFDCA states that the Agency may use
data on the actual percent of food treated for assessing chronic
dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis
to show what percentage of the food derived from such crop is likely to
contain such pesticide residue; Condition 2, that the exposure estimate
does not underestimate exposure for any significant subpopulation
group; and Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the

[[Page 20825]]

Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
under section 408(b)(2)(F) of the FFDCA, EPA may require registrants to
submit data on PCT.

The Agency used PCT information as follows:

The cancer dietary exposure analysis used 52 PCT for sugarbeets and
67 PCT for soybeans. The sugarbeet 52 PCT was based on information from
the United States Department of Agriculture (USDA) and from a
propietary source used by the Agency. The soybean 67 PCT was taken from
the maximum acreage per state allowed on Section 18 applications for
tetraconizole on soybeans; the maximum acreages for the 28 States with
these Section 18 applications were added together and divided by an
estimate of the total number of acres where soybeans would be grown in
the United States.

The Agency believes that the three conditions listed in Unit
C.1.iv. have been met. With respect to Condition 1, PCT estimates are
derived from Federal and private market survey data which are reliable
and have a valid basis.For acute dietary exposure estimates, EPA uses
an estimated maximum PCT. The exposure estimates resulting from this
approach reasonably represent the highest levels to which an individual
could be exposed, and are unlikely to underestimate an individual's
acute dietary exposure. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions 2 and 3, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which tetraconazole
may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for tetraconazole 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 tetraconazole.

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 (screenimg concentration in ground water) 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. While both FIRST and PRZM/EXAMS incorporate an
index reservoir environment, the PRZM/EXAMS model includes a percent
crop (PC) area factor as an adjustment to account for the maximum PC
coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %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 tetraconazole they are
further discussed in the aggregate risk sections in Unit III. E.
Based on the PRZM 3.12/ EXAMS 2.7.97 model, the estimated EECs of
tetraconazole for acute exposures are estimated to be 8.38 parts per
billion (ppb) for surface water, representing the 1 in 10 year annual
peak concentrations. The surface water EECs are estimated to be 5.58
ppb for chronic non-cancer exposures (the 1 in 10 year annual average
concentration) and 4.46 ppb for chronic cancer exposures (the 30 year
annual average concentration).

Based on the SCI-GROW model the ground water EECs for all exposures
are estimated to be 0.5 ppb.

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). Tetraconazole 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 tetraconazole and any
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that tetraconazole 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/.

However, the Agency does have concern about potential toxicity to
1,2,4-triazole and two conjugates, triazolylalanine and triazolyl
acetic acid, metabolites common to most of the triazole fungicides. To
support the extension of existing parent triazole-derivative fungicide
tolerances, EPA conducted an interim human health assessment for
aggregate exposure to 1,2,4-triazole. The exposure and risk estimates
presented in this assessment are overestimates of actual likely
exposures and therefore, should be considered to be highly conservative.

[[Page 20826]]

Based on this assessment EPA concluded that for all exposure durations
and population subgroups, aggregate exposures to 1,2,4-triazole are not
expected to exceed its level of concern. This assessment should be
considered interim due to the ongoing series of studies being conducted
by the U.S. Triazole Task Force (USTTF). Those studies are designed to
provide the Agency with more complete toxicological and residue
information for free triazole. Upon completion of the review of these
data, EPA will prepare a more sophisticated assessment based on the
revised toxicological and exposure databases.

The toxicological database for 1,2,4-triazole is
incomplete. Preliminary summary data presented by the USTTF to EPA
indicate that the most conservative endpoint currently available for
use in a risk assessment for 1,2,4-triazole is a LOAEL of 15 mg/kg/day,
based on body weight decreases in male rats in the reproductive
toxicity study (currently underway). This endpoint, with an uncertainty
factor of 1,000 was used for both acute and chronic dietary risk,
resulting in an RfD of 0.015 mg/kg/day. The uncertainty factor of 1,000
includes an additional 10X safety factor for the protection of infants
and children. The resulting PAD is 0.015 mg/kg/day.

