[Federal Register Volume 68, Number 182 (Friday, September 19, 2003)]
[Rules and Regulations]
[Pages 54808-54818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23854]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0278; FRL-7326-4]


Cyprodinil; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyprodinil in or on brassica, head and stem, subgroup 5A; brassica, 
leafy greens, subgroup 5B; carrot; herb, subgroup 19A, dried; herb, 
subgroup 19A, fresh; longan; lychee; pulasan; rambutan; spanish lime; 
and turnip, greens. Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA).

DATES: This regulation is effective September 19, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0278, 
must be received on or before November 18, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you an are 
agricultural producer, food manufacturer, and pesticide manufacturer 
Potentially affected entities may include, but are not limited to:
    [bull] Crop production (NAICS 111)
    [bull] Animal production (NAICS 112)
    [bull] Food manufacturing (NAICS 311)
    [bull] Pesticide manufacturing (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System

[[Page 54809]]

(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0278. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under 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.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of April 21, 2003 (68 FR 19528) (FRL-7301-
6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
pesticide petitions (PP 2E6447, 2E6461, 2E6485, 3E6529, and 3E6530) by 
IR-4, 681 US Highway 1 South, New Brunswick, NJ 08902-3390. 
That notice included a summary of the petitions prepared by Syngenta 
Crop Protection Incorporated, the registrant.
    The petitions requested that 40 CFR 180.532 be amended by 
establishing tolerances for residues of the fungicide, cyprodinil, CGA 
219417; 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on the 
following commodities: brassica, head and stem, subgroup 5A at 2.0 
parts per million (ppm); and brassica, leafy greens, subgroup 5B at 
10.0 ppm (PP 2E6485); carrot at 0.5 (PP 2E6461); herb subgroup 19A at 
10.0 ppm (3E6529); longan; lychee; pulasan; rambutan; and spanish lime 
at 2.0 ppm (PP 2E6447); and turnip, greens at 10.0 ppm (PP 2E6485).
    Petition numbers 2E6485, 2E6461 and 3E6529 were subsequently 
amended to propose tolerances for brassica, head and stem, subgroup 5A 
at 1.0 ppm; and brassica, leafy greens, subgroup 5B at 10.0 ppm (PP 
2E6485); carrot at 0.75 ppm (PP 2E6461); herb, subgroup 19A, dried at 
15.0 ppm, and herb, subgroup 19A, fresh at 3.0 ppm (3E6529); longan; 
lychee; pulasan; rambutan; and spanish lime at 2.0 ppm (PP 2E6447); and 
turnip, greens at 10.0 ppm (PP 2E6485). There were no comments received 
on these petitions.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that`` there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for tolerances for residues of cyprodinil, CGA 
219417; 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine on brassica, 
head and stem, subgroup 5A at 1.0 ppm; brassica, leafy greens, subgroup 
5B at 10.0 ppm; carrot at 0.75; herb, subgroup 19A, dried at 15.0 ppm; 
herb, subgroup 19A, fresh at 3.0 ppm; longan, lychee, pulasan, 
rambutan, and spanish lime at 2.0 ppm; and turnip, greens at 10.0 ppm. 
EPA's assessment of exposures and risks associated with establishing 
the tolerances follow.

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 cyprodinil 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.

[[Page 54810]]



