[Federal Register Volume 65, Number 251 (Friday, December 29, 2000)]
[Rules and Regulations]
[Pages 82927-82937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-33168]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301093; FRL-6760-9]
RIN 2070-AB78


Fludioxonil; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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

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

[[Page 82928]]

the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT By mail: Mary Waller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9354; and e-mail address: 
[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 Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

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

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

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

II. Background and Statutory Findings

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

III. Aggregate Risk Assessment and Determination of Safety

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

[[Page 82929]]

final set of residue chemistry data are submitted and reviewed. EPA's 
assessment of exposures and risks associated with establishing the 
tolerances follows.

A. Toxicological Profile

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

                               Table 1.-- Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100a                                90-Day oral toxicity in     NOAEL = 64 mg/kg/day (M) and 70 mg/kg/day
                                          rats                        (F)
                                                                     LOAEL = 428 mg/kg/day (M) and 462 mg/kg/day
                                                                      (F) based on decreased weight gain (both
                                                                      sexes), chronic nephropathy (M) and
                                                                      centrilobular hepatocyte hypertrophy (F).
----------------------------------------------------------------------------------------------------------------
870.3100b                                90-Day oral toxicity in     NOAEL = 445 mg/kg day (M) and 559 mg/kg/day
                                          mice                        (F)
                                                                     LOAEL = 1052 mg/kg/day (M) and 1307 mg/kg/
                                                                      day (F) based on decreased body weight
                                                                      gain (F), increased alkaline phosphatase
                                                                      (M), increased relative liver weight,
                                                                      increased incidence of nephropathy and
                                                                      centrilobular hypertrophy (both sexes)
----------------------------------------------------------------------------------------------------------------
870.3100c                                90-Day oral toxicity in     NOAEL = 5 mg/kg/day (both sexes)
                                          dogs
                                                                     LOAEL = 50 mg/kg/day based on an increased
                                                                      incidence of diarrhea (both sexes).
----------------------------------------------------------------------------------------------------------------
870.3200                                 21/28- Day dermal toxicity  NOAEL1,000 mg/kg/day for both sexes
----------------------------------------------------------------------------------------------------------------
870.3250                                 90-Day dermal toxicity      N/A
----------------------------------------------------------------------------------------------------------------
870.3465                                 90-Day inhalation toxicity  N/A
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870.3700a                                Prenatal developmental in   Maternal NOAEL = 100 mg/kg/day
                                          rodents
                                                                     LOAEL = 1,000 mg/kg/day based on reduction
                                                                      in corrected weight gain
                                                                     Developmental NOAEL = 100 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on increase
                                                                      in the fetal incidence and litter
                                                                      incidence of dilated renal pelvis and
                                                                      dilated ureter.
----------------------------------------------------------------------------------------------------------------
870.3700b                                Prenatal developmental in   Maternal NOAEL = 10 mg/kg/day
                                          nonrodents
                                                                     LOAEL = 100 mg/kg/day based on decreased
                                                                      body weight gain and decreased food
                                                                      efficiency
                                                                     Developmental NOAEL  300 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 22.13 mg/kg/day
                                          effects                     (M) and 24.24 mg/kg/day (F)
                                                                     LOAEL = 221.61mg/kg/day (M) and 249.67 mg/
                                                                      kg/day (F) based on increased clinical
                                                                      signs, decreased body weights, decreased
                                                                      weight gain, and decreased food
                                                                      consumption in both sexes
                                                                     Reproductive/Offspring NOAEL = 22.13 mg/kg/
                                                                      day (M) and 24.24 mg/kg/day (F)
                                                                     LOAEL = 221.61 mg/kg/day (M) and 249.67 mg/
                                                                      kg/day (F) based on reduced pup weights
                                                                      during lactation
----------------------------------------------------------------------------------------------------------------
870.4100b                                Chronic toxicity dogs       NOAEL = 3.3 mg/kg/day (F) and 33.1 mg/kg/
                                                                      day (M).
                                                                     LOAEL = 35.5 mg/kg/day (F) and 297.8 mg/kg/
                                                                      day (M) based upon decreased weight gain
                                                                      (F) and decreased body weight, reduction
                                                                      in hematological parameters (platelets),
                                                                      increase in cholesterol and alkaline
                                                                      phosphatase, and increased relative liver
                                                                      weight (M)
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined Chronic Toxicity/  NOAEL = 37 mg/kg/day (M) and 44 mg/kg/day
                                          Carcinogenicity in rats     (F)
                                                                     LOAEL = 113 mg/kg/day (M) and 141 mg/kg/day
                                                                      (F) based on decreased mean body weight
                                                                      gain, slight anemia (F), and increased
                                                                      incidence and severity of liver lesions
                                                                      (degeneration) in both sexes. There was no
                                                                      evidence of carcinogenicity in male rats,
                                                                      but there was a statistically significant
                                                                      increase, both trend and pairwise, of
                                                                      combined hepatocellular tumors in female
                                                                      rats. Classified as ``Group D'' by OPP
                                                                      Cancer Peer Review Committee.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice        NOAEL = 11.3 mg/kg/day (M) and 133 mg/kg/
                                                                      day (F)

[[Page 82930]]

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

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to

[[Page 82931]]

