[Federal Register Volume 68, Number 136 (Wednesday, July 16, 2003)]
[Rules and Regulations]
[Pages 41927-41936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17731]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0219; FRL-7313-6]


Cymoxanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cymoxanil in or on hop, dried cones; lettuce, head; imported lychee; 
vegetable, cucurbit, group 9; and vegetable, fruiting, group 8. The 
Interregional Research Project Number 4 (IR-4), the Taipai Economic and 
Cultural Representative Office, and E.I du Pont Nemours and Company 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of 
1996. EPA is also deleting the time-limited tolerance for hop, dried 
cones established in connection with use of the pesticide under section 
18 emergency exemptions and the tolerance for imported tomato. These 
tolerances are no longer needed since this rule establishes tolerances 
in support of the U.S. registration for hops and tomato.

DATES: This regulation is effective July 16, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0219, 
must be received on or before September 15, 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: 
brothers.shaja]@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] 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 (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-2003-0219. 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

[[Page 41928]]

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 July 6, 2001 (66 FR 130) (FRL-6784-9) 
and February 28, 2003 (68 FR 9660) (FRL-7288-9), EPA issued notices 
pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA 
(Public Law 104-170), announcing the filing of a pesticide petition 
(1E6224) by IR-4, 681 U.S. Highway 1 South, North Brunswick, 
NJ 08902-3390; PP 1E6233 from the Taipai Economic and Cultural 
Representative Office, 4301 Connecticut Ave., NW Suite 420, Washington, 
DC 20008; and PP 0F6072 from E.I. duPont de Nemours and Company, DuPont 
Agricultural Products, Barley Mill Plaza, Wilmington, DE 19880-0038. 
Those notices included summaries of the petitions prepared by E.I. 
duPont de Nemours and Company, DuPont Agricultural Products, the 
registrant. The petitions requested that 40 CFR 180.503 be amended by 
establishing tolerances for residues of the fungicide cymoxanil, [2-
cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino) acetamide], in or on 
hop at 1.0 part per million (ppm) (PP 1E6224); lettuce, head at 4.0 ppm 
(PP 6F6072); imported lychee at 1.0 ppm (PP 1E6233); vegetable, 
cucurbit, group at 0.05 ppm (PP 0F6072); and vegetable, fruiting, group 
at 0.2 ppm (PP 0F6072).
    The World Wildlife Fund (WWF) submitted comments on August 7, 2001 
in response to the notice of filing for hops and lychee. WWF urged EPA 
to apply the full 10X FQPA safety factor to cymoxanil ``because 
completed studies for this fungicide are inadequate to detect endocrine 
disruption and the endocrine disruptor data gap is of critical 
importance when determining a reasonable certainty of no harm to 
embryos, fetus, infants and children.'' In addition, WWF stated that 
there may be evidence of increased developmental susceptibility for 
cymoxanil. EPA reviewed the comments submitted by WWF and has addressed 
them in Unit III. D. of this document.
    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 November 26, 1997 (62 FR 62961) (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 cymoxanil on 
hop, dried cones at 1.0 ppm; lettuce, head at 4.0 ppm; vegetable, 
cucurbit, group 9 at 0.05 ppm; vegetable, fruiting, group 8 at 0.2 ppm; 
and imported lychee at 1.0 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by cymoxanil are 
discussed in Table 1 of this unit as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        Systemic toxicity NOAEL = 47.6 milligrams/
                                          rodents (rat)               kilogram/day (mg/kg/day) in males and 59.9
                                                                      mg/kg/day in females
                                                                     Systemic toxicity LOAEL = 102 mg/kg/day in
                                                                      males and 137 mg/kg/day in females, based
                                                                      on decreases in body weights, body weight
                                                                      gains and food efficiency in the females,
                                                                      and body weight decreases and testicular
                                                                      and epididymal changes in males.
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     Systemic toxicity NOAEL not established
                                          nonrodents (dog)           Systemic toxicity LOAEL = 3 mg/kg/day,
                                                                      based on decreased body weights (13%) and
                                                                      food consumption in females.
----------------------------------------------------------------------------------------------------------------
870.3200                                 21/28-Day dermal toxicity   Systemic and dermal toxicity NOAEL = 1,000
                                          (rat)                       mg/kg/day, highest dose tested (HDT)
                                                                     Systemic and dermal toxicity LOAEL was not
                                                                      established.
----------------------------------------------------------------------------------------------------------------