            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                         90-Day oral         NOAEL = 73.3/103 mg/
                                  toxicity (mouse)    kg/day, M/F
                                                     LOAEL = 257/349 mg/
                                                      kg/day, M/F, based
                                                      on
                                                      histopathological
                                                      changes in the
                                                      liver
------------------------------------------------------------------------
870.3100                         90-Day oral         NOAEL =3.14 mg/kg/
                                  toxicity (rat)      day
                                                     LOAEL = 19 mg/kg/
                                                      day based on
                                                      increased tubular
                                                      kidney lesions in
                                                      males
------------------------------------------------------------------------
Non-guideline                    28-Day Feeding/     NOAEL = 64.8/62.2
                                  Range               mg/kg/day, M/F
                                  Finding(rat)       LOAEL = 316/299 mg/
                                                      kg/day, M/F, based
                                                      on lower body-
                                                      weight gains,
                                                      microcytosis,
                                                      increase
                                                      cholesterol and
                                                      phospholipid
                                                      levels, and
                                                      hepatocyte
                                                      hypertrophy
------------------------------------------------------------------------
Non-guideline                    28-Day Gavage/      NOAEL = 10 mg/kg/
                                  Range               day
                                  Finding(rat)       LOAEL = 100 mg/kg/
                                                      day based on
                                                      increased liver
                                                      weights and
                                                      abnormalities in
                                                      liver morphology
------------------------------------------------------------------------
870.3150                         90-Day oral         NOAEL =210/232 mg/
                                  toxicity (dog)      kg/day, M/F
                                                     LOAEL = 560/581 mg/
                                                      kg/day, M/F, based
                                                      on lower body-
                                                      weight gains and
                                                      decreased food
                                                      consumption in
                                                      both sexes
------------------------------------------------------------------------
870.3200                         21/28-Day dermal-   NOAEL = 25/125 mg/
                                  toxicity(rat)       kg/day, F/M
                                                     LOAEL = 125/1000 mg/
                                                      kg/day, F/M, based
                                                      on clinical signs
                                                      (hunched posture
                                                      and/or
                                                      piloerection).
------------------------------------------------------------------------
870.3200                         Carcinogenicity -   NOAEL = 16.1 mg/kg/
                                  (mouse)             day
                                                     LOAEL = 212.4 mg/kg/
                                                      day based on a
                                                      dose-related
                                                      increase in the
                                                      incidence of focal
                                                      and multifocal
                                                      hyperplasia of the
                                                      exocrine pancreas
                                                      in males
                                                     No evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.3700                         Prenatal            Maternal NOAEL =
                                  developmental(rat   200 mg/kg/day
                                  )                  Maternal LOAEL =
                                                      1,000 mg/kg/day
                                                      based on lower
                                                      body-weight/body-
                                                      weight gain and
                                                      reduced food
                                                      consumption
                                                     Developmental NOAEL
                                                      = 200 mg/kg/day
                                                     Developmental LOAEL
                                                      = 1,000 mg/kg/day
                                                      based on lower
                                                      mean fetal weights
                                                      and increased
                                                      incidence of
                                                      delayed
                                                      ossification
------------------------------------------------------------------------
870.3700                         Prenatal            Maternal NOAEL =
                                  developmental       150 mg/kg/day
                                  (rabbit)           Maternal LOAEL =
                                                      400 mg/kg/day
                                                      based on decreased
                                                      body-weight gain
                                                     Developmental NOAEL
                                                      = 150 mg/kg/day
                                                     Developmental LOAEL
                                                      = 400 mg/kg/day
                                                      based on slight
                                                      increase of
                                                      litters showing
                                                      extra (13th) ribs
------------------------------------------------------------------------
870.3800                         Reproduction and    Maternal/Systemic
                                  fertility           NOAEL = 81 mg/kg/
                                  effects(rat)        day
                                                     Maternal/Systemic
                                                      LOAEL = 326 mg/kg/
                                                      day based on
                                                      decreased body
                                                      weight gain in the
                                                      F0 females during
                                                      the pre-mating
                                                      period.
                                                     Reproductive/
                                                      Developmental
                                                      NOAEL = 81 mg/kg/
                                                      day
                                                     Reproductive/
                                                      Developmental
                                                      LOAEL = 326 mg/kg/
                                                      day based on
                                                      decreased pup
                                                      weights (F1 and
                                                      F2)
------------------------------------------------------------------------
870.4300                         Chronic toxicity/   NOAEL = 2.7 mg/kg/
                                  Carcinogenicity     day
                                  (feeding)(rat)     LOAEL = 35.6 mg/kg/
                                                      day based on
                                                      degenerative liver
                                                      lesions
                                                      (spongiosis
                                                      hepatis) in males
                                                     No evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.4100                         Chronic toxicity    NOAEL = 65.63/67.99
                                  (dog)               mg/kg/day, M/F
                                                     LOAEL = 449.25/
                                                      446.3, M/F, mg/kg/
                                                      day based on lower
                                                      body-weight gains
                                                      and decreased food
                                                      consumption and
                                                      food efficiency
------------------------------------------------------------------------
870.5100                         Gene Mutation -     In a reverse gene
                                  Bacteria            mutation assay
                                                      with Salmonella
                                                      typhimurium/
                                                      Escherichia coli,
                                                      cyprodinil was
                                                      negative up to
                                                      concentrations
                                                      (>=1,250 [mu]g/
                                                      plate +/-S9) that
                                                      produced
                                                      reproducible
                                                      cytotoxicity for
                                                      the majority of
                                                      strains. Compound
                                                      insolubility was
                                                      reported at >=313
                                                      [mu]g/plate.
------------------------------------------------------------------------
870.5100 CGA 249287              Metabolite Gene     In repeat gene
                                  Mutation -          mutation assays in
                                  Bacteria            bacteria, CGA
                                                      249287 was
                                                      negative for
                                                      induction of
                                                      reverse mutation
                                                      in the bacterial
                                                      cultures assayed
                                                      under the
                                                      conditions of the
                                                      experiments.
------------------------------------------------------------------------

