Trifloxystrobin (IR-4). Sept 10, 2003. Pesticide Tolerances. Final Rule.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Trifloxystrobin (IR-4). September 10, 2003. Pesticide Tolerance. Final Rule.

http://www.epa.gov/fedrgstr/EPA-PEST/2003/September/Day-10/p23054.htm

[Federal Register: September 10, 2003 (Volume 68, Number 175)]
[Rules and Regulations]
[Page 53297-53304]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se03-10]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0244; FRL-7322-7]

Trifloxystrobin; Pesticide Tolerance

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

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

SUMMARY: This regulation establishes tolerances for combined residues
of trifloxystrobin in or on leaf petioles subgroup 4B; and vegetable,
root, except sugar beet, subgroup 1B, except radish. Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 10, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0244,
must be received on or before November 10, 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. 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-2003-0244. 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. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
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 March 5, 2003 (68 FR 10469) (FRL-7294-
5), 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
a pesticide petition (PP 3E6522) by IR-4, 681 U.S. Highway #1
South, New Brunswick, NJ 08902-3390. That notice included a summary of
the petition prepared by Bayer CropScience, the registrant. There were
no comments received on this petition.
The petition requested that 40 CFR 180.555 be amended by
establishing tolerances for combined residues of the fungicide,
trifloxystrobin, (benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-, methyl
ester) and the free form of its acid metabolite CGA-321113((E,E)-
methoxyimino-[2-[1-(3-trifluoromethylphenyl) ethylideneaminooxymethyl]
phenyl]acetic acid), in or on the

[[Page 53298]]

following commodities: Leaf petioles subgroup 4B at 2.0 parts per
million (ppm), and vegetable, root, except sugar beet, subgroup 1B,
except radish at 0.10 ppm. The petition was subsequently amended to
propose the tolerance for the leaf petioles subgroup 4B at 3.5 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 combined residues of
trifloxystrobin and the free form of its acid metabolite CGA-321113 on
leaf petioles subgroup 4B at 3.5 ppm, and vegetable, root, except sugar
beet, subgroup 1B, except radish at 0.10 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerances
follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by trifloxystrobin are
discussed in Unit III.A. of the final rule on trifloxystrobin, which
was published in the Federal Register of May 22, 2002 (67 FR 35915)
(FRL-7178-6).

B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
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 trifloxystrobin used for human risk assessment is shown
in Table 1 of this unit:

[[Page 53299]]

