Fludioxonil (IR-4). Sept 29, 2004. Pesticide tolerances. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Fludioxonil (IR-4). September 29, 2004. Pesticide Tolerances. Final Rule. Federal Register.

Docket identification (ID) number OPP-2004-0321

http://www.epa.gov/fedrgstr/EPA-PEST/2004/September/Day-29/p21803.htm

[Federal Register: September 29, 2004 (Volume 69, Number 188)]
[Rules and Regulations]
[Page 58084-58091]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se04-16]
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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:
jackson.sidney@epa.gov.
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

Exposure Scenario Dose Used in Risk Assessment, Interspecies and Intraspecies and any Traditional UF Special FQPA SF and Level of Concern for Risk Assessment Study and Toxicological Effects

Acute Dietary (Females 13-49 years of age) NOAEL = 100 mg/kg/day
UF = 100
Acute RfD = 1.0 mg/kg/day. Special FQPA SF = 1X aPAD = acute RfD / Special FQPA SF = 1.0 mg/kg/day. Developmental Toxicity Study
LOAEL = 1,000 mg/kg/day based on increased incidence of fetuses and litters with dilated renal pelvis and dilated ureter

Chronic Dietary (All populations) NOAEL = 3.3 mg/kg/day UF = 100............... Chronic RfD = 0.03 mg/kg/day. Special FQPA SF = 1X cPAD = chronic RfD / Special FQPA SF = 0.03 mg/kg/day. One year chronic toxicity study - dog
LOAEL = 35.5 mg/kg/day based on decreased body weight gain in female dogs

Incidental Oral, Short-Term Dermal Oral study NOAEL = 10 mg/kg/day LOC for MOE = 100 (Residential) Rabbit developmental study LOAEL = 100 mg/kg/day based on decreased body weight gain during gestation

[[Page 58086]]

Incidental Oral, Intermediate-Term Dermal Oral study NOAEL = 3.3 mg/kg/day LOC for MOE = 100 (Residential) One year chronic toxicity study - dog LOAEL = 35.5 mg/kg/day based on decreased body weight gain in female dogs

Short- and Intermediate-Term Dermal (1-30 days and 1-6 months) (Occupational/Residential) None No systemic toxicity was seen at the limit dose (1,000 mg/kg/day) in the 28-day dermal toxicity study in rats. Additionally, there were no developmental concerns. There risk
assessments are not required Endpoint was not selected

Long-Term Dermal (6 months-lifetime) (Occupational/Residential) Oral study NOAEL = 3.3 mg/kg/day (dermal absorption rate = 40% when appropriate) LOC for MOE = 100 (Occupational)
LOC for MOE = 100 LOAEL = 35.5 (Residential). One year chronic toxicity study - dog mg/kg/day based on decreased body weight gain in
females dogs

Short-Term Inhalation (1 to 30 days) (Inhalation) Inhalation (or oral) study NOAEL = 10 mg/kg/ day (inhalation absorption rate = 100%) LOC for MOE = 100 (Occupational)
LOC for MOE = 100 (Residential). Rabbit developmental study LOAEL = 100 mg/kg/day based on decreased body weight gain
during gestation

Intermediate-Term Inhalation (1 month- 6 months) (Inhalation) Oral study NOAEL = 3.3 mg/kg/day (inhalation absorption rate = 100%) LOC for MOE = 100 (Occupational)
LOC for MOE = 100 (Residential). One year chronic toxicity study LOAEL = 35.5 mg/kg/day based on decreased
body weight gain in female dogs

Long-Term Inhalation (6 months- lifetime) (Occupational/Residential) Oral study NOAEL= 3.3 mg/kg/day (inhalation absorption rate = 100%) LOC for MOE = 100 (Occupational)
LOC for MOE = 100 (Residential). One year chronic toxicity study - dog LOAEL = 35.5 mg/kg/day based on decreased body weight gain in female dogs

Cancer (oral, dermal, inhalation) ``Group D'' - not classified as to human carcinogenicity via relevant routes of exposure Not applicable Acceptable oral rat and mouse carcinogenicity studies; evidence of carcinogenic and 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

Population Subgroup aPAD (mg/ kg) % aPAD (Food) Surface Water EEC (ppb) GroundWater EEC (ppb) Acute DWLOC (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

Population Subgroup cPAD mg/kg/day % cPAD (Food) Surface Water EEC (ppb) GroundWater EEC (ppb) Acute 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

Population Subgroup Aggregate MOE (Food + Residential) Aggregate Level of Concern (LOC) Surface Water EEC (ppb) GroundWater EEC (ppb) Short-Term DWLOC (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 300 100 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

