[Federal Register Volume 69, Number 189 (Thursday, September 30, 2004)]
[Rules and Regulations]
[Pages 58290-58299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21931]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0211; FRL-7367-4]


Cyazofamid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for the combined 
residues of cyazofamid and its metabolite CCIM in or on potatoes, 
tomatoes, cucurbits, and imported wine. ISK Biosciences Corporation 
requested this tolerance 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 30, 2004. Objections and 
requests for hearings must be received on or before November 29, 2004.

ADDRESSES:  To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2004-0211. All documents in the docket are listed in the 
EDOCKET index athttp://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either electronically in 
EDOCKET or in hard copy at the Public Information and Records Integrity 
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. Bell St., 
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.

FOR FURTHER INFORMATION CONTACT: Janet Whitehurst, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 305-6129; 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 are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    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 Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), 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 E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of May 7, 2003 (68 FR 24463) (FRL-7305-7), 
EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1F06305) by ISK Biosciences Corporation, Concord, OH. That notice 
included a summary of the petition prepared by ISK Biosciences 
Corporation, the registrant. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for combined residues of the fungicide 
cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-
imidazole-1-sulfonamide and its metabolite CCIM, 4-chloro-5-(4-
methylphenyl)-1H-imidazole-2-carbonitrile, expressed as cyazofamid, in 
or on cucurbit vegetables (Group 9) at 0.10 parts per million (ppm), 
potato at 0.01 ppm, tomato at 0.20 ppm, and grape wine at 1.0 ppm.
    Following review of the residue and metabolism data, EPA has made 
several minor changes to the proposed tolerances. For cucurbits and 
potatoes, EPA expanded the tolerance expression to cover both 
cyazofamid and its metabolite CCIM, which is also a residue of concern. 
This expansion of the toleranceexpression necessitated a raising of the 
tolerance level for potatoes from 0.01 ppm to 0.02 ppm. No change in 
the tolerance values was needed for tomatoes. Finally, residue and 
processing data for grape wine showed that residues might slightly 
exceed 1.0

[[Page 58291]]

ppm; accordingly, the tolerance for grape wine was raised to 1.5 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of 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 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 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 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 FFDCA, for a tolerance for combined residues of cyazofamid 
on cucurbits at 0.10 ppm, potatoes at 0.01 ppm, tomatoes at 0.2 ppm, 
and wine grape 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 cyazofamid 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.--Toxicity Profile of Cyazofamid [IKF-916] Technical
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-day oral toxicity in     NOAEL = 29.5 [M] mg/kg/day
                                          rats                       LOAEL = 295 [M] mg/kg/day based on
                                                                      increased number of ``basophilic kidney
                                                                      tubules,'' and increased urinary volume,
                                                                      pH, and protein.
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL = 1,000 [M/F] mg/kg/day
                                          dogs                       LOAEL = not observed.
----------------------------------------------------------------------------------------------------------------
870.3200                                 28-Day dermal toxicity in   NOAEL = 1,000 [M/F] mg/kg/day
                                          rats                       LOAEL = not observed.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 1,000 mg/kg/day
                                          rats                       LOAEL = not observed
                                                                     Developmental NOAEL = 100 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on increased
                                                                      incidence of bent ribs.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 1,000 mg/kg/day
                                          rabbits                    LOAEL = not observed
                                                                     Developmental NOAEL = 1,000 mg/kg/day
                                                                     LOAEL = not observed
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870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 1,114/1,416 [M/F]
                                          effects in rats             mg/kg/day
                                                                     LOAEL = not observed
                                                                     Reproductive NOAEL = 1,114/1,416 [M/F] mg/
                                                                      kg/day
                                                                     LOAEL = not observed
                                                                     Offspring NOAEL = 1,114/1,416 [M/F] mg/kg/
                                                                      day
                                                                     LOAEL = not observed
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity in rats    NOAEL = 171/ 856 [M/F] mg/kg/day
                                                                     LOAEL = not observed.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity in dogs    NOAEL = 200 [M/F] mg/kg/day
                                                                     LOAEL = 1,000 [M/F] mg/kg/day based on
                                                                      increased cysts in parathyroids in both
                                                                      sexes and increased pituitary cysts in
                                                                      females.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity rats        NOAEL = 171/ 856 [M/F] mg/kg/day
                                                                     LOAEL = not observed.
                                                                     No evidence of carcinogenicity
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870.4300                                 Carcinogenicity mice        NOAEL = 94.8 [M] mg/kg/day
                                                                     LOAEL = 985 [M] mg/kg/day based on
                                                                      increased incidence of skin lesions
                                                                      including hair loss, body sores,
                                                                      dermatitis, ulceration, and acanthosis.
                                                                     No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------