[[Page 54811]]

 
870.5300                         In vitro mammalian  In a Chinese
                                  cell                hamster V79 cell
                                                      HGPRT forward gene
                                                      mutation assay,
                                                      cyprodinil was
                                                      negative up to
                                                      cytotoxic
                                                      concentrations
                                                      (>=96.0 [mu]g/mL
                                                      with S9) (>=24
                                                      [mu]g/mL without
                                                      S9).
------------------------------------------------------------------------
870.5375                         Cytogenetics/In     In an in vitro
                                  vitro Chromosomal   assay for
                                  Aberration          chromosome
                                                      aberrations in
                                                      Chinese hamster
                                                      ovary (CHO) cells,
                                                      cyprodinil gave
                                                      negative results
                                                      up to cytotoxic
                                                      concentrations
                                                      (>=50 [mu]g/mL
                                                      without S9, 18- or
                                                      42-hour cell
                                                      harvest or >=25
                                                      [mu]g/mL with S9,
                                                      18- hour cell
                                                      harvest) or to the
                                                      highest sub-
                                                      cytotoxic
                                                      concentration (50
                                                      [mu]g/mL with S9,
                                                      42-hour cell
                                                      harvest).
------------------------------------------------------------------------
870.5395                         Cytogenetics/In     In an in vivo bone
                                  vivo bone marrow    marrow
                                  micronucleus        micronucleus
                                                      assay, cyprodinil
                                                      was negative when
                                                      administered
                                                      orally (gavage) at
                                                      5,000 mg/kg (HDT)
                                                      to both sexes of
                                                      Tif:MAGF mice. No
                                                      signs of overt
                                                      toxicity or clear
                                                      evidence of
                                                      cytotoxicity for
                                                      the target organ
                                                      were noted at any
                                                      dose or sacrifice
                                                      time.
------------------------------------------------------------------------
870.5550                         UDS                 In an UDS assay in
                                                      primary rat
                                                      hepatocytes,
                                                      cyprodinil was
                                                      negative up to a
                                                      cytotoxic
                                                      concentration (80
                                                      [mu]g/mL)
------------------------------------------------------------------------
870.7485                         Metabolism and      Single oral doses
                                  pharmacokinetics    (0.5 or 100 mg/kg
                                                      bw) of phenyl or
                                                      pyrimidyl-
                                                      radiolabelled
                                                      cyprodinil (purity
                                                      >=98%) were
                                                      administered to
                                                      Tif:RAIf(SPF)
                                                      rats, with one low-
                                                      dose group
                                                      receiving
                                                      unlabelled
                                                      cyprodinil (purity
                                                      >=99%) for 2 weeks
                                                      prior to treatment
                                                      with radiolabelled
                                                      compound.
                                                      Absorption was
                                                      very rapid with
                                                      rapid clearance. A
                                                      minimum of 75% of
                                                      the administered
                                                      dose was absorbed.
                                                      Excretion was
                                                      rapid and almost
                                                      complete, with
                                                      urine as the
                                                      principle route of
                                                      excretion (48-
                                                      68%), and >90% of
                                                      the administered
                                                      dose detected in
                                                      the urine and
                                                      feces within 48
                                                      hours. Excretion,
                                                      distribution and
                                                      metabolite
                                                      profiles were
                                                      essentially
                                                      independent of
                                                      dose level,
                                                      pretreatment, and
                                                      type of label,
                                                      although there
                                                      were some
