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Trifloxystrobin - Pesticide Tolerance 5/02

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0052; FRL-7178-6]
Trifloxystrobin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for trifloxystrobin
regulated as trifloxystrobin and the free form of its acid metabolite
CGA-321113 in or on fruit, stone, group; nut, tree, group; pistachio;
corn, field, grains; corn, field, forage; corn field stover; corn,
field, refined oil; corn, pop, grain; corn, pop, stover; rice, grain;
rice, hulls; rice, straw; citrus, dried pulp; citrus oil; fruit,
citrus, group; egg; poultry, fat; poultry, meat; and poultry, meat by
products. Bayer, Inc. requested these tolerances under the Federal
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection
Act of 1996.
DATES: This regulation is effective May 22, 2002. Objections and
requests for hearings, identified by docket control number OPP-2002-
0052, must be received by EPA on or before July 22, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION section. To ensure proper receipt by EPA, your objections
and hearing requests must identify docket control number OPP-2002-0052
in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: (703) 305-7740 and e-mail address: giles-
parker.cynthia@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
    You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under the section FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select "Laws and
Regulations", "Regulations and Proposed Rules" and then look up the
entry for this document under the "Federal Register--Environmental
Documents." You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml--00/Title--40/40cfr 180--00.html, a beta site
currently under development.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-2002-0052. The official
record consists of the documents specifically referenced in this
action, and other information related to this action, including any
information claimed as Confidential Business Information (CBI). This
official record includes the documents that are physically located in
the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall ι2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings
    In the Federal Register of November 14, 2001 (66 FR 57074) (FRL-
6806-6), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
announcing the filing of a pesticide petition (PP) 0F6121 for
tolerances by Bayer Corporation, 8400 Hawthorn Road, P.O. Box 4913,
Kansas City, MO 64121-0013. This notice included a summary of the
petition prepared by Bayer Corporation, the registrant. No comments
were received in response to the amendment.
    The petition requested that 40 CFR 180.555 be amended by
establishing tolerances for combined residues of the fungicide
trifloxystrobin and the free form of its acid metabolite CGA-321113, in
or on fruit, stone, group at 2 parts per million (ppm); nut, tree,
group at 0.05 ppm; pistachio at 0.05 ppm; corn, field, grains at 0.05
ppm; corn, field, forage at 0.05 ppm; corn, field, stover at 7 ppm;
corn, field, refined oil at 0.1 ppm; corn, pop, grain at 0.05 ppm;
corn, pop, stover at 7 ppm; rice, grain at 3.5 ppm; rice, hulls at 8
ppm; rice, straw at 7.5 ppm; citrus, dried pulp at 0.8 ppm; citrus, oil
at 7 ppm; fruit, citrus, group at 0.3 ppm; egg at 0.04 ppm; poultry,
fat; and poultry, meat; poultry, kidney; poultry, liver; and poultry,
meat by products at 0.05 ppm. Bayer, Inc. requested these tolerances
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is "safe." Section
408(b)(2)(A)(ii) defines "safe" to mean that "there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information." This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to "ensure that there is a reasonable 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 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), 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
trifloxystrobin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a tolerance for combined
residues of trifloxystrobin and the free form of its acid metabolite
CGA-321113 on fruit, stone, group at 2 ppm; nut, tree, group at 0.04
ppm; pistachio at 0.04 ppm; corn, field, grains at 0.05 ppm; corn,
field, forage at 0.2 ppm; corn, field, stover at 7 ppm; corn, field,
refined oil at 0.1 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover
at 7 ppm; rice, grain at 3.5 ppm; rice, hulls at 8 ppm; rice, straw at
7.5 ppm; citrus, dried pulp at 0.8 ppm; citrus oil at 30 ppm; fruit,
citrus, grroup at 0.3 ppm; egg at 0.04 ppm; poultry, fat at 0.04 ppm;
poultry, meat at 0.04 ppm; poultry, meat by products at 0.04 ppm. In
examining the data for corn field forage and citrus oil the Agency
found that the residue data supports a higher tolerance than was
proposed. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance 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
and the free form of its acid metabolite CGA-321113 are discussed below
as well as the no observed adverse effect level (NOAEL) and the lowest
observed adverse effect level (LOAEL) from the toxicity studies
reviewed.
