Fludioxonil. Sept 12, 2001. Pesticide tolerances for Emergency Exemptions; for residues in or on pomegranates at 5 ppm. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Fludioxonil. September 12, 2001. Pesticide Tolerances for Emergency Exemptions; for residues in or on pomegranates at 5 ppm. Final Rule. Federal Register

http://www.epa.gov/fedrgstr/EPA-PEST/2001/September/Day-12/p22524.htm

[Federal Register: September 12, 2001 (Volume 66, Number 177)]
[Rules and Regulations]
[Page 47403-47410]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se01-11]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301161; FRL-6797-5]
RIN 2070-AB78

Fludioxonil; Pesticide Tolerances for Emergency Exemptions

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

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SUMMARY: This regulation establishes a time-limited tolerance for
residues of fludioxonil (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-
pyrrole-3-carbonitrile) in or on pomegranates. This action is in
response to EPA's granting of an emergency exemption under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing
use of the pesticide on pomegranates. This regulation establishes a
maximum permissible level for residues of fludioxonil in this food
commodity. The tolerance will expire and is revoked on June 30, 2003.

DATES: This regulation is effective September 12, 2001. Objections and
requests for hearings, identified by docket control number OPP-301161,
must be received by EPA on or before November 13, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301161 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9367; and e-mail address:
ertman.andrew@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 categories and entities may include, but are not
limited to:

------------------------------------------------------------------------
Examples of
Categories NAICS codes Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------

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

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

1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://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_180/Title_40/40cfr180_00.html, a beta site currently
under development.
2.In person. The Agency has established an official record for this
action under docket control number OPP-301161. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA,
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for residues of the fungicide
fludioxonil, (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile), in or on pomegranates at 5.0 parts per million (ppm).
This tolerance will expire and is revoked on June 30, 2003. EPA will
publish a document in the Federal Register to remove the revoked
tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable

[[Page 47404]]

certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue. . . .''
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that ``emergency conditions
exist which require such exemption.'' This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Fludioxonil on Pomegranates and FFDCA
Tolerances

Losses due to Botrytis have increased dramatically over the course
of the last 2 years for pomegranate growers and packers. In the 1999
and 2000 packing seasons, growers and packers experienced approximately
a 20% loss of fruit after packing for the fresh market due to Botrytis
mold and had never experienced such frequency of decay before.
Previously, they had been able to hold pomegranates for 2 to 3 months,
but now have difficulties storing much beyond 2 to 3 weeks. EPA has
authorized under FIFRA section 18 the use of fludioxonil on
pomegranates for control of gray mold (Botrytis cinerea) in California.
After having reviewed the submission, EPA concurs that emergency
conditions exist for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of fludioxonil in or on
pomegranates. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on June 30, 2003, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on pomegranates after that date will not be
unlawful, provided the pesticide is applied in a manner that was lawful
under FIFRA, and the residues do not exceed a level that was authorized
by this tolerance at the time of that application. EPA will take action
to revoke this tolerance earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether fludioxonil
meets EPA's registration requirements for use on pomegranates or
whether a permanent tolerance for this use would be appropriate. Under
these circumstances, EPA does not believe that this tolerance serves as
a basis for registration of fludioxonil by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any State other than California to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
fludioxonil, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
fludioxonil and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of fludioxonil in or on pomegranates at 5.0 ppm. EPA's
assessment of the dietary exposures and risks associated with
establishing the tolerance follows.

