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Fludioxonil - Pesticide Tolerance 7/02

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0158; FRL-7188-7]
Fludioxonil; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fludioxonil in or on bushberry subgroup, caneberry subgroup, fruit,
stone, group, juneberry, lingonberry, pistachio, salal, and watercress.
Interregional Research Project Number 4 (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 August 2, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0158
must be received on or before October 1, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0158 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 308-3194; e-mail
address: brothers.shaja@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112...............  Animal production
                                  311...............  Food manufacturing
                                  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select "Laws and
Regulations," "Regulations and Proposed Rules," and then look up the
entry for this document under the "Federal Register--Environmental
Documents." You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40
CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/
cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under
development. To access the OPPTS Harmonized Guidelines referenced in
this document, go directly to the guidelines at 
http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0158. 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 March 29, 2000 (65 FR 16602) (FRL-6495-
5) and May 1, 2002 (67 FR 21671) (FRL-6833-4), EPA issued notices
pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act
of 1996 (FQPA) (Public Law 104-170), announcing the filing of pesticide
petitions (PP 8E5026, 9E6049, 2E6359, 2E6365, 2E6377, and 2E6393]) by
IR-4, New Jersey Agricultural Experiment Station, P. O. Box 231 Rutgers
University, New Brunswick, NJ 08903. These notices included summaries
of the petitions prepared by Novartis Crop Protection Inc., and
Syngenta Crop Protection Inc., the registrants. There were no comments
received in response to the notices of filing.
    The petitions 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)-1 H-pyrrole-3-carbonitrile), in or
on bushberry subgroup at 2.0 part per million (ppm), caneberry subgroup
at 5.0 ppm, juneberry at 2.0 ppm, lingonberry at 2.0 ppm, pistachio at
0.10 ppm, salal at 2.0 ppm, stone fruit group at 2.0 ppm, and
watercress at 7.0 ppm. The petition for the stone fruit group was
amended to propose a tolerance for fludioxonil at 5.0 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
these actions. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for residues of fludioxonil in or on the
bushberry subgroup at 2.0 ppm, caneberry subgroup at 5.0 ppm, fruit,
stone, group at 5.0 ppm, juneberry at 2.0 ppm, lingonberry at 2.0 ppm,
pistachio at 0.10 ppm, salal at 2.0 ppm, and watercress at 7.0 ppm.
EPA's assessment of exposures and risks associated with establishing
these tolerances follow.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by fludioxonil are
discussed in Unit III.A. of the final rule on fludioxonil, which
published in the Federal Register of December 29, 2000 (65 FR 82927)
(FRL-6760-9). Additionally, recent toxicological studies (May 2002)
concluded findings in conjunction to the toxicological profile noted in
Unit III.A. of the final rule on fludioxonil (65 FR 82927). These
studies are shown in Table 1:
Table 1.--Carcinogenic and Other Toxicity
Guideline No.
Study Type
Results
870.4200b Carcinogenicity rats NOAEL = 590 mg/kg/day (M) and 715 mg/kg/day (F).
LOAEL: 851 mg/kg/day (M) and 1,008 mg/kg/day (F) based on reduced survival (F),
decreased body weights (M), bile duct hyperplasia (M) and severe nephropathy
(both sexes). No evidence of carcinogenicity.
870.5395 In vivo Rat hepatocyte
micronucleus assay
Male rats were orally dosed at 50, 250, and 1,250 mg/kg and hepatocytes were harvested.
There was no evidence of a significant increase in micronucleated
hepatocytes in treated groups in comparison to controls.
870.5550 Unscheduled DNA synthesis
assay
There was no evidence that unscheduled DNA synthesis, as determined by nuclear
silver grain counts, was induced in hepatocyte cultures obtained from male rats
dosed at 2,500 or 5,000 mg/kg.
