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triflumizole (Terraguard, Procure) Pesticide Tolerance 5/02

   
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0063; FRL-7180-5]
Triflumizole; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for the combined
residues of triflumizole, 1-(1-((4-chloro-2-
(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1H-imidazole) and its
metabolites containing the 4-chloro-2-trifluoromethylaniline moiety,
calculated as the parent compound in or on cucurbit vegetables,
strawberries, sweet cherries, and tart cherries. Uniroyal Chemical
Company requested these tolerances under the Federal Food, Drug, and
Cosmetic Act, as amended by the Food Quality Protection Act of 1996. In
addition, this regulatory action is part of the tolerance reassessment
requirements of section 408(q) of the Federal Food, Drug, and Cosmetic
Act (FFDCA) 21 U.S.C. 346a(q), as amended by the Food Quality
Protection Act (FQPA) of 1996. By law, EPA is required to reassess 66%
of the tolerances in existence on August 2, 1996, by August 2002, or
about 6,400 tolerances. This regulatory action will count for 26
reassessments toward the August 2002 deadline.
DATES: This regulation is effective June 12, 2002. Objections and
requests for hearings, identified by docket ID number
OPP-2002-0063, must be received on or before August 12,
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 theSUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0063 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Mary 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/. 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-2002-0063. 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 July 6, 2001 (66 FR 35623)
(FRL-6790-1), EPA issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as
amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law
104-170), announcing the filing of pesticide petitions (PP) by
Uniroyal Chemical Company, 74 Amity Road, Bethany, CT 06525. This
notice included a summary of the petitions prepared by Uniroyal
Chemical Company, the registrant. There were no comments received in
response to the notice of filing.
    The petitions requested that 40 CFR 180.476 be amended by
establishing tolerances for residues of the fungicide triflumizole, 1-
(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1H-
imidazole), in or on food commodities as follows:
    1. PP 1F6297 proposed the establishment of tolerances for
strawberries at 2.0 parts per million (ppm).
    2. PP 0F6077 proposed the establishment of tolerances for the
cucurbit crop group at 0.5 ppm.
    3. PP 8F4938 proposed the establishment of tolerances for cherries
at 2.0 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) 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) 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 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), 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), for a tolerance for combined residues of triflumizole and
its metabolites containing 4-chloro-2-trifluoromethylaniline moiety,
expressed as the parent on cucurbit vegetables, strawberries, and
cherries at 0.5 ppm, 2.0 ppm, and 1.5 ppm, respectively. 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 triflumizole 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 rodents (rat) NOAEL = Males: 15.3 mg/kg/day; Females: 17.2 mg/kg/day
LOAEL = Males: 176.5 mg/kg/day; Females: 217.9 mg/kg/day based on increased kidney and liver weights and the accumulation of fat droplets in the liver.
870.3100 90-Day oral toxicity rodents (mouse) NOAEL = Males: 33.1 mg/kg/day; Females: 42.6 mg/kg/day
LOAEL = Males: 380.7 mg/kg/day; Females 466.2 mg/kg/day based on reduced growth.
870.3200 21/28-Day dermal toxicity (rat) NOAEL ≥ 1,000 mg/kg/day
LOAEL = not identified
870.3700 Prenatal developmental in rodents (rat) Maternal
NOAEL = 10 mg/kg/day
LOAEL = 35 mg/kg/day based on decreased body weight gain and food consumption, and increased placental, spleen and liver weights.
Developmental
NOAEL = 10 mg/kg/day
LOAEL = 35 mg/kg/day based on decreased numbers of viable fetuses, increased dead or resorbed fetuses, increased numbers of late resorptions, decreased fetal body weight, and increased incidences of cervical ribs.
870.3700 Prenatal developmental in nonrodents (rabbit) Maternal
NOAEL = 50 mg/kg/day
LOAEL = 100 mg/kg/day based on decreased body weight gains, food consumption, and placental weights.
Developmental
NOAEL = 50 mg/kg/day
LOAEL = 100 mg/kg/day based on decreased 24-hour survival, decreased placental weights, and increased fetal and litter incidences of lumbar ribs.
