[Federal Register Volume 69, Number 188 (Wednesday, September 29, 2004)]
[Rules and Regulations]
[Pages 58084-58091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21803]



[[Page 58084]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0321; FRL-7682-3]


Fludioxonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fludioxonil in or on bean, dry; bean, succulent; citrus, crop group 10; 
fruit, pome, group 11; grapefruit, oil; kiwifruit; leafy greens 
subgroup 4A, except spinach; melon subgroup 9A; and yam, true. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 29, 2004. Objections and 
requests for hearings must be received on or before November 29, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004-0321. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 South 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Sidney C. Jackson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 305-7610; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of March 17, 2004 (69 FR 12680) (FRL-7347-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
3E6551, 3E6639, 3E6701, 3E6742, and 3E6803) by IR-4, 681 US Highway 
1 South, New Brunswick, NJ 08902-3390. These 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)-1H-pyrrole-3-carbonitrile, in or on bean, dry and bean, succulent 
at 0.4 parts per million (ppm) (PP 3E6701); citrus, crop group 10 at 10 
ppm; citrus, dried pulp at 20 ppm, citrus, oil at 500 ppm, and 
pomegranate at 2.0 ppm (PP 3E6803); fruit, pome, group 11 at 5.0 ppm, 
yam at 8.0 ppm, and melon subgroup 9A at 0.03 ppm (PP 3E6742); 
kiwifruit at 20 ppm (PP 3E6551); and leafy greens subgroup 4A, except 
spinach at 30 ppm (PP 3E6639). That notice included a summary of the 
petitions prepared by Syngenta Crop Protection, Incorporated, the 
registrant. Subsequently, PP 3E6803 has been amended to delete citrus, 
dried pulp at 20 ppm, and pomegranate at 2.0 ppm. In addition, 
``citrus, oil'' at 500 ppm, and ``yam'' at 8.0 ppm has been translated 
to ``grapefruit, oil'' at 500 ppm, and ``yam, true'' at 8.0, 
respectively. There were no comments received in response to the notice 
of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure,

[[Page 58085]]

consistent with section 408(b)(2) of FFDCA, for tolerances for residues 
of fludioxonil on bean, dry; bean, succulent at 0.4 ppm; citrus, crop 
group 10 at 10 ppm; fruit, pome, group 11 at 5.0 ppm; grapefruit, oil 
at 500 ppm; kiwifruit at 20 ppm; leafy greens subgroup 4A, except 
spinach at 30 ppm; melon subgroup 9A at 0.03; and yam, true at 8.0 ppm. 
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 as well 
as the no observed adverse effect level (NOAEL) and the lowest observed 
adverse effect level (LOAEL) from the toxicity studies reviewed are 
discussed in the Federal Register of December 29, 2000 (65 FR 82927) 
(FRL-6760-9).

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional uncertainty factor or a special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, this additional factor is applied to the RfD by dividing the RfD 
by such additional factor. The acute or chronic Population Adjusted 
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this 
type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-\5\), one in a million (1 X 10-\6\), or one in 
ten million (1 X 10-\7\). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' is 
identified below which carcinogenic effects are not expected. The point 
of departure is typically a NOAEL based on an endpoint related to 
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 Table 1. of this unit:

     Table 1.--Summary of Toxicological Dose and Endpoints for Fludioxonil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
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Acute Dietary (Females 13-49 years of  NOAEL = 100 mg/kg/day    Special FQPA SF = 1X     Developmental Toxicity
 age)                                  UF = 100...............  aPAD = acute RfD /        Study
                                       Acute RfD = 1.0 mg/kg/    Special FQPA SF = 1.0   LOAEL = 1,000 mg/kg/day
                                        day.                     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    Special FQPA SF = 1X     One year chronic
                                       UF = 100...............  cPAD = chronic RfD /      toxicity study - dog
                                       Chronic RfD = 0.03 mg/    Special FQPA SF = 0.03  LOAEL = 35.5 mg/kg/day
                                        kg/day.                  mg/kg/day.               based on decreased
                                                                                          body weight gain in
                                                                                          female dogs
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Short-Term Dermal     Oral study NOAEL = 10    LOC for MOE = 100        Rabbit developmental
                                        mg/kg/day                (Residential)            study
                                                                                         LOAEL = 100 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gain
                                                                                          during gestation
----------------------------------------------------------------------------------------------------------------