Table 1.--Summary of Toxicological Dose and Endpoints for Trifloxystrobin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk *Special FQPA SF and Study and Toxicological
Exposure Scenario Assessment, UF LOC for Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-49 only.... NOAEL = 250 mg/kg/day FQPA SF = 1X Developmental toxicity-
UF = 100 aPAD = aRfD / FQPA SF = Rat
Acute RfD = 2.5 mg/kg/ 2.5 mg/kg/day. LOAEL = 500 mg/kg/day,
day. based upon increased
fetal skeletal
anomalies
----------------------------------------------------------------------------------------
Acute dietary general population There were no appropriate toxicological effects attributable to a single
including infants and children. exposure (dose) observed in oral toxicity studies including maternal
effects in developmental studies in rats and rabbits. Therefore, a dose
and endpoint were not identified for this risk assessment
----------------------------------------------------------------------------------------
Chronic dietary all populations..... Parental NOAEL = 3.8 mg/ FQPA SF = 1X 2-generation
kg/day UF = 100 cPAD = cRfD / FQPA SF = reproduction study-Rat
Chronic RfD = 0.038 mg/ 0.038 mg/kg/day. LOAEL = 55.3 mg/kg/day,
kg/day. based upon decreases in
body weight, body
weight gains, reduced
food consumption and
histopathological
lesions in the liver,
kidneys and spleen
----------------------------------------------------------------------------------------
Short-Term Oral (1-30 days)......... Offspring NOAEL = 3.8 LOC for MOE = 100 2-Generation
Intermediate-Term Oral (1-6 months). mg/kg/day (Residential, includes reproduction study-Rat
the FQPA SF) LOAEL = 55.3 mg/kg/day,
based upon reduced pup
body weights during
lactation
----------------------------------------------------------------------------------------
Short-Term Dermal (1-30 days)....... Dermal study NOAEL = LOC for MOE = 100 28-Day dermal toxicity
Intermediate-term dermal (1-6 100 mg/kg/day (Residential, includes study-Rat
months). the FQPA SF) LOAEL = 1,000 mg/kg/day,
based upon increases in
mean absolute and
relative liver and
kidney weights
----------------------------------------------------------------------------------------
Long-term dermal (>6 months)........ Oral study NOAEL = 3.8 LOC for MOE = 100 2-Generation
mg/kg/day (dermal (Residential, includes reproduction study-Rat
absorption rate = 33%) the FQPA SF) LOAEL = 55.3 mg/kg/day,
based upon reduced pup
body weights during
lactation
----------------------------------------------------------------------------------------
Short-term inhalation (1-30 days)... Oral study NOAEL = 3.8 LOC for MOE = 100 2-Generation
Intermediate-Term Inhalation (1-6 mg/kg/day (inhalation (Residential, includes reproduction study-Rat
months). absorption rate = the FQPA SF) LOAEL = 55.3 mg/kg/day,
Long-Term Inhalation (> 6 months)... 100%) based upon reduced pup
body weights during
lactation
----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)... Trifloxystrobin is classified as ``Not Likely Human Carcinogen'' based on
the lack of evidence of carcinogenicity in mouse and rat cancer studies
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.555) for the residues of trifloxystrobin, in or
on a variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from trifloxystrobin 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. In conducting this acute dietary risk assessment EPA
used the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Data base (DEEM-FCID[reg]) which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 nationwide Continuing Surveys of Food Intake by Individuals
(CSFII) and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the acute exposure assessment:
The acute dietary exposure analysis for trifloxystrobin is a Tier I
assessment because no additional data were used to refine the analysis.
One hundred percent of proposed and registered crops are assumed
treated with trifloxystrobin (``100% CT''), and tolerance-level
residues were used in the analysis.
ii. Chronic exposure. In conducting this acute dietary risk
assessment EPA used the DEEM[reg]
software with the DEEM-FCID[reg]
which incorporates food consumption data as reported by respondents in
the USDA 1994-1996 and 1998 nationwide CSFII and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the chronic exposure assessment: The chronic dietary exposure
analysis for trifloxystrobin is a Tier I assessment because no
additional data were used to refine the analysis. One hundred percent
of proposed and registered crops are assumed treated with
trifloxystrobin, and tolerance-level residues were used in the
analysis.
iii. Cancer. The Agency determined that trifloxystrobin should be
classified as a ``Not Likely Human Carcinogen.''
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for trifloxystrobin in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates

[[Page 53300]]