870.3800 Reproduction and fertility effects (rat) Parental/Systemic
NOAEL = 8.5 mg/kg/day
LOAEL = 21 mg/kg/day based on decreased body weight and overall body weight gain, increased relative liver weights, and increased mortality in females.
Reproductive
NOAEL = not identified
LOAEL = 3.5 mg/kg/day based on increased gestation length in P.
Offspring
NOAEL = 8.5 mg/kg/day
LOAEL = 21 mg/kg/day based on decreased pup body weight, survival indices, and litter sizes and a slight increased incidence of hydronephrosis in F1apups.
870.3800 Reproduction and fertility effects (rat) Parental/Systemic
NOAEL = 8.5 mg/kg/day
LOAEL = not established
Reproductive
NOAEL = 1.5 mg/kg/day
LOAEL = 3.5 mg/kg/day based on based on increased gestation length in dams of the F3ainterval.
Offspring
NOAEL = 3.5 mg/kg/day
LOAEL = 8.5 mg/kg/day based on decreased pup weights, survival indices, and litter sizes in both F3litters, reduced litter size in the F1alitter, increased total-litter mortality in the F3alitter, and developmental effects in the F1band F2bprogeny.
870.4100 Chronic toxicity nonrodents (dog) NOAEL = Males: 10.00 mg/kg/day; Females: 10.69 mg/kg/day
LOAEL = Males: 34.10 mg/kg/day; Females: 35.17 mg/kg/day based on increased alkaline phosphatase activity and a mild, macrocytic anemia in males, increased absolute and relative liver weights in both sexes, and on macroscopic findings in the liver of both sexes.
870.4200 Carcinogenicity (mouse) NOAEL = Males: 16.2 mg/kg/day; Females: 21.7 mg/kg/day
LOAEL = Males: 67.4 mg/kg/day; Females: 86.1 mg/kg/day based on microscopic lesions of the liver.
No evidence of carcinogenicity
870.4300 Combined chronic/oncogenicity (rat) NOAEL = Males: < 3.5-3.7 mg/kg/day; Females: < 4.5-4.6 mg/kg/day
LOAEL = Males: 3.5-3.7 mg/kg/day; Females: 4.5-4.6 mg/kg/day based on liver toxicity (eosinophilic foci in male rats and fatty vacuolation and inflammation and necrosis in female rats).
No evidence of carcinogenicity.
870.5100 Bacterial reverse mutation Negative with or without S9 activation at 5,000 µg/plate and less.
870.5100 Bacterial reverse mutation Negative with or without S9 activation at 8,000 µg/plate and less.
870.5375 In vitro mammalian chromosome abberation (CHL) Negative with or without S9.
870.5395 In vitro mammalian cytogenetics (mouse bone marrow) Negative. Not clastogenic for the production of micronuclei in bone marrow polychromatic erythrocytes in mice at single oral doses up to 1,600 mg/kg.
870.5500 DNA damage/repair REC assay Negative. No evidence of DNA damage up to 24,000 mg/disk.
Study is unacceptable because a metabolic activation system was not used.
870.5550 UDS in primary rat hepatocytes Negative. No evidence of unscheduled DNA synthesis up to cytotoxic concentrations.
870.6200 Acute neurotoxicity screening battery Data gap
870.6200 Subchronic neurotoxicity screening battery Data gap
870.7485 Metabolism and pharmacokinetics (rat) Following oral treatment of rats with [phenyl-U-14C]-NF-114, no sex-related differences were observed in absorption, metabolism, distribution or excretion. Maximum concentrations of radioactivity in plasma were attained within 1 hour of dosing in both sexes. Low levels of radioactivity were detectable in all tissue, organ, and blood samples. Radioactivity in urine accounted for 69.5-74.4% of the dose and feces accounted for 21.7-21.9% of the dose. Based on themetabolite profile, the metabolism in rats primarily involves oxidation to FM-8-1 and FA-1-5, followed by sulfation and glucuronidation.
870.7485 Metabolism and pharmacokinetics (rat) Following oral treatment of rats with [phenyl-U-14C]-NF-114, approximately 93.8-100.6% of the administered dose was recovered. Urine was the major route of excretion. Low levels of radioactivity were detectable in all tissue, organ, and blood samples collected 2 days (10 mg/kg group) or 4 days (300 mg/kg group) post-dose with tissue concentrations generally higher in males than females. The metabolite profile in the excreta was quantitatively and qualitatively similar between the sexes and dose groups. Based on the metabolite profile, the biotransformation of NF-114 in rats primarily involved oxidation of parent to FM-8-1 and FA-1-5, followed by conjugation yielding sulfate and glucuronic acid conjugates.