                                                      quantitative
                                                      differences sex-
                                                      dependent
                                                      qualitative
                                                      differences in two
                                                      urinary metabolite
                                                      fractions.
------------------------------------------------------------------------
870.7485                         Metabolism and      Excreta and bile
                                  pharmacokinetics    from radiolabelled
                                                      cyprodinil-treated
                                                      Tif:RAIf(SPF) rats
                                                      were used to
                                                      characterize,
                                                      isolate and
                                                      identify
                                                      cyprodinil
                                                      metabolites.
                                                      Eleven metabolites
                                                      were isolated from
                                                      urine, feces and
                                                      bile, and the
                                                      metabolic pathways
                                                      in the rat were
                                                      proposed. All
                                                      urinary and
                                                      biliary
                                                      metabolites (with
                                                      the exception of
                                                      7U) were
                                                      conjugated with
                                                      glucuronic acid or
                                                      sulfonated, and
                                                      excreted.
                                                      Cyprodinil was
                                                      almost completely
                                                      metabolized by
                                                      hydroxylation of
                                                      the phenyl ring
                                                      (position 4) or
                                                      pyrimidine ring
                                                      (position 5),
                                                      followed by
                                                      conjugation. An
                                                      alternative
                                                      pathway involved
                                                      oxidation of the
                                                      phenyl ring
                                                      followed by
                                                      glucuronic acid
                                                      conjugation. A
                                                      quantitative sex
                                                      difference was
                                                      observed with
                                                      respect to
                                                      sulfonation of the
                                                      major metabolite
                                                      that formed 6U.
                                                      The monosulfate
                                                      metabolite (1U)
                                                      was predominant in
                                                      females, whereas
                                                      equal amounts of
                                                      mono- and
                                                      disulfate (6U)
                                                      conjugates were
                                                      noted in males.
                                                      Most of the
                                                      significant
                                                      metabolites in
                                                      feces were exocons
                                                      of biliary
                                                      metabolites (2U,
                                                      3U, 1G). These
                                                      were assumed to be
                                                      deconjugated in
                                                      the intestines,
                                                      partially
                                                      reabsorbed into
                                                      the general
                                                      circulation,
                                                      conjugated again,
                                                      and eliminated
                                                      renally. The major
                                                      metabolic pathways
                                                      of cyprodinil were
                                                      not significantly
                                                      influenced by the
                                                      dose, treatment
                                                      regimen, or sex of
                                                      the animal.
------------------------------------------------------------------------
870.7600                         Dermal Absorption   In a dermal
                                  (rat)               absorption study
                                                      with cyprodinil
                                                      formulated as
                                                      SWITCH 62.5 WG in
                                                      the rat, the
                                                      maximum systemic
                                                      absorption was
                                                      21.71% (at 24
                                                      hours). An
                                                      additional 12% of
                                                      the applied dose
                                                      (that is
                                                      potentially
                                                      available for
                                                      absorption)
                                                      remained on the
                                                      treated skin at 24
                                                      hours.
------------------------------------------------------------------------