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

                 Table 2.--Summary of Toxicological Endpoints Used for Human Risk Assessment\*\
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF and Level of
          Exposure Scenario              Dose Used in Risk         Concern for Risk      Study and Toxicological
                                           Assessment, UF             Assessment                 Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50           NOAEL = 100 mg/kg/day;   FQPA SF = 1X; aPAD =     Developmental Toxicity
                                       UF = 100; Acute RfD =    acute RfD/FQPA SF =      Study - rat
                                       1.0 mg/kg/day            1.0 mg/kg/day
                                                                                        Developmental LOAEL =
                                                                                         1,000 mg/kg/day based
                                                                                         on increased incidence
                                                                                         of fetuses and litters
                                                                                         with dilated renal
                                                                                         pelvis and dilated
                                                                                         ureter
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations       NOAEL= 3.3 mg/kg/day;    FQPA SF = 1X; cPAD =     One year chronic
                                       UF = 100; Chronic RfD    chronic RfD/FQPA SF =    toxicity study - dog
                                       = 0.03 mg/kg/day         0.03 mg/kg/day
                                                                                        LOAEL = 35.5 mg/kg/day
                                                                                         based on decreased
                                                                                         weight gain in female
                                                                                         dogs
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1-7 days)          none                     No systemic toxicity     Endpoint was not
 (Occupational/Residential)                                     was seen at the limit    selected
                                                                dose (1,000 mg/kg/day)
                                                                in the 28-day dermal
                                                                toxicity study in
                                                                rats. This risk
                                                                assessment is not
                                                                required.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term (1 week - several   Oral study NOAEL= 64 mg/ LOC for MOE = 100        13 Week Oral Feeding
 months) Dermal (Occupational/         kg/day (dermal           (Occupational); LOC      Study - rat
 Residential)                          penetration = 40%)       for MOE = 100
                                                                (Residential)
                                                                                        Systemic LOAEL = 428 mg/
                                                                                         kg/day based on
                                                                                         decreased body weight
                                                                                         gain in both sexes,
                                                                                         chronic nephropathy in
                                                                                         males, and
                                                                                         centrilobular
                                                                                         hepatocyte hypertrophy
                                                                                         in females
----------------------------------------------------------------------------------------------------------------
Long-Term (several months-lifetime)   Oral study NOAEL = 3.3   LOC for MOE = 100        one year chronic
 Dermal (Occupational/ Residential)    mg/kg/day (dermal        (Occupational) LOC for   toxicity study - dog
                                       penetration = 40%)       MOE = 100
                                                                (Residential)
                                                                                        LOAEL = 35.5 mg/kg/day
                                                                                         based on decreased
                                                                                         weight gain in female
                                                                                         dogs
----------------------------------------------------------------------------------------------------------------
Short-Term (1-7 Days) Inhalation      NOAEL = 64 mg/kg/day     LOC for MOE = 100        13 Week Oral Feeding
 (Occupational/Residential)            (inhalation absorption   (Occupational); LOC      Study - rat
                                       rate = 100%)             for MOE = 100
                                                                (Residential)
                                                                                        Systemic LOAEL = 428 mg/
                                                                                         kg/day based on
                                                                                         decreased body weight
                                                                                         gain in both sexes,
                                                                                         chronic nephropathy in
                                                                                         males, and
                                                                                         centrilobular
                                                                                         hepatocyte hypertrophy
                                                                                         in females
----------------------------------------------------------------------------------------------------------------
Intermediate-term (1 week - several   NOAEL = 64 mg/kg/day     LOC for MOE = 100        13 Week Oral Feeding
 months) Inhalation (Occupational/     (inhalation absorption   (Occupational) LOC for   Study - rat Systemic
 Residential)                          rate = 100%)             MOE = 100
                                                                (Residential)

[[Page 82932]]

 
                                                                                        LOAEL = 428 mg/kg/day
                                                                                         based on decreased body
                                                                                         weight gain in both
                                                                                         sexes, chronic
                                                                                         nephropathy in males,
                                                                                         and centrilobular
                                                                                         hepatocyte hypertrophy
                                                                                         in females
----------------------------------------------------------------------------------------------------------------
Long-Term (several months-lifetime)   NOAEL = 3.3 mg/kg/day    LOC for MOE = 100        one year chronic
 Inhalation (Occupational/             (inhalation absorption   (Occupational); LOC      toxicity study - dog
 Residential)                          rate = 100%)             for MOE = 100
                                                                (Residential)
                                                                                        LOAEL = 35.5 mg/kg/day
                                                                                         based on decreased
                                                                                         weight gain in female
                                                                                         dogs
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)     ``Group D''- not         not applicable           Acceptable oral rat and
                                       classifiable as to                                mouse carcinogenicity
                                       human carcinogenicity                             studies; evidence of
                                       via relevant routes of                            carcinogenic and
                                       exposure                                          mutagenic potential.
----------------------------------------------------------------------------------------------------------------
\*\ UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
  lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
  dose, MOE = margin of exposure, LOC = level of concern. The FQPA factor being referenced is the factor unique
  to the FQPA and does not include FQPA factors related to data uncertainty.

C. Exposure Assessment

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

[[Page 82933]]

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

D. Safety Factor for Infants and Children

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

[[Page 82934]]

E. Aggregate Risks and Determination of Safety

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

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

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

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


[[Page 82935]]

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

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

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

IV. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

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

C. Conditions

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

V. Conclusion

    Therefore, the tolerance is established for residues of fludioxonil 
4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrilein or on 
grapes at 1.0 ppm, strawberries at 2.0 ppm, dry bulb onions at 0.20 
ppm, and green onions at 7.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

[[Page 82936]]

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

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

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require OMB review or 
any Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408(d), such 
as the tolerance in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various

[[Page 82937]]

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

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: December 18, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


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


Sec. 180.516  Fludioxonil; tolerances for residues.

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

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

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