[Federal Register Volume 67, Number 113 (Wednesday, June 12, 2002)]
[Rules and Regulations]
[Pages 40219-40229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14768]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0063; FRL-7180-5]


Triflumizole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

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: [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://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

[[Page 40220]]

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         NOAEL = Males:
                                   toxicity rodents    15.3 mg/kg/day;
                                   (rat)               Females: 17.2 mg/
                                                       kg/day
                                                      LOAEL = Males:
                                                       176.5 mg/kg/day;
                                                       Females: 217.9 mg/
                                                       kg/daybased on
                                                       increased kidney
                                                       and liver weights
                                                       and
                                                       theaccumulation
                                                       of fat droplets
                                                       in the liver.
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = Males:
                                   toxicity rodents    33.1 mg/kg/day;
                                   (mouse)             Females: 42.6 mg/
                                                       kg/day
                                                      LOAEL = Males:
                                                       380.7 mg/kg/day;
                                                       Females 466.2 mg/
                                                       kg/daybased on
                                                       reduced growth.
------------------------------------------------------------------------
870.3200                          21/28-Day dermal    NOAEL 1,000 mg/kg/
                                   toxicity (rat)      day
                                                      LOAEL = not
                                                       identified
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal
                                   developmental in   NOAEL = 10 mg/kg/
                                   rodents (rat)       day
                                                      LOAEL = 35 mg/kg/
                                                       day based on
                                                       decreased body
                                                       weight gainand
                                                       food consumption,
                                                       and increased
                                                       placental, spleen
                                                       and liverweights.
                                                      Developmental
                                                      NOAEL = 10 mg/kg/
                                                       day
                                                      LOAEL = 35 mg/kg/
                                                       day based on
                                                       decreased numbers
                                                       of viablefetuses,
                                                       increased dead or
                                                       resorbed fetuses,
                                                       increased
                                                       numbersof late
                                                       resorptions,
                                                       decreased fetal
                                                       body weight, and
                                                       increasedincidenc
                                                       es of cervical
                                                       ribs.
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal
                                   developmental in   NOAEL = 50 mg/kg/
                                   nonrodents          day
                                   (rabbit)           LOAEL = 100 mg/kg/
                                                       day based on
                                                       decreased body
                                                       weightgains, food
                                                       consumption, and
                                                       placental
                                                       weights.
                                                      Developmental
                                                      NOAEL = 50 mg/kg/
                                                       day
                                                      LOAEL = 100 mg/kg/
                                                       day based on
                                                       decreased 24-hour
                                                       survival,decrease
                                                       d placental
                                                       weights, and
                                                       increased fetal
                                                       and
                                                       litterincidences
                                                       of lumbar ribs.
------------------------------------------------------------------------

[[Page 40221]]

 
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects  NOAEL = 8.5 mg/kg/
                                   (rat)               day
                                                      LOAEL = 21 mg/kg/
                                                       day based on
                                                       decreased body
                                                       weight andoverall
                                                       body weight gain,
                                                       increased
                                                       relative liver
                                                       weights,
                                                       andincreased
                                                       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
                                                       incidenceof
                                                       hydronephrosis in
                                                       F1a pups.
------------------------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects  NOAEL = 8.5 mg/kg/
                                   (rat)               day
                                                      LOAEL = not
                                                       established
                                                      Reproductive
                                                      NOAEL = 1.5 mg/kg/
                                                       day
                                                      LOAEL = 3.5 mg/kg/
                                                       day based on
                                                       based on
                                                       increased
                                                       gestationlength
                                                       in dams of the
                                                       F3a interval.
                                                      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 F3 litters,
                                                       reduced litter
                                                       size in the F1a
                                                       litter, increased
                                                       total-litter
                                                       mortality in the
                                                       F3a litter, and
                                                       developmental
                                                       effects in theF1b
                                                       and F2b progeny.
------------------------------------------------------------------------
870.4100                          Chronic toxicity    NOAEL = Males:
                                   nonrodents (dog)    10.00 mg/kg/day;
                                                       Females: 10.69 mg/
                                                       kg/day
                                                      LOAEL = Males:
                                                       34.10 mg/kg/day;
                                                       Females: 35.17 mg/
                                                       kg/daybased on
                                                       increased
                                                       alkaline
                                                       phosphatase
                                                       activity and a
                                                       mild,macrocytic
                                                       anemia in males,
                                                       increased
                                                       absolute and
                                                       relativeliver
                                                       weights in both
                                                       sexes, and on
                                                       macroscopic
                                                       findings in
                                                       theliver of both
                                                       sexes.
------------------------------------------------------------------------
870.4200                          Carcinogenicity     NOAEL = Males:
                                   (mouse)             16.2 mg/kg/day;
                                                       Females: 21.7 mg/
                                                       kg/day
                                                      LOAEL = Males:
                                                       67.4 mg/kg/day;
                                                       Females: 86.1 mg/
                                                       kg/daybased on
                                                       microscopic
                                                       lesions of the
                                                       liver.
                                                      No evidence of
                                                       carcinogenicity
------------------------------------------------------------------------
870.4300                          Combined chronic/   NOAEL = Males:
                                   oncogenicity        <3.5-3.7 mg/kg/
                                   (rat)               day; Females:<4.5-
                                                       4.6 mg/kg/day
                                                      LOAEL = Males: 3.5-
                                                       3.7 mg/kg/day;
                                                       Females: 4.5-
                                                       4.6mg/kg/day
                                                       based on liver
                                                       toxicity
                                                       (eosinophilic
                                                       foci in male
                                                       ratsand fatty
                                                       vacuolation and
                                                       inflammation and
                                                       necrosis in
                                                       femalerats).
                                                      No evidence of
                                                       carcinogenicity.
------------------------------------------------------------------------
870.5100                          Bacterial reverse   Negative with or
                                   mutation            without S9
                                                       activation at
                                                       5,000 g/plate
                                                       andless.
------------------------------------------------------------------------
870.5100                          Bacterial reverse   Negative with or
                                   mutation            without S9
                                                       activation at
                                                       8,000 g/plate and
                                                       less.
------------------------------------------------------------------------
870.5375                          In vitro mammalian  Negative with or
                                   chromosome          without S9.
                                   abberation (CHL)
------------------------------------------------------------------------
870.5395                          In vitro mammalian  Negative. Not
                                   cytogenetics        clastogenic for
                                   (mouse bone         the production of
                                   marrow)             micronuclei
                                                       inbone marrow
                                                       polychromatic
                                                       erythrocytes in
                                                       mice at single
                                                       oral doses up to
                                                       1,600 mg/kg.
------------------------------------------------------------------------
870.5500                          DNA damage/repair   Negative. No
                                   REC assay           evidence of DNA
                                                       damage up to
                                                       24,000 mg/disk.
                                                      Study is
                                                       unacceptable
                                                       because a
                                                       metabolic
                                                       activation
                                                       systemwas not
                                                       used.
------------------------------------------------------------------------