[[Page 58086]]

 
Incidental Oral, Intermediate-Term     Oral study NOAEL = 3.3   LOC for MOE = 100        One year chronic
 Dermal                                 mg/kg/day                (Residential)            toxicity study - dog
                                                                                         LOAEL = 35.5 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gain in
                                                                                          female dogs
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate-Term Dermal    None                     No systemic toxicity     Endpoint was not
 (1-30 days and 1-6 months)                                      was seen at the limit    selected
 (Occupational/Residential)                                      dose (1,000 mg/kg/day)
                                                                 in the 28-day dermal
                                                                 toxicity study in
                                                                 rats. Additionally,
                                                                 there were no
                                                                 developmental
                                                                 concerns. There risk
                                                                 assessments are not
                                                                 required
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (6 months-lifetime)   Oral study NOAEL = 3.3   LOC for MOE = 100        One year chronic
 (Occupational/Residential)             mg/kg/day (dermal        (Occupational)           toxicity study - dog
                                        absorption rate = 40%   LOC for MOE = 100        LOAEL = 35.5 mg/kg/day
                                        when appropriate)        (Residential).           based on decreased
                                                                                          body weight gain in
                                                                                          females dogs
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 30 days)   Inhalation (or oral)     LOC for MOE = 100        Rabbit developmental
 (Inhalation)                           study NOAEL = 10 mg/kg/  (Occupational)           study
                                        day (inhalation         LOC for MOE = 100        LOAEL = 100 mg/kg/day
                                        absorption rate =        (Residential).           based on decreased
                                        100%)                                             body weight gain
                                                                                          during gestation
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 month- Oral study NOAEL = 3.3   LOC for MOE = 100        One year chronic
 6 months) (Inhalation)                 mg/kg/day (inhalation    (Occupational)           toxicity study
                                        absorption rate =       LOC for MOE = 100        LOAEL = 35.5 mg/kg/day
                                        100%)                    (Residential).           based on decreased
                                                                                          body weight gain in
                                                                                          female dogs
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (6 months-        Oral study NOAEL= 3.3    LOC for MOE = 100        One year chronic
 lifetime) (Occupational/Residential)   mg/kg/day (inhalation    (Occupational)           toxicity study - dog
                                        absorption rate =       LOC for MOE = 100        LOAEL = 35.5 mg/kg/day
                                        100%)                    (Residential).           based on decreased
                                                                                          body weight gain in
                                                                                          female dogs
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      ``Group D'' - not        Not applicable           Acceptable oral rat and
                                        classified as to human                            mouse carcinogenicity
                                        carcinogenicity via                               studies; evidence of
                                        relevant routes of                                carcinogenic and
                                        exposure                                          mutagenic potential
----------------------------------------------------------------------------------------------------------------

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 which includes the following: 
Brassica, head and stem, Brassica, leafy greens, bushberry, caneberry, 
carrot, cereal grain, forage, fodder, and straw, cotton gin byproducts, 
cotton, undelinted seed, flax, seed, grape, grass, forage, fodder and 
hay, herb and spice group, juneberry, leafy vegetables except Brassica, 
lingonberry, longan, lychee, non-grass animal feed, dry bulb and green 
onion, peanut hay, peanut, pistachio, pulasan, rambutan, rapeseed and 
rapeseed forage, safflower seed, salal, Spanish lime, stone fruit, 
strawberry, sunflower seed, turnip greens, bulb vegetables, cucurbit 
vegetables, fruiting legume vegetables, root and tuber vegetables, 
foliage of legume vegetables, and watercress. 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.
    In conducting the acute dietary risk assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\), which incorporates food consumption 
data as reported by respondents in the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII), and accumulated exposure to the 
chemical for each commodity. The following assumptions were made for 
the acute exposure assessments: An unrefined, Tier 1 acute dietary 
exposure assessment used tolerance-level residue values and 100% crop 
treated (CT) as assumptions for all of the registered and proposed 
uses.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the DEEM-FCID\TM\, which incorporates food 
consumption data as reported by respondents in the USDA 1994-1996 and 
1998 Nationwide CSFII, and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: A partially refined, Tier 2 chronic dietary 
exposure assessment was conducted for the general U.S. population and 
related population subgroups. Tolerance-level values and a default of 
100% CT were used for all the current and proposed fludioxonil 
tolerances except for apple, grapefruit, lemon, lime, orange, and pear. 
Average application rate (AR) values replaced tolerances for apple,