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.
    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 factors 
(SF) 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

[[Page 54812]]

chronic Population Adjusted Dose (aPAD or cPAD) is a modification of 
the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for cyprodinil used for human risk assessment is shown in the 
following Table 2:

      Table 2.--Summary of Toxicological Dose and Endpoints for Cyprodinil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose used in Risk       FQPA SF and Endpoint     Study, Toxicological
          Exposure Scenerio                 Assessment UF         for Risk Assessment            Endpoint
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of   Developmental NOAEL =    Special FQPA SF* = 1X    Developmental Toxicity
 age                                    150 mg/kg/day           aPAD = acute RfD /         rabbit
                                       UF = 100...............   Special FQPA SF = 1.5   Developmental LOAEL =
                                       Acute RfD = 1.5 mg/kg/    mg/kg/day.               400 mg/kg/day based on
                                        day.                                              slight increase of
                                                                                          litters showing extra
                                                                                          ribs (13th).
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL= 2.7               Special FQPA SF = 1X     2-Year Chronic Toxicity/
                                       UF = 100...............  cPAD = chronic RfD /       Carcinogenicity-rat
                                       Chronic RfD = 0.03 mg/    Special FQPA SF = 0.03  LOAEL = 35.6 mg/kg/day
                                        kg/day.                  mg/kg/day.               based on degenerative
                                                                                          liver lesions
                                                                                          (spongiosis hepatis)
                                                                                          in males.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short-Term (1-30       oral NOAEL= 62 mg/kg/    LOC for MOE = 100        28-Day Feeding/Range-
 days)(Residential)                     day                      (Residential, includes   finding - rat
                                                                 the Special FQPA SF of  LOAEL = 299 mg/kg/day
                                                                 1X)                      based on decreased
                                                                                          body-weight gain,
                                                                                          increased cholesterol
                                                                                          and phospholipid
                                                                                          levels, microcytosis,
                                                                                          and hepatocyte
                                                                                          hypertrophy.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Intermediate-Term (1-  oral NOAEL= 2.7 mg/kg/   LOC for MOE = 100        2-Year Chronic Toxicity/
 6 months)(Residential)                 day                      (Residential, includes    Carcinogenicity -rat
                                                                 the Special FQPA SF of  LOAEL = 35.6 mg/kg/day
                                                                 1X)                      based on degenerative
                                                                                          liver lesions
                                                                                          (spongiosis hepatis)
                                                                                          in males.
----------------------------------------------------------------------------------------------------------------
Dermal Short-Term (1-30                oral NOAEL= 62 mg/kg/    LOC for MOE = 100        28-Day Feeding/Range-
 days)(Residential)                     day (dermal absorption   (Residential, includes   finding - rat
                                        rate = 30%)              the Special FQPA SF of  LOAEL = 299 mg/kg/day
                                                                 1X)                      based on decreased
                                                                                          body-weight gain,
                                                                                          increased cholesterol
                                                                                          and phospholipid
                                                                                          levels, microcytosis,
                                                                                          and hepatocyte
                                                                                          hypertrophy.
----------------------------------------------------------------------------------------------------------------
Dermal Intermediate-Term(1-6 months)   oral NOAEL= 2.7 mg/kg/   LOC for MOE = 100        2-Year Chronic Toxicity/
 and Long-Term (26                      day(dermal absorption    (Residential, includes    Carcinogenicity - Rat
 months)(Residential)                   rate = 30%)              the Special FQPA SF of  LOAEL = 35.6 mg/kg/day
                                                                 1X)                      based on degenerative
                                                                                          liver lesions
                                                                                          (spongiosis hepatis)
                                                                                          in males.
----------------------------------------------------------------------------------------------------------------
Inhalation Short-Term(1-30 days)       oral NOAEL = 62 mg/kg/   LOC for MOE = 100        28-Day Feeding/Range-
 (Residential)                          day (inhalation          (Residential, includes   finding - rat
                                        absorption rate =        the Special FQPA SF of  LOAEL = 299 mg/kg/day
                                        100%)                    1X)                      based on decreased
                                                                                          body-weight gain,
                                                                                          increased cholesterol
                                                                                          and phospholipid
                                                                                          levels, microcytosis,
                                                                                          and hepatocyte
                                                                                          hypertrophy.
----------------------------------------------------------------------------------------------------------------
Inhalation Intermediate-Term(1-6       oral NOAEL = 2.7 mg/kg/  LOC for MOE = 100        2-Year Chronic Toxicity/
 months) and Long-Term (26 months)      day (inhalation          (Residential, includes    Carcinogenicity in
 (Residential)                          absorption rate =        the Special FQPA SF of   Rats
                                        100%)                    1X)                     LOAEL = 35.6 mg/kg/day
                                                                                          based on degenerative
                                                                                          liver lesions
                                                                                          (spongiosis hepatis)
                                                                                          in males.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)             Classification: ``Not likely to be carcinogenic to humans''
----------------------------------------------------------------------------------------------------------------
*The reference to the special FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.