[[Page 40222]]

 
870.5550                          UDS in primary rat  Negative. No
                                   hepatocytes         evidence of
                                                       unscheduled DNA
                                                       synthesis up
                                                       tocytotoxic
                                                       concentrations.
------------------------------------------------------------------------
870.6200                          Acute               Data gap
                                   neurotoxicity
                                   screening battery
------------------------------------------------------------------------
870.6200                          Subchronic          Data gap
                                   neurotoxicity
                                   screening battery
------------------------------------------------------------------------
870.7485                          Metabolism and      Following oral
                                   pharmacokinetics    treatment of rats
                                   (rat)               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.Radioacti
                                                       vity in urine
                                                       accounted for
                                                       69.5-74.4% of the
                                                       dose andfeces
                                                       accounted for
                                                       21.7-21.9% of the
                                                       dose. Based on
                                                       themetabolite
                                                       profile, the
                                                       metabolism in
                                                       rats primarily
                                                       involvesoxidation
                                                       to FM-8-1 and FA-
                                                       1-5, followed by
                                                       sulfation
                                                       andglucuronidatio
                                                       n.
------------------------------------------------------------------------
870.7485                          Metabolism and      Following oral
                                   pharmacokinetics    treatment of rats
                                   (rat)               with [phenyl-U-
                                                       14C]-NF-114,
                                                       approximately
                                                       93.8-100.6% of
                                                       the administered
                                                       dose
                                                       wasrecovered.
                                                       Urine was the
                                                       major route of
                                                       excretion. Low
                                                       levelsof
                                                       radioactivity
                                                       were detectable
                                                       in all tissue,
                                                       organ, and
                                                       bloodsamples
                                                       collected 2 days
                                                       (10 mg/kg group)
                                                       or 4 days (300mg/
                                                       kg group) post-
                                                       dose with tissue
                                                       concentrations
                                                       generallyhigher
                                                       in males than
                                                       females. The
                                                       metabolite
                                                       profile in
                                                       theexcreta was
                                                       quantitatively
                                                       and qualitatively
                                                       similar between
                                                       thesexes and dose
                                                       groups. Based on
                                                       the metabolite
                                                       profile,
                                                       thebiotransformat
                                                       ion of NF-114 in
                                                       rats primarily
                                                       involvedoxidation
                                                       of parent to FM-8-
                                                       1 and FA-1-5,
                                                       followed
                                                       byconjugation
                                                       yielding sulfate
                                                       and glucuronic
                                                       acid conjugates.
------------------------------------------------------------------------
Special studies                   Hepatic enzyme      The study provides
                                   induction           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 = point of 
departure/exposures) is calculated. A

[[Page 40223]]