Special studies Hepatic enzyme induction The study provides evidence that triflumizole induces hepatic microsomal enzymes when administered orally.However, no correlation between the increased enzyme activities and hepatic lesions observed following chronic administration was made since no histopathology was performed.
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 intraspecies differences. Due to
the lack of an acute neurotoxicity study and a subchronic neurotoxicity
study, the Agency has applied an additional 3X uncertainty factor to
this assessment to account for an incomplete toxicology data base.
    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 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
&equal; point of departure/exposures) is calculated. A
summary of the toxicological endpoints for triflumizole used for human
risk assessment is shown in the following Table 2:
Table 2. Summary of Toxicological Dose and Endpoints for Triflumizole for Use in Human Risk Assessment
Exposure Scenario
Dose Used in Risk Assessment, UF
Special FQPA SF* and Level of Concern for Risk Assessment
Study and Toxicological Effects
Acute dietary females 13-50 years of age NOAEL = 10 mg/kg/day UF = 3X
Acute RfD = 0.03 mg/kg/day
Special FQPA SF = 1X
aPAD = acute RfD/FQPA SF = 0.03 mg/kg/day
Developmental Toxicity Study - Rat
Developmental
LOAEL = 35 mg/kg/day based on decreased numbers of viable fetuses, increased dead or resorbed fetuses, increased numbers of late resorptions, decreased fetal body weight,and increased incidences of cervical ribs.
Acute dietary general population including infants and children No acute dietary endpoint of concern was chosen for the general population (including infants and children).
Chronic dietary all populations NOAEL = 1.5 mg/kg/day
UF = 3X
Chronic RfD = 0.005 mg/kg/day
Special FQPA SF = 1X
cPAD = chronic RfD/FQPA
cPAD = chronic RfD/FQPA
Multi-generation Reproduction Study - Rat
Reproductive
LOAEL = 3.5 mg/kg/day based on increased gestation length in dams of the F3ainterval.
Short-term oral (1-30 days) (Residential) oral NOAEL= 8.5 mg/kg/day LOC for MOE = 300 (includes the total FQPA SF) Multi-generation Reproduction Study - Rat
LOAEL = 21 mg/kg/day, based on decreased body weight gain in pups during lactation.
Intermediate-term oral (1-6 months)
(Residential)
oral NOAEL= 8.5 mg/kg/day LOC for MOE = 300 (includes the total FQPA SF) Multi-generation Reproduction Study - Rat
LOAEL = 21 mg/kg/day, based on decreased body weight gain in pups during lactation and decreased body weight and body weight gain in parental animals.
Short-term dermal (1-30 days)
(Residential)
oral NOAEL = 8.5 mg/kg/day
(dermal absorption rate = 3.5%)
LOC for MOE = 300 (includes the total FQPA SF) Multi-generation Reproduction Study - Rat
LOAEL = 21 mg/kg/day, based on decreased body weight gain in pups during lactation.
Intermediate- and long-term dermal (1-6 months and 6-month or longer)
(Residential)
oral study
NOAEL= 1.5 mg/kg/day (dermal absorption rate = 3.5%)
LOC for MOE = 300 (includes the total FQPA SF) Multi-generation Reproduction Study - Rat
LOAEL = 3.5 mg/kg/day based on increased gestation length in the dams of the F3ainterval.
Short-term inhalation (1-30 days)
(Residential)
oral NOAEL= 8.5 mg/kg/day
(inhalation absorption rate = 100%)
LOC for MOE = 300 (includes the total FQPA SF) Multi-generation Reproduction Study - Rat
LOAEL = 21 mg/kg/day, based on decreased body weight gain in pups during lactation.
Intermediate- and long-term inhalation (1-6 months and 6-month or longer)
(Residential)
oral study
NOAEL= 1.5 mg/kg/day (inhalation absorption rate = 100%)
LOC for MOE = 300 (includes the total FQPA SF) Multi-generation Reproduction Study - Rat
LOAEL = 3.5 mg/kg/day based on increased gestation length in the dams of the F3ainterval.