[[Page 58087]]

grapefruit, lemon, lime, orange, and pear. In addition, processing 
factors from processing studies were used for apple juice and citrus 
juices.
    iii. Cancer. EPA's Cancer Peer Review Committee (CPRC) classified 
fludioxonil as a Group D chemical that is considered not classifiable 
as to human carcinogenicity. Therefore, a cancer risk assessment was 
not performed.
    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 FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The SCI-GROW model is used to predict pesticide 
concentrations in shallow ground water. For a screening-level 
assessment for surface water EPA will use FIRST (a tier 1 model) before 
using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the 
PRZM/EXAMS model that uses a specific high-end runoff scenario for 
pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir 
environment, and both models include a percent crop area factor as an 
adjustment to account for the maximum percent crop coverage within a 
watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead drinking water levels of comparison (DWLOCs) are calculated and 
used as a point of comparison against the model estimates of a 
pesticide's concentration in water. DWLOCs are theoretical upper limits 
on a pesticide's concentration in drinking water in light of total 
aggregate exposure to a pesticide in food, and from residential uses. 
Since DWLOCs address total aggregate exposure to fludioxonil they are 
further discussed in the aggregate risk sections in Unit III.E.1.-4.
    Based on the FIRST and SCI-GROW models, the EECs of fludioxonil for 
acute exposures are estimated to be 132 parts per billion (ppb) for 
surface water and 0.11 ppb for ground water. The EECs for chronic 
exposures are estimated to be 49 ppb for surface water and 0.11 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 currently registered for use on the following 
residential non-dietary sites: Turfgrass and ornamentals in residential 
landscapes (registered product: Medallion[reg], EPA Reg. No. 100-769). 
Medallion[reg] is a wettable powder 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 1,000 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 effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to fludioxonil and any other 
substances and 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 policy statements released by EPA's OPP concerning 
common mechanism determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's web site at 
http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The developmental and 
reproductive toxicity data did not indicate increased quantitative or 
qualitative susceptibility

[[Page 58088]]

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 SF to protect infants and children should be reduced to 1X 
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 
because there was no evidence of neurotoxicity in the current toxicity 
data base.
     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 EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
fludioxonil will occupy 0.13% of the aPAD for females 13 years and 
older. 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 Table 2. of 
this unit:

                      Table 2.--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)
----------------------------------------------------------------------------------------------------------------
Female 13-49 years old                                   1.0         0.13          132         0.11       26,000
----------------------------------------------------------------------------------------------------------------

    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 39.4% of the cPAD for the U.S. 
population, 43.7% of the cPAD for all infants < 1 year old, 65.2% of 
the cPAD for children 1-2 years old, and 39.4% of the cPAD for females 
13-49 years old. Based on 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 Table 3. of this unit:

              Table 3.--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         39.4           49         0.11          630
----------------------------------------------------------------------------------------------------------------
All infants < 1 year old                                0.03         43.7           49         0.11          170
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                  0.03         65.2           49         0.11          100
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                                 0.03         39.4           49         0.11          570
----------------------------------------------------------------------------------------------------------------

