Triticonazole; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: September 27, 2002 (Volume 67, Number 188)]
[Rules and Regulations]
[Page 60950-60960]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se02-22]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0199; FRL-7200-6]

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

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SUMMARY: This regulation establishes a tolerance for residues of
triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-
(1 H-1,2,4-triazol-1-ylmethyl)cyclopentanol, in or on barley, grain;
barley, hay; barley, straw; wheat, forage; wheat, grain; wheat, hay;
and wheat, straw. Aventis CropScience USA requested this tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA). Subsequent to the
filing of this petition, Bayer Corporation acquired Aventis CropScience
to form Bayer Crop Science. Therefore, the registrant is now Bayer Crop
Science.

DATES: This regulation is effective September 27, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0199,
must be received on or before November 26, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0199 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Mary L. Waller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460;
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 affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112............... Animal production
311............... Food manufacturing
32532............. Pesticide
manufacturing
------------------------------------------------------------------------

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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of this
Document and Other Related Documents?

1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.

[[Page 60951]]

A frequently updated electronic version of 40
CFR part 180 is available at , 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.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0199. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of March 14, 2002 (67 FR 11476) (FRL-6825-
1), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C.
346a, as amended by the FQPA (Public Law 104-170), announcing the
filing of a pesticide petition (PP 9F6051) by Aventis Crop Science USA,
2 TW Alexander Drive, Research Triangle Park, NC 27709. This notice
included a summary of the petition prepared by Aventis CropScience USA,
the registrant. Subsequent to the filing of this petition, Bayer
Corporation acquired Aventis CropScience to form Bayer Crop Science.
Therefore, the registrant is now Bayer Crop Science. There were no
comments received in response to the notice of filing.
The petition requested that 40 CFR 180.583 be amended by
establishing tolerances for residues of the fungicide triticonazole,
(1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-
triazol-1-ylmethyl)cyclopentanol, in or on barley, grain; barley, hay;
barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat,
straw at 0.05 parts per million (ppm).
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 (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 a tolerance for residues of triticonazole,
(1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1 H-1,2,4-
triazol-1-ylmethyl)cyclopentanol, on barley, grain; barley, hay;
barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat,
straw 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 triticonazole are
discussed in the following Table 1 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 toxicity in NOAEL = M: 2, F: 22.3 mg/kg/day
rodents-rat LOAEL = M: 19.8, F: 1183.5 mg/kg/day based
on M: Increases in the incidence of
adrenocortical fatty vacuolation in males
receiving £= 250 ppm, F: Hair
loss, decreased food efficiencies,
adrenocortical fatty vacuolation, zona
reticularis degeneration, centriacinar
hepatocytic fatty vacuolation, and more
severe anisocytosis and spherocytosis in
females receiving £=12,500 ppm.
----------------------------------------------------------------------------------------------------------------
870.3200 28-Day dermal toxicity-rat NOAEL = Dermal and systemic: 1,000 mg/kg/
day (limit dose).
LOAEL = Were not identified.
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental in Maternal NOAEL = 200 mg/kg/day
rodents-rat LOAEL = 1,000 mg/kg/day based on reduction
in mean body weight gain from GD 12-16.
Developmental NOAEL = 200 mg/kg/day
LOAEL = 1,000 mg/kg/day based on treatment-
related increases in unilateral and
bilateral supernumerary ribs.
----------------------------------------------------------------------------------------------------------------

[[Page 60952]]

