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Fludioxonil - Pesticide Tolerance 12/00

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301093; FRL-6760-9]
RIN 2070-AB78
Fludioxonil; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of
fludioxonil 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile in or on grapes, strawberries, dry bulb onions, and green
onions. Novartis Crop Protection, Inc. and the Inter-Regional Project
Number (IR-4) requested these tolerances under the Federal Food, Drug,
and Cosmetic Act, as amended by the Food Quality Protection Act of
1996.

DATES: This regulation is effective December 29, 2000. Objections and
requests for hearings, identified by docket control number OPP-301093,
must be received by EPA on or before February 27, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301093 in

[[Page 82928]]

the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT By mail: Mary Waller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9354; and e-mail address:
waller.mary@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select "Laws and
Regulations", "Regulations and Proposed Rules," and then look up the
entry for this document under the "Federal Register---Environmental
Documents." You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-301093. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of August 26, 1998 (63 FR 45497) (FRL-6023-
4), EPA issued a notice pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing
the filing of a pesticide petition (PP) for tolerances for fludioxonil
on grapes by Novartis Crop Protection, Inc, 410 Swing Road, Greensboro,
NC 27419. This notice included a summary of the petition prepared by
Novartis Crop Protection, Inc, the registrant. There were no comments
received in response to the notice of filing.
     The petition requested that 40 CFR 180.516 be amended by
establishing tolerances for residues of the fungicide fludioxonil, 4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3- carbonitrile, in or
on grapes at 1.0 ppm.
    In the Federal Register of March 29, 2000 (65 FR 45498) (FRL-6495-
5), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C.
346a as amended by the FQPA announcing the filing of a pesticide
petition (PP) for tolerances for fludioxonil on strawberries, bulb
vegetables, and stone fruit by the Interregional Research Project
Number 4 (IR-4), New Jersey Agricultural Experiment Station, P.O. Box
231, Rutgers University, New Brunswick, NJ 08903. This notice included
a summary of the petition prepared by the Interregional Research
Project Number 4 (IR-4), the registrant. There were no comments
received in response to the notice of filing.
    The petition requested that 40 CFR 180.516 be amended by
establishing tolerances for residues of the fungicide fludioxonil, 4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3- carbonitrile, in or
on strawberries at 2.0 ppm; dry bulb onion; great-headed garlic;
shallot; and welsh onion at 0.2 ppm; green onion and leek at 7.0 ppm;
and stone fruit group at 2.0 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is "safe." Section
408(b)(2)(A)(ii) defines "safe" to mean that "there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information." This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to "ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue...."
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for residues of fludioxonil on grapes at 1.0
ppm, strawberries at 2.0 ppm, dry bulb onions at 0.20 ppm, and green
onions at 7.0 ppm. Tolerances are not being established for stone fruit
at this time due to additional preliminary residue chemistry data (not
yet available to the Agency for review) that indicate that a tolerance
of 2.0 ppm may be too low for stone fruit. The Agency will not
establish a stone fruit tolerance until the

[[Page 82929]]

final set of residue chemistry data are submitted and reviewed. EPA's
assessment of exposures and risks associated with establishing the
tolerances 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 fludioxonil are
discussed in the following Table 1 as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.