[[Page 54813]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.532) for the residues of cyprodinil, in or on a 
variety of raw agricultural commodities: almond, hulls; almond 
nutmeats; apple, wet pomace; fruit, pome; fruit, stone; grape; and 
raisins. Time-limited tolerances are established (40 CFR 180.532 
(a)(2)) for onion, dry bulb; onion, green; and strawberry (each set to 
expire December 31, 2003). A time-limited tolerance (40 CFR 180.532 
(b)) on caneberries is also set to expire December 31, 2003. Risk 
assessments were conducted by EPA to assess dietary exposures from 
cyprodinil in food as follows:
    i. Acute exposure. In conducting this acute dietary risk assessment 
EPA used the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Database (DEEM-FCID[reg]) which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-1996 and 1998 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: An unrefined, Tier 1 acute dietary exposure assessment 
(using tolerance-level residues, DEEM (version 7.76) default processing 
factors and assuming 100% CT for all proposed commodities) was 
conducted for the females 13- 49 years old population subgroup.
    ii. Chronic exposure. In conducting this acute dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID[reg]) which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The following assumptions was made for the chronic exposure 
assessment: An unrefined, Tier 1 chronic dietary exposure assessment 
(using tolerance-level residues, DEEM default processing factors, and 
assuming 100% CT for all proposed commodities) was conducted for the 
general U.S. population and various population subgroups.
    iii. Cancer. A quantitative cancer aggregate-risk assessment was 
not performed because cyprodinil is not carcinogenic.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for cyprodinil in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of cyprodinil.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The SCI-GROW model is used to predict pesticide 
concentrations in shallow groundwater. 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. FIRST and PRZM/EXAMS incorporate an index reservoir 
environment, and 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 screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would 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 cyprodinil they are further 
discussed in the aggregate risk sections in Unit III.E.
    Environmental fate data suggest that as cyprodinil dissipates from 
the environment, it forms the transformation product CGA 249287 and 
other metabolites under natural conditions. CGA 249287 was observed at 
<11% of the applied parent in aerobic soil metabolism studies. It was 
also one of the transformation products observed at <14% in the 
terrestrial field dissipation studies.
    EPA concluded that CGA 249287 is a potential concern in drinking 
water. Therefore, EEC's of CGA 249287 (along with the parent) were also 
simulated. The maximum application rate and relevant environmental fate 
parameters for cyprodinil and its metabolite CGA 249287 were used in 
the two screening models PRZM/EXAMS and SCI-GROW for EEC's in surface 
water and groundwater, respectively. The outputs of the two screening 
models represent estimates of the concentrations that might be found in 
surface water and groundwater due to the use of cyprodinil on cabbage 
and strawberry.

