[Federal Register Volume 68, Number 175 (Wednesday, September 10, 2003)]
[Rules and Regulations]
[Pages 53297-53304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23054]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0244; FRL-7322-7]


Trifloxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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: 
[email protected].

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:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] 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 (MOEcancer = 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: 
[email protected].

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 [email protected], 
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: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
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