Cancer (oral, dermal, inhalation) evidence for non-carcinogenicity for humans Not applicable Combined Chronic
Toxicity/Carcinogenicity Study - Rat
Carcinogenicity Study - Mouse
No evidence of carcinogenicity in rats and mice.
*The reference to the Special FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA. The total or overall FQPA Safety Factor includes both the Special FQPA Safety Factor and any traditional, additional safety, or uncertainty factors.
C. Exposure Assessment
    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.476) for the combined residues of triflumizole,
1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1H-
imidazole) and its metabolites containing the 4-chloro-2-
trifluoromethylaniline moiety, calculated as the parent compound, in or
on a variety of raw agricultural commodities. The tolerance expression
for meat, milk and poultry commodities also include residues of the
metabolite 4-chloro-2-hydroxy-6-trifluoromethylaniline sulfate. Risk
assessments were conducted by EPA to assess dietary exposures from
triflumizole and its metabolites in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. The Dietary
Exposure Evaluation Model (DEEM) analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992
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
conservative, unrefined Tier 1 acute dietary exposure assessment was
conducted for females 13-50 years old using tolerance level residues
and modified DEEM processing factors for apples and grapes, based on
the results of previously submitted processing studies. The Agency
assumed 100% crop treatment for all other registered and proposed
triflumizole food uses.
    ii. Chronic exposure. In conducting this chronic dietary
riskassessment, the (DEEM) analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992
nationwide CSFII and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: A partially refined, Tier 3 chronic dietary assessment was
conducted for the general U.S. population and all population subgroups
(including infants and children) using anticipated residues, modified
DEEM processing factors for apples and grapes based on the results of
previously submitted processing studies, and average weighted percent
crop treated information for apples, grapes, and pears.
    iii. Cancer. Triflumizole is classified as a "Group E"
(evidence of non-carcinogenicity in humans) chemical based on adequate
studies in two species of animal. Therefore, a cancer dietary exposure
assessment was not performed.
    iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a Data Call-In for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of percent crop
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency used PCT information as follows. In conducting its
chronic dietary risk assessment, EPA utilized PCT data for the
registered uses on grapes, apples, and pears. EPA based these
assumptions on use data for the period 1996 to 1997 and 1998 to 1999.
For all other registered uses as well as the new uses (cucurbits,
strawberries, and cherries), EPA assumed that 100% of the U.S. crop
would be treated with triflumizole.
    The Agency believes that the three conditions listed in Unit III.C.
have been met. With respect to Condition 1, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which triflumizole
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for triflumizole in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking waterconcentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of triflumizole.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentrations in Ground Water (SCI-GROW) model is used
to predict pesticide concentrations in shallow ground water. For a
screening-level assessment for surface water EPA will use FIRST (a tier
1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an
index reservoir environment, the PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a
coarse screen for sorting out pesticides for which it is highly
unlikely that drinking water concentrations would ever exceed human
health 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 triflumizole, they are
further discussed in the aggregate risk sections in Unit III.E.
    Based on the FIRST and SCI-GROW models the EECs of triflumizole for
acute exposures are estimated to be 191 parts per billion (ppb) for
surface water and 0.12 ppb for ground water. The EECs for chronic
exposures are estimated to be 40 ppb for surface water and 0.12 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).
Triflumizole is currently registered for use on the following
residential non-dietary sites: Commercial applicators may treat
"woody" ornamental species, such as trees, shrubs, and
vines with triflumizole products. There are no proposed or registered
uses for triflumizole on turf or lawns. EPA believes that residential,
post-application, re-entry exposures from these use sites are not
probable and, therefore, no residential exposure assessment has been
conducted.
    4. Cumulative exposure to substances with a common mechanism
oftoxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider "available information" concerning the cumulative
effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity."
    EPA does not have, at this time, available data to determine
whether triflumizole 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,
triflumizole 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 triflumizole 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. There is qualitative
evidence of increased susceptibility demonstrated in the oral prenatal
developmental toxicity studies in rats. Developmental toxicity resulted
in fetal death as compared to maternal toxicity which included
decreases in body weight gain and food consumption and increases in
placental, spleen and liver weights at the same dosages.