870.3700 Prenatal developmental in Maternal NOAEL = 25 mg/kg/day
nonrodents-rabbit LOAEL = 50 mg/kg/day based on decreased
body weight gain, reduced food
consumption, and mortality.
Developmental NOAEL = 50 mg/kg/day
LOAEL = 75 mg/kg/day based on cranial
variations, abortion, and increased pre-
and post-implantation losses.
----------------------------------------------------------------------------------------------------------------
870.3800 Reproduction and fertility Parental/Systemic NOAEL = 37.5 mg/kg/day
effects-rat LOAEL = 250 mg/kg/day based on reduced body
weights of the F₀ females and the F₁ males
and females, F₀ maternal mortality, and
microscopic lesions in the adrenal gland
of F₀ and F₁ males and females.
Reproductive NOAEL = 37.5 mg/kg/day
LOAEL = 250 mg/kg/day based on decreased
fertility of the F₁ animals, reduced F₁
and F₂ pup survival, and reduced F₁ and F₂
pup body weight.
----------------------------------------------------------------------------------------------------------------
870.4100 Chronic toxicity dogs NOAEL = 25 mg/kg/day
LOAEL = 150 mg/kg/day based on decreased
absolute body weights of females,
decreased weight gain by males and
females, and treatment-related toxicity to
the eye, liver, and adrenals.
----------------------------------------------------------------------------------------------------------------
870.4200 Carcinogenicity rats NOAEL = M: £= 203.6, F: 38.3 mg/
kg/day
LOAEL = M: Adverse effects were not
observed, F: 286.6 mg/kg/day based on
decreased body weight and body weight
gain, adrenal cortical and liver toxicity.
----------------------------------------------------------------------------------------------------------------
870.4300 Carcinogenicity mice NOAEL = M: 17.4; F: 20.1 mg/kg/day
LOAEL = M: 202.2, F: 209.5 mg/kg/day based
on decreased body weight gain and liver
toxicity. No significant increase in the
incidence of neoplastic lesions. No
evidence of compound-induced
carcinogenicity.
----------------------------------------------------------------------------------------------------------------
870.5250 Gene mutation There was no evidence of induced mutant
colonies over background.
----------------------------------------------------------------------------------------------------------------
870.5300 Cytogenetics There was no consistent evidence of
chromosomal aberrations induced over
background.
----------------------------------------------------------------------------------------------------------------
870.5375 Chromosome aberration There was no significant increase in the
frequency of micronucleated polychromatic
erythrocytes in bone marrow after any
tested triticonazole dose at any harvest
time.
----------------------------------------------------------------------------------------------------------------
870.5395 Micronucleus There was no evidence that unscheduled DNA
synthesis, as determined by radioactive
tracer procedures [nuclear silver grain
counts]
was induced.
----------------------------------------------------------------------------------------------------------------
870.6200 Acute neurotoxicity NOAEL = 400 mg/kg/day
screening battery-rat LOAEL = 2,000 mg/kg/day (limit dose) based
on dose-related increases in motor
activity in both sexes...
----------------------------------------------------------------------------------------------------------------
870.6200 Subchronic neurotoxicity NOAEL = M: 695; F: 820 mg/kg/day
screening battery-rat LOAEL = Not established.
----------------------------------------------------------------------------------------------------------------
870.6300 Developmental Study is not available. Identified this as
neurotoxicity a data gap.
----------------------------------------------------------------------------------------------------------------
870.7485 Metabolism and Study is not available. Identified this as
pharmacokinetics-rat a data gap.
----------------------------------------------------------------------------------------------------------------
870.7600 Dermal penetration-rat Dermal Absorption Factor [C \14\]: 2 %.
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

The dose at which no adverse effects are observed (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 lowest dose at which adverse effects of concern are
identified (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 intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to 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 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.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when

[[Page 60953]]

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 (MOE_cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for triticonazole used for human risk assessment is shown in
the following Table 2:

Table 2.--Summary of Toxicological Dose and Endpoints for Triticonazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of NOAEL = 50 mg/kg/day FQPA SF = 1 Developmental study-
age) UF = 100............... aPAD = acute RfD / FQPA rabbit
Acute RfD = 0.5 mg/kg/ SF = 0.5 mg/kg/day. Developmental LOAEL =
day. 75 mg/kg/day based on
cranial variations,
abortions, and
increased pre-and post-
implantation losses.
-----------------------------------------------------------------------------------------
Acute Dietary (General population NOAEL = 400 mg/kg/day FQPA SF = 1 Acute Neurotoxicity
including infants and children) UF = 100............... aPAD = acute RfD / FQPA study
Acute RfD = 4 mg/kg/day SF = 4 mg/kg/day. LOAEL = 2,000 mg/kg/day
based on dose-related
increases in motor
activity in both
sexes.
-----------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL= 17.4 mg/kg/day FQPA SF = 1x Carcinogenicity study-
UF = 100............... cPAD = chronic RfD / mouse
Chronic RfD = 0.17 mg/ FQPA SF = 0.17 mg/kg/ LOAEL = M: 202.2, F:
kg/day. day. 209.5 mg/kg/day based
on decreased body
weight gain and liver
toxicity.
-----------------------------------------------------------------------------------------
Incidental Oral Short-Term NOAEL= 25 (Maternal LOC for MOE = 100 Developmental study-
toxicity) (Residential) rabbit
Maternal LOAEL = 50 mg/
kg/day based on
decreased body weight
gain, reduced food
consumption, and
mortality.
-----------------------------------------------------------------------------------------
Incidental Oral Intermediate-Term NOAEL = 17.4 LOC for MOE = 100 Carcinogenicity study-
(Residential) mouse
LOAEL = M: 202.2, F:
209.5 mg/kg/day based
on decreased body
weight gain and liver
toxicity.
-----------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days) Inhalation (or oral) LOC for MOE = 100 Developmental study-
(Residential) study NOAEL= 25 mg/kg/ (Residential) rabbit
day (inhalation Maternal LOAEL = 50 mg/
absorption rate = kg/day based on
100%) (maternal decreased body weight
toxicity) gain, reduced food
consumption, and
mortality.
-----------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week Inhalation (or oral) LOC for MOE = 100 Carcinogenicity study-
to several months) (Residential) study NOAEL = 17.4 mg/ (Residential) mouse
kg/day (inhalation LOAEL = M: 202.2, F:
absorption rate = 209.5 mg/kg/day based
100%) on decreased body
weight gain and liver
toxicity.
-----------------------------------------------------------------------------------------
Long-Term Inhalation (Several months Inhalation (or oral) LOC for MOE = 100 Carcinogenicity study-
to lifetime) (Residential) study NOAEL= 17.4 mg/ (Residential) mouse
kg/day (inhalation LOAEL = M: 202.2, F:
absorption rate = 209.5 mg/kg/day based
100%) on decreased body
weight gain and liver
toxicity.
-----------------------------------------------------------------------------------------
Cancer This fungicide has not
been classified. While
the Agency has
acceptable data to
assess carcinogenicity
in both sexes of mice
and female rats,
acceptable data are
not available in male
rats. Since the doses
tested in male rats
were too low to assess
the carcinogenic
potential for
triticonazole, the
cancer risk assessment
was conducted using a
potency factor (Q1*)
of 8.56 x 10-\3\ based
on data available at
lower doses in the
carcinogenicity study
in male rats.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

[[Page 60954]]

Due to the lack of adequate carcinogenicity data in male rats, the
Agency is not currently able to classify triticonazole in terms of its
carcinogenicity. To assess the potential cancer risk associated with
triticonazole, the Agency analyzed the pituitary gland and skin tumors
seen in the male rat carcinogenicity data along with tumor data for
female rats (pituitary adenomas and carcinomas; mammary gland
fibroadenomas) and male mice (pulmonary adenomas and carcinomas, and
liver adenomas), and female mice (pulmonary adenomas and carcinomas).
Structure-Activity data for other triazole fungicides indicate that
some are carcinogenic while others are not. For these uses, the Agency
developed a Q1* based upon the doses in the male rat carcinogenicity
study and the apparent increase in tumor incidence to provide a ``worst
case'' upper limit on cancer. It is unclear from the currently
available data whether this apparent increase in tumor incidence in
male rats is statistically significant. Therefore, by assuming that the
increase in tumor incidence is statistically significant, the use of
the Q1* approach is worst-case.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Triticonazole is a new
chemical and currently there are no tolerances established in 40 CFR
180.583. Risk assessments were conducted by EPA to assess dietary
exposures from triticonazole 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 (DEEM\TM\)
analysis evaluated the individual food consumption as reported by
respondents in the 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: A Tier I acute DEEM\TM\ analysis was performed.
This analysis assumed tolerance-level residues and 100 percent crop
treated (PCT).
ii. Chronic Exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the 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 chronic exposure
assessments: Tolerance level residues and 100% crop treated (CT)
estimates were assumed.
iii. Cancer. The cancer dietary risk assessment was conducted using
a potency factor (Q1*) of 8.56 x 10-\3\, based on male CD
rat pituitary combined adenomas and carcinoma tumor rates from the rat
carcinogenicity study. Although the Agency determined that the doses
tested in both sexes of mice and female rats were adequate to assess
the carcinogenic potential of triticonazole, the doses tested in male
rats were too low. A hypothetic Q1* value has been calculated as a
worse-case, upper bound estimate of cancer risk until a partial
carcinogenicity study in male rats, in which higher dose levels are
evaluated, becomes available. The cancer risk estimate (food only) for
the U.S. population (total) is 7.0 x 10-\7\. This risk
estimate is based upon a dietary exposure of 0.000082 mg/kg/day.
In conducting this chronic (cancer) dietary risk assessment the
Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated the
individual food consumption as reported by respondents in the 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 chronic (cancer) exposure
assessments: Tolerance level residues and 100% CT estimates were
assumed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for triticonazole 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 triticonazole.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in groundwater. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. 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 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 triticonazole they are
further discussed in the aggregate risk sections in Unit III.E.
Based on the PRZM/EXAMS and SCI-GROW models, the estimated
environmental concentrations (EECs) of triticonazole for acute
exposures are estimated to be 0.9 parts per billion (ppb) for surface
water and 0.008 ppb for ground water. The EECs for chronic exposures
are estimated to be 0.6 ppb for surface water and 0.008 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). Triticonazole is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative exposure to 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