[[Page 58292]]

 
870.5100                                 Gene Mutation               Negative  S9 up to 5,000 [mu]g/
                                         Bacterial reverse mutation   plate by standard plate and tube
                                          assay.                      preincubation (not cytotoxic but there was
                                                                      precipitation at >= 1,500 [mu]g/plate.
----------------------------------------------------------------------------------------------------------------
870.5300                                 Gene Mutation               Negative  S9 up to cytotoxic
                                         Mammalian cell culture....   and precipitating concentration of 100
                                                                      [mu]g/mL
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870.5375                                 Cytogenetics                Negative  S9 for clastogenic/
                                         Chromosomal aberrations...   aneugenic activity up to cytotoxic and
                                                                      precipitating 200 [mu]g/mL
----------------------------------------------------------------------------------------------------------------
870.5395                                 Cytogenetics                Negative up to the highest dose tested
                                         Micronucleus test on mouse   (limit dose) 2,000 mg/kg
----------------------------------------------------------------------------------------------------------------
870.5500                                 Other Effects               Negative  S9 up to limit of
                                         Bacterial DNA repair test    solubility at 8,000 [mu]g/disc
                                          (Rec-assay).
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              There was rapid absorption (irrespective of
                                          pharmacokinetics in rats    dose tcmax = 0.25-0.5 hrs) and rapid
                                                                      elimination at the low dose (t[frac12] 4.4-
                                                                      5.8 hrs) while there was saturated
                                                                      absorption with prolonged elimination
                                                                      (t[frac12] of 7.6-11.6 hrs) at the high-
                                                                      dose. The extent of absorption (as per
                                                                      cent of administered dose) was highly dose-
                                                                      dependent being nearly 75% at the low dose
                                                                      and only about 5% at the high dose. Both
                                                                      the urine and feces were major routes of
                                                                      excretion at the low dose with most of the
                                                                      urinary radioactivity being a metabolite
                                                                      named CCBA (4-(4-chloro-2-cyanoimidazol-5-
                                                                      yl)benzoic acid). The biliary elimination
                                                                      was highly variable at the low dose (12-
                                                                      39% of the administered low dose) and
                                                                      negligible (<2%) in the high-dose groups.
                                                                      Urinary or biliary excretion in the high-
                                                                      dose groups was low (each 2%) with most of
                                                                      the radioactivity being CCBA. Irrespective
                                                                      of the dosing regimen, most of the
                                                                      recovered fecal radioactivity was
                                                                      unchanged parent compound; the major fecal
                                                                      metabolites were CCBA and 4-chloro-5-p-
                                                                      tolylimidazole-2-carbonitrile (CCIM) each
                                                                      of which being less than 5% of the
                                                                      administered dose. Tissue burdens at
                                                                      t[frac12], tmax, and at 168 hours post
                                                                      dose indicated rapid clearance and low
                                                                      tissue burdens suggesting little or no
                                                                      bioaccumulation or sequestration.
----------------------------------------------------------------------------------------------------------------

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.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional uncertainty factor or a special FQPA safety factor).
    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 an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, 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 safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-\5\), one in a million (1 X 10-\6\), or one in 
ten million (1 X 10-\7\). 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

[[Page 58293]]

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 cyazofamid used for 
human risk assessment is shown in Table 2 of this unit:

                      Table 2.--Summary of Toxicological Dose and Endpoints for Cyazofamid
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF* and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of  NOAEL = 100 mg/kg        FQPA SF = 1X             Rat Prenatal
 age)                                  UF = 100...............  aPAD = acute RfD / FQPA   Developmental Toxicity
                                       Acute RfD = 1.0 mg/kg..   SF = 1.0 mg/kg.          (MRID 45408933)
                                                                                         LOAEL = 1,000 mg/kg
                                                                                          based on developmental
                                                                                          toxicity findings of
                                                                                          increased incidence of
                                                                                          bent ribs.
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population      NOAEL = NA               FQPA SF = NA             Not Required. No
 including infants and children)       UF = NA................  aPAD = acute RfD / FQPA   adverse effects were
                                       Acute RfD = NA.........   SF = NA.                 observed which could
                                                                                          be attributed to a
                                                                                          single-dose exposure.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= 94.8 mg/kg/day    FQPA SF = 1X             18-Month Mouse Oral
                                       UF = 100...............  cPAD = chronic RfD /      Carcinogenicity (MRID
                                       Chronic RfD = 0.95 mg/    FQPA SF = 0.95 mg/kg/    45408932)
                                        kg/day.                  day.                    LOAEL = 985 mg/kg/day
                                                                                          based on increased
                                                                                          skin lesions.
----------------------------------------------------------------------------------------------------------------
Short- (1-30 days) and Intermediate-   NOAEL= NA                Residential LOC for MOE  NA
 Term (1 to 6 months) Incidental Oral  No Residential Uses....   = NA
                                                                Occupational = NA......
----------------------------------------------------------------------------------------------------------------
Short- (1-30 days) and Intermediate-   Oral study NOAEL = 100   Residential LOC for MOE  Rat Prenatal
 Term (1 to 6 months) Dermal            mg/kg/day                = NA                     Developmental Toxicity
                                       (dermal absorption rate  Occupational LOC for      (MRID 45408933)
                                        = 37%).                  MOE = 100.              LOAEL = 1,000 mg/kg
                                                                                          based on developmental
                                                                                          toxicity findings of
                                                                                          increased incidence of
                                                                                          bent ribs.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (>6 months)           Oral study NOAEL = 94.8  Residential LOC for MOE  18-Month Mouse Oral
                                        mg/kg/day                = NA                     Carcinogenicity (MRID
                                       (dermal absorption rate  Occupational LOC for      45408932)
                                        = 37%).                  MOE = 100.              LOAEL = 985 mg/kg/day
                                                                                          based on increased
                                                                                          skin lesions.
----------------------------------------------------------------------------------------------------------------
Short- (1-30 days) and Intermediate-   Oral study NOAEL = 100   Residential LOC for MOE  Rat Prenatal
 Term (1 to 6 months) Inhalation        mg/kg/day                = NA                     Developmental Toxicity
                                                                Occupational LOC for      (MRID 45408933)
                                                                 MOE = 100.              LOAEL = 1,000 mg/kg
                                                                                          based on developmental
                                                                                          toxicity findings of
                                                                                          increased incidence of
                                                                                          bent ribs.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (>6 months)       Oral study NOAEL = 94.8  Residential LOC for MOE  18-Month Mouse Oral
                                        mg/kg/day                = NA                     Carcinogenicity (MRID
                                                                Occupational LOC for      45408932)
                                                                 MOE = 100.              LOAEL = 985 mg/kg/day
                                                                                          based on increased
                                                                                          skin lesions.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Not Applicable           NA                       NA
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL =
  lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
  dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Permanent and 
temporary tolerances for residues of cyazofamid and its metabolites are 
not currently established. Risk assessments were conducted by EPA to 
assess dietary exposures from the proposed uses of cyazofamid on food 
and feed crops 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 risk assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCIDTM) and LifelineTM, 
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: As an acute dietary endpoint was not identified 
for the general population including infants and children, the acute 
dietary analysis was performed for the population subgroup females 13 
to 49 years old only. The assumptions of this dietary exposure 
assessment are tolerance level residues and 100% crop-treated.
    At the 95th percentile of exposure, the Tier 1 acute DEEM-
FCIDTM and LifelineTM analysis gave the results 
listed in Table 3. For the acute analysis, the exposure at the 95th 
percentile for Females 13 to 49 years old is 0.003769 mg/kg/day for 
DEEM-FCIDTM or