    No quantitative or qualitative evidence of increased susceptibility
was demonstrated in the prenatal developmental toxicity studies in
rabbits or the multi-generation reproduction studies in rats. In the
rabbit developmental studies, 24-hour fetal survival was decreased at
the highest dose tested. This endpoint is not a recommended guideline
parameter and is generally believed to have limited value in the
assessment of development toxicity; rather, it is more an indicator of
fetal endurance in the absence of critical maternal care, following
removal from the uterus. The Hazard Identification Assessment Review
Committee did not consider this effect to be a measurement of
treatment-related effects on fetal viability and, thus, did not
consider it to be relevant to the assessment of fetal susceptibility.
There was no evidence of quantitative or qualitative susceptibility in
the 2-generation reproduction study in rats. In that study, increased
gestation length was observed at the study LOAEL. In rats, this
alteration in normal reproductive function can result in equally
adverse consequences (i.e., mortality) in both dams and offspring.
    3. Conclusion. The Agency has determined that a FQPA safety factor
of 3X was safe for infants and children based upon the following
considerations: (1) There was no quantitative or qualitative evidence
of increased susceptibility in the rabbit fetuses following in utero
exposure or the rat following prenatal and postnatal exposure; (2)
while there was evidence of qualitative susceptibility in the
developmental rat study, there are no residual uncertainties, and the
use of the developmental NOAEL and the endpoint for the acute RfD for
females 13-50 is protective of the prenatal toxicity following an acute
dietary exposure; (3) while the toxicological data base is incomplete
due to the lack of acute and subchronic neurotoxicity studies, the
additional safety factor 3X is applied for acute and chronic dietary
risk assessments to account for this uncertainty; and (4) in the
exposure data base, there are no residual uncertainties identified. The
drinking water exposure assessments incorporateconservative (Tier I)
assumptions, and there are no residential exposures anticipated with
the use of this chemical. The FQPA safety factor of 3X was found to be
adequate based upon the following factors: (1) In the acute studies,
clinical signs were seen at very high doses which resolved within 24
hours and no treatment-related effects were seen in the surviving
animals; (2) in the chronic study, cholinesterase inhibition was seen
during the first year, but not in a consistent manner; while plasma
inhibition was seen in both sexes, erythrocyte was inhibited in males
but not in females at the highest dose tested, no inhibition of brain
cholinesterase activity was seen in either sex at any dose level; (3)
there was no evidence of neurotoxicity in the subchronic studies in
mice or rats; (4) there was no evidence of neuropathology in the data
base; and (5) the doses used in risk assessments are significantly
lower than the doses that induce the clinical signs following acute
exposure or cholinesterase inhibition following repeated exposures.
E. Aggregate Risks and Determination of Safety
    To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the 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 ground water are less than the
calculatedDWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
triflumizole will occupy 19% of the aPAD for females 13 years and
older. No acute dietary endpoint was selected by EPA for the general
U.S. population, including infants and children. Therefore, an acute
dietary exposure assessment was not performed for these population
subgroups. In addition, there is potential for acute dietary exposure
to triflumizole 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 Triflumizole
Population Subgroup
aPAD (mg/kg)
% aPAD (Food)
Surface Water EEC (ppb)
Ground Water EEC (ppb)
Acute DWLOC (ppb)
Females, 13-50 years 0.03 19 191 0.12 710
    2. Chronic risk. Using the exposure assumptions described inthis
unit for chronic exposure, EPA has concluded that exposure to
triflumizole from food will utilize 18% of the cPAD for the U.S.
population and all population subgroups. The most highly exposed
subpopulation is children 1-6 years old at 18% of the cPAD. There are
no residential uses for triflumizole that result in chronic residential
exposure to triflumizole. In addition, there is potential for chronic
dietary exposure to triflumizole 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 Triflumizole
Population Subgroup
cPAD mg/kg/day
%cPAD (Food)
Surface Water EEC (ppb)
Ground Water EEC (ppb)
Chronic DWLOC (ppb)
U.S. population 0.005 8 40 0.12 160
All infants, < 1 year old 0.005 11 40 0.12 45
Children, 1-6 years old 0.005 18 40 0.12 41
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure assessments take into account
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    For triflumizole, the Agency did not perform short-term or
intermediate-term assessments because there are currently no registered
or proposed uses for homeowner application and residential post-
application exposures are expected to be negligible.