    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

[[Page 58089]]

aggregate chronic food and water and short-term exposures for 
fludioxonil.
    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 390 for all infants < 1 year 
old, 300 for children 1-2 years old, and 320 for children 3-5 years 
old. These aggregate MOEs do not exceed the Agency's level of concern 
for aggregate exposure to food and residential uses. In addition, 
short-term DWLOCs were calculated and compared to the EECs for chronic 
exposure of fludioxonil in ground and surface water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect short-term aggregate exposure to exceed the Agency's 
level of concern, as shown in Table 4. of this unit:

                   Table 4.--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)
----------------------------------------------------------------------------------------------------------------
All infants < 1 year old                                 390          100           49         0.11          740
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                   300          100           49         0.11          670
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                   320          100           49         0.11          690
----------------------------------------------------------------------------------------------------------------

    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.
    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 160 for 
all infants < 1 year old, 120 for children 1-2 years old, and 130 for 
children 3-5 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 
Table 5. of this unit:

                Table 5.--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)
----------------------------------------------------------------------------------------------------------------
All infants < 1 year old                               160          100           49         0.11           100
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                 120          100           49         0.11            30
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                 130          100           49         0.11            50
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. EPA has classified 
fludioxonil in ``Group D'' - not classifiable as to human 
carcinogenicity. Based on available data, the Agency concludes that the 
proposed use of fludioxonil does not present discernable aggregate 
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

    Adequate enforcement methodology is available to enforce the 
tolerance expression. Apple, pear, kiwifruit, cantaloupe, yam, citrus, 
and pomegranate were analyzed for fludioxonil using Syngenta tolerance 
enforcement method AG-597B, Analytical Method for the Determination of 
CGA-219417 in Crops by High Performance Liquid Chromatography Including 
Validation Data, with Modifications. Head and leaf lettuce, lima bean, 
dry bean, and snap bean were analyzed for fludioxonil using Novartis 
working method AG-631B, Determination of Residues of CGA-219417 in 
Crops by High Performance Liquid Chromatography with Column Switching.
    Adequate enforcement methodology (liquid chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican tolerances/maximum residue 
levels (MRLs) for fludioxonil residues on kiwifruit, yam, bean, dry and 
bean, succulent, citrus, leafy greens except spinach, melons, or pome 
fruit. Thus, harmonization is not an issue at this time.

V. Conclusion

    Therefore, the tolerances are established for residues of 
fludioxonil,

[[Page 58090]]

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, in or 
on bean, dry; bean, succulent at 0.4; citrus, crop group 10 at 10 ppm; 
fruit, pome, group 11 at 5.0 ppm; grapefruit, oil at 500 ppm; kiwifruit 
at 20 ppm; leafy greens subgroup 4A, except spinach at 30 ppm; melon 
subgroup 9A at 0.03; and yam, true at 8.0 ppm.

VI. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0321 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
29, 2004.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0321, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have

[[Page 58091]]

``substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government.'' This 
final rule directly regulates growers, food processors, food handlers 
and food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of FFDCA. 
For these same reasons, the Agency has determined that this rule does 
not have any ``tribal implications'' as described in Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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


    Dated: September 22, 2004.
Lois Rossi,
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), 346a and 371.

    2. Section 180.516 is amended as follows:
    a. By alphabetically adding commodities to the table in paragraph 
(a).
    b. By removing the commodities ``Apricot,'' ``Caneberry,'' 
``Nectarine,'' ``Peach,'' and ``Plum'' in the table in paragraph (b).


Sec.  180.516  Fludioxonil; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bean, dry..................................................          0.4
Bean, succulent............................................          0.4
                                * * * * *
Citrus, crop group 10......................................           10
                                * * * * *
Fruit, pome, group 11......................................          5.0
                                * * * * *
Grapefruit, oil............................................          500
                                * * * * *
Kiwifruit..................................................           20
Leafy greens subgroup 4A, except spinach...................           30
                                * * * * *
Melon subgroup 9A..........................................         0.03
                                * * * * *
Yam, true..................................................          8.0
------------------------------------------------------------------------

* * * * *

[FR Doc. 04-21803 Filed 9-28-04; 8:45 am]
BILLING CODE 6560-50-S