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 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 (MOE = 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 Dose and Endpoints for Fludioxonil for Use in Human Risk Assessment
Exposure Scenario
Dose Used in Risk Assessment,
UF
FQPA SF and Level of
Concern for Risk Assessment
Study and Toxicological Effects
Acute Dietary females 13–50
years of age
NOAEL = 100 mg/kg/day
UF = 100
Acute RfD = 1.0 mg/kg/day
FQPA SF = 1X
aPAD = acute RfD/ FQPA
SF = 1.0 mg/kg/day
Developmental Toxicity Study - rat
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
UF = 100
Chronic RfD = 0.03 mg/kg/day
FQPA SF = 1X
cPAD = chronic RfD / FQPA SF = 0.03 mg/kg/day
1 year chronic toxicity study - dog
LOAEL = 35.5 mg/kg/day based on decreased
weight gain in female dogs
Incidental Oral, Short-Term NOAEL = 10 mg/kg/day LOC for MOE = 100 Rabbit developmental study
LOAEL = 100 mg/kg/day based on decreased weight gain during gestation
Incidental Oral, Intermediate-Term NOAEL = 3.3 mg/kg/day LOC for MOE = 100 1 year chronic toxicity study - dog
LOAEL = 35.5 mg/kg/day based on decreased
weight gain in female dogs
Short-and Intermediate Term
Dermal (1–30 days and 1–6
months) (Residential)
None No systemic toxicity was
seen at the limit dose
(1,000 mg/kg/day) in the
28–day dermal toxicity
study in rats
Endpoint was not selected
Long-Term (several months-lifetime)
Dermal (Residential)
Oral study
NOAEL = 3.3 mg/kg/day
(dermal penetration =
40%)
LOC for MOE = 100 (Occupational)
LOC for MOE = 100 (Residential)
1 year chronic toxicity study - dog
LOAEL = 35.5 mg/kg/day based on decreased
weight gain in female dogs
Short-Term (1–30 Days) Inhalation
(Residential)
Oral NOAEL = 10 mg/kg/
day (inhalation absorption
rate = 100%)
LOC for MOE = 100 (Occupational)
LOC for MOE = 100 (Residential)
Rabbit developmental study
LOAEL = 100 mg/kg/day based on decreased
weight gain during gestation
Intermediate-term (1 month – 6
months) Inhalation (Residential)
Oral NOAEL = 3.3 mg/kg/
day (inhalation absorption
rate = 100%)
LOC for MOE = 100 (Occupational)
LOC for MOE = 100 (Residential)
1 year chronic toxicity study - dog
LOAEL = 35.5 mg/kg/day based on decreased
weight gain in female dogs
Long-Term (several months-lifetime)
Inhalation (Residential)
Oral NOAEL = 3.3 mg/kg/
day (inhalation absorption
rate = 100%)
LOC for MOE = 100 (Occupational)
LOC for MOE = 100 (Residential)
1 year chronic toxicity study - dog
LOAEL = 35.5 mg/kg/day based on decreased
weight gain in female dogs
Cancer (oral, dermal, inhalation) "Group D" - not classifiable as to human carcinogenicity
via relevant routes of exposure
Not applicable There was no evidence of carcinogenicity in mice when tested up to the limited dose 7,000 ppm. 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. The pairwise increase for combined tumors was significant at p=0.03, which is not a strong indication of a positive effect. In addition, the increase in these tumors was within, but at the high end, of the historical controls.
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 ranging from 0.01 ppm to 7.0
ppm as follows: cotton gin byproducts; flax, seed; forage, fodder, and
straw of cereal grains; fruiting vegetables except cucurbits; grain,
cereal; grape; grass, forage, fodder and hay, group; herbs and spices;
leafy vegetables except brassica; leaves and roots of tuber vegetables;
legume vegetables; non-grass animal feed; onion, dry bulb; onion,
green; peanut hay; peanuts meat (hulls removed); rape forage; rape
seed; safflower, seed; strawberry; sunflower, seed; undelinted
cottonseed; vegetable, brassica, leafy, group; vegetable, bulb, group;
vegetable, cucurbit, group; vegetable, legume, foliage; and vegetable,
root and tuber, group. 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 one day
or single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the acute
exposure assessments: A conservative 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.
    ii. Chronic Exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: A chronic analysis was performed for the U.S. population,
and other population subgroups using published and proposed tolerance
levels, default concentration factors, and 100% CT assumptions for all
commodities.
    iii. Cancer. In accordance with the EPA Draft Guidelines for
Carcinogen Risk Assessment (July, 1999), the Agency classified
fludioxonil as a "Group D" - not classifiable as to human
carcinogenicity.
    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 are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of fludioxonil.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The SCI-GROW model is used to predict pesticide concentrations in
shallow groundwater. For a screening-level assessment for surface water
EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. While both FIRST and
PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
    None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a 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 in Unit II.E. of
this document.
    Fludioxonil is relatively immobile in soil (Koc = 991 -
2440 ml/g). Laboratory adsorption-desorption studies suggest that the
parent compound would be bound to soil and have a relatively low
potential to leach to ground water and move in runoff to surface water.
Degradates of fludioxonil are highly mobile and may enter both surface
and ground water. Based on their low Koc values, two of the
three photolytic degradates identified in the laboratory studies (CGA-
192155 and CGA-339833) are expected to be highly mobile in the
environment. The third major photolytic degradate was found to be
extremely unstable in the batch-equilibrium system; therefore, the
mobility of this degradate could not be determined.