[[Page 41929]]

 
870.3700                                 Prenatal developmental in   Maternal NOAEL = 25 mg/kg/day
                                          rodents (rat)              Maternal LOAEL = 75 mg/kg/day, based upon
                                                                      reduced body weight, body weight change
                                                                      and food consumption
                                                                     Developmental NOAEL = 10 mg/kg/day
                                                                     Developmental LOAEL = 25 mg/kg/day, based
                                                                      upon significant increase in overall
                                                                      malformations, and generalized dose-
                                                                      related delay in skeletal ossification; at
                                                                      75 and 150 mg/kg/day significant decrease
                                                                      in fetal body weights; at 150 mg/kg/day
                                                                      increased early resorptions resulting in
                                                                      reduced litter size.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL 32 mg/kg/day
                                          nonrodents (rabbit)        Maternal LOAEL was not established
                                                                     Developmental NOAEL = 4 mg/kg/day
                                                                     Developmental LOAEL = 8 mg/kg/day, based
                                                                      upon an increase in skeletal anomalies of
                                                                      the cervical and thoracic vertebrae and
                                                                      ribs; at 32 mg/kg/day, cleft palate was
                                                                      also observed.
----------------------------------------------------------------------------------------------------------------
870.3800                                 2-Generation reproduction   Systemic toxicity NOAEL = 6.5 males and 7.9
                                          and fertility effects       females mg/kg/day
                                          (rat)                      Systemic toxicity LOAEL = 32.1 males and
                                                                      40.6 females mg/kg/day, based on reduced
                                                                      pre-mating body weight, body weight gain,
                                                                      and food consumption for P males; and
                                                                      decreased gestation and lactation body
                                                                      weight for F1 females
                                                                     Reproductive toxicity NOAEL 97.9 mg/kg/day
                                                                      for males and 130 mg/kg/day for females.
                                                                     Reproductive toxicity LOAEL was not
                                                                      established
                                                                     Offspring toxicity NOAEL = 6.5 males and
                                                                      7.9 females mg/kg/day
                                                                     Offspring toxicity LOAEL = 32.1 female and
                                                                      40.6 females mg/kg/day, based upon
                                                                      decreased F1 pup viability on postnatal
                                                                      days 0-4 and on a significant reduction in
                                                                      F2b pup weight.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity (dog)      Systemic toxicity NOAEL = 3.0/3.1 mg/kg/day
                                                                      for males/ and females
                                                                     Systemic toxicity LOAEL = 5.7 mg/kg/day
                                                                      (HDT in males), based upon depressed
                                                                      weight gains through week 12 and changes
                                                                      in the hematology and blood chemistry in
                                                                      males
                                                                     LOAEL was not established for females.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined chronic toxicity/  Systemic toxicity NOAEL = 4.08 mg/kg/day
                                          carcin ogenicity rodents    for males and 5.36 mg/kg/day for females
                                          (rat)                      Systemic toxicity LOAEL = 30.3 mg/kg/day
                                                                      for males and 38.4 mg/kg/day for females,
                                                                      based upon decreased body weight, body
                                                                      weight gain, and food efficiency,
                                                                      increased incidence of elongate spermatid
                                                                      degeneration and increased aggressiveness
                                                                      and/or hyperactivity in males and
                                                                      increased incidence of non-neoplastic
                                                                      lesions of the lungs, liver, sciatic nerve
                                                                      and retinal atrophy in females
                                                                     No evidence of carcinogenicity.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity mice        Systemic toxicity NOAEL = 4.19 mg/kg/day
                                                                      for males and 5.83 mg/kg/day for females,
                                                                      lowest dose tested (LDT)
                                                                     Systemic toxicity LOAEL = 42 mg/kg/day for
                                                                      males and 58.1 mg/kg/day for females HDT,
                                                                      based upon increased frequency of sperm
                                                                      cyst/cystic dilatation, tubular dilatation
                                                                      and lymphoid aggregates in males and
                                                                      hyperplastic gastropathy in females
                                                                     No evidence of carcinogenicity.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation               Cytotoxicity in all strains was seen at 750
                                                                      [mu]g/plate -S9 and 1.000 [mu]g/plate +S9.
                                                                      The positive controls induced the expected
                                                                      mutagenic responses in the appropriate
                                                                      tester strain. There was, however, no
                                                                      evidence that the test material induced a
                                                                      mutagenic effect under any test condition.
----------------------------------------------------------------------------------------------------------------
870.5300                                 In vitro mammalian cell     Severe cytotoxicity was seen at 750 [mu]g/
                                          gene mutation assay (CHO)   mL -S9 and 1,000 [mu]g/mL +S9. The
                                                                      positive controls induced the expected
                                                                      mutagenic responses. There was, however,
                                                                      no evidence that the test material was
                                                                      mutagenic at the Hypoxanthine Guanine
                                                                      Phophoribosyl Transferase locus at any
                                                                      dose under any assay condition.
----------------------------------------------------------------------------------------------------------------
8 70.6200                                Subchronic neurotoxicity    No effects on the functional observation
                                          screening battery (rat)     battery, or motor activity were observed.
                                                                      No treatment-related gross or microscopic
                                                                      findings in the nervous system or skeletal
                                                                      muscles of the male and female rats were
                                                                      observed
                                                                     The neurotoxicity NOAEL 3,000 ppm (224 mg/
                                                                      kg/day in males and 333 mg/kg/day in
                                                                      females; HDT). Neurotoxicity LOAEL was not
                                                                      established.
----------------------------------------------------------------------------------------------------------------