A. 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 endpoint. 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.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (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 shown in
the following Table 1:

[[Page 47405]]

Table 1.--Summary of Toxicological Dose and Endpoints for Fludioxonil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk FQPA SF and LOC for Study and Toxicological
Exposure Scenario Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of NOAEL = 100 mg/kg/day FQPA SF = 1X Developmental toxicity
age) UF = 100............... aPAD = acute RfD study - rat
Acute RfD = 1.0 mg/kg/ FQPA SF. Developmental LOAEL =
day. = 1.0 mg/kg/day........ 1,000 mg/kg/day based
on increased incidence
of fetuses and litters
with dilated renal
pelvis and dilated
ureter
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL = 3.3 mg/kg/day FQPA SF = 1X 1 Year chronic toxicity
UF = 100............... cPAD = chronic RfD study - dog LOAEL =
Chronic RfD = 0.03 mg/ FQPA SF. 35.5 mg/kg/day based
kg/day. = 0.03 mg/kg/day....... on decreased weight
gain in female dogs
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1-7 days) none No systemic toxicity Endpoint was not
(occupational/residential) was seen at the limit selected
dose (1,000 mg/kg/day)
in the 28-day dermal
toxicity study in
rats. This risk
assessment is not
required.
----------------------------------------------------------------------------------------------------------------
Intermediate-term (1 week - several Oral study NOAEL= 64 mg/ LOC for MOE = 100 13 Week Oral Feeding
months) dermal (occupational/ kg/day (dermal (Occupational) Study - rat Systemic
residential) penetration = 40%) LOC for MOE = 100 LOAEL = 428 mg/kg/day
(Residential). based on decreased
body weight gain in
both sexes, chronic
nephropathy in males,
and centrilobular
hepatocyte hypertrophy
in females
----------------------------------------------------------------------------------------------------------------
Long-term (several months-lifetime) Oral study NOAEL = 3.3 LOC for MOE = 100 1 Year chronic toxicity
dermal (occupational/residential) mg/kg/day (dermal (Occupational) study - dog LOAEL =
penetration = 40%) LOC for MOE = 100 35.5 mg/kg/day based
(Residential). on decreased weight
gain in female dogs
----------------------------------------------------------------------------------------------------------------
Short-term (1-7 Days) inhalation NOAEL = 64 mg/kg/day LOC for MOE = 100 13 Week Oral Feeding
(occupational/residential) (inhalation absorption (Occupational) Study - rat Systemic
rate = 100%) LOC for MOE = 100 LOAEL = 428 mg/kg/day
(Residential). based on decreased
body weight gain in
both sexes, chronic
nephropathy in males,
and centrilobular
hepatocyte hypertrophy
in females
----------------------------------------------------------------------------------------------------------------
Intermediate-term (1 week - several NOAEL = 64 mg/kg/day LOC for MOE = 100 13 Week Oral Feeding
months) inhalation (occupational/ (inhalation absorption (Occupational) Study - rat Systemic
residential) rate = 100%) LOC for MOE = 100 LOAEL = 428 mg/kg/day
(Residential). based on decreased
body weight gain in
both sexes, chronic
nephropathy in males,
and centrilobular
hepatocyte hypertrophy
in females
----------------------------------------------------------------------------------------------------------------
Long-term (several months-lifetime) NOAEL = 3.3 mg/kg/day LOC for MOE = 100 1 Year chronic toxicity
inhalation (occupational/ (inhalation absorption (Occupational) study - dog LOAEL =
residential)- rate = 100%) LOC for MOE = 100 35.5 mg/kg/day based
(Residential). on decreased weight
gain in female dogs
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) ``Group D''- not Not applicable Acceptable oral rat and
classifiable as to mouse carcinogenicity
human carcinogenicity studies; evidence of
via relevant routes of carcinogenic and
exposure mutagenic potential.
----------------------------------------------------------------------------------------------------------------

B. 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. Risk assessments were
conducted by EPA to assess dietary exposures from fludioxonil in food
as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\)
analysis evaluated the individual food

