[Federal Register Volume 67, Number 149 (Friday, August 2, 2002)]
[Rules and Regulations]
[Pages 50354-50362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19442]


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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: [email protected].

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://

[[Page 50355]]

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                                 Carcino-genicity 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      Male rats were orally dosed at 50, 250, and
                                          micronucleus assay          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  There was no evidence that unscheduled DNA
                                          assay                       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.
----------------------------------------------------------------------------------------------------------------


[[Page 50356]]

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 (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 Dose and Endpoints for Fludioxonil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  FQPA SF and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of    NOAEL = 100 mg/kg/day   FQPA SF = 1X             Developmental Toxicity
 age                                   UF = 100...............  aPAD = acute RfD          Study - rat
                                       Acute RfD = 1.0 mg/kg/     FQPA SF = 1.0  Developmental LOAEL =
                                        day.                     mg/kg/day.               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             1 year chronic toxicity
                                       UF = 100...............  cPAD = chronic RfD        study - dog
                                       Chronic RfD = 0.03 mg/     FQPA SF =      LOAEL = 35.5 mg/kg/day
                                        kg/day.                  0.03 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- None                     No systemic toxicity      Endpoint was not
 30 days and 1-6 months)                                         was seen at the limit    selected
 (Residential)                                                   dose (1,000 mg/kg/day)
                                                                 in the 28-day dermal
                                                                 toxicity study in rats
----------------------------------------------------------------------------------------------------------------
Long-Term (several months-lifetime)    Oral study               LOC for MOE = 100        1 year chronic toxicity
 Dermal (Residential)                  NOAEL = 3.3 mg/kg/day     (Occupational)           study - dog
                                        (dermal penetration =   LOC for MOE = 100        LOAEL = 35.5 mg/kg/day
                                        40%).                    (Residential).           based on decreased
                                                                                          weight gain in female
                                                                                          dogs
----------------------------------------------------------------------------------------------------------------
Short-Term (1-30 Days) Inhalation      Oral NOAEL = 10 mg/kg/   LOC for MOE = 100        Rabbit developmental
 (Residential)                          day (inhalation          (Occupational)           study
                                        absorption rate =       LOC for MOE = 100        LOAEL = 100 mg/kg/day
                                        100%)                    (Residential).           based on decreased
                                                                                          weight gain during
                                                                                          gestation
----------------------------------------------------------------------------------------------------------------
Intermediate-term (1 month - 6         Oral NOAEL = 3.3 mg/kg/  LOC for MOE = 100        1 year chronic toxicity
 months) Inhalation (Residential)       day (inhalation          (Occupational)           study - dog
                                        absorption rate =       LOC for MOE = 100        LOAEL = 35.5 mg/kg/day
                                        100%)                    (Residential).           based on decreased
                                                                                          weight gain in female
                                                                                          dogs
----------------------------------------------------------------------------------------------------------------

[[Page 50357]]

 
Long-Term (several months-lifetime)    Oral NOAEL = 3.3 mg/kg/  LOC for MOE = 100        1 year chronic toxicity
 Inhalation (Residential)               day (inhalation          (Occupational)           study - dog
                                        absorption rate =       LOC for MOE = 100        LOAEL = 35.5 mg/kg/day
                                        100%)                    (Residential).           based on decreased
                                                                                          weight gain in female
                                                                                          dogs
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      ``Group D'' - not        Not applicable           There was no evidence
                                        classifiable as to                                of carcinogenicity in
                                        human carcinogenicity                             mice when tested up to
                                        via relevant routes of                            the limited dose 7,000
                                        exposure                                          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

[[Page 50358]]

 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

[[Page 50359]]

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
----------------------------------------------------------------------------------------------------------------
                                                                             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          0.7          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
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     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.

[[Page 50360]]

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
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (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
----------------------------------------------------------------------------------------------------------------
                                                             Aggregate
                                                Aggregate     Level of     Surface       Ground    Intermediate-
             Population Subgroup               MOE (Food +    Concern     Water EEC    Water EEC     Term DWLOC
                                              Residential)     (LOC)        (ppb)        (ppb)         (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,

[[Page 50361]]

 Environmental Protection Agency, 701 Mapes Road, Fort George G. Mead, 
MD 20755-5350; telephone number (410) 305-2905; e-mail address: 
[email protected].

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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    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: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. 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

[[Page 50362]]

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]
BILLING CODE 6560-50-S