ii. Dietary exposure. The USTTF conducted an acute dietary exposure
assessment based on the highest triazole-derivative fungicide tolerance
level combined with worst-case molecular weight and plant/livestock
metabolic conversion factors. This approach provides a conservative
estimate of all sources for 1,2,4-triazole except the in vivo
conversion of parent compounds to free-triazole following dietary
exposure. The degree of animal in vivo conversion is dependent on the
identity of the parent fungicide. In rats, this conversion ranges from
0 to 77%--the in vivo conversion for tetraconazole is 77%. For purposes
of this interim assessment, EPA used the dietary exposure estimates
provided by the USTTF adjusted based on the highest rate of conversion
observed for any of the parent triazole-derivative fungicides to
account for this metabolic conversion. The assessment includes residue
estimates for all food commodities with either existing or pending
triazole-derivative fungicide registrations. The resulting acute
dietary exposure estimates are extremely conservative and range from
0.0032 mg/kg/day for males 20+ years old to 0.014 mg/kg/day for
children 1 to 6 years old. Estimated risks range from 22 to 93% of the
PAD. In order to estimate chronic exposures via food, EPA used the
70th percentile of exposures from the acute assessment. The
70th percentile is a common statistic used to estimate
central tendency from a distribution and its use to estimate chronic
exposures is appropriate. Estimated risks range from 10 to 47% of the
PAD. The dietary assessment does not include potential exposure via
residues in water. It is emphasized that the use of both highest-
tolerance-level residues and the highest in vivo conversion factor
results in dietary risk estimates that far exceed the likely actual risk.

iii. Non-dietary exposure. Triazole-derivative fungicides are
registered for use on turf, resulting in the potential for residues of
free triazole in grass and/or soil. Thus, dermal and incidental oral
exposures to children may occur. It is believed that residues of free
triazole occur within the plant matrices and are not available as
surface residues. Therefore, direct dermal exposure to 1,2,4-triazole
due to contact with plants is not likely to occur. However, dermal
exposure to parent fungicide and subsequent in vivo conversion to
1,2,4-triazole may occur. In order to account for this indirect
exposure to free triazole, EPA used a conversion factor of 10%, which
is the highest rate of in-vivo conversion observed in rats for any of
the triazole-derivative fungicides with registrations on turf.

Incidental oral exposure may occur by direct and indirect routes. To
assess direct exposure, EPA used a conversion factor of 17%, which is
the highest rate of conversion to free triazole observed in any of the
plant metabolism studies. As with indirect dermal exposure, EPA used a
conversion factor of 10% in its assessment of indirect oral exposure.
Based on residential exposure values estimated for propiconazole
(0.0005 mg/kg/day via the dermal route and 0.03 mg/kg/day via the oral
route) and the conversion factors described above, combined direct and
indirect dermal exposures are estimated to be less than 0.0001 mg/kg/
day and combined oral exposures are estimated to be less than 0.0019
mg/kg/day. The overall residential exposure is likely to be less than
0.0020 mg/kg/day. Relative to the 15 mg/kg/day point of departure, this
gives an MOE of approximately 7,500 for children. Based on the current
set of uncertainty factors, the target MOE is 1,000, indicating that
the risk associated with residential exposure to 1,2,4-triazole for
children is below EPA's level of concern. The adult dermal exposure
estimate is slightly less than that of children. Incidental oral
exposure is not expected to occur with adults.

iv. Drinking water. Modeled estimates of 1,2,4-triazole residues in
surface and ground water, as reported by the USTTF, and the DWLOC
approach were used to address exposure to free triazole in drinking
water. Estimated environmental concentrations (EECs) of free triazole
in ground water were obtained from the SCI-GROW model and range from
0.0 to 0.026 ppb, with the higher concentrations associated with uses
on turf. Surface water EECs were obtained using the FIRST model. Acute
surface water EECs ranged from 0.29 to 4.64 ppb for agricultural uses
and up to 32.1 ppb from use on golf course turf. EPA notes that ground
water monitoring studies in New Jersey and California showed maximum
residues of 16.7 and 0.46 ppb, respectively, which exceed the SCI-GROW
estimates significantly. Contrarily, preliminary monitoring data from
USDA's Pesticide Data Program for 2004 show no detectable residues of
1,2,4-triazole in any drinking water samples, either treated or
untreated (maximum limit of detection (LOD) = 0.73 ppb, n=40 each).