[[Page 47406]]

consumption as reported by respondents in the USDA 1989-1992 nationwide
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the acute exposure assessments: For the acute
DEEM\TM\ analysis (version 7.72), published and proposed tolerances
level residues were used. Default processing factors and 100% crop
treated (CT) were assumed for all commodities.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment, the DEEM\TM\ analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: For the
chronic DEEM\TM\ analysis (version 7.73), published and proposed
tolerances level residues were used. Default processing factors and
100% CT were assumed for all commodities.
iii. Cancer. Fludioxonil has been put in ``Group D''- not
classifiable as to human carcinogenicity via relevant routes of
exposure and therefore this risk assessment is not required.
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 Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in ground water. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to fludioxonil they are further
discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models, the EECs of fludioxonil
for acute exposures are estimated to be 46 parts per billion (ppb) for
surface water and 0.35 ppb for ground water. The EECs for chronic
exposures are estimated to be 11 ppb for surface water and 0.35 ppb for
ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Fludioxonil is not currently registered for residential (outdoor,
non-food) uses, however, the registrant is seeking registration for the
use of fludioxonil by commercial applicators on residential lawns. For
adults, post-application exposures may result from dermal contact with
treated turf. For toddlers, dermal and non-dietary oral post-
application exposures may result from dermal contact with treated turf
as well as hand-to-mouth transfer of residues from turfgrass.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether fludioxonil has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
fludioxonil does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that fludioxonil has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

1. Safety factor for infants and children--i. In general. FFDCA
section 408 provides that EPA shall apply an additional tenfold margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
data base on toxicity and exposure unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans.
ii. Developmental toxicity studies. In the rat developmental study,
the maternal (systemic) NOAEL was 100 mg/kg/day, based on reduction in
mean body weight gain in dams during gestation period at the LOAEL of
1,000 mg/kg/day. The developmental (fetal) NOAEL was 100 mg/kg/day,
based on increased fetal and litter incidence of dilated renal pelvis
and dilated ureter at the LOAEL of 1,000 mg/kg/day. In the rabbit
developmental toxicity study, the maternal (systemic) NOAEL was 10 mg/
kg/day, based on decreased body weight gains and food efficiency at the
LOAEL of 100 mg/kg/day. The developmental (pup) NOAEL was 300 mg/kg/
day, the highest dose tested.
iii. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the parental (systemic) NOAEL was 22.13 mg/kg/
day (males)

[[Page 47407]]

and 24.24 mg/kg/day (females), based on clinical signs and decreased
body weight, body weight gain and food consumption at the LOAEL of
221.6 mg/kg/day (males) and 249.7 mg/kg/day (females). The
reproductive/developmental (pup) NOAEL was 22.13 mg/kg/day (males) and
24.24 mg/kg/day (females), based on reduced pup weights at the LOAEL of
221.6 mg/kg/day (males) and 249.7 mg/kg/day (females).
iv. Prenatal and postnatal sensitivity. The toxicological data base
for evaluating prenatal and postnatal toxicity for fludioxonil is
complete with respect to current data requirements. There are no
prenatal or postnatal toxicity concerns for infants and children, based
on the results of the rat and rabbit developmental toxicity studies and
the 2-generation rat reproductive toxicity study.
v. Conclusion. EPA concludes that reliable data support the removal
of the additional uncertainty factor; the standard hundred-fold
uncertainty factor is adequate to protect the safety of infants and
children.

D. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + chronic non-dietary, non-occupational exposure).
This allowable exposure through drinking water is used to calculate a
DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to fludioxonil 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
fludioxonil on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. Because the acute endpoint applies to one population
subgroup, females (13-50 years old), the acute risk assessment was
conducted only for this group. An acute dose and endpoint were not
selected for the U.S. population (including infants and children)
because there were no effects of concern observed in oral toxicology
studies, including maternal toxicity in the developmental toxicity
studies in rats and rabbits, that are attributable to a single exposure
(dose).
Using the exposure assumptions discussed in this unit for acute
exposure, the acute dietary exposure from food to fludioxonil will
occupy 0.7% of the aPAD for females (13-50 years old). In addition,
despite the potential for acute dietary exposure to fludioxonil in
drinking water, after calculating DWLOCs and comparing them to
conservative model estimated environmental concentrations of
fludioxonil in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to Fludioxonil
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 1.0 0.7 46 0.35 30,000
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fludioxonil from food will utilize 5.5% of the cPAD for the U.S.
population, 22% of the cPAD for all infants <1 year old) and 14% of the
cPAD for children 1 to 6 years old. Based on the use pattern, chronic
residential exposure to residues of fludioxonil is not expected. In
addition, despite the potential for chronic dietary exposure to
fludioxonil in drinking water, after calculating DWLOCs and comparing
them to conservative model of EECs fludioxonil in surface and ground
water, EPA does not expect the aggregate exposure to exceed 100% of the
cPAD, as shown in the following Table 3:

Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fludioxonil
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.03 5.5 11 0.35 990
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old) 0.03 22 11 0.35 230
----------------------------------------------------------------------------------------------------------------
Children (1 to 6 years old) 0.03 14 11 0.35 260
----------------------------------------------------------------------------------------------------------------

[[Page 47408]]

Children (7 to 12 years old) 0.03 8.2 11 0.35 280
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.03 3.8 11 0.35 870
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old) 0.03 3.2 11 0.35 1,000
----------------------------------------------------------------------------------------------------------------
Males (20+ years old) 0.03 3.5 11 0.35 1,000
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old) 0.03 5.1 11 0.35 1,000
----------------------------------------------------------------------------------------------------------------

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 not currently registered for residential (outdoor,
non-food) uses, however, the registrant is seeking registration for the
use of fludioxonil by commercial applicators on residential lawns. For
adults, post-application exposures may result from dermal contact with
treated turf. For toddlers, dermal and non-dietary oral post-
application exposures may result from dermal contact with treated turf
as well as hand-to-mouth transfer of residues from turfgrass.
For the U.S. population and all infants (<1 year old) population
subgroups, the total food and residential short-term aggregate MOEs are
1,900 and 995, respectively. As these values are greater than 100, the
short-term food and residential aggregate risks for the U.S. population
and all infants (<1 year old) population subgroups are below the
Agency's level of concern. Because the all infants (<1 year old)
population subgroup has the highest exposure to fludioxonil residues
from dietary sources, including all infants (<1 year old) is adequately
protective of the children 1-6 and 7-12 years old population subgroups.
In addition, short-term DWLOCs were calculated and compared to the
EECs for chronic exposure of fludioxonil in ground water 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 the
following Table 4:

Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Fludioxonil
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 1,900 100 11 0.35 21,000
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old) 995 100 11 0.35 5,800
----------------------------------------------------------------------------------------------------------------

4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Though residential exposure could occur with the use of
fludioxonil, no residential exposure scenarios for fludioxonil are
expected to have intermediate-term durations. Therefore, an
intermediate-term aggregate risk assessment is not required.
5. Aggregate cancer risk for U.S. population. Fludioxonil has been
put in ``Group D''- not classifiable as to human carcinogenicity via
relevant routes of exposure and therefore this risk assessment is not
required.
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.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (example - gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

B. International Residue Limits

There are no CODEX, Canadian, or Mexican Maximum Residue Limits
(MRLs) for fludioxonil on pomegranates.

VI. Conclusion

Therefore, the tolerance is established for residues of
fludioxonil, (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile), in or on pomegranates at 5.0 ppm.

VII. Objections and Hearing Requests

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

[[Page 47409]]

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

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301161 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
13, 2001.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at 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.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3.Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket control number OPP-301161, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: 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).

VIII. Regulatory Assessment Requirements

This final rule establishes a time-limited tolerance under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
This final rule does not contain any information collections subject to
OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any 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 FIFRA section 18 exemption under FFDCA
section 408, such as the [tolerance/exemption]
in this final rule, do
not require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
In addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of

[[Page 47410]]

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

IX. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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

Dated: August 14, 2001.
Peter Caulkins, Acting
Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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

Sec. 180.516 Fludioxonil; tolerances for residues.

* * * * *
(b) * * *

------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
* * * * *
Pomegranate 5.0 6/30/03
* * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-22524 Filed 9-11-01; 8:45 am]
BILLING CODE 6560-50-S

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Last Updated: Sep 20 18:12:50 2001
URL: http://www.epa.gov/fedrgstr/EPA-PEST/2001/September/Day-12/p22524.htm