    4. Aggregate cancer risk for U.S. population. Since triflumizole
has been determined to not be carcinogenic, it is not expected to pose
a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to triflumizole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
    Suitable methods are available for collecting data on residues of
triflumizole and its metabolites. For cucurbits, the Agency has
determined that the GC/nitrogen/phosphorus detector (NPD) method
(Uniroyal Method CRM-3-96) is adequate for collecting data on residues of
triflumizole and its metabolites. For strawberries, the GC/MSD (Morse
Method METH-115, Revision #2) is adequate for collecting data on
residues of triflumizole and its metabolites. For cherries, the GC/
electron capture detection (ECD) method (Uniroyal Method CRM-3-96,
modified) is adequate for data collection. For each of these
commodities, the Agency has determined that a GC/nitrogen/phosphorus
detector (NPD) method previously submitted tosupport petitions for the
use of triflumizole on apples, grapes, and pears is similar to the
above-referenced methods. This method is also acceptable as a tolerance
enforcement method for these new commodities. This method has been
forwarded to the Food and Drug Administration (FDA) for inclusion in
the Pesticide Analytical Manual (PAM), Volume II, as Method I.
    Adequate enforcement methodology (example gas chromatography)
is available to enforce the tolerance expression. The method may be
requested from: Francis Griffith, Analytical Chemistry Branch,
Environmental Science Center, U.S. Environmental Protection Agency, 701
Mapes Road, Fort George G. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: griffith.francis@epa.gov.
B. International Residue Limits
    There are no Codex, Canadian or Mexican maximum residue limits
established for triflumizole residues in/on crop commodities.
Therefore, no compatibility issues exist with regard to the proposed
U.S. tolerances discussed in this risk assessment.
C. Conditions
    A limited field rotation study in wheat will be required as a
condition of the cucurbit registration. As a condition of registration,
the Agency will require the submission of acute and subchronic
neurotoxicity studies in order to better characterize the neurological
effects seen in the rat and mouse acute oral, the rat acute inhalation,
and the rat chronic studies.
V. Conclusion
    Therefore, the tolerance is established for combined residues of
triflumizole, 1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-
propoxyethyl)-1H-imidazole) and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent
compound in or on cucurbit vegetables, strawberries, sweet cherries,
and tart cherries at 0.5 ppm, 2.0 ppm, 1.5 ppm, and 1.5 ppm,
respectively. In establishing the tolerances for sweet cherries and
tart cherries, the Agency has determined that, based upon the submitted
residue field trials, the appropriate tolerance level is 1.5 ppm since
residues are not expected to exceed this value. In addition, the Agency
is correcting the commodity definitions from the proposed
"cherries" to "cherry, tart" and "cherry,
sweet" to reflect currently accepted terminology.
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) provides essentially
the same process for persons to "object" to a regulation
for an exemption from the requirement of a tolerance issued by EPA
under new section 408(d), as was provided in the old 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 control number OPP-2002-0063 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 August 12, 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 (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202)
260-4865.
    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-2002-0063, 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 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, entitledProtection of
Children from Environmental Health Risks and SafetyRisks (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. 601et 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,
entitledFederalism (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 theFederal 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: May 31, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:
PART 180 [AMENDED]
    1. The authority citation for part 180 continues to read as
follows:
    Authority: 21 U.S.C. 321(q), 346(a) and 374.
    2. Section 180.476 is amended by alphabetically adding commodities
to the table in paragraph (a)(1) to read as follows:
Sec. 180.476   Triflumizole; tolerances for residues.
    (a) General. (1) *  *  *
------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
*    *    *    *    *
Cherry, sweet.............................                           1.5
Cherry, tart..............................                           1.5
*    *    *    *    *
Strawberry................................                           2.0
Vegetable, cucurbit, Group 9..............                           0.5
------------------------------------------------------------------------
* * * * *
[FR Doc. 02-14768 Filed 6-11-02; 8:45 am]