[[Page 60955]]

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 triticonazole has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
triticonazole 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 triticonazole 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 final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

1. In general. FFDCA section 408 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 margin of exposure
(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. The Agency concluded that
there is no concern for pre- and/or postnatal toxicity resulting from
exposure to triticonazole. Developmental toxicity studies showed that
triticonazole had limited maternal toxicity, with no significant
evidence of increased sensitivity or susceptibility to offspring. In a
developmental toxicity study on rats, there were no compound-related
deaths, abortions, or clinical signs of toxicity throughout the study
period. Based on reduction in mean body weight gain, the maternal
toxicity LOAEL is 1,000 mg/kg/day and the NOAEL is 200 mg/kg/day.
Treatment did not cause any statistically significant or treatment-
related changes in gestational or cesarean section parameters at any
treatment level. Based on a treatment-related increase in unilateral
and bilateral supernumerary ribs, the developmental toxicity LOAEL is
1,000 mg/kg/day and the developmental NOAEL is 200 mg/kg/day. In a
developmental study on rabbits, there was maternal toxicity. Based on
decreased body weight gain after dosing initiation, reduced food
consumption, and mortality, the LOAEL for maternal toxicity is 50 mg/
kg/day and the NOAEL is 25 mg/kg/day. No treatment-related increased
incidences of external or visceral malformations/variations were
observed in any group as compared with the controls. In the high-dose
group slight increases in the percent of fetuses with variations in
midline cranial sutures were observed. Based on cranial variations,
abortion, and pre- and post-implantation losses, the developmental
LOAEL is 75 mg/kg/day and the NOAEL is 50 mg/kg/day. In a two-
generation reproduction study with rats the systemic parental LOAEL is
250 mg/kg/day based on reduced body weights of F₀ females
and F₁ males and females and microscopic lesions in the
adrenal gland of F₀ and F₁ males and females. The
reproductive NOAEL is 37.5 mg/kg/day and the LOAEL is 250 mg/kg/day
based on F₀ maternal mortality, decreased fertility of the
F₁ animals, reduced F₁ and F₂ pup
survival and body weights.
3. Conclusion. There is a complete toxicity data base for
triticonazole and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposure. EPA determined
that the 10X safety factor 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.
? There is no indication of quantitative or qualitative
increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure.
? The requirement of a developmental neurotoxicity study is
not based on criteria reflecting special concern for the developing
fetuses or young which are generally used for requiring a DNT study -
and a safety factor (e.g., neuropathy in adult animals; CNS
malformations following prenatal exposure; brain weight or sexual
maturation changes in offspring; and/or functional changes in
offspring) - and, therefore, does not warrant an FQPA safety factor.
? The dietary (food and drinking water) and residential
exposure assessments will contain all identified metabolites and/or
degradates of concern and will not underestimate the potential
exposures for infants and children.
The Agency has identified the need for a developmental
neurotoxicity study for this compound based upon the following
considerations:
? Clinical signs indicative of neurotoxicity in the rat and
mice, acute oral and inhalation toxicity studies; micronucleus assay;
and chronic toxicity study in the dog.
? Concern for structure-activity relationship. Triticonazole
is structurally related to triademenol, biteranol, uniconazole,
propiconazole, etaconazole, azaconazole, hexaconazole, and
cyproconazole. All of these compounds, except etaconazole and
hexaconazole, have shown a developmental toxicity LOAEL below the
maternal toxicity LOAEL in rats and/or rabbits.
Although EPA has required submission of a developmental
neurotoxicity study (DNT) for triticonazole, EPA believes it has
sufficient reliable toxicity data to make a safety finding for infants
and children without use of the additional 10X safety factor. The DNT
study will help to complete the overall picture of triticonazole's
neurotoxicity profile; however, the toxicity data currently available
to the Agency indicate that the DNT is unlikely to affect the manner in
which triticonazole is regulated. Three considerations are of
importance here. First, the requirement for the DNT for triticonazole
was based only on the presence of clinical signs indicative of
neurotoxicity in adult animals and the concern for Structure-Activity
Relationship (similar chemicals demonstrating neurotoxicity in adult
animals). Generally, a DNT is not requested unless the underlying data
reveal some special concern for the developing fetuses or young (e.g.,
neuropathy in adult animals; CNS malformations following prenatal
exposure; brain weight or sexual maturation changes in offspring; and/
or functional changes in offspring). No such evidence was seen in
triticonazole studies. Second, although the request for the DNT
indicates some uncertainty regarding neurotoxic effects, existing
triticonazole toxicity data demonstrate that neurotoxic effects are
unlikely to be a regulatory endpoint other than with regard to acute
effects for the general population and that even here the overall
conservativeness of the EPA assessment indicates that it is unlikely
that the DNT results will cause any regulatory change. The available
data show that the neurotoxic effects resulting from triticonazole
exposure all occurred at dose levels far exceeding the levels chosen
for making risk evaluations and regulatory