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
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF* and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50years of    NOAEL = 10 mg/kg/day     Special FQPA SF = 1X     Developmental Toxicity
 age                                   UF = 3X................  aPAD = acute RfD/FQPA     Study - Rat
                                       Acute RfD =0.03 mg/kg/    SF= 0.03 mg/kg/day.     Developmental
                                        day.                                             LOAEL = 35mg/kg/day
                                                                                          based on
                                                                                          decreasednumbers of
                                                                                          viable
                                                                                          fetuses,increased dead
                                                                                          or resorbedfetuses,
                                                                                          increased numbers
                                                                                          oflate resorptions,
                                                                                          decreased fetalbody
                                                                                          weight, and
                                                                                          increasedincidences of
                                                                                          cervical ribs.
----------------------------------------------------------------------------------------------------------------
Acute dietary general                  No acute dietary endpoint of concern was chosen for the generalpopulation
 populationincluding infants and                            (including infants and children).
 children
----------------------------------------------------------------------------------------------------------------
Chronic dietaryall populations         NOAEL = 1.5mg/kg/day     Special FQPA SF = 1X     Multi-generation
                                       UF = 3X................  cPAD = chronic RfD/FQPA   ReproductionStudy -
                                       Chronic RfD =0.005 mg/    SF= 0.005 mg/kg/day.     Rat
                                        kg/day.                                          Reproductive
                                                                                         LOAEL = 3.5mg/kg/day
                                                                                          based on
                                                                                          increasedgestation
                                                                                          length in dams of
                                                                                          theF3a interval.
----------------------------------------------------------------------------------------------------------------
Short-termoral (1-30 days)             oral NOAEL=8.5 mg/kg/    LOC for MOE =300         Multi-generation
(Residential)........................   day                      (includes thetotal       ReproductionStudy -
                                                                 FQPA SF)                 Rat
                                                                                         LOAEL = 21 mg/kg/day,
                                                                                          basedon decreased body
                                                                                          weight gainin pups
                                                                                          during lactation.
----------------------------------------------------------------------------------------------------------------
Intermediate-term oral (1-6months)     oral NOAEL=8.5 mg/kg/    LOC for MOE =300         Multi-generation
(Residential)........................   day                      (includes thetotal       ReproductionStudy -
                                                                 FQPA SF)                 Rat
                                                                                         LOAEL = 21 mg/kg/day,
                                                                                          basedon decreased body
                                                                                          weight gainin pups
                                                                                          during lactation
                                                                                          anddecreased body
                                                                                          weight andbody weight
                                                                                          gain in
                                                                                          parentalanimals.
----------------------------------------------------------------------------------------------------------------
Short-termdermal (1-30 days)           oral NOAEL =8.5 mg/kg/   LOC for MOE =300         Multi-generation
(Residential)........................   day                      (includes thetotal       ReproductionStudy -
                                       (dermalabsorption rate    FQPA SF)                 Rat
                                        =3.5%).                                          LOAEL = 21 mg/kg/day,
                                                                                          basedon decreased body
                                                                                          weight gainin pups
                                                                                          during lactation.
----------------------------------------------------------------------------------------------------------------
Intermediate- and long-termdermal (1-  oral study               LOC for MOE =300         Multi-generation
 6 months and 6-month or longer)       NOAEL= 1.5mg/kg/day....   (includes thetotal       ReproductionStudy -
(Residential)........................  (dermalabsorption rate    FQPA SF)                 Rat
                                        =3.5%).                                          LOAEL = 3.5 mg/kg/day
                                                                                          basedon increased
                                                                                          gestation length inthe
                                                                                          dams of the F3a
                                                                                          interval.
----------------------------------------------------------------------------------------------------------------
Short-terminhalation (1-30 days)       oral NOAEL=8.5 mg/kg/    LOC for MOE =300         Multi-generation
(Residential)........................   day                      (includes thetotal       ReproductionStudy -
                                       (inhalationabsorption     FQPA SF)                 Rat
                                        rate =100%).                                     LOAEL = 21 mg/kg/day,
                                                                                          basedon decreased body
                                                                                          weight gainin pups
                                                                                          during lactation.
----------------------------------------------------------------------------------------------------------------
Intermediate- and long-terminhalation  oral study               LOC for MOE =300         Multi-generation
 (1-6 months and 6-month or longer)    NOAEL= 1.5mg/kg/day....   (includes the total      ReproductionStudy -
(Residential)........................  (inhalationabsorption     FQPA SF)                 Rat
                                        rate =100%).                                     LOAEL = 3.5 mg/kg/day
                                                                                          basedon increased
                                                                                          gestation length inthe
                                                                                          dams of the F3a
                                                                                          interval.
----------------------------------------------------------------------------------------------------------------
Cancer (oral,dermal, inhalation)       evidence fornon-         Not applicable           Combined Chronic
                                        carcinogenicityfor                               Toxicity/
                                        humans                                            Carcinogenicity Study-
                                                                                          Rat
                                                                                         Carcinogenicity Study -
                                                                                          Mouse
                                                                                         No evidence of
                                                                                          carcinogenicityin 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, oruncertainty 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

[[Page 40224]]

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

[[Page 40225]]

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.

[[Page 40226]]

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
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (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
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     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

[[Page 40227]]

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: [email protected].

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 [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-2002-0063, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection

[[Page 40228]]

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: [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, 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) *     *    *

[[Page 40229]]



------------------------------------------------------------------------
                 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]
BILLING CODE 6560-50-S