    Tier I models, FIRST and SCI-GROW, were used to derive the surface
water and ground water EECs, respectively. According to the proposed
label information, the maximum application rate for fludioxonil is 4
lbs ai/Acre/year on turf (maximum single application rate of 0.675 lbs
ai/Acre). Application to turf provided the high exposure scenario;
therefore, the drinking water EECs were derived from the use on turf.
    Based on the [FIRST]
model the estimated environmental
concentrations (EECs) of fludioxonil for acute and chronic exposures
are estimated to be 132 parts per billion (ppb) and 49 ppb,
respectively, for surface water.
    Based on the SCI GROW model the estimated environmental
concentration (EEC) of fludioxonil for ground water is estimated to be
0.11 ppb for both the acute and chronic exposures.
    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 currently registered for use on the following
residential non-dietary sites: Based on the registered labels,
fludioxonil is used as a protectant fungicide for control of certain
diseases of turfgrass and certain foliar, stem and root diseases in
ornamentals in residential and commercial landscapes.
Medallion (EPA Reg. No. 100-769) is registered for use on
residential lawns and ornamentals. Medallion is a wettable
powder packaged in water-soluble packets, and the current label
indicates that this product is "for professional use only." As such,
no residential handler (i.e., applicator) exposures are anticipated.
    However, short- and intermediate-term dermal (adults and toddlers),
and incidental ingestion (toddlers) post-application residential
exposures are anticipated based on the use pattern for turfgrass
applications detailed on the Medallion label (specifies that
the product be applied at 14-day application intervals, with an annual
maximum rate of 2 lbs ai/A/yr, which equates to about 3 applications at
the maximum per application rate. Also, fludioxonil has half-lives
ranging from 95 to 440 days in thatch sod). A residential post-
application dermal assessment was not performed since the risks from
short- and intermediate-term dermal exposure are negligible. Short- and
intermediate-term dermal endpoints were not selected due to the NOAEL
of 1000 mg/kg/day (highest dose tested) in the 28-day dermal toxicity
study in rats and also since there were no developmental concerns. EPA
has concluded that there are no significant post-application exposures
anticipated from treated landscape ornamentals. Therefore, the risk
assessment was conducted using the following residential exposure
assumption: post-residential lawn applications for toddler incidental
ingestion.
    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

    1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The developmental and
reproductive toxicity data did not indicate increased quantitative or
qualitative susceptibility of rats or rabbits to in utero and/or
postnatal exposure.
    3. 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. EPA determined
that the 10X safety factor to protect infants and children should be
reduced to 1X. The FQPA factor was reduced because the toxicology data
base is complete; the developmental and reproductive toxicity data did
not indicate increased quantitative or qualitative susceptibility of
rats or rabbits to in utero and/or postnatal exposure; a developmental
neurotoxicity study is not required by the Agency because there was no
evidence of neurotoxicity in the current toxicity data base; and the
exposure assessment approach will not underestimate the potential
dietary (food and water) and non-dietary exposures for infants and
children resulting from the use of fludioxonil.

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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
fludioxonil will occupy 0.7% of the aPAD for the females 13 years and
older. Risk estimated for the general U.S. population subgroups were
included in the representative population (females 13-50 years old). 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
Population Subgroup
aPAD (mg/
kg)
% aPAD
(Food)
Surface
Water EEC
(ppb)
Ground
Water EEC
(ppb)
Acute
DWLOC
(ppb)
Females 13–50 years old 1.0 0.7 132 0.11 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 6.6% of the cPAD for the U.S.
population; 32% of the cPAD for all infants (< 1 year old); 16% of the
cPAD for children (1-6 years old); and 4.2% of the cPAD for females
(13-50 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
Population Subgroup
cPAD mg/
kg/day
% cPAD
(Food)
Surface
Water EEC
(ppb)
Ground
Water EEC
(ppb)
Chronic
DWLOC
(ppb)
U.S. population 0.03 6.6 49 0.11 980
All infants (< 1 year old) 0.03 32 49 0.11 200
Children 1–6 years old 0.03 16 49 0.11 250
Females 13–50 years old 0.03 4.2 49 0.11 860
    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).
    Fludioxonil is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for fludioxonil. The label specifies that residential
application is restricted to commercial handlers. Therefore, only post-
application exposure is expected to result from the residential uses of
fludioxonil. 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. However, the Agency did not select short- dermal endpoints
for fludioxonil. Therefore, the short-term aggregate risk for
fludioxonil considers food, water, and residential non-dietary oral
exposures (for toddlers).