v. Aggregate exposure. In estimating aggregate exposure, EPA
combined potential dietary and non-dietary sources of 1,2,4-triazole.
To account for the drinking water component of dietary exposure, EPA
used the DWLOC approach, as noted above. The DWLOC represents a maximum
concentration of a chemical in drinking water at or below which
aggregate exposure will not exceed EPA's level of concern. In
considering non-dietary exposure, EPA used the residential exposure
estimate for children and applied it to all population subgroups. As
previously noted, this estimate is considered to be highly conservative
for children. Since adults are not expected to have non-dietary oral
exposure to 1,2,4-triazole and that pathway makes up the majority of
the residential exposure estimate for children, application of that
exposure estimate to adults is considered to be extremely conservative.
Residential exposure is expected to occur for short-term and/or
intermediate-term durations, and therefore, is not a component in the
acute or chronic aggregate exposure assessment. In order to assess
aggregate short-term and intermediate-term exposure, EPA combined the
residential exposure estimate and the background level of exposure to
free triazole via food. Less than 1% of lawns in the United States are
expected to be treated with triazole fungicides, so the likelihood of
co-occurring dietary and residential exposures is very low.
With the exception of the acute DWLOCs for infants and children 1 to

[[Page 20827]]

6 years old, all DWLOCs are greater than the largest EEC (surface water
estimate from use on turf). The EEC's for these two population groups
exceed the DWLOC's by 1.1 to 3.2-fold, a result typically interpreted
to mean that aggregate exposure exceeds EPA's level of concern.
Although comparing the EEC's and the acute DWLOCs for infants and
children 1 to 6 years old indicate that aggregate exposure may exceed
the aPAD of 0.015 mg/kg/day, EPA does not believe this to be the case
due to the extremely conservative nature of the overall assessment
(highest-tolerance level residues, 100% crop treated (CT), 77% in vivo
conversion factor). Furthermore, the drinking water monitoring data
from the Pesticide Data Program found no detectable residues of either
free triazole or parent triazole - derivative fungicide in its
preliminary 2004 dataset, indicating that neither parent compounds nor
1,2,4-triazole are likely to occur in drinking water. For all exposure
durations and population subgroups, EPA does not expect aggregate
exposures to 1,2,4-triazole to exceed its level of concern.
The Agency is planning to conduct a more sophisticated human health
assessment in 2005 following submission and review of the ongoing
toxicology and residue chemistry studies for 1,2,4-triazole.

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. 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 uncertainty factors and/or special FQPA safety
factors, as appropriate.

2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of rat or rabbit fetuses to in utero exposure
to tetraconazole. In the developmental toxicity study in rats,
developmental effects were seen at the same dose that induced maternal
toxicity. In the developmental toxicity study in rabbits, no
developmental toxicity was seen at the HDT. In the two-generation
reproduction study, offspring toxicity occurred at doses higher than
the dose that induced parental/systemic toxicity. There are no concerns
or residual uncertainties for prenatal and/or postnatal toxicity.
Additionally, there is no concern for neurotoxicity resulting from
exposure to tetraconazole since there was no evidence of neurotoxicity
in short-term studies in rats, mice and dogs; and a long-term toxicity
study in dogs.