                               Table 1.-- Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100a                                90-Day oral toxicity in NOAEL = 64 mg/kg/day (M) and 70 mg/kg/day
                                          rats                        (F)
LOAEL = 428 mg/kg/day (M) and 462 mg/kg/day
(F) based on decreased weight gain (both
sexes), chronic nephropathy (M) and
centrilobular hepatocyte hypertrophy (F).
----------------------------------------------------------------------------------------------------------------
870.3100b                                90-Day oral toxicity in NOAEL = 445 mg/kg day (M) and 559 mg/kg/day
                                          mice                        (F)
LOAEL = 1052 mg/kg/day (M) and 1307 mg/kg/
day (F) based on decreased body weight
gain (F), increased alkaline phosphatase
(M), increased relative liver weight,
increased incidence of nephropathy and
centrilobular hypertrophy (both sexes)
----------------------------------------------------------------------------------------------------------------
870.3100c                                90-Day oral toxicity in NOAEL = 5 mg/kg/day (both sexes)
                                          dogs
LOAEL = 50 mg/kg/day based on an increased
incidence of diarrhea (both sexes).
----------------------------------------------------------------------------------------------------------------
870.3200                                 21/28- Day dermal toxicity NOAEL1,000 mg/kg/day for both sexes
----------------------------------------------------------------------------------------------------------------
870.3250                                 90-Day dermal toxicity      N/A
----------------------------------------------------------------------------------------------------------------
870.3465                                 90-Day inhalation toxicity  N/A
----------------------------------------------------------------------------------------------------------------

870.3700a                                Prenatal developmental in Maternal NOAEL = 100 mg/kg/day
                                          rodents
LOAEL = 1,000 mg/kg/day based on reduction
in corrected weight gain
Developmental NOAEL = 100 mg/kg/day
LOAEL = 1,000 mg/kg/day based on increase
in the fetal incidence and litter
incidence of dilated renal pelvis and
dilated ureter.
----------------------------------------------------------------------------------------------------------------
870.3700b                                Prenatal developmental in Maternal NOAEL = 10 mg/kg/day
                                          nonrodents
LOAEL = 100 mg/kg/day based on decreased
body weight gain and decreased food
efficiency
Developmental NOAEL  300 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility Parental/Systemic NOAEL = 22.13 mg/kg/day
                                          effects (M) and 24.24 mg/kg/day (F)
LOAEL = 221.61mg/kg/day (M) and 249.67 mg/
kg/day (F) based on increased clinical
signs, decreased body weights, decreased
weight gain, and decreased food
consumption in both sexes
Reproductive/Offspring NOAEL = 22.13 mg/kg/
day (M) and 24.24 mg/kg/day (F)
LOAEL = 221.61 mg/kg/day (M) and 249.67 mg/
kg/day (F) based on reduced pup weights
during lactation
----------------------------------------------------------------------------------------------------------------
870.4100b                                Chronic toxicity dogs NOAEL = 3.3 mg/kg/day (F) and 33.1 mg/kg/
                                                                      day (M).
LOAEL = 35.5 mg/kg/day (F) and 297.8 mg/kg/
day (M) based upon decreased weight gain
(F) and decreased body weight, reduction
in hematological parameters (platelets),
increase in cholesterol and alkaline
phosphatase, and increased relative liver
weight (M)
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined Chronic Toxicity/ NOAEL = 37 mg/kg/day (M) and 44 mg/kg/day
                                          Carcinogenicity in rats     (F)
LOAEL = 113 mg/kg/day (M) and 141 mg/kg/day
(F) based on decreased mean body weight
gain, slight anemia (F), and increased
incidence and severity of liver lesions
(degeneration) in both sexes. There was no
evidence of carcinogenicity in male rats,
but there was a statistically significant
increase, both trend and pairwise, of
combined hepatocellular tumors in female
rats. Classified as "Group D" by OPP
Cancer Peer Review Committee.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice NOAEL = 11.3 mg/kg/day (M) and 133 mg/kg/
                                                                      day (F)

[[Page 82930]]