[[Page 41930]]

 
870.6300                                 Developmental               Maternal toxicity NOAEL = 50 mg/kg/day
                                          neurotoxicity (rat)        Maternal toxicity LOAEL = 100 mg/kg/day,
                                                                      based on slight decrease body weight, body
                                                                      weight gains (17%) and food consumption.
                                                                     Offspring NOAEL = 50 mg/kg/day
                                                                     Offspring LOAEL = 100 mg/kg/day, based on
                                                                      decreased pup survival, decreased pup
                                                                      weight and body weight gain during early
                                                                      lactation (less than 6%), increases in
                                                                      morphometric measurements (anterior/
                                                                      posterior cerebrum for males, cerebellar
                                                                      height for females) at PND 79-83, and
                                                                      decreased retention in the water maze task
                                                                      for adult females (latency 158% of control
                                                                      levels) seen at the LOAEL of 100 mg/kg/
                                                                      day.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              Cymoxanil was readily absorbed and 86 to
                                          pharmacokinetics (rat)      94% of the administered dose was excreted
                                                                      in 96 hours. The majority of the
                                                                      administered dose was recovered in the
                                                                      urine (64 - 57%) with smaller amounts
                                                                      excreted in the feces (16 - 24%) and
                                                                      carcass (<1%). There were no sex-related
                                                                      differences in the absorption,
                                                                      distribution and metabolism of cymoxanil.
                                                                      In urine about 37 - 55% of the dose was
                                                                      free and/or conjugated [14C]glycine and 2
                                                                      cyano-2-methoxyiminoacetic acid (IN-W3595;
                                                                      about 7 to 33% of the dose). Intact
                                                                      cymoxanil was not isolated in urine. In
                                                                      feces intact 14C cymoxanil (<1%) and IN
                                                                      W3595 was detected, but the majority of
                                                                      radioactivity was 14C glycine (about 9 -
                                                                      13%). Based on the data, the metabolic
                                                                      pathway involves hydrolysis of cymoxanil
                                                                      to IN W3595, which is then degraded to
                                                                      glycine, which in turn is incorporated
                                                                      into natural constituents or further
                                                                      metabolized.
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern. However, the the LOAEL is sometimes 
used for risk assessment if no NOAEL was achieved in the toxicology 
study selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for intra 
species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by the appropriate UF (RfD = 
NOAEL/UF). Where an additional safety factors 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 SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the lever of concern. 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 lever of concern.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer =point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for cymoxanil used for human risk assessment is shown in the 
following Table 2.