Population Subgroup Aggregate MOE (Food + Residential) Aggregate Level of Concern (LOC) Surface Water EEC (ppb) GroundWater EEC (ppb) Intermediate-Term DWLOC (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: residuemethods@epa.gov.
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: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. 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 (59 FR 22951, 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 million
Commodity
------------------------------------------------------------------------
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

Table 1.--Summary of Toxicological Dose and Endpoints for Fludioxonil for Use in Human Risk Assessment
Exposure Scenario	Dose Used in Risk Assessment, Interspecies and Intraspecies and any Traditional UF	Special FQPA SF and Level of Concern for Risk Assessment	Study and Toxicological Effects
Acute Dietary (Females 13-49 years of age)	NOAEL = 100 mg/kg/day UF = 100 Acute RfD = 1.0 mg/kg/day.	Special FQPA SF = 1X aPAD = acute RfD / Special FQPA SF = 1.0 mg/kg/day.	Developmental Toxicity Study LOAEL = 1,000 mg/kg/day based on increased incidence of fetuses and litters with dilated renal pelvis and dilated ureter
Chronic Dietary (All populations)	NOAEL = 3.3 mg/kg/day UF = 100............... Chronic RfD = 0.03 mg/kg/day.	Special FQPA SF = 1X cPAD = chronic RfD / Special FQPA SF = 0.03 mg/kg/day.	One year chronic toxicity study - dog LOAEL = 35.5 mg/kg/day based on decreased body weight gain in female dogs
Incidental Oral, Short-Term Dermal	Oral study NOAEL = 10 mg/kg/day	LOC for MOE = 100 (Residential)	Rabbit developmental study LOAEL = 100 mg/kg/day based on decreased body weight gain during gestation
[[Page 58086]] Incidental Oral, Intermediate-Term Dermal	Oral study NOAEL = 3.3 mg/kg/day	LOC for MOE = 100 (Residential)	One year chronic toxicity study - dog LOAEL = 35.5 mg/kg/day based on decreased body weight gain in female dogs
Short- and Intermediate-Term Dermal (1-30 days and 1-6 months) (Occupational/Residential)	None	No systemic toxicity was seen at the limit dose (1,000 mg/kg/day) in the 28-day dermal toxicity study in rats. Additionally, there were no developmental concerns. There risk assessments are not required	Endpoint was not selected
Long-Term Dermal (6 months-lifetime) (Occupational/Residential)	Oral study NOAEL = 3.3 mg/kg/day (dermal absorption rate = 40% when appropriate)	LOC for MOE = 100 (Occupational) LOC for MOE = 100 LOAEL = 35.5 (Residential).	One year chronic toxicity study - dog mg/kg/day based on decreased body weight gain in females dogs
Short-Term Inhalation (1 to 30 days) (Inhalation)	Inhalation (or oral) study NOAEL = 10 mg/kg/ day (inhalation absorption rate = 100%)	LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential).	Rabbit developmental study LOAEL = 100 mg/kg/day based on decreased body weight gain during gestation
Intermediate-Term Inhalation (1 month- 6 months) (Inhalation)	Oral study NOAEL = 3.3 mg/kg/day (inhalation absorption rate = 100%)	LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential).	One year chronic toxicity study LOAEL = 35.5 mg/kg/day based on decreased body weight gain in female dogs
Long-Term Inhalation (6 months- lifetime) (Occupational/Residential)	Oral study NOAEL= 3.3 mg/kg/day (inhalation absorption rate = 100%)	LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential).	One year chronic toxicity study - dog LOAEL = 35.5 mg/kg/day based on decreased body weight gain in female dogs
Cancer (oral, dermal, inhalation)	``Group D'' - not classified as to human carcinogenicity via relevant routes of exposure	Not applicable	Acceptable oral rat and mouse carcinogenicity studies; evidence of carcinogenic and mutagenic potential

Table 2.--Aggregate Risk Assessment for Acute Exposure to Fludioxonil
Population Subgroup	aPAD (mg/ kg)	% aPAD (Food)	Surface Water EEC (ppb)	GroundWater EEC (ppb)	Acute DWLOC (ppb)
Female 13-49 years old	1.0	0.13	132	0.11	26,000

Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fludioxonil
Population Subgroup	cPAD mg/kg/day	% cPAD (Food)	Surface Water EEC (ppb)	GroundWater EEC (ppb)	Acute 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

Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Fludioxonil
Population Subgroup	Aggregate MOE (Food + Residential)	Aggregate Level of Concern (LOC)	Surface Water EEC (ppb)	GroundWater EEC (ppb)	Short-Term DWLOC (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	300	100	49	0.11	690

Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure to Fludioxonil
Population Subgroup	Aggregate MOE (Food + Residential)	Aggregate Level of Concern (LOC)	Surface Water EEC (ppb)	GroundWater EEC (ppb)	Intermediate-Term DWLOC (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