[[Page 60956]]

determinations. In other words, a large margin of safety already exists
to protect the young against any potential neurotoxic effects that
might be seen in the DNT. Clinical signs of neurotoxicity (the reason
for requiring a DNT) were seen only at a very high dose (2,000 mg/kg/
day; twice the Limit Dose) in the acute neurotoxicity study. In the
subchronic neurotoxicity, no evidence of neurotoxicity or
neuropathology was seen at the highest dose tested that approached the
Limit Dose. The NOAEL was 695 mg/kg/day in males and 820 mg/kg/day in
females; a LOAEL was not established in the subchronic neurotoxicity
study.
In contrast, the NOAEL of 50 mg/kg/day used for acute dietary risk
assessment for Females 13-50 years of age (i.e. pre-natal children) is
8X lower than the NOAEL of 400 mg/kg/day established following a single
dose in the acute neurotoxicity study and the LOAELs from these two
studies differ by approximately 27X. Similarly, the NOAEL of 17.4 mg/
kg/day used for chronic dietary risk assessment is 40X lower than the
NOAEL of 700 mg/kg/day established following repeated dosing in the
subchronic neurotoxicity study. Additionally, although the NOAEL of 400
mg/kg/day from the acute neurotoxicity study was used for acute dietary
risk assessment for the General Population including infants and
children the choice of this NOAEL was itself very conservative. The
NOAEL is believed to be conservative since the NOAEL could be an
artifact of the dose selection (0, 80, 400 or 2,000 mg/kg/day). Because
of this wide gap in the doses tested, the ``true'' NOAEL could have
been higher (i.e., somewhere between 400 and 2,000 mg/kg/day) than the
one established. Additionally, the NOAEL of 400 mg/kg/day used for
acute dietary risk assessment for the General Population is 5X lower
than the dose (2,000 mg/kg/day) that caused neurotoxic effects in that
study. Third, in addition to the DNT being requested due to effects
seen in adult animals (and not due to neurological findings in the
young) and the large margin of safety between these effects and
regulatory endpoints, it is worth reiterating that there is no evidence
(quantiative or qualitative) of increased susceptibility in the pre-
natal developmental or two generation reproduction toxicity studies.

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: 2L/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 groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP 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, OPP 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
triticonazole will occupy < 1% of the aPAD for all population subgroup.
In addition, there is potential for acute dietary exposure to
triticonazole in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 3:

Table 3.--Aggregate Risk Assessment for Acute Exposure to Triticonazole
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 4 < 1.0 0.9 0.008 1.4 x 10
\5\
---------------------------------------------------------------------------
All infants 4 < 1.0 0.9 0.008 4.0 x 10
\4\
---------------------------------------------------------------------------
Females (13-50 years) 0.5 < 1.0 0.9 0.008 1.5 x 10
\4\
---------------------------------------------------------------------------
Children (1-6 years) 4 < 1.0 0.9 0.008 4.0 x 10
\4\
---------------------------------------------------------------------------
Males (13-19 years) 4 < 1.0 0.9 0.008 1.4 x 10
\5\
----------------------------------------------------------------------------------------------------------------