      Table 2.--Summary of Toxicological Dose and Endpoints for Cymoxanil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of  NOAEL = 4 mg/kg/day      FQPA SF = 1X             Developmental toxicity
 age)                                  UF = 100...............  aPAD = aRfD............   study - rabbit
                                       aRfD = 0.04 mg/kg/day..  FQPA SF = 0.04 mg/kg/    Developmental LOAEL = 8
                                                                 day.                     mg/kg/day based on
                                                                                          increased skeletal
                                                                                          anomalies of the
                                                                                          cervical and thoracic
                                                                                          vertebrae
                                                                                          (hemivertebrae) and
                                                                                          ribs; at 32 mg/kg/day,
                                                                                          cleft palate was also
                                                                                          observed.
----------------------------------------------------------------------------------------------------------------

[[Page 41931]]

 
Acute dietary (general population      NA                       NA                       An effect attributable
 including infants and children)                                                          to a single exposure
                                                                                          was not observed in
                                                                                          the oral toxicity
                                                                                          studies, including the
                                                                                          developmental toxicity
                                                                                          studies in rats and
                                                                                          rabbits. Therefore, an
                                                                                          aRfD was not
                                                                                          established for this
                                                                                          population.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 4 mg/kg/day      FQPA SF = 1X             Combined chronic
                                       UF = 100...............  cPAD = chronic RfD.....   toxicity/
                                       cRfD = 0.04 mg/kg/day..  FQPA SF = 0.04 mg/kg/     carcinogenicity study
                                                                 day.                      rat
                                                                                         Systemic LOAEL = 30.3
                                                                                          mg/kg/day based on
                                                                                          decreases in body
                                                                                          weight, body weight
                                                                                          gain, reduced food
                                                                                          efficiency and
                                                                                          histopathological
                                                                                          lesions in the eyes
                                                                                          and testes of males.
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 30 days)       Oral study NOAEL = 4 mg/ LOC for MOE = 100        Developmental toxicity
(Residential)........................   kg/day                  (Residential)..........   study - rabbit
                                       (Dermal absorption rate                           Developmental LOAEL = 8
                                        = 2.5%).                                          mg/kg/day based on
                                                                                          increased skeletal
                                                                                          anomalies of the
                                                                                          cervical and thoracic
                                                                                          vertebrae
                                                                                          (hemivertebrae) and
                                                                                          ribs; at 32 mg/kg/day,
                                                                                          cleft palate was also
                                                                                          observed.
----------------------------------------------------------------------------------------------------------------
Intermediate-term dermal (1 to 6       Oral study NOAEL = 4 mg/ LOC for MOE = 100        Developmental toxicity
 months)                                kg/day                  (Residential)..........   study - rabbit
(Residential)........................  (Dermal absorption rate                           Developmental LOAEL = 8
                                        = 2.5%.                                           mg/kg/day based on
                                                                                          increased skeletal
                                                                                          anomalies of the
                                                                                          cervical and thoracic
                                                                                          vertebrae
                                                                                          (hemivertebrae) and
                                                                                          ribs; at 32 mg/kg/day,
                                                                                          cleft palate was also
                                                                                          observed.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (>6 months)           Oral study NOAEL= 4 mg/  LOC for MOE = 100        Combined chronic
(Residential)........................   kg/day                  (Residential)..........   toxicity/
                                       (Dermal absorption rate                            carcinogenicity study
                                        = 2.5% when                                        rat
                                        appropriate).                                    Systemic LOAEL = 30.3
                                                                                          mg/kg/day based on
                                                                                          decreases in body
                                                                                          weight, body weight
                                                                                          gain, reduced food
                                                                                          efficiency and
                                                                                          histopathological
                                                                                          lesions in the eyes
                                                                                          and testes of males.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days)   Oral study NOAEL= 4 mg/  LOC for MOE = 100        Developmental toxicity
(Residential)........................   kg/day                  (Residential)..........   study - rabbit
                                       (Inhalation absorption                            Developmental LOAEL = 8
                                        rate = 100%).                                     mg/kg/day based on
                                                                                          increased skeletal
                                                                                          anomalies of the
                                                                                          cervical and thoracic
                                                                                          vertebrae and ribs; at
                                                                                          32 mg/kg/day, cleft
                                                                                          palate was also
                                                                                          observed.
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 to 6   Oral study NOAEL = 4 mg/ LOC for MOE = 100        Developmental toxicity
 months)                                kg/day                  (Residential)..........   study - rabbit
(Residential)........................  (Inhalation absorption                            Developmental LOAEL = 8
                                        rate = 100%).                                     mg/kg/day based on
                                                                                          increased skeletal
                                                                                          anomalies of the
                                                                                          cervical and thoracic
                                                                                          vertebrae and ribs; at
                                                                                          32 mg/kg/day, cleft
                                                                                          palate was also
                                                                                          observed.
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (> 6 months)      Oral study NOAEL= 4 mg/  LOC for MOE = 100        Combined chronic
                                        kg/day                  (Residential)..........   toxicity/
(Residential)........................  (Inhalation absorption                             carcinogenicity study
                                        rate = 100%).                                      rat
                                                                                         Systemic LOAEL = 30.3
                                                                                          mg/kg/day based on
                                                                                          decreases in body
                                                                                          weight, body weight
                                                                                          gain, reduced food
                                                                                          efficiency and
                                                                                          histopathological
                                                                                          lesions in the eyes
                                                                                          and testes of males.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      NA                       NA                       Classification: not
                                                                                          likely human
                                                                                          carcinogen Q1* = none.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.503) for the residues of cymoxanil, in or on a 
variety of raw agricultural commodities. A permanent tolerance of 0.05 
ppm for residues of cymoxanil per se in/on potatoes has been 
established under 40 CFR 180.503(a). A time-limited tolerance of 1 ppm 
for residues of cymoxanil per se in/on hops, dried has