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 5,000 for the U.S. population;
780 for all infants (< 1 year old); 820 for children (1-6 years old);
and 7,900 for females (13-50 years old). These aggregate MOEs do not
exceed the Agency's level of concern for aggregate exposure to food and
residential uses. In addition, short-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 short-term aggregate exposure to
exceed the Agency's level of concern, as shown in the following Table
5:
Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Fludioxonil
Population Subgroup
Aggregate
MOE (Food
+ Residential)
Aggregate
Level of
Concern
(LOC)
Surface
Water EEC
(ppb)
Ground
Water EEC
(ppb)
Short-Term
DWLOC
(ppb)
U.S. population 5,000 100 49 0.11 3,400
All infants (< 1 year old) 450 100 49 0.11 780
Children 1–6 years old 570 100 49 0.11 820
Females 13–50 years old 7,900 100 49 0.11 3,000
    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). Fludioxonil
is currently registered for use(s) that could result in intermediate-
term residential exposure and the Agency has determined that it is
appropriate to aggregate chronic food and water and intermediate-term
exposures for fludioxonil. The label specifies that the residential
application of fludioxonil is restricted to commercial handlers.
Therefore, only post-application exposure is expected to result from
the residential uses of fludioxonil. 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. However, the data did not indicate
any adverse effects as a result of intermediate-term dermal exposure.
Therefore, the intermediate-term aggregate risk for fludioxonil
considers food, water, and residential non-dietary oral exposures (for
toddlers).
    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 1,700 for
the U.S. population; 190 for all infants (< 1 year old); 270 for
(children 1-6 years old); and 2,600 for females (13-50 years old).
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 6:
Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to Fludioxonil
Population Subgroup
Aggregate
MOE (Food
+ Residential)
Aggregate
Level of
Concern
(LOC)
Surface
Water EEC
(ppb)
Ground
Water EEC
(ppb)
Intermediate-
Term
DWLOC
(ppb)
U.S. population 1,700 100 49 0.11 980
All infants (< 1 year old) 190 100 49 0.11 130
Children 1–6 years old 270 100 49 0.11 180
Females 13–50 years old 2,600 100 49 0.11 860
    5. Aggregate cancer risk for U.S. population. The Agency classified
fludioxonil as (a "Group D") not classifiable as to human
carcinogenicity based on the lack of evidence in mice when tested up to
the limited dose 7,000 ppm. Additionally, there was no evidence of
carcinogenicity in male rats, despite the statistically significant
increase in both trend and pairwise of combined hepatocellular tumors
in female rats. The pairwise increase for combined tumors was
significant at p=0.03, which is not a strong indication of a positive
effect. Furthermore, the increase in these tumors was within, but at
the high end, of the historical controls.
    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

    Based on the concurrent recovery values obtained from the crop
field trial analyses and the previous successful petition method
validation (PMV) conducted by EPA's Analytical Chemistry Branch (ACB),
EPA concludes that HPLC method AG-597B is adequate to enforce the
recommended tolerance levels for residues of fludioxonil per se in the
bushberry subgroup, the caneberry subgroup, fruit, stone, group,
juneberry, lingonberry, pistachio, salal, and watercress.
    Adequate enforcement methodology (example--gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Francis Griffith, Analytical Chemistry Branch,
Environmental Science Center,
Environmental Protection Agency, 701 Mapes Road, Fort George G. Mead,
MD 20755-5350; telephone number (410) 305-2905; e-mail address:
griffith.francis@epa.gov.

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) for residues of fludioxonil in/on the bushberry subgroup, the
caneberry subgroup, fruit, stone, group, juneberry, lingonberry,
pistachio, salal, and watercress. Therefore, compatibility issues are
not relevant to the proposed tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of fludioxonil,
(4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1 H-pyrrole-3-carbonitrile), in
or on bushberry subgroup at 2.0 ppm, caneberry subgroup at 5.0 ppm,
fruit, stone, group at 5.0 ppm, juneberry at 2.0 ppm, lingonberry at
2.0 ppm, pistachio at 0.10 ppm, salal at 2.0 ppm, and watercress 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.

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-2002-0158 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 October
1, 2002.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it "Tolerance Petition Fees."
    EPA is authorized to waive any fee requirement "when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection." For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at 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 ID number OPP-2002-0158, 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 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, 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 levels of government." This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this rule does not have any "tribal
implications" as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure "meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications." "Policies that have tribal implications" is
defined in the Executive order to include regulations that have
"substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes." This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in 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: July 18, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 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) *  *  *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bushberry subgroup.........................................          2.0
Caneberry subgroup.........................................          5.0
              *        *        *        *        *
Fruit, stone, group........................................          5.0
              *        *        *        *        *
Juneberry..................................................          2.0
              *        *        *        *        *
Lingonberry................................................          2.0
              *        *        *        *        *
Pistachio..................................................         0.10
              *        *        *        *        *
Salal......................................................          2.0
              *        *        *        *        *
Watercress.................................................          7.0
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-19442 Filed 8-1-02; 8:45 am]