LOAEL = 112 mg/kg/day (M) and 417 mg/kg/day
(F) based on the increased incidence of
mice convulsing when handled (M) and
increased absolute liver weight and
grossly enlarged livers (F). Statistically
significant trend for malignant lymphomas
in females.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation in bacteria Strains TA 98, 100, 1535, 1537 of S.
typhimurium, and strain WP2uvrA of E. coli
were negative for mutagenic activity when
tested from 20 to 5,000 g/plate
in absence and presence of metabolic
activation.
----------------------------------------------------------------------------------------------------------------
870.5300                                 Gene mutation in mammalian Chinese hamster V79 ovary cells were tested
                                          cells in culture from 0.50 to 60 g/mL. Negative up
to limit of solubility and cytotoxicity.
----------------------------------------------------------------------------------------------------------------
870.5375                                 In vitro Chromosome Chinese hamster ovary cells were tested
                                          aberration with and without metabolic activation from
1.37 to 700 g/mL. Positive for
nondisjunction of chromosomes both in the
presence and absence of activation.
----------------------------------------------------------------------------------------------------------------
870.5385                                 Bone marrow chromosome Chinese hamsters were orally dosed at
                                          aberrations assay levels from 1,250 to 5,000 mg/kg. There
was no significant increase in the
frequency of chromosome aberrations in
bone marrow at any dose tested.
----------------------------------------------------------------------------------------------------------------
870.5395                                 In vivo Mouse micronucleus Both sexes of NMRI mice were dosed up to
                                          assay 5,000 mg/kg/day. There were no significant
increases in the number or percentage of
micronucleated polychromatic erythrocytes.
----------------------------------------------------------------------------------------------------------------
870.5395                                 In vivo Rat hepatocyte Male rats were orally dosed 1250, 2500 and
                                          micronucleus assay 5,000 mg/kg and hepatocytes were
harvested. Micronucleated hepatocytes were
found in Phase II at the low and mid dose
levels but not at the high dose level and
not in Phase I. Positive for mutagenicity
in hepatocytes exposed in vivo.
----------------------------------------------------------------------------------------------------------------
870.5550                                 In vitro unscheduled DNA There was no evidence of unscheduled DNA
                                          synthesis assay synthesis in rat hepatocytes at doses from
4.1 to 5,000 g/mL.
----------------------------------------------------------------------------------------------------------------
870.5450                                 Dominant lethal assay in Male mice singly dosed at 0, 1,250, 2,500,
                                          mice or 5,000 mg/kg/day and mated for 8
consecutive weeks had no evidence of a
dominant lethal mutation
----------------------------------------------------------------------------------------------------------------
870.6200a                                Acute neurotoxicity Available data do not indicate a need for
                                          screening battery acute or subchronic neurotoxicity studies
----------------------------------------------------------------------------------------------------------------
870.6200b                                Subchronic neurotoxicity Available data do not indicate a need for
                                          screening battery acute or subchronic neurotoxicity studies
----------------------------------------------------------------------------------------------------------------
870.6300                                 Developmental Available data do not indicate a need for
                                          neurotoxicity acute or subchronic neurotoxicity studies
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and C14-Fludioxonil given by gavage and bile
                                          pharmacokinetics duct-cannulation to groups of male and
female rats. Absorption was estimated to
be between 67-91%. Terminal tissue
distribution showed that terminal residues
were below the limit of detection for most
tissues except the liver, kidneys, blood,
and lungs, which showed low levels. The
major route of excretion was the feces,
with approximately 80% of the administered
radioactivity excreted by this route in
male and female rats at both the low and
high dose. The remaining radioactivity was
excreted through urine. In bile duct-
cannulated rats, approximately 70% of an
administered radioactive dose was excreted
via this route, supporting the bile as the
origin of the fecal radioactivity. There
were no apparent sex- or dose-related
differences in the routes of excretion for
fludioxonil. Examination of urine for
metabolites of fludioxonil showed at least
20 metabolites, each comprising a minor
fraction of the administered dose (0.1-
                                                                      3.1%).
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal penetration          N/A
----------------------------------------------------------------------------------------------------------------
N/A                                      Special studies             N/A
----------------------------------------------------------------------------------------------------------------

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 intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the
UF to

