Fludioxonil. July 3, 2003. Pesticide tolerances. Final Rule.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Fludioxonil (IR-4). July 3, 2003. Pesticide Tolerance. Final Rule. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2003/July/Day-03/p16931.htm

[Federal Register: July 3, 2003 (Volume 68, Number 128)]
[Rules and Regulations]
[Page 39846-39853]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jy03-10]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0135; FRL-7313-7]

Fludioxonil; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

-----------------------------------------------------------------------

[[Page 39847]]

SUMMARY: This regulation establishes tolerances for residues of
fludioxonil in or on Brassica, head and stem, subgroup 5A; brassica,
leafy greens, subgroup 5B; carrot; herb, fresh, subgroup 19A; herb,
dried, subgroup 19A; longan; lychee; pulasan; rambutan; spanish lime;
and turnip, greens. 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). This regulation also deletes brassica, leafy, group at 0.01
parts per million (ppm), which is replaced with brassica, leafy greens,
subgroup 5B at 10 ppm, and brassica, head and stem, subgroup 5A at 2.0
ppm.

DATES: This regulation is effective July 3, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0135,
must be received on or before September 2, 2003.

ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you an are
agricultural producer, food manufacturer, and pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
¥ Crop production (NAICS 111)
¥ Animal production (NAICS 112)
¥ Food manufacturing (NAICS 311)
¥ Pesticide manufacturing (NAICS 32532)
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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in. 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 Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0135. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2,
1921 Jefferson Davis Hwy., 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.
2. Electronic access. 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 http://www.access.
gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html,
a beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.

II. Background and Statutory Findings

In the Federal Register of April 2, 2003 (68 FR 16046) (FRL-7299-
6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
pesticide petitions (PP 2E6448, 2E6462, 2E6486, and 3E6526) by IR-4,
681 US Highway #1 South, New Brunswick, NJ 08902-3390. That
notice included a summary of the petitions prepared by Syngenta Crop
Protection, Inc., the registrant.
The petitions requested that 40 CFR 180.516 be amended by
establishing tolerances for residues of the fungicide fludioxonil, (4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile), in or
on the following commodities: Brassica, head and stem, subgroup 5A at
1.5 ppm; brassica, leafy greens, subgroup 5B at 9.0 ppm; carrot at 0.5
ppm; herb subgroup 19A at 33 ppm; longan, lychee, pulasan, rambutan,
and spanish lime at 2.0 ppm; and turnip, greens at 9.0 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the 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 the 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 the 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 the 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, consistent with section
408(b)(2) of the FFDCA, for tolerances for residues of fludioxonil on
Brassica, head and stem, subgroup 5A at 2.0 ppm; brassica, leafy
greens, subgroup 5B at 10 ppm; carrot at 0.75 ppm; herb, fresh,
subgroup 19A at 10 ppm; herb, dried, subgroup 19A at

[[Page 39848]]

65 ppm; longan, lychee, pulasan, rambutan, and spanish lime at 1.0 ppm;
and turnip, greens at 10 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerances follow.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by fludioxonil are
discussed in Unit III.A. of the final rule on fludioxonil, which
published in the Federal Register of December 29, 2000 (65 FR 82927)
(FRL-6760-9), and August 2, 2002 (67 FR 50354) (FRL-7188-7).