[[Page 41932]]

also been established under 40 CFR 180.503(b) in connection with EPA's 
granting of a section 18 emergency exemption. The time-limited 
tolerance for hops, dried cone was set to expire December 31, 2003. 
Tolerances for residues of cymoxanil per se in/on imported grapes and 
tomatoes at 0.1 ppm are established under 40 CFR 180.503(e). Risk 
assessments were conducted by EPA to assess dietary exposures from 
cymoxanil 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. In conducting the acute dietary exposure assessment 
EPA used the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Data base (FCDI DEEMTM) which incorporates 
food consumption data as reported by respondents in the United States 
Department of Agriculture (USDA) 1994-1996, and 1998 nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The acute 
dietary exposure analyses assumed tolerance level residues, 100% crop 
treated and DEEMTM (ver. 7.76) default processing factors 
for all registered/proposed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessments EPA used the DEEMTM software with the FCID which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-l996, and 1998 nationwide CSFII and accumulated exposure to 
the chemical for each commodity. The following assumptions were made 
for the chronic exposure assessments: The chronic dietary exposure 
analyses assumed tolerance level residues, 100% CT, and 
DEEMTM (ver. 7.76) default processing factors for all 
registered/proposed commodities.
    iii. Cancer. In accordance with the EPA Draft Guidelines for 
Carcinogen Risk Assessment (July 1999), the Agency classified cymoxanil 
as a ``not likely'' human carcinogen. Therefore, a cancer dietary 
exposure analysis was not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for cymoxanil 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 cymoxanil.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) to estimate pesticide concentrations in surface 
water and Screening Concentration in Ground water (SCI-GROW), which 
predicts pesticide concentrations in ground water. In general, EPA will 
use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) 
for a screening-level assessment for surface water. The GENEEC model is 
a subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    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 cymoxanil they are further 
discussed in the aggregate risk sections in Unit II.E.
    Cymoxanil appears to be mobile in soils. However, the rapid 
dissipation of cymoxanil in the environment precludes the possibility 
of extensive leaching. No detections of cymoxanil were observed below 
the 0-15 cm soil depth at any of the test sites. Though the degradates 
of cymoxanil are mobile, the aerobic soil metabolism study showed that 
the degradates are short-lived. Cymoxanil and its degradates should not 
pose a threat to ground water. Therefore, ground water EEC values were 
not included in the risk assessment.
    Based on the GENEEC model the EECs of cymoxanil for surface water 
are estimated to be 4.13 parts per billion (ppb) for acute exposures 
and 0.19 ppb for chronic exposure.
    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).
    Cymoxanil is not registered for use on any sites that would result 
in residential exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the 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 cymoxanil 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 cymoxanil and 
any other substances and cymoxanil 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 cymoxanil 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