[[Page 58294]]

0.004013 mg/kg/day for LifelineT, which utilizes <1% of the acute PAD 
for cyazofamid for both DEEM-FCIDTM and 
LifelineTM. The results of the LifelineTM and 
DEEM-FCIDTM analyses are fully consistent.
    A summary of the acute dietary exposure estimates for cyazofamid 
and its metabolote CCIM used for human risk assessment are shown in 
Table 3 of this unit:

                            Table 3.--Acute Dietary Exposure Estimates for Cyazofamid
----------------------------------------------------------------------------------------------------------------
                                                                     DEEM-FCIDTM               LifeLineTM
                                                 aPAD (mg/kg/---------------------------------------------------
              Population Subgroup                    day)       Exposure                  Exposure
                                                              (mg/kg/day)    %aPAD\1\   (mg/kg/day)    %aPAD\1\
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                                  1.0     0.003769           <1     0.004013           <1
----------------------------------------------------------------------------------------------------------------
\1\ Percent Acute PAD = (Exposure / Acute PAD) x 100%.

    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the DEEM-FCIDTM and 
LifelineTM, 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 chronic exposure assessments: The 
assumptions of this dietary exposure assessment are tolerance level 
residues and 100% crop-treated.
    The Tier 1 chronic DEEM-FCIDTM and LifelineTM 
analysis gave the results listed in Table 4. For the chronic analysis, 
the most highly exposed population subgroup and the highest risk 
estimate was for Children 1 to 2 years old. The chronic exposures for 
Children 1 to 2 years old are 0.004778 mg/kg/day for DEEM-
FCIDTM) or 0.004529 mg/kg/day for LifelineTM), 
which utilize <1.0% (for both DEEM-FCIDTM and Lifeline 
TM) of the chronic PAD for cyazofamid. The results of the 
LifelineTM and DEEM-FCIDTM analyses are fully 
consistent.
    A summary of the chronic dietary exposure estimates for cyazofamid 
used for human risk assessment is shown in Table 4 of this unit:

                           Table 4.--Chronic Dietary Exposure Estimates for Cyazofamid
----------------------------------------------------------------------------------------------------------------
                                                                     DEEM-FCIDTM               LifeLineTM
                                                 cPAD (mg/kg/---------------------------------------------------
              Population Subgroup                    day)       Exposure                  Exposure
                                                              (mg/kg/day)    %cPAD\1\   (mg/kg/day)    %cPAD\1\
----------------------------------------------------------------------------------------------------------------
General U.S. Population                                 0.95     0.001016           <1     0.000988           <1
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old)                               0.95     0.001448           <1     0.001501           <1
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                  0.95     0.004778           <1     0.004529           <1
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                  0.95     0.003101           <1     0.003236           <1
----------------------------------------------------------------------------------------------------------------
Children 6-12 years old                                 0.95     0.001338           <1      0.00131           <1
----------------------------------------------------------------------------------------------------------------
Youth 13-19 years old                                   0.95     0.000567           <1     0.000589           <1
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                                  0.95     0.000684           <1     0.000751           <1
----------------------------------------------------------------------------------------------------------------
Adults 50+ years old                                    0.95     0.000774           <1     0.000802           <1
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                                 0.95     0.000720           <1     0.000816           <1
----------------------------------------------------------------------------------------------------------------
\1\ Percent Chronic PAD = (Exposure / Chronic PAD) x 100%.