[[Page 82931]]

calculate an acute or chronic reference dose (acute RfD or chronic RfD)
where the RfD is equal to the NOAEL divided by the appropriate UF (RfD
= NOAEL/UF). Where an additional safety factor is retained due to
concerns unique to the FQPA, this additional factor is applied to the
RfD by dividing the RfD by such additional factor. The acute or chronic
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to
accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
    The linear default risk methodology (Q*) is the primary
method currently used by the Agency to quantify carcinogenic risk. The
Q* approach assumes that any amount of exposure will lead to some
degree of cancer risk. A Q* is calculated and used to estimate risk
which represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1  x  10-\6\ or one in a
million). Under certain specific circumstances, MOE calculations will
be used for the carcinogenic risk assessment. In this non-linear
approach, a "point of departure" is identified below which
carcinogenic effects are not expected. The point of departure is
typically a NOAEL based on an endpoint related to cancer effects though
it may be a different value derived from the dose response curve. To
estimate risk, a ratio of the point of departure to exposure
(MOEcancer = point of departure/exposures) is calculated. A
summary of the toxicological endpoints for fludioxonil used for human
risk assessment is shown in the following Table 2:

                 Table 2.--Summary of Toxicological Endpoints Used for 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           NOAEL = 100 mg/kg/day;   FQPA SF = 1X; aPAD =     Developmental Toxicity
                                       UF = 100; Acute RfD =    acute RfD/FQPA SF =      Study - rat
                                       1.0 mg/kg/day            1.0 mg/kg/day
Developmental LOAEL =
1,000 mg/kg/day based
on increased incidence
of fetuses and litters
with dilated renal
pelvis and dilated
ureter
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations       NOAEL= 3.3 mg/kg/day;    FQPA SF = 1X; cPAD =     One year chronic
                                       UF = 100; Chronic RfD chronic RfD/FQPA SF =    toxicity study - dog
                                       = 0.03 mg/kg/day         0.03 mg/kg/day
LOAEL = 35.5 mg/kg/day
based on decreased
weight gain in female
dogs
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1-7 days)          none                     No systemic toxicity     Endpoint was not
 (Occupational/Residential)                                     was seen at the limit    selected
                                                                dose (1,000 mg/kg/day)
                                                                in the 28-day dermal
toxicity study in
                                                                rats. This risk
assessment is not
                                                                required.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term (1 week - several   Oral study NOAEL= 64 mg/ LOC for MOE = 100        13 Week Oral Feeding
 months) Dermal (Occupational/         kg/day (dermal (Occupational); LOC      Study - rat
 Residential)                          penetration = 40%)       for MOE = 100
                                                                (Residential)
Systemic LOAEL = 428 mg/
kg/day based on
decreased body weight
gain in both sexes,
chronic nephropathy in
males, and
centrilobular
hepatocyte hypertrophy
in females
----------------------------------------------------------------------------------------------------------------
Long-Term (several months-lifetime)   Oral study NOAEL = 3.3   LOC for MOE = 100        one year chronic
 Dermal (Occupational/ Residential)    mg/kg/day (dermal (Occupational) LOC for   toxicity study - dog
                                       penetration = 40%)       MOE = 100
                                                                (Residential)
LOAEL = 35.5 mg/kg/day
based on decreased
weight gain in female
dogs
----------------------------------------------------------------------------------------------------------------
Short-Term (1-7 Days) Inhalation      NOAEL = 64 mg/kg/day     LOC for MOE = 100        13 Week Oral Feeding
 (Occupational/Residential)            (inhalation absorption (Occupational); LOC      Study - rat
                                       rate = 100%)             for MOE = 100
                                                                (Residential)
Systemic LOAEL = 428 mg/
kg/day based on
decreased body weight
gain in both sexes,
chronic nephropathy in
males, and
centrilobular
hepatocyte hypertrophy
in females
----------------------------------------------------------------------------------------------------------------
Intermediate-term (1 week - several   NOAEL = 64 mg/kg/day     LOC for MOE = 100        13 Week Oral Feeding
 months) Inhalation (Occupational/     (inhalation absorption (Occupational) LOC for   Study - rat Systemic
 Residential)                          rate = 100%)             MOE = 100
                                                                (Residential)