[[Page 41933]]

level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There is an indication of 
increased susceptibility (qualitative and quantitative) of rats and 
rabbits to in utero exposure to cymoxanil. In the rat developmental 
toxicity study, decreased fetal body weights and skeletal malformations 
were observed at 25 mg/kg/day LOAEL, which is below the maternal 
toxicity of 75 mg/kg/day LOAEL. In the rabbit developmental study 
increased skeletal malformations were observed at 8 mg/kg/day LOAEL, 
also below the maternal NOAEL of 32 mg/kg/day. In the 2-generation 
reproduction study there was an indication of increased qualitative 
susceptibility in the offspring, since there was decreased pup 
viability at a maternally toxic dose.
    3. Conclusion. There is a complete toxicity data base for cymoxanil 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. EPA determined that the 
10X SF to protect infants and children should be reduced to 1X. The 
FQPA factor is reduced to 1X because in the developmental and postnatal 
studies (including a developmental neurotoxicity study in rats) the 
effects are well characterized and conservative NOAELs were established 
for all developmental and offspring effects. In addition, the doses 
selected for risk assessment are lower than the NOAELs from these 
studies and are protective of any potential prenatal and post-natal 
effects. Therefore, there are low levels of concern and no residual 
uncertainties for prenatal and postnatal toxicity.
    In response to the notice of filing of July 6, 2001, WWF urged EPA 
to apply the full 10X FQPA safety factor to cymoxanil. According to WWF 
the data for cymoxanil is inadequate to address potential endocrine 
disruption and there is evidence of increased susceptibility in the 
prenatal developmental rabbit study. WWF claimed the multigeneration 
reproduction study in rats is inadequate because it was conducted 
before the 1996 guideline changes which added additional endpoints 
responsive to estrogenic and/or androgenic endocrine disruption. In 
addition, WWF noted that inferences about endocrine disruption based on 
current guidelines are still not fully adequate to evaluate endocrine 
disruption. In particular, the Endocrine Disruptor Screening and 
Testing Advisory Committee (EDSTAC) recommended the inclusion of more 
endpoints relevant to thyroid disruption and measurement of estradiol, 
testerone, luteinizing hormone, follicle stimulating hormone, T4 and 
thyroid stimulating hormone levels in multigeneration studies. WWF 
further argued for the inclusion of certain adrenal hormones such as 
ACTH and corticosterone (the primary glucocorticoid in rodents) to 
fully address the endocrine disruption issue. In addition, WWF believes 
that there is an increased developmental susceptibility to rabbits 
fetuses. WWF questioned the conclusions reached by the Office of 
Pesticide Programs' Hazard Identification Assessment Review Committee 
(HIARC) Jan 20, 1998 that there is no sensitivity in fetuses compared 
to maternal animals. Developmental malformations were observed at 8 mg/
kg/day, which is below the maternal NOAEL of 16 mg/kg/day. These 
results were discounted due to uncertainties regarding the source of 
the parental rabbits. In another rabbit study, developmental 
malformations were observed at the same dose (8 mg/kg/day) as in the 
previous study, however, HIARC did not consider this to show increased 
susceptibility because the effects were observed at 8 mg/kg/day, which 
is also a maternal toxic dose.
    On June 18, 2002, HIARC reviewed the WWF comments and concluded 
that possible endocrine-related effects on testicular and/or epididymal 
tissues are fully characterized and well defined in mouse, subchronic 
and chronic rat and dog studies with clear NOAELs. Further, in the 
reproduction toxicity study in rats, testicular effects were seen, 
however, these effects did not affect any measured reproductive 
parameters, indicating no adverse effects on reproduction. Additional 
measurements recommended by EDSTAC and WWF are unlikely to provide any 
significant additional information for cymoxanil since NOAELs are 
clearly defined for the testicular and/or epididymal effects and there 
are no indications of endocrine disruption in other organs e.g., 
thyroid (thyroid weight changes and hyperplasia), adrenal toxicity.
    Prior to receipt of WWF letter, the HIARC on August 21, 2001, 
reevaluated the toxicology data base and modified certain study reviews 
resulting in the selection of new endpoints. The reevaluations resulted 
in the qualitative and quantitative evidence of increased 
susceptibility to rabbit fetuses (as suggested by WWF) and rat fetuses. 
In addition, reevaluation of rat reproduction toxicity study resulted 
in the qualitative increased susceptibility to offspring. A 
conservative NOAEL from the rabbit developmental study was used for 
establishing the aRfD. Nonetheless, it was concluded that reliable data 
supported applying no additional safety factor since endpoints chosen 
for risk assessments adequately protect infants and children with 
regard to the prenatal and/or postnatal toxicity that has been 
identified.