    iii. Cancer. A cancer dietary assessment was not conducted because 
cyazofamid has been classified as ``not likely to be carcinogenic to 
humans''.
    iv. Anticipated residue and percent crop treated (PCT) information. 
The Agency did not use anticicated residue estimates and PCT 
information in the cyazofamid dietary exposure assessment.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for cyazofamid and its 
metabolites 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 cyazofamid.
    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 Screening Concentration in Groudwater (SCI-GROW) model 
is used to predict pesticide concentrations in shallow ground water. 
For a screening-level assessment for surface water EPA will use FIRST 
(a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST 
model is a subset of the PRZM/EXAMS model that uses a specific high-end 
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate 
an index reservoir environment, and both models include 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

[[Page 58295]]

(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), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a percent of the 
reference dose (%RfD) or percent of the population adjusted dose 
(%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.
    Based on the FIRST and SCI-GROW models, the EECs of cyazofamid and 
its metabolites for acute exposures are estimated to be 6.436 parts per 
billion (ppb) for surface water and 0.002680 ppb for ground water. The 
EECs for chronic exposure is estimated to be 0.495 ppb for surface 
water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Cyazofamid is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of 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.''
    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 cyazofamid and any other 
substances and cyazofamid 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 cyazofamid 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 OPP concerning common mechanism 
determinations and procedures for cumulating effects from substances 
found to have a common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of 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 based on reliable data 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. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There are no concernsor 
residual uncertainties for pre- and or postnatal toxicity.
    3. Conclusion. EPA determined that the 10X safety factor to protect 
infants and children should be removed i.e., reduced to 1X. The FQPA 
factor is removed because:
    i. In the prenatal developmental toxicity study in rabbits, there 
was no indication of increased susceptibility (qualitative or 
quantitative) of rabbit fetuses to in utero exposure to cyazofamid. No 
maternal or developmental effects were seen at any dose up to the limit 
dose of 1,000 mg/kg/day.
    ii. In the prenatal developmental toxicity study in rabbits, there 
was no indication of increased susceptibility (qualitative or 
quantitative) of rabbit fetuses to in utero exposure to cyazofamid. No 
maternal or developmental effects were seen at any dose up to the limit 
dose of 1,000 mg/kg/day.
    iii. In the two-generation reproduction study, the highest dose 
tested (>1,000 mg/kg/day) did not cause maternal systemic toxicity nor 
did it elicit reproductive or offspring toxicity.
    iv. The Agency concluded that the concern is low for the 
quantitative susceptibility seen in the rat developmental toxicity 
study and there are no residual uncertainties because:
    a. The developmental effect is well identified with clear NOAEL/
LOAEL.
    b. The developmental effect (increased bent ribs) is a variation 
rather than a malformation.
    c. The developmental effect is seen only at the limit dose of 1,000 
mg/kg/day.
    d. This endpoint is used to establish the acute RfD for Females 13-
49 years old.
    e. The overall toxicity profile indicates that cyazofamid is not a 
very toxic compound.
    v. There were no indications of pre- or postnatal toxicity and no 
residual uncertainties from the rabbit developmental study or the rat 
two generation reproduction study.
    vi. The exposure assessments are Tier 1, conservative, high-end 
assessments and will not underestimate the potential dietary (food and 
water) exposures.
    vii. There are no proposed residential uses.

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 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 EPA's 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

[[Page 58296]]

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 OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
cyazofamid will occupy <1% of the aPAD for females 13 years and older. 
In addition, there is potential for acute dietary exposure to 
cyazofamid in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in Table 5 of 
this unit:

                      Table 5.--Aggregate Risk Assessment for Acute Exposure to Cyazofamid
----------------------------------------------------------------------------------------------------------------
                                                                              Ground      Surface
                                                  Acute 95%     Maximum       Water        Water        Acute
        Population Subgroup         aPAD (mg/kg/     Food     Acute Water    EDWC\3\      EDWC\3\      DWLOC\4\
                                        day)     Exposure\1\  Exposure\2\    (ppb or      (ppb or      (ppb or
                                                 (mg/kg/day)  (mg/kg/day)    [mu]g/L)     [mu]g/L)     [mu]g/L)
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                     1.0     0.004013          1.0        0.495        6.436    3.0 x 104
----------------------------------------------------------------------------------------------------------------
\1\ The exposure from the model producing the highest exposure estimate for the population subgroup was used.
\2\ Maximum Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Dietary (Food) Exposure.
\3\ The highest level was used.
\4\ DWLOC([mu]g/L) = [maximum water exposure (mg/kg/day) x body weight (kg)] [water consumption (L) x 10-\3\ mg/
  [mu]g]. A body weight of 70 kg is assumed for adults, 60 kg for females and youth, and 10 kg for children;
  water consumption is assumed to be 2 L for adults and 1 L for children.