3. Conclusion. Based on the following, EPA concluded that the
additional safety factor for the protections of infants and children
could be removed:
• There is no quantitative or qualitative evidence of
increased susceptibility of rat and rabbit fetuses to in utero exposure
in developmental studies.
• There is no quantitative or qualitative evidence of
increased susceptibility of rat offspring in the multi-generation
reproduction study.
• There are no residual uncertainties for prenatal/postnatal toxicity.
• The toxicological database is complete for FQPA assessment.
• The chronic non-cancer dietary food exposure assessment
utilizes anticipated residue data and assumed 100% CT.
• The chronic assessment will not underestimate exposure or
risk since the refinement is based on reliable data derived from
studies designed to produce worst-case residues.
• At this time, only agricultural uses have been proposed
for tetraconazole. There are no uses that would result in residential
or recreational exposures.

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 U.S. EPA 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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
tetraconazole will occupy 0.5% of the aPAD for females 13 to 49 years
old, the only population subgroup for which an acute toxicity endpoint
was determined. In addition, there is potential for acute dietary
exposure to tetraconazole 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 aPAD, as
shown in the following Table 2.

[[Page 20828]]

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
tetraconazole from food will utilize 3.9% of the cPAD for the U.S.
population, 11.1% of the cPAD for non-nursing infants and 8.9% of the
cPAD for all infants < 1 year old. There are no residential uses for
tetraconazole that result in chronic residential exposure to
tetraconazole. In addition, there is potential for chronic dietary
exposure to tetraconazole 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 following Table 3.

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). Tetraconazole 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. The risk does not exceed the Agency's level of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Tetraconazole 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. The risk does not exceed the
Agency's level of concern.

5. Aggregate cancer risk for U.S. population. The estimated cancer
risk for the proposed use on sugarbeets and existing section 18
exemptions for soybeans is 2.5 x 10-6, a value that falls
within the Agency's risk standard for cancer in the range of 1 x 10-6.

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 tetraconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology
Adequate enforcement methodology (capillary gas chromotography with
electron capture detector (GC/ECD)) 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
There are no established Codex, Canadian, or Mexican Maximum
Residue Limits (MRLs) established for tetraconazole.

C. Conditions
The following conditions will be applied to the registration of
tetraconazole for use on sugarbeets:

1. Registration and tolerances will be time-limited to allow review
of triazole data and completion of the triazole risk assessment.

2. Registrations will be limited to the following States: Colorado,
Minnesota, Michigan, Montana, North Dakota, Nebraska, and Wyoming where
use has previously occurred under section 18 of FIFRA.

3. The registrant will be required to provide one additional side-
by-side sugarbeet field trial comparing two and six applications of
Eminent 125SL at 0.10 lb ai/acre/application.

4. The registrant will be required to provide a 28 day inhalation
study.

5. Well documented estimates of how many pounds of tetraconazole
will be placed on the market to treat sugarbeets.

[[Page 20829]]

6. Tetraconazole use reporting on sugarbeets. This information
should be reported as how many pounds of tetraconazole will be applied
per acre on sugarbeets.

V. Conclusion

Therefore, the tolerances are established for residues of
tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-
tetrafluoroethoxy)propyl]-1H-1,2,4-triazole in or on sugarbeet root at
0.05 ppm, sugarbeet top at 3.0 ppm, sugarbeet dried pulp at 0.15 ppm,
sugarbeet molasses at 0.15 ppm, meat of cattle, goat, horse, and sheep
at 0.05 ppm, liver of cattle, goat, horse, and sheep at 4.0 ppm, fat of
cattle, goat, horse, and sheep at 0.30 ppm, meat byproducts except
liver of cattle, goat, horse and sheep at 0.10 ppm and milk at 0.05 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. 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),
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-2004-0388 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 June 21, 2005.

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 (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-2004-0388, 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: 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 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

[[Page 20830]]

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: April 14, 2005.
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), 346a and 371.

• 2. Section 180.557 is revised to read as follows:

Sec. 180.557 Tetraconazole; tolerances for residues.
(a) General. [Reserved]
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. Tolerances are
established for residues of the fungicide, tetraconazole 1-[2-(2,4-
dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy)propyl]-1H-1,2,4-triazole
in or on the following commodities:

[FR Doc. 05-8123 Filed 4-21-05; 8:45 am]
BILLING CODE 6560-50-S