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 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 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which 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.

[[Page 41934]]

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
cymoxanil will occupy <71% of the aPAD for females 13 to 49 years old. 
This is the only population for which an acute toxicological endpoint 
has been determined. In addition, there is potential for acute dietary 
exposure to cymoxanil in drinking water derived from surface 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 Cymoxanil
----------------------------------------------------------------------------------------------------------------
                                                                                          Surface
                     Population Subgroup                       aPAD (mg/      % aPAD     Water EEC   Acute DWLOC
                                                                  kg)         (Food)       (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                                            0.04          <71         4.13          350
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to cymoxanil 
from food will utilize 13% of the cPAD for the U.S. population, and all 
population subgroups. Adults 20-49 years old and females 13-49 years 
old were the most highly exposed subpopulations. There are no 
residential uses for cymoxanil that result in chronic residential 
exposure. In addition, there is potential for chronic dietary exposure 
to cymoxanil in drinking water derived from surface water. After 
calculating DWLOCs and comparing them to the EECs for surface water 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 Cymoxanil
----------------------------------------------------------------------------------------------------------------
                                                                                          Surface
                     Population Subgroup                      cPAD mg/kg/     % cPAD     Water EEC     Chronic
                                                                  day         (Food)       (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                                      0.04          <13         0.19        1,200
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. In accordance with 
the EPA Draft Guidelines for Carcinogen Risk Assessment (July, 1999), 
the Agency classified cymoxanil as a ``not likely'' human carcinogen. 
Cymoxanil is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to cymoxanil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Cymoxanil was shown to be recoverable using Protocol D of FDA's 
Pesticide Analytical Manual I methodology. The residue of concern in 
plants was previously determined to be parent only. In addition, Method 
AMR 3060-94 Revision 2, a High Performance Liquid Chromotography 
Ultraviolet (HPLC/UV) method, should be adequate for lychee tolerance 
enforcement purposes.

B. International Residue Limits

    There are no CODEX, Canadian or Mexican Maximum Residue Levels 
established for cymoxanil on hops, lychee, or cucurbit vegetables. The 
U.S. tolerance for fruiting vegetables is compatible with Codex. 
Therefore, no compatibility problems exist for the tolerances 
established by this rule.

V. Conclusion

    Therefore, the tolerance is established for residues of cymoxanil, 
[2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino) acetamide], in or on 
hop, dried cones at 1.0 ppm; lettuce, head at 4.0 ppm; vegetable, 
cucurbit group 9 at 0.05 ppm; vegetable, fruiting, group 8 at 0.2 ppm; 
and lychee at 1.0 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-2003-0219 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 September 
15, 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

[[Page 41935]]

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-2003-0219, 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 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

[[Page 41936]]

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: June 30, 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 180.503 is amended by adding alphabetically the following 
commodities and a footnote to the table in paragraph (a) and removing 
paragraph (e) to read as follows:


Sec.  180.503  Cymoxanil, tolerance for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Grape1...............................................                0.1
Hop, dried cones.....................................                1.0
Lettuce, head........................................                4.0
Lychee1..............................................                1.0
                                * * * * *
Vegetable, cucurbit, group 9.........................               0.05
Vegetable, fruiting, group 8.........................                0.2
------------------------------------------------------------------------
\1\There are no U.S. registrations for grape and lychee.

* * * * *
[FR Doc. 03-17731 Filed 7-15-03; 8:45 am]
BILLING CODE 6560-50-S