    2. Chronic risk. The chronic dietary exposure analyses in this 
assessment for cyazofamid result in dietary risk (food only) estimates 
that are below the Agency's level of concern for chronic dietary (food 
only) exposure. For the chronic analysis, the most highly exposed 
population subgroup and the highest risk estimate was for children 1 to 
2 years old. The chronic exposures for children 1 to 2 years old are 
0.004778 mg/kg/day for DEEM-FCIDTM or 0.004529 mg/kg/day for 
LifelineTM, which utilize <1.0% (for both DEEM-
FCIDTM and LifelineTM) of the chronic PAD for 
cyazofamid. EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in Table 6 of this unit:

               Table 6.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Cyazofamid
----------------------------------------------------------------------------------------------------------------
                                                                Maximum       Ground      Surface
                                                   Chronic      Chronic       Water        Water       Chronic
        Population Subgroup         cPAD (mg/kg/     Food        Water       EDWC\3\      EDWC\3\      DWLOC\4\
                                        day)     Exposure\1\  Exposure\2\    (ppb or      (ppb or      (ppb or
                                                 (mg/kg/day)  (mg/kg/day)    [mu]g/L)     [mu]g/L)     [mu]g/L)
----------------------------------------------------------------------------------------------------------------
General U.S. Population                    0.95     0.001016         0.95           NA           NA    3.3 x 104
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old)                  0.95     0.001501         0.95           NA           NA    9.5 x 103
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                     0.95     0.004778         0.95           NA           NA    9.5 x 103
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old                     0.95     0.003236         0.95           NA           NA    9.5 x 103
----------------------------------------------------------------------------------------------------------------
Children 6-12 years old                    0.95     0.001338         0.95        0.495        8.085    9.5 x 103
----------------------------------------------------------------------------------------------------------------
Youth 13-19 years old                      0.95     0.000589         0.95           NA           NA    2.8 x 104
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                     0.95     0.000751         0.95           NA           NA    3.3 x 104
----------------------------------------------------------------------------------------------------------------
Adults 50+ years old                       0.95     0.000802         0.95           NA           NA    3.3 x 104
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                    0.95     0.000816         0.95           NA           NA    2.8 x 104
----------------------------------------------------------------------------------------------------------------
\1\ The exposure from the model producing the highest exposure estimate for the population subgroup was used.
\2\ Maximum Water Exposure (mg/kg/day) = cPAD (mg/kg/day) - Dietary (Food) Exposure
\3\ The highest level was used.
\4\ DWLOC([mu]g/L) = [maximum water exposure (mg/kg/day) x body weight (kg)] [water consumption (L) x 10-\3\ mg/
  [mu]g]. A body weight of 70 kg is assumed for adults, 60 kg for females and youth, and 10 kg for children;
  water consumption is assumed to be 2L for adults and 1L for children.

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).

[[Page 58297]]

    Cyazofamid is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Cyazofamid is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    5. Aggregate cancer risk for U.S. population. The Agency classified 
cyazofamid as ``not likely to be carcinogenic to humans.'' Thus, 
cyazofamid is not expected to pose a risk.
    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 cyazofamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The Food and Drug Administration's (FDA's) Multi-Residue Protocol D 
(without cleanup) is the acceptable enforcement method in crops. The 
petitioner should provide the Agency with a single modified method for 
all crops with the inclusion of the minor variations for crops as 
needed.

B. International Residue Limits

    There are currently no Codex, Canadian, or Mexican MRL's or 
tolerances for cyazofamid on cucurbits, tomato, potato, and wine. 
Therefore, international harmonization is not an issue for this 
petition.