The EECs for assessing acute aggregate dietary risk are 0.008
[mu]g/L (for groundwater, based on SCI GROW) and 0.9 [mu]g/L (in
surface water, based on PRZM/EXAMS). The back-calculated DWLOCs (Table
3) for assessing acute aggregate dietary risk range from 15,000 [mu]g/L
for the population subgroup females (13 to 50 years old) to 140,000
[mu]g/L for the U.S. population and males (13 to 19 years old).
The SCI GROW and PRZM/EXAMS acute EECs are less than the Agency's
level of comparison (the DWLOC value for each population subgroup) for

[[Page 60957]]

triticonazole residues in drinking water as a contribution to acute
aggregate exposure. EPA thus concludes with reasonable certainty that
residues of triticonazole in drinking water will not contribute
significantly to the aggregate acute human health risk and that the
acute aggregate exposure from triticonazole residues in food and
drinking water will not exceed the Agency's level of concern (100% of
the Acute PAD) for acute dietary aggregate exposure by any population
subgroup. EPA generally has no concern for exposures below 100% of the
Acute PAD, because it is a level at or below which daily aggregate
dietary exposure over a lifetime will not pose appreciable risks to the
health and safety of any population subgroup. This risk assessment is
considered high confidence, very conservative, and very protective of
human health.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
triticonazole from food will utilize < 1% of the cPAD for all
population subgroups. There are no residential uses for triticonazole
that result in chronic residential exposure to triticonazle. In
addition, there is potential for chronic dietary exposure to
triticonazole in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in the
following Table 4:

Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Triticonazole
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.17 < 1.0 0.6 0.008 5.9 x 10
\3\
---------------------------------------------------------------------------
All infants 0.17 < 1.0 0.6 0.008 1.7 x 10
\3\
---------------------------------------------------------------------------
Children (1-6 years) 0.17 < 1.0 0.6 0.008 1.7 x 10
\3\
---------------------------------------------------------------------------
Females (13-50 years) 0.17 < 1.0 0.6 0.008 5.1 x 10
\3\
---------------------------------------------------------------------------
Males (55 years +) 0.17 < 1.0 0.6 0.008 5.9 x 10
\3\
----------------------------------------------------------------------------------------------------------------

The EECs for assessing chronic aggregate dietary risk are 0.008
[mu]g/L (for groundwater) and 0.6 [mu]g/L (for surface water). The
back-calculated DWLOCs (Table 4) for assessing chronic aggregate
dietary risk range from 1,700 [mu]g/L for the population subgroups. All
infants and children (1 to 6 years old) to 5,900 [mu]g/L for the U.S.
population and males (55 years + ).
The SCI GROW and PRZM/EXAMS chronic EECs are less than the Agency's
level of comparison (the DWLOC value for each population subgroup) for
triticonazole residues in drinking water as a contribution to chronic
aggregate exposure. EPA thus concludes with reasonable certainty that
residues of triticonazole in drinking water will not contribute
significantly to the aggregate chronic human health risk and that the
chronic aggregate exposure from triticonazole residues in food and
drinking water will not exceed the Agency's level of concern (100% of
the Chronic PAD) for chronic dietary aggregate exposure by any
population subgroup. EPA generally has no concern for exposures below
100% of the Chronic PAD, because it is a level at or below which daily
aggregate dietary exposure over a lifetime will not pose appreciable
risks to the health and safety of any population subgroup. This risk
assessment is considered high confidence, very conservative, and very
protective of human health.
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). Triticonazole is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Triticonzole
is not registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. As summarized
previously, the cancer risk estimate (food only) for the U.S.
population (total) is 7.01 x 10-\7\. This risk estimate is
based upon an exposure of 0.000082 mg/kg/day. The results of this
dietary exposure analysis should be viewed as very conservative (health
protective). Refinements such as use of PCT information and/or
anticipated residue values would yield even lower estimates of chronic
dietary exposure.
The EECs for assessing chronic (cancer) aggregate dietary risk are
0.008 [mu]g/L (for ground water) and 0.4 [mu]g/L (for surface water).
The back-calculated DWLOC) for assessing chronic (cancer) aggregate
dietary risk is 1.2 [mu]g/L.
The SCI-GROW and PRZM/EXAMS chronic (cancer) EECs are less than the
Agency's level of comparison for triticonazole residues in drinking
water as a contribution to chronic (cancer) aggregate exposure. The
Agency thus concludes with reasonable certainty that residues of
triticonazole in drinking water will not contribute significantly to
the aggregate chronic (cancer) human health risk and that the chronic
(cancer) aggregate exposure from triticonazole residues in food and
drinking water will not exceed the Agency's level of concern (i.e.
cancer risk estimate in the range of 1 x 10-\6\) for chronic
(cancer) dietary aggregate exposure by the U.S. population. EPA
generally has no concern for exposures which result in a cancer risk
estimate in the range of or below 1 x 10-\6\, because it is
a level at which daily aggregate dietary exposure over a lifetime will
pose no greater than negligible risks to the health and safety of any
population subgroup. This risk assessment is considered high
confidence, very conservative, and very protective of human health.
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

