[Federal Register Volume 67, Number 188 (Friday, September 27, 2002)]
[Rules and Regulations]
[Pages 60950-60960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24650]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0199; FRL-7200-6]


Triticonazole; Pesticide Tolerance

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. [email protected].

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://

[[Page 60951]]

www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under 
development. To access the OPPTS Harmonized Guidelines referenced in 
this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    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 (MOEcancer = 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:
    [sbull] The toxicological data base is complete for FQPA 
assessment.
    [sbull] There is no indication of quantitative or qualitative 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure.
    [sbull] 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.
    [sbull] 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:
    [sbull] 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.
    [sbull] 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 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
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: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. 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