are made by reliance on simulation or modeling taking into account data
on the physical characteristics of trifloxystrobin.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The 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 I model) before using PRZM/EXAMS (a Tier II 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 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
LOC.
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 trifloxystrobin they are
further discussed in the aggregate risk sections in Unit III.E.
Trifloxystrobin is immobile, and degrades rapidly in soil and
aquatic environments to the primary isomer, CGA-321113. EECs were
calculated for total trifloxystrobin residues (parent trifloxystrobin
plus metabolites) using the FIRST model for surface water and the SCI-
GROW model for ground water. EPA's interim method for drinking water
estimates for pesticides used in rice paddies was also used to generate
surface water EECs.
Surface water concentrations for total trifloxystrobin residues are
92 parts per billion (ppb) for the peak value (acute) and 50 ppb for
the chronic value using the FIRST model for terrestrial uses
(turfgrass). To estimate surface water concentrations for use on rice,
an interim rice paddy model was used. For surface water concentrations
from treated rice, the acute estimate for the parent is 48 ppb, and the
chronic estimate for the total parent plus degradate is 140 ppb. The
rice estimate is considered to be an overestimate of the true value
found in the environment due to the assumptions used in the drinking
water model for rice. Further, EPA considers the turfgrass estimate to
be a more realistic estimate of drinking water residues. The ground
water screening concentration used for both acute and chronic
assessments is 3.4 ppb. These values represent upper-bound estimates of
the concentrations of total residues of trifloxystrobin that might be
found in surface water and ground water from uses on turfgrass at the
maximum application rate.
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).
Trifloxystrobin is currently registered for use on the following
residential non-dietary sites: Turfgrass and ornamental
(CompassTM). Postapplication exposures from various
activities following lawn treatment are considered to be the most
common and significant in residential settings. There is potential for
dermal exposure to adults and children and oral exposure to children
during postapplication activities. Four postapplication exposure
scenarios resulting from lawn treatment were assessed, as follows: (1)
Dermal exposure from pesticide residues on lawns, (2) incidental non-
dietary ingestion of pesticide residues on lawns from hand- to-mouth
transfer, (3) incidental non-dietary ingestion of residues from object-
to mouth activities (pesticide-treated turfgrass), and (4) incidental
non-dietary ingestion of soil from pesticide-treated residential areas.
Exposure via incidental non-dietary ingestion involving plant material
may occur but is considered negligible. Since the application of
trifloxystrobin on turf grass and ornamental is limited to certified
pest control operators, an assessment of dermal or inhalation exposure
for residential handlers was not performed.
The MOE for adult dermal risk from postapplication exposure is
1,300 and 800 for children. Children's risk from oral exposures range
from 1,600 to 220,000. When incidental oral exposure from all possible
residential sources are combined (ingestion of residues on turfgrass
from hand-to-mouth activities, mouthing turfgrass and eating soil), the
result is an MOE of 1,100. Therefore, postapplication exposure and risk
estimates for adults and children are considered to be below EPA's LOC.
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 trifloxystrobin 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
trifloxystrobin and any other substances and trifloxystrobin 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 trifloxystrobin 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

[[Page 53301]]

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. There is no indication of
increased susceptibility of rat or rabbits to trifloxystrobin.
3. Conclusion. There is a complete toxicity data base for
trifloxystrobin 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:
i. There is no indication of increased susceptibility of rat or
rabbits to trifloxystrobin. In the developmental and reproduction
toxicity studies, effects in the fetuses/offspring were observed only
at or above treatment levels which resulted in evidence of parental
toxicity.
ii. The Agency determined that a developmental neurotoxicity study
in rats is not required.
iii. Although an acute neurotoxicity study is required (the
submitted study was unacceptable), the lack of an acute neurotoxicity
study does not impact EPA's ability to make an FQPA SF decision.
iv. The acute and chronic dietary food exposure assessments utilize
existing and proposed tolerance level residues and 100% crop treated
information for all commodities. By using these screening-level
assessments, actual exposures/risks will not be underestimated.
v. The exposure assessments will not underestimate the potential
dietary (food and drinking water) or non-dietary exposures for infants
and children from the use of trifloxystrobin.
vi. The dietary drinking water assessment utilizes water
concentration values generated by model and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations which are not
likely to be exceeded.
vii. The residential postapplication assessment is based upon the
residential Standard Operating Procedures (SOPs). The assessment is
based upon surrogate study data. These data are reliable and are not
expected to underestimate risk to adults or children. The residential
SOPs are based upon reasonable ``worst-case'' assumptions and are not
expected to underestimate risk.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 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, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA 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, EPA 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
trifloxystrobin will occupy <1% of the aPAD for females 13-49 years
old. An acute dietary endpoint for the general population including
infants and children was not identified. In addition, there is
potential for acute dietary exposure to trifloxystrobin 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
2 of this unit:

Table 2.--Aggregate Risk Assessment for Acute Exposure to Trifloxystrobin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old)...................... 2.5 <1 92 turf 3.4 75,000
48 rice
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
trifloxystrobin from food will utilize 14% of the cPAD for the U.S.
population, 54% of the cPAD for children 1-2 years old, 10% of the cPAD
for females 13-49 years old, and 10% of the cPAD for adults 50+ years
old. Based on the use pattern, chronic residential exposure to residues
of trifloxystrobin is not expected. In addition, there is potential for
chronic dietary exposure to trifloxystrobin in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in Table 3 of this unit:

[[Page 53302]]

Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Trifloxystrobin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................ 0.038 14 140 rice 3.4 1,100
50 turf
---------------------------------------------------------------------------
Children (1-2 years old)....................... 0.038 54 140 rice 3.4 170
50 turf
---------------------------------------------------------------------------
Females (13-49 years old)...................... 0.038 10 140 rice 3.4 1,000
50 turf
---------------------------------------------------------------------------
Adults (50+ years old)......................... 0.038 10 140 rice 3.4 1,200
50 turf
----------------------------------------------------------------------------------------------------------------

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). Trifloxystrobin 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 trifloxystrobin.
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 690 for the U.S. Population; 154
for children 1-2 years old; 970 for females 13-49 years old; and 950
for adults 50+ years old. These aggregate MOEs do not exceed the
Agency's LOC for aggregate exposure to food and residential uses. In
addition, short-term DWLOCs were calculated and compared to the EECs
for chronic exposure of trifloxystrobin in ground water and surface
water. After calculating DWLOCs and comparing them to the EECs for
surface water and ground water, EPA does not expect short-term
aggregate exposure to exceed the Agency's LOC, as shown in Table 4 of
this unit:

Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Trifloxystrobin
----------------------------------------------------------------------------------------------------------------
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............................... 690 100 140 rice 3.4 1,100
50 turf
---------------------------------------------------------------------------
Children 1-2 years old........................ 154 100 140 rice 3.4 130
50 turf
---------------------------------------------------------------------------
Females 13-50 years old....................... 970 100 140 rice 3.4 1,000
50 turf
---------------------------------------------------------------------------
Adults 50+ years old.......................... 950 100 140 rice 3.4 1,200
50 turf
----------------------------------------------------------------------------------------------------------------

4. Intermediate-term risk. The intermediate-term aggregate risk
assessment estimates risks likely to result from 1 to 6 months of
exposure (30 to 180 days) to trifloxystrobin residues from food,
drinking water, and residential pesticide uses. Intermediate-term
exposure to trifloxystrobin is not expected to occur based on the
chemical's short soil half-life (about 2 days). Therefore, no
intermediate-term aggregate risk is expected.
5. Aggregate cancer risk for U.S. population. Trifloxystrobin is
not expected to pose a cancer risk to humans.
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 trifloxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (gas chromatography method using
nitrogen/phosphorus detector) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.

B. International Residue Limits

There are no Codex, Canadian, or Mexican maximum residue limits
established for trifloxystrobin. Harmonization is thus not an issue at
this time.

V. Conclusion

Therefore, the tolerances are established for combined residues of
trifloxystrobin, (benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-, methyl
ester) and the free form of its acid metabolite CGA-321113((E,E)-
methoxyimino-[2-[1-(3-trifluoromethyl phenyl) ethylideneaminooxymethyl]
phenyl]acetic acid) in or on leaf petioles subgroup 4B at 3.5 ppm, and
vegetable, root, except sugar beet, subgroup 1B, except radish at 0.10
ppm.

[[Page 53303]]

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.

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-2003-0244 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
10, 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-2003-0244, 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

[[Page 53304]]

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 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: August 29, 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 180.555 is amended by adding commodities to the table in
paragraph (a) to read as follows:

Sec. 180.555 Trifloxystrobin; tolerances for residues.

(a) * * *

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Leaf petioles subgroup 4B............................ 3.5
* * * * *
Vegetable, root, except sugar beet, subgroup 1B, 0.10
except radish.......................................
* * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 03-23054 Filed 9-9-03; 8:45 am]
BILLING CODE 6560-50-S