[[Page 82932]]

LOAEL = 428 mg/kg/day
based on decreased body
weight gain in both
sexes, chronic
nephropathy in males,
and centrilobular
hepatocyte hypertrophy
in females
----------------------------------------------------------------------------------------------------------------
Long-Term (several months-lifetime)   NOAEL = 3.3 mg/kg/day    LOC for MOE = 100        one year chronic
 Inhalation (Occupational/             (inhalation absorption (Occupational); LOC      toxicity study - dog
 Residential)                          rate = 100%)             for MOE = 100
                                                                (Residential)
LOAEL = 35.5 mg/kg/day
based on decreased
weight gain in female
dogs
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)     "Group D"- not         not applicable           Acceptable oral rat and
                                       classifiable as to mouse carcinogenicity
                                       human carcinogenicity studies; evidence of
                                       via relevant routes of carcinogenic and
                                       exposure mutagenic potential.
----------------------------------------------------------------------------------------------------------------
\*\ UF = uncertainty factor, FQPA SF = 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. The FQPA factor being referenced is the factor unique
  to the FQPA and does not include FQPA factors related to data uncertainty.

C. Exposure Assessment

     1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.516) for the residues of fludioxonil, in or on
a variety of raw agricultural commodities. Fludioxonil is the active
ingredient in registered products used as a seed treatment for many
crops (with the exception of tree crops and berries). In addition,
several Section 18 emergency exemptions for use as a foliar spray on
strawberries, caneberries and as a post-harvest spray treatment on
apricots, nectarines, peaches, and plums have been approved. Risk
assessments were conducted by EPA to assess dietary exposures from
fludioxonil in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure. The Dietary Exposure Evaluation Model (DEEM
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The acute analysis was performed for the females
13-50 years old population subgroup using published and proposed
tolerance levels, default concentration factors, and 100% CT
assumptions for all commodities. The acute dietary exposure estimate at
the 95th percentile of exposure for females 13-50 years old is 0.004512
mg/kg/day, representing 0.5% of the aPAD.
    For acute dietary risk estimates, EPA's level of concern is >100%
aPAD. The results of the acute analysis indicate that at the 95th
percentile of exposure, the acute dietary risk associated with the
proposed uses of fludioxonil is below EPA's level of concern.
    ii. Chronic exposure. The chronic DEEM analysis evaluated
the individual food consumption as reported by respondents in the USDA
1989-92 nationwide CSFII and accumulated exposure to the chemical for
each commodity using published and proposed tolerance levels, default
concentration factors, and 100% crop treated (CT) assumptions for all
commodities. Chronic dietary exposure estimates ranged from 0.000609
mg/kg/day (2.0% of the cPAD) for males 13-19 years old, up to 0.003506
mg/kg/day (12% of the cPAD) for all infants (< 1 year old). All other
population subgroups fell in between these two figures, including the
U.S. population (0.001107 mg/kg/day; 3.7% of the cPAD), children 1-6
years old (0.002934 mg/kg/day; 9.8% of the cPAD), children 7-12 years
old (0.001522 mg/kg/day; 5.1% of the cPAD), females 13-50 years old
(0.000823 mg/kg/day; 2.7% of the cPAD), males 20+ years old (0.000726
mg/kg/day; 2.4% of the cPAD), and seniors 55+ years old (0.000961 mg/
kg/day; 3.2% of the cPAD).
    Since the FQPA factor was reduced to 1x for all population
subgroups, the Agency's level of concern is 100% cPAD = 100% cRfD. The
results of this analysis indicate that the chronic dietary risk
associated with the existing uses and the proposed uses of fludioxonil
is below EPA's level of concern.
    iii. Cancer. EPA has classified Fludioxonil as a Group D - not
classifiable as to human carcinogenicity. The evidence is inadequate
and cannot be interpreted as showing either the presence or absence of
a carcinogenic effect. In one mouse study, there was a significant
trend for malignant lymphomas in female mice up to 3,000 ppm. However,
in a second study up to 7,000 ppm, the limit dose, there was no
evidence of carcinogenicity for either sex. In rats, fludioxonil
produced a significant trend and pair-wise increase in hepatocellular
tumors, combined, in female rats at doses adequate to assess
carcinogenicity. EPA determined that based on the increase in liver
tumors in female rats that was statistically significant for combined
adenoma/carcinoma only, the lack of tumorogenic response in male rats
or in either sex of mice, and the need for additional mutagenicity
studies, a Group D classification was appropriate.
    Fludioxonil was not mutagenic in the tests for gene mutations.
However, because of the powerful induction of polyploidy in the in
vitro Chinese hamster ovary cell cytogenetic assay and the suggestive
evidence of micronuclei induction in rat hepatocytes in vivo,
additional mutagenicity testing was performed in an in vivo study
specifically designed for aneuploidy analysis.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fludioxonil in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates

[[Page 82933]]

are made by reliance on simulation or modeling taking into account data
on the physical characteristics of fludioxonil.
    The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in groundwater. 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.
    None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to fludioxonil they are further
discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the estimated environmental
concentrations (EECs) of fludioxonil for acute exposures are estimated
to be 46 parts per billion (ppb) for surface water and 0.35 ppb for
ground water. The EECs for chronic exposures are estimated to be 32 ppb
for surface water and 0.35 ppb for ground water.
    3. From non-dietary exposure. The term "residential exposure" is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
     Fludioxonil is not currently registered for residential (outdoor,
non-food) uses. The registrant is seeking registration for the use of
fludioxonil by commercial applicators on residential lawns.
     There is potential residential postapplication exposure to adults
and children entering residential areas treated with fludioxonil. Since
the Agency did not select a short-term endpoint for dermal exposure,
only intermediate-term dermal exposures were considered. Based on the
residential use pattern, no long-term post-application residential
exposure is expected. Short-term non-dietary oral exposures for
toddlers were not assessed since the acute dietary endpoint for
fludioxonil is only relevant for females 13-50 years old. Intermediate-
term, non-dietary ingestion exposure for toddlers is possible and was
assessed using the intermediate-term dose and endpoint identified from
the 13 week oral feeding study in rats. Intermediate-term exposure is
not expected from the proposed ornamental uses of fludioxonil.
     There are no chemical-specific data available to determine the
potential risks from post-application activities associated with the
proposed uses of fludioxonil. The exposure estimates are based on
assumptions and generic data as specified by the newly proposed
Residential SOPs. The MOEs for postapplication exposures from full lawn
uses are 2,000 and 1,200 for adults and children, respectively. The
dermal MOE for postapplication exposure for the hand to mouth scenario
is 13,000. The aggregate intermediate MOE for postapplication
residential exposure to toddlers is 1,100. These estimates indicate
that the potential intermediate-term risks from residential uses of
fludioxonil do not exceed the Agency's level of concern. The Agency's
level of concern is for MOEs below 100.
    4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider "available information" concerning the cumulative effects of
a particular pesticide's residues and "other substances that have a
common mechanism of toxicity."
    EPA does not have, at this time, available data to determine
whether fludioxonil has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
fludioxonil 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 fludioxonil has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    Safety factor for infants and children--i. In general. FFDCA
section 408 provides that EPA shall apply an additional tenfold margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
data base on toxicity and exposure unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans.
    ii. Prenatal and postnatal sensitivity. The rat and rabbit
developmental toxicity studies were tested at doses that produced
maternal toxicity. There were no developmental findings in rabbits. The
findings in the rat developmental toxicity studies were considered to
be related to maternal toxicity, rather than an indication of increased
susceptibility. In the reproductive study, maternal and reproductive/
offspring toxicity occurred at the same dose indicating no evidence of
susceptibility.
    iii. Conclusion. There is a complete toxicity data base for
fludioxonil and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. Accordingly,
taking into account the data on pre- and post-natal toxicity, EPA
determined that an additional tenfold safety factor was not necessary
to protect infants and children.