C. Conditions

    The following confirmatory data are needed for wheat. Data are 
listed below by guideline series.
    1. Harmonized guideline 860.1300--Nature of the residue. The 
metabolism studies conducted on plants (grapes, potatoes, and tomatoes) 
and livestock (goats and hen) as well as the confined rotational crop 
study are deemed tentatively acceptable. To fully upgrade each study, 
the petitioner is required to provide information pertaining to dates 
of sample collection, extraction, and final analysis. This information 
is required for each study to determine actual sample storage 
intervals.
    The metabolic profiles in crop matrices (grape, wine; potato and 
tomato) determined at the beginning and at the end of the analytical 
phase were not provided. Representative chromatograms of the 
radiolabeled residues taken before and after storage under frozen 
conditions should be submitted. In the future, additional metabolism 
data might be required if uses on additional crops are requested.
    2. Harmonized guideline 860.1340--Residue analytical methods. The 
petitioner has provided the proposed enforcement method entitled, 
``Analytical Method for IKF-916 and CCIM in Tomato Samples'' as an 
attachment to the ILV of the method. The Agency finds that the Residue 
Analytical Methods used for data collection may be used as a single 
analyte confirmatory method. However, the petitioner should provide the 
Agency with a single modified method for all crops with the inclusion 
of the minor variations for crops as needed. The FDA's Multi-Residue 
Protocol D (without cleanup) is the acceptable enforcement method in 
crops.
    3. Harmonized guideline 860.1380--Storage stability. Storage 
stability data for 18 months on the representative commodities of the 
cucurbit group should be submitted to support the storage intervals and 
conditions of the crop field trials.
    4. Harmonized guideline 860.1850--Confined Accumulation in 
rotational Crops. The submitted study is tentatively deemed adequate to 
satisfy data requirements for a confined rotational crop study pending 
submission of information pertaining to extraction and analysis dates 
of samples from the 31-day PBI. These dates are required to determine 
the actual sample storage intervals and need for additional storage 
stability data. The supporting storage stability data from the current 
submission indicate that the parent and its metabolites CCIM and CCBA 
are relatively stable in fortified samples of carrot roots, lettuce, 
and wheat forage stored frozen for up to 4 months. The identities of 
the parent, CCIM, CCIM-AM, and sugars are deemed adequately identified 
pending submission of representative TLC or data from TLC analyses.
    5. Other data. Historical control data for dog toxicity studies.

V. Conclusion

    Therefore, tolerances are established for the combined residues of 
cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-
imidazole-1-sulfonamide, and its metabolite CCIM, 4-chloro-5-(4-
methylphenyl)-1H-imidazole-2-carbonitrile, expressed as cyazofamid, in 
or on cucurbit vegetables (Group 9) at 0.10 ppm, potato at 0.02 ppm, 
tomato at 0.20 ppm, and grape, wine at 1.5 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of 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 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-2004-0211 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 
29, 2004.
    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

[[Page 58298]]

confidential may be disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
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 Suite 350, 1099 14th Street, NW., Suite 
350, Washington, DC. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. 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 ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0211 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 ADDRESSES. 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 
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 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 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

[[Page 58299]]

and pests, Reporting and recordkeeping requirements.

    Dated:___________
 ________________
Director, 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), 346a and 371.


0
2. Section 180.601 is added to read as follows:


Sec.  180.601  Cyazofamid; tolerances for residues.

    (a) General. Tolerances are established for the combined residues 
of cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-
imidazole-1-sulfonamide, and its metabolite CCIM, 4-chloro-5-(4-
methylphenyl)-1H-imidazole-2-carbonitrile, expressed as cyazofamid, in 
or on the following commodities:

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
Cucurbit vegetables (Group 9)..........................             0.10
Grape, wine,* import...................................              1.5
Potato.................................................             0.02
Tomato.................................................             0.20
------------------------------------------------------------------------
*No domestic registrations.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 04-21931 Filed 9-29-04; 8:45 am]
BILLING CODE 6560-50-S