B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factors
(SF) is retained due to concerns unique to the FQPA, this additional
factor is applied to the RfD by dividing the RfD by such additional
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is
a modification of the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOE _cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for fludioxonil used for human risk assessment is Unit
III.B.of the final rule on fludioxonil, which published in the Federal
Register of December 29, 2000 (65 FR 82927) and August 2, 2002 (67 FR
50354).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.516) for the residues of fludioxonil, in or on
a variety of raw agricultural commodities. Fludioxonil is registered
for foliar application (grape, strawberry, green onion, dry bulb onion,
bushberry, caneberry, juneberry, longonberry, pistachio, salal, and
watercress), post-harvest application (stone fruit), and for seed
treatment purposes (numerous crops) with tolerances for residues of
fludioxonil ranging from 0.01-7.0 ppm (40 CFR 180.516(a)). A section 18
registration is also established for post-harvest application to
pomegranate with a tolerance for residues of fludioxonil of 5.0 ppm (40
CFR 180.516(b)). Currently there are no tolerances established for
residues of fludioxonil in/on livestock. Risk assessments were
conducted by EPA to assess dietary exposures from fludioxonil in food
as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure. The Dietary Exposure Evaluation Model
(DEEMTM) analysis evaluated the individual food consumption
as reported by respondents in the USDA 1994-1996, 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: The acute
analysis assumed tolerance level residues, 100% crop treatment (CT),
and DEEM (ver. 7.76) default processing factors for all registered/
proposed commodities (tier 1).
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM analysis evaluated the individual food consumption
as reported by respondents in the USDA 1994-1996, 1998 nationwide CSFII
and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the chronic exposure assessments:
The chronic analysis assumed tolerance level residues, 100% CT, and
DEEM (ver. 7.76) default processing factors for all registered/proposed
commodities (tier 1).
iii. Cancer. EPA's Cancer Peer Review Committee (CPRC) classified
fludioxonil as a Group D - not classifiable as to human
carcinogenicity.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fludioxonil in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of fludioxonil.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The Screening Concentration in Ground Water (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. FIRST and PRZM/EXAMS incorporate an
index reservoir environment, and 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

[[Page 39849]]

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) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to fludioxonil they are further
discussed in the aggregate risk sections E.
There are no ground or surface water monitoring data available for
fludioxonil. Tier I models, FIRST and SCI-GROW, were used to derive the
surface water and ground water EECs, respectively. According to the
proposed label information, the maximum application rate for
fludioxonil is 4 lbs active ingredient (ai)/Acre/year on turf (maximum
single application rate of 0.675 lbs ai/Acre). Application to turf
provided the high exposure scenario; therefore, the drinking water EECs
were derived from the use on turf.
Ground water. SCI-GROW provides a ground water screening exposure
value for use in determining the potential risk to human health from
drinking ground water contaminated with pesticides. The ground water
modeling generated a ground water EEC of 0.11 parts per billion (ppb)
for fludioxonil.
Surface water. The predicted index reservoir concentrations for
total residues using FIRST for the proposed use of fludioxonil
generated acute and chronic surface water EECs of 132 ppb and 49 ppb,
respectively.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Fludioxonil is currently registered for use on the following
residential non-dietary sites: Based on the registered labels,
fludioxonil can be used as a protectant fungicide for control of
certain diseases of turfgrass and certain foliar, stem and root
diseases in ornamentals in residential and commercial landscapes. The
risk assessment was conducted using the following residential exposure
assumptions: Short- and intermediate-term dermal exposures (adults and
toddlers), and short- and intermediate-term incidental ingestion
exposures (toddlers).
Fludioxonil is registered for uses on residential lawns and
ornamentals; however, it is restricted to professional applicators
only. As such, no residential handler (i.e., applicator) exposures are
anticipated.
EPA did not select short- or intermediate-term dermal endpoints;
subsequently, no residential post-application dermal assessment is
included. Additionally, due to the low vapor pressure of fludioxonil,
no significant post-application inhalation exposure is anticipated. As
a result, there are no significant post-application exposures
anticipated from treated landscape ornamentals. Therefore, the
residential component of this assessment only includes a post-
application assessment for toddler incidental ingestion exposures
related to residential lawn applications.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
EPA does not have, at this time, available data to determine
whether fludioxonil has a common mechanism of toxicity with other
substances. 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 Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/
cumulative/.

D. Safety Factor for Infants and Children

1. In general. Section 408 of the 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 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.
2. Prenatal and postnatal sensitivity. The developmental and
reproductive toxicity data did not indicate increased quantitative or
qualitative susceptibility of rats or rabbits to in utero and/or
postnatal exposure.
3. Conclusion. There is a complete toxicity data base for
fludioxonil and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X 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 the model estimates of
a pesticide's concentration in water EECs. DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure

[[Page 39850]]

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 milligram/kilogram (mg/kg/day) = cPAD - (average
food + residential exposure)). This allowable exposure through drinking
water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 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 1% of the aPAD for females 13-49 years old.
Fludioxonil is not expected to pose an acute dietary risk for the
general population (including children and infants). 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 for females 13-49 years old, as shown in Table
1 of this unit:

Table 1.--Aggregate Risk Assessment for Acute Exposure to fludioxonil
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 1.0 1 132 0.11 30,000
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fludioxonil from food will utilize 11% of the cPAD for the U.S.
population, 30% of the cPAD for all infants (<1 year old) and 38% of
the cPAD for children 1-2 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 2 of
this unit:

Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to fludioxonil
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.3 11 49 0.11 940
----------------------------------------------------------------------------------------
All infants (<1 year old) 0.3 30 49 0.11 210
----------------------------------------------------------------------------------------
Children (1-2 years old) 0.3 38 49 0.11 190
----------------------------------------------------------------------------------------
Females (13-49 years old) 0.3 8 49 0.11 830
----------------------------------------------------------------------------------------------------------------

3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Fludioxonil is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for fludioxonil.
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 460 for all infants < 1 year
old; 410 for children 1-2 years old; 490 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 3 of this unit:

[[Page 39851]]

Table 3.--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) 460 100 49 0.11 780
----------------------------------------------------------------------------------------
Children (1-2 years old) 410 100 49 0.11 760
----------------------------------------------------------------------------------------
Children (3-5 years old) 490 100 49 0.11 800
----------------------------------------------------------------------------------------------------------------

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 200 for
all infants <1 year old; 180 for children 1-2 years old; and 220 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 4 of this unit:

Table 4.--Aggregate Risk Assessment for Intermediate-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) 200 100 49 0.11 130
----------------------------------------------------------------------------------------
Children (1-2 years old) 180 100 49 0.11 140
----------------------------------------------------------------------------------------
Children (3-5 years old) 220 100 49 0.11 180
----------------------------------------------------------------------------------------------------------------

5. Aggregate cancer risk for U.S. population. EPA's Cancer Peer
Review Committee (CPRC) classified fludioxonil as a Group D - not
classifiable as to human carcinogenicity.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to fludioxonil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The methods used in the field trial studies were similar to a
method validated by the Analytical Chemistry Branch. Since adequate
method validation and concurrent recoveries were attained in the field
trial studies, EPA concludes that the ACB validated method is
appropriate for enforcement of the tolerances associated with this
petition. No further validation is necessary.
Adequate enforcement methodology (high pressure liquid
chromatography method AG-597B) 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

Canada, Codex, and Mexico do not have maximum residue limits (MRLs)
for residues of fludioxonil in/on the subject crops. Therefore,
harmonization is not an issue.

V. Conclusion

Therefore, the tolerances are established for residues of
fludioxonil, (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile) in or on brassica, head and stem, subgroup 5A at 2.0 ppm;
brassica, leafy greens, subgroup 5B at 10 ppm; carrot at 0.75 ppm;
herb, fresh, subgroup 19A at 10 ppm; herb, dried, subgroup 19A at 65
ppm; longan, lychee, pulasan, rambutan, and spanish lime at 1.0 ppm;
and turnip, greens at 10 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the 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 the FFDCA.
However, the period for filing objections is now 60 days, rather than
30 days.

[[Page 39852]]

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-2003-0135 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 September
2, 2003.
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 (1900C),
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 Rm. 104, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must

mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0135, 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 Unit I.B.1. 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 the
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 the 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

[[Page 39853]]

include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of the 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: June 25, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

¥ Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

¥ 2. Section 180.516 is amended by removing the entry for ``Vegetable,
brassica, leafy, group'' and by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec. 180.516 Fludioxonil; tolerances for residues.

(a) * * *

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A........... 2.0
Brassica, leafy greens, subgroup 5B............ 10
* * * * *
Carrot......................................... 0.75
* * * * *
Herb, dried, subgroup 19A...................... 65
Herb, fresh, subgroup 19A...................... 10
* * * * *
Longan......................................... 1.0
Lychee......................................... 1.0
* * * * *
Pulasan........................................ 1.0
* * * * *
Rambutan....................................... 1.0
* * * * *
Spanish lime................................... 1.0
* * * * *
Turnip, greens................................. 10
* * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 03-16931 Filed 7-2-03; 8:45 am]
BILLING CODE 6560-50-S