[[Page 82934]]

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater 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. The acute dietary exposure estimate at the 95th
percentile of exposure for females 13-50 years old is 0.004512 mg/kg/
day, representing 0.5% of the aPAD. An acute dose and endpoint was not
selected for the U. S. population (including infants and children)
because there were no effects of concern observed in oral toxicology
studies, including maternal toxicity in the developmental toxicity
studies in rats and rabbits, that are attributable to a single exposure
dose. In addition, there is potential for acute dietary exposure to
fludioxonil in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 3:

                      Table 3.--Aggregate Risk Assessment for Acute Exposure to Fludioxonil
----------------------------------------------------------------------------------------------------------------
Surface       Ground
              Population Subgroup                 aPAD  (mg/     % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg) (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old                                  1.0 0.5%           46         0.35       30,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fludioxonil from food will utilize 3.7% of the cPAD for the U.S.
population, 12% of the cPAD for all infants (< 1 year old) and 9.8% of
the cPAD for children 1-6 years old. Based the use pattern, chronic
residential exposure to residues of fludioxonil is not expected. In
addition, there is potential for chronic dietary exposure to
fludioxonil in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in the
following Table 4:

              Table 4.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fludioxonil
----------------------------------------------------------------------------------------------------------------
Surface       Ground
              Population Subgroup                cPAD  mg/kg/    % cPAD     Water EEC    Water EEC     Chronic
                                                     day (Food)       (ppb)*       (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                          0.3 3.7           11         0.35        1,000
----------------------------------------------------------------------------------------------------------------
All infants ( < 1 year old)                              0.3 12           11         0.35          260
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                                   0.3 9.8           11         0.35          270
----------------------------------------------------------------------------------------------------------------
Children 7-12 years old                                  0.3 5.1           11         0.35          280
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old                                  0.3 2.7           11         0.35          880
----------------------------------------------------------------------------------------------------------------
Males 13-19 years old                                    0.3 2.0           11         0.35        1,000
----------------------------------------------------------------------------------------------------------------
Males 20 + years old                                     0.3 2.4           11         0.35        1,000
----------------------------------------------------------------------------------------------------------------
Seniors 55 + years old                                   0.3 3.2           11         0.35        1,000
----------------------------------------------------------------------------------------------------------------
\*\GENEEC model estimated 56-day (average) concentration was divided by a factor of 3 prior to comparison with
  the DWLOC; 32/3 = 11.

[[Page 82935]]

    3. Short-term risk. In aggregating short-term risk, the Agency
considers background chronic dietary exposure (food + drinking water)
and short-term inhalation and dermal exposures from residential uses.
EPA did not identify a dermal endpoint of concern for the short-term
duration. Short-term inhalation endpoints were identified, however,
they are not relevant for the short-term aggregate risk since
homeowners would not be applying fludioxonil. The registrant indicated
that the requested residential uses are only for professional
applications. Therefore, the short-term aggregate risk assessment is
not required.
    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).
    For adults, post-application exposures may result from dermal
contact with treated turf. For toddlers, dermal and non-dietary oral
post-application exposures may result from dermal contact with treated
turf as well as hand-to-mouth transfer of residues from turfgrass.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 1,200 for
the U.S. population and 530 for infants/children. These aggregate MOEs
do not exceed the Agency's level of concern for aggregate exposure to
food and residential uses. In addition, intermediate-term DWLOCs were
calculated and compared to the EECs for chronic exposure of fludioxonil
in ground and surface water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect
intermediate-term aggregate exposure to exceed the Agency's level of
concern, as shown in the following Table 5:

                Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure to Fludioxonil
----------------------------------------------------------------------------------------------------------------
                                                Aggregate    Aggregate
                                              MOE  (Food +    Level of     Surface       Ground    Intermediate-
             Population Subgroup                              Concern Water EEC    Water EEC     Term DWLOC
                                              Residential)     (LOC) (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                      1,200 100           11         0.35         1,100
----------------------------------------------------------------------------------------------------------------
Infants/Children                                       530 100           11         0.35           220
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. The EPA classified
Fludioxonil as a Group D - not classifiable as to human
carcinogenicity. The evidence is inadequate and cannot be interpreted
as showing either the presence or absence of a carcinogenic effect. In
one mouse study, there was a significant trend for malignant lymphomas
in female mice up to 3,000 ppm. However, in a second study up to 7,000
ppm, the limit dose, there was no evidence of carcinogenicity for
either sex. In rats, fludioxonil produced a significant trend and pair-
wise increase in hepatocellular tumors, combined, in female rats at
doses adequate to assess carcinogenicity. The EPA determined that based
on the increase in liver tumors in female rats that was statistically
significant for combined adenoma/carcinoma only, the lack of
tumorogenic response in male rats or in either sex of mice, and the
need for additional mutagenicity studies, a Group D classification was
appropriate.
    However, the Agency has since received the additional mutagenicity
studies and based on the negative preliminary findings of the studies,
the fact that the statistical increase in liver tumors in female rats
occurred only at the highest dose, the lack of tumorigenic response in
male rats and mice, the Agency has concluded that fludioxonil does not
pose a significant cancer 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 fludioxonil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The registrant has proposed high performance liquid chromatography
using ultraviolet detection Method AG-597B as the analytical
enforcement method. This method is a reissue of Method(s) AG-597/AG-
597A which has successfully undergone an ILV trial as well as Agency
petition method validation (PMV). The original method is available for
enforcement purposes until the new method is validated. The method may
be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington DC 20460. Office location and telephone number:
Rm. 101FF, CM # 2, 1921 Jefferson Davis Hwy, Arlington, VA, (703) 305-
5229.

B. International Residue Limits

    There are no Codex Maximum Residue Limits (MRLs) for fludioxonil.
Therefore, international harmonization is not an issue at this time.

C. Conditions

    Registration is conditional upon submission of the two dry bulb
onion residue trials in Regions 5 and 12.

V. Conclusion

    Therefore, the tolerance is established for residues of fludioxonil
4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrilein or on
grapes at 1.0 ppm, strawberries at 2.0 ppm, dry bulb onions at 0.20
ppm, and green onions at 7.0 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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to "object" to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

[[Page 82936]]

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

    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301093 on 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 February
27, 2001.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it "Tolerance Petition Fees."
    EPA is authorized to waive any fee requirement "when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection." For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301093, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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 prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or require 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 FFDCA section 408(d), such
as the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 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

[[Page 82937]]

levels of government." This final rule directly regulates growers,
food processors, food handlers and food retailers, not States. This
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in 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: December 18, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.516 is amended by alphabetically adding commodities
to the table in paragraph (a) to read as follows:

Sec. 180.516  Fludioxonil; tolerances for residues.

    (a) General. A tolerance is established for residue of the
fungicide fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-
pyrrole-3-carbonitrile) in or on the following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                   *      *      *      *      *
Grape......................................................          1.0
                   *      *      *      *      *
Onion, dry bulb............................................         0.20
Onion, green...............................................          7.0
                   *      *      *      *      *
Strawberry.................................................          2.0
                   *      *      *      *      *
------------------------------------------------------------------------

* * * * *
[FR Doc. 00-33168 Filed 12-28-00; 8:45 am]
BILLING CODE 6560-50-S