    1. Subchronic-feeding study--rat. The No Observed Adverse Effects
Level (NOAEL) was 500 ppm (30.6-32.8 mg/kg/day). Decreased body weight,
hypertrophy of hepatocytes in males and pancreatic atrophy were
observed at the Lowest Observed Adverse Effects Level (LOAEL) of 2,000
ppm (127-133 mg/kg/day).
    2. Subchronic-feeding study--mouse. The NOAEL was 500 ppm (76.9-110
mg/kg/day). Increased liver weights and necrosis of hepatocytes were
observed at the LOAEL of 2,000 ppm (315-425 mg/kg/day).
    3. Subchronic-feeding study--dog. The NOAEL was 30 mg/kg/day.
Increased liver weight and hepatocyte hypertrophy in males were
observed at the LOAEL of 150 mg/kg/day.
    4. 28-day dermal toxicity study--rat. The NOAEL was 100 mg/kg/day.
Increased liver and kidney weight were observed at the LOAEL of 1,000
mg/kg/day.
    5. Developmental toxicity study--rat. The maternal NOAEL was 10 mg/
kg/day. Decreased body weight gain and food consumption were observed
at the maternal LOAEL of 100 mg/kg/day. The developmental NOAEL was
1,000 mg/kg/day. No developmental effects were observed. The
developmental LOAEL was equal to or greater than 1,000 mg/kg/day.
    6. Developmental toxicity study--rabbit. The maternal NOAEL was 10
mg/kg/day. Decreased mean body weights and decreased mean body weight
gain (compared to control), food consumption and efficiency were
observed at the maternal LOAEL of 50 mg/kg/day. The developmental NOAEL
was 250 mg/kg/day. Skeletal anomolies were observed at the
Developmental LOAEL of 500 mg/kg/day.
    7. Reproductive toxicity study--rat. The parental NOAEL was 50 ppm
(3.8 mg/kg/day). Decreased mean body weight and decreased mean weight
gain (compared to control), decreased food consumption, and increased
incidence of liver, kidney and spleen effects were observed at the
parental LOAEL of 750 ppm (55.3 mg/kg/day). The reproductive NOAEL was
1,500 ppm (110.6 mg/kg/day). The reproductive LOAEL was greater than
1,500 ppm (110.6 mg/kg/day).
    8. Chronic-feeding study--dog. The NOAEL was 5 mg/kg/day. Increased
clinical signs, increased liver weight and hepatocellular hypertrophy
were observed at the LOAEL of 50 mg/kg/day.
    9. Carcinogenicity study--mouse. The NOAEL was 300 ppm (39.4 mg/kg/
day). Liver effects were observed at the LOAEL of 1,000 ppm (131.1 mg/
kg/day).
    10. Chronic toxicity/carcinogenicity study--rat. The NOAEL was 250
ppm (9.81-11.37 mg/kg/day). Decreased mean body weight and decreased
mean body weight gain (compared to control) were observed at the LOAEL
of 750 ppm (29.7-34.5 mg/kg/day).
    11. Gene mutation study--Salmonella. Negative.
    12. Gene mutation study--Chinese Hamster Cultured V-79. Positive.
    13. Structural chromosome aberration-micronucleus study--mouse.
Negative.
    14. Structural chromosome aberration-cytogenetics study--Chinese
Hamster. Negative.
    15. DNA Repair study-hepatocytes--rat. Negative.
    16. Acute oral neurotoxicity study--rat. The NOAEL and LOAEL could
not be determined.
    17. Metabolism study--rat. The tissue half-lives ranged from 13 to
42 hours. The highest residues were found in liver, kidneys, spleen and
blood. The parent compound was extensively metabolized to approximately
35 metabolites.
B. Toxicological Endpoints
    The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used
to determine the 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 the following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for trifloxystrobin for Use in Human Risk Assessment
Exposure Scenario
Dose(mg/kg/day)
Endpoint
Study
Acute Dietary Females a 13–50 only NOAEL = 250
UF = 100.................
Increased fetal skeletal anomalies. Developmental Toxicity - Rabbit
Chronic Dietary b General population NOAEL = 3.8...........
UF = 100.................