                     Table 3.--Summary of EPA's EEC's in Surface Water and Groundwater Table
----------------------------------------------------------------------------------------------------------------
                                                  Surface Water ([mu]g/L)
               Chemical                --------------------------------------------     Groundwater ([mu]g/L)
                                              Acute           Non-Cancer Chronic
----------------------------------------------------------------------------------------------------------------
                                                 Florida Cabbage
----------------------------------------------------------------------------------------------------------------
Cyprodinil                                           23.9                     6.63                          0.04
---------------------------------------
CGA 249287                                           5.29                     1.42                          0.12
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
Total                                                29.2                      8.1                          0.16
----------------------------------------------------------------------------------------------------------------

[[Page 54814]]

 
                                               Florida Strawberry
----------------------------------------------------------------------------------------------------------------
Cyprodinil                                          26.67                     5.32                          0.04
---------------------------------------
CGA 249287                                           6.20                     1.04                          0.12
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
Total                                                32.9                      6.4                          0.16
----------------------------------------------------------------------------------------------------------------

    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).
    Cyprodinil is not registered for use on any sites that would result 
in residential exposure. There are no registered or proposed uses of 
cyprodinil which result in potential residential exposures.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether cyprodinil has a common mechanism of toxicity with other 
substances. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, EPA 
has not made a common mechanism of toxicity finding as to cyprodinil 
and any other substances and cyprodinil 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 cyprodinil has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There are no concerns or 
residual uncertainties for pre- and/or postnatal exposure.
    3. Conclusion. There is a complete toxicity data base for 
cyprodinil and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X Safety factor to protect infants and children should be 
reduced to 1X because:
    i. The toxicological data base is complete for the assessment of 
toxicity and susceptibility following pre- and/or post-natal exposures. 
No clinical signs of neurotoxicity or neuropathology were observed in 
the data base, and the developmental neurotoxicity study was not 
required.
    ii. There is no evidence of increased susceptibility of rat or 
rabbit fetuses following in utero exposure in the developmental studies 
with cyprodinil. There is no evidence of increased susceptibility of 
young rats in the reproduction study with cyprodinil.
    iii. There are no residual concerns regarding pre- or post-natal 
toxicity or completeness of the toxicity or exposure data base.
    iv. The dietary food exposure assessment is Tier 1, screening 
level, which is based on tolerance level residues and assumes 100% of 
all crops will be treated with cyprodinil. By using these screening 
level assessments, actual exposures/risks will not be underestimated.
    v. The dietary drinking water assessment utilizes water 
concentration values generated by models and associated modeling 
parameters which are designed to provide conservative, health 
protective, high-end estimates of water concentrations which will not 
likely be exceeded.
    vi. There are currently no registered residential uses of 
cyprodinil.
    vii. These assessments will not underestimate the exposure/risks 
posed by current or proposed uses of cyprodinil.

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: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative

[[Page 54815]]

drinking water exposure assessments. Different populations will have 
different DWLOCs. Generally, a DWLOC is calculated for each type of 
risk assessment used: Acute, short-term, intermediate-term, chronic, 
and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, 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 
cyprodinil will occupy 2% of the aPAD for the females 13-49 years old. 
In addition, there is potential for acute dietary exposure to 
cyprodinil in drinking water. For the general U.S. population, no toxic 
effects of concern that could be attributed to a single exposure were 
observed in the oral-toxicity studies, including the developmental 
toxicity studies in rats and rabbits. Therefore, an acute RfD was not 
established for this population subgroup and an acute dietary exposure 
assessment was not conducted for this population subgroup. 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 4:

                      Table 4.--Aggregate Risk Assessment for Acute Exposure to Cyprodinil
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                                  1.5            2         32.9         0.16       44,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
cyprodinil from food will utilize 25% of the cPAD for the U.S. 
population, 65% of the cPAD for (the most highly exposed population 
subgroup) children 1-2 years old, 32% of the cPAD for all infants <1 
year old, and 21% of the cPAD for females 13-49 years old. Based on the 
use pattern, chronic residential exposure to residues of cyprodinil is 
not expected. In addition, there is potential for chronic dietary 
exposure to cyprodinil 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 5:

               Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Cyprodinil
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.03           25          8.1         0.16          790
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                0.03           65          8.1         0.16          100
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old)                               0.03           32          8.1         0.16          200
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                               0.03           21          8.1         0.16          710
----------------------------------------------------------------------------------------------------------------

    3. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in mice and rats at doses that were judged 
to be adequate to assess the carcinogenic potential, cyprodinil was 
classified as ``not likely to be carcinogenic to humans.'' Therefore, 
cyprodinil is not expected to pose a cancer risk to humans.
    4. 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 cyprodinil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The results of Multiresidue Method testing of cyprodinil and its 
metabolite CGA-232449 have been forwarded to the Food and Drug 
Administration (FDA). Cyprodinil was tested according to the FDA 
Multiresidue protocols (Protocols C, D, and E), and acceptable 
recoveries were obtained for cyprodinil fortified in apples at 0.50 ppm 
using Protocol D. The petitioner is proposing the Method AG-631A as a 
tolerance enforcement method for residues of cyprodinil in/on the 
subject crops. The method includes confirmatory procedures using gas 
chromatography/nitrogen/phosphorus detector (GC/NPD). The method has 
successfully undergone radiovalidation using 14C-labeled 
tomato samples and independent laboratory validation. In addition, the 
method has been the subject of acceptable Agency petition method 
validations on stone fruits and almond nutmeat and hulls. The method 
may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
[email protected].

B. International Residue Limits

    Canada, Codex, and Mexico do not have maximum residue limits (MRLs) 
for residues of cyprodinil in/on the proposed crops. Therefore, 
harmonization is not an issue.

[[Page 54816]]

V. Conclusion

    Therefore, the tolerances are established for residues of 
cyprodinil, CGA 219417; 4-cyclopropyl-6-methyl-N-phenyl-2-
pyrimidinamine, in or on brassica, head and stem, subgroup 5A at 1.0 
ppm; brassica, leafy greens, subgroup 5B at 10.0 ppm; carrot at 0.75 
ppm; herb, subgroup 19A, dried at 15.0 ppm; herb, subgroup 19A, fresh 
at 3.0 ppm; longan, lychee, pulasan, rambutan, and spanish lime at 2.0 
ppm; and turnip, greens at 10.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0278 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
18, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    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 20460-0001.
    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.1. Mail your 
copies, identified by docket ID number OPP-2003-0278, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. 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. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income

[[Page 54817]]

Populations (59 FR 7629, February 16, 1994); or OMB review or any 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a petition under section 408(d) of the 
FFDCA, such as the tolerance in this final rule, do not require the 
issuance of a proposed rule, the requirements of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, 
the Agency has determined that this action will not have a substantial 
direct effect on States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 10, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.532 is amended by adding alphabetically commodities to 
the table in paragraph (a)(1) to read as follows:


Sec.  180.532  Cyprodinil; tolerances for residues.

    (a) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Brassica, head and stem, subgroup 5A                                                                         1.0
Brassica, leafy greens, subgroup 5B                                                                         10.0
                                                    * * * * *
Carrot                                                                                                      0.75
Herb, subgroup 19A, dried                                                                                   15.0
Herb, subgroup 19A, fresh                                                                                    3.0
                                                    * * * * *
Longan                                                                                                       2.0
Lychee                                                                                                       2.0
                                                    * * * * *
Pulasan                                                                                                      2.0
Rambutan                                                                                                     2.0
                                                    * * * * *
Spanish lime                                                                                                 2.0
Turnip, greens                                                                                              10.0
                                                    * * * * *
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[[Page 54818]]

* * * * *
[FR Doc. 03-23854 Filed 9-18-03; 8:45 am]
BILLING CODE 6560-50-S