[[Page 60958]]

from aggregate exposure to triticonazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The petitioner has proposed liquid chromatography/mass spectrometer
(LC/MS) and liquid chromatography/mass spectrometer/mass spectrometer
(LC/MS/MS) methods (Aventis Method MS 148.02) for determining residues
and enforcing tolerances for uses of triticonazole. The methods
determine residues of triticonazole and two of its dihydroxy
metabolites (RPA 404886 and RPA 406341). Each residue is measured
individually in/on wheat and barley RACs and processed commodities. The
Agency has determined that the residues of concern in plants for the
proposed seed treatment uses are triticonazole per se. The LC/MS/MS
method was used in the submitted crop field trials and processing
studies. The validated level of quantitation (LOQ) based on the field
trial and processing data for the LC/MS/MS method is 0.005 ppm for
residues in forage, straw and grain. The petitioner submitted adequate
concurrent method recovery data for the LC/MS/MS method in conjunction
with the crop field trials and processing studies on wheat and barley.
A successful independent laboratory validation (ILV) (MRID 44904518)
was conducted for the LC/MS and LC/MS/MS methods on wheat forage. The
Agency is conducting a petition method validation (PMV) for Analytical
Method MS 148.02, Revision 2 for both LC/MS and LC/MS/MS detection
methods for use with wheat grain, forage, and straw. Pending a
successful EPA petition method validation of Aventis Method 148.02, the
method is adequate for enforcement of the proposed tolerances on wheat
and barley resulting from the proposed seed treatment uses. The
petitioner will be required to make any modifications or revisions to
the proposed method resulting from EPA's validation.
The Agency currently has adequate fortification recovery data for
triticonazole from wheat and barley commodities. The method was
adequately validated by an independent laboratory for use with a
representative commodity (wheat forage).

B. International Residue Limits

There are currently no established Codex, Canadian, or Mexican
maximum residue limits (MRLs) for residues of triticonazole in/on wheat
and barley commodities. Therefore, no compatibility issues exist with
regard to the proposed U.S. tolerances.

V. Conclusion

Therefore, the tolerance is established for residues of
triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-
(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, in or on barley, grain;
barley, hay; barley, straw; wheat, forage; wheat, grain; wheat, hay;
and wheat, straw 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. 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 of 1996, 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 the FFDCA, as was provided in the old FFDCA
sections 408 and 409. 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-2002-0199 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
26, 2002.
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. You may also deliver your written request to the
Office of the Hearing Clerk in Rm. 104, Crystal Mall i2, 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.
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.
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.2. Mail your
copies, identified by docket ID number OPP-2002-0199, 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.
In person or by courier, bring a copy to the location of

[[Page 60959]]

the PIRIB described in Unit I.B.2. 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. Regulatory Assessment Requirements

This final rule establishes a tolerance under FFDCA section 408(d)
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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. Submission to Congress and the Comptroller General

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 19, 2002.
James Jones,
Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR part 180 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 180.583 is added to subpart C to read as follows:

Sec. 180.583 Triticonazole; tolerances for residues.

(a) General. Tolerances are established for residues of the
fungicide triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-
dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, from the
treatment of seed prior to planting in or on raw agricultural
commodities as follows:

[[Page 60960]]

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley, grain.............................................. 0.05
Barley, hay................................................ 0.05
Barley, straw.............................................. 0.05
Wheat, forage.............................................. 0.05
Wheat, grain............................................... 0.05
Wheat, hay................................................. 0.05
Wheat, straw............................................... 0.05
------------------------------------------------------------------------

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

[FR Doc. 02-24650 Filed 9-26-02; 8:45 am]
BILLING CODE 6560-50-S

Triticonazole; Pesticide Tolerance

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