Decreased pup body weights during lactation. Reproductive Toxicity - Rat
Short-Term and Intermediate-Term (Dermal) Dermal NOAEL= 100. Increases in liver and kidney weights. 28-Day Dermal Toxicity Study in Rats
Long-Term (Dermal) c Oral NOAEL = 5...... Increased incidence of clinical signs, increased mean liver weight, and hepatocellular hypertrophy. Chronic Toxicity - Dog
Short-, Intermediate- and Long-Term (Inhalation) d Oral NOAEL = 3.8... Decreased pup body weights during lactation. Reproductive Toxicity - Rat
Short-Term and Intermediate-Term (Incidental Oral) Oral NOAEL = 3.8... Decreased pup body weights during lactation. Reproductive Toxicity - Rat
a Acute RfD=2.5 mg/kg
b Chronic RfD=0.038 mg/kg/day
c Since an oral NOAEL was selected, a dermal absorption factor of 33% should be used for route-to-route extrapolation.
d Since an oral NOAEL was selected, inhalation absorption factor of 100% should be used for route-to-route extrapolation.
C. Exposure assessment
    1. Dietary exposure from food and feed uses. Tolerances have been
established for the combined residues of trifloxystrobin and the free
form of its acid metabolite CGA-321113 on several commodities;
including almonds, bananas, sugarbeets, pomefruit, grapes, peanuts,
potatoes, cucurbit vegetables, fruiting vegetables, and wheat. The
Agency conducted a new assessment incorporating these commodities and
the following additional tolerances: fruit, stone, group at 2 ppm; nut,
tree, group at 0.04 ppm; pistachio at 0.04 ppm; corn, field, grains at
0.05 ppm; corn, field, forage at 0.2 ppm; corn, field, stover at 7 ppm;
corn, field, refined oil at 0.1 ppm; corn, pop, grain at 0.05 ppm;
corn, pop, stover at 7 ppm; rice, grain at 3.5 ppm; rice, hulls at 8
ppm; rice, straw at 7.5 ppm; citrus, dried pulp at 0.8 ppm; citrus oil
at 30 ppm; fruit, citrus, group at 0.3 ppm; egg at 0.04 ppm; poultry,
fat at 0.04 ppm; poultry, meat at 0.04 ppm; poultry, meat by products
at 0.04 ppm. Risk assessments were conducted by EPA to assess dietary
exposures from trifloxystrobin in food as follows:
    i. Acute exposure. The acute dietary exposure analysis for
trifloxystrobin is a Tier 1 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. The acute dietary
endpoint (increased fetal incidence of fused sternebrae) is only
applicable to the population subgroup Females 13-50 years old. An acute
dietary endpoint for the general population including infants and
children was not identified. The estimated dietary exposure for females
13-50 years old occupies less than 1 percent of the acute PAD and does
not exceed EPA's level of concern.
Table 2.--Results of Acute Dietary Exposure Analysis at the 95th Percentile of Exposure
Population Subgroup
aPAD
(mg/kg/day)
Exposure
(mg/kg/day)
% aPAD
Females 13–50 years old
2.5
0.011587
0.46
    ii. Chronic exposure. The chronic dietary exposure analysis for
trifloxystrobin is a Tier 1 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. The chronic dietary
endpoint applies to all population subgroups including infants and
children. A listing of the subgroups with the highest exposure are
reported below in Table 3.
    The results of the chronic dietary analysis show that risk ranges
from 9% of the cPAD for adult males (20 years and older), to 39% of the
cPAD for all infants (>1 year). Risk estimates for all population
subgroups are below EPA's level of concern (100% of the cPAD).
Table 3.--Results of Chronic Dietary Exposure Analysis
Population Subgroup
cPAD
(mg/kg/day)
Exposure
(mg/kg/day)
% cPAD
U.S. Population (total)
0.038
0.00503
13
All Infants ( < 1 year)
0.038
0.015
39
Children 1–6 years
0.038
0.014
37
Children 7–12 years
0.038
0.0069
18
Females 13–50
0.038
0.0036
9.3
Males 13–19
0.038
0.0035
9.1
Males 20+ years
0.038
0.0034
9.0
Seniors 55+
0.038
0.0039
10
    iii. Cancer. Trifloxystrobin was classified as a "not likely human
carcinogen." Therefore, a cancer risk assessment was not conducted.
    2. Water exposure. Trifloxystrobin is immobile, degrades and
transforms rapidly, in soil (half life is about 2 days) and aquatic
environments (half life is about 15-55 days), mostly to a series of
isomers and the primary acid metabolite, CGA-321113. The major isomer
forms at the average rate of 80% of the applied parent, is persistent,
(half life is about 301 days), and soluble, 30.9 ppm and is also
mobile. The major degradate minimum Koc is 49, the median Koc is 127
and is also stable to hydrolysis. The major degradate, CGA-321113 is
persistent and mobile and has a potential to leach into groundwater.
CGA-321113 has been found in the soil profile at the 36 inch depth.
    Estimated environmental concentrations (EECs) were calculated for
total trifloxystrobin residues (parent trifloxystrobin and its major
degradate, CGA-321113 ) using EPA's FIRST model for surface water and
the screeninig concentration in ground water (SCI-GROW) model. EPA's
interim method for drinking water estimates for pesticides used in rice
paddies was also used to generate EECs. No degradation process of the
chemical and no dilution with uncontaminated water outside of the paddy
were taking into account. The rice estimates are "expected to vastly
exceed the `true' values found in the environment, especially for
trifloxystrobin, since available environmental fate data show that this
compound degrades fairly rapidly in water and soil."
    EECs were estimated for total trifloxystrobin residues because the
environmental fate studies indicated that the parent compound forms
transformation compounds (isomers) which are similar in structure to
the parent under most conditions. Further, the EPA concluded that both
trifloxystrobin and the free form of its acid metabolite CGA-321113 are
of concern for both regulatory and risk assessment purposes for plant
and livestock commodities.
    The use site with the highest application rate is turfgrass, with a
maximum label rate of 1.078 pounds active ingredient per acre per year
(lbs/ai/ac/yr) (three applications at 0.359 lbs/ai/ac/yr). Drinking
water estimates were also provided for rice paddies that may be treated
with trifloxystrobin.
    Surface water concentrations of trifloxystrobin and its major
degradate CGA-321113 are 92 parts per billion (ppb) for the peak value
(acute) and 50 ppb for the chronic value using the FIRST model. The
groundwater screening concentration to be 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 groundwater from the use of
trifloxystrobin on turfgrass at the maximum application rate.
    3. Non-dietary exposure. Trifloxystrobin's residential uses include
turfgrass/ornamental disease control (Compass). Because the
FQPA requires consideration of aggregate exposure to all likely non-
occupational uses, this assessment uses non-occupational
postapplication contact with trifloxystrobin following
Compass use on turfgrass as the most common and worst case
contributor to such exposures. The margin of exposure (MOEs) for
applicable residential scenarios (i.e., postapplication dermal exposure
from pesticide residues on lawns, incidental non-dietary ingestion of
pesticide residues on lawns from hand-to-mouth transfer, incidental
non-dietary ingestion of residues from pesticide-treated turfgrass from
object-to-mouth activities, and incidental non-dietary ingestion of
soil from pesticide-treated residential areas) were calculated
separately, and then combined.
    i. Residential handler. This current petition does not propose
residential uses for trifloxystrobin. However, the label for the
trifloxystrobin product, Compass, includes residential use
on turfgrass and ornamentals. This product may only be applied by a
Certified Pest Control Operartor (PCO), not by homeowners directly.
    ii. Postapplication. There is potential for dermal (adults and
children) and oral exposure (children only) during postapplication
activities. The following postapplication exposure scenarios resulting
from lawn treatment were assessed: (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. Postapplication
exposures from various activities following lawn treatment are
considered to be the most common and significant in residential
settings. Exposure via incidental non-dietary ingestion involving other
plant material may occur but is expected to result in much less
exposure than the four exposure scenarios listed above.
    The exposure and risk estimates for the four residential exposure
scenarios are assessed for the day of application (day "0") because
it is assumed that adults and toddlers could contact the lawn
immediately after application. On
the day of application, it was assumed that 5 percent of the
application rate is available from the turfgrass as transferrable
residue (20 percent for object-to-mouth activities). Intermediate-term
exposure (1 to 6 months) is not expected based on trifloxystrobin's
short half-life in soil (about 2 days). Chronic or long-term
(continuous exposure over more than 6 months) exposure is not expected.
The short-term MOEs for adults and children are above 100, they DO NOT
exceed EPA's level of concern.
    iii. Recreational. Trifloxystrobin may be used on turf at
recreational use sites, and, therefore may result in postapplication
exposure to adults and children involved in recreational activities.
Exposures to adults and children from the use of trifloxystrobin at
recreational use sites are assumed to be the same as those assessed for
residential use sites. Residential turf exposure assessment results in
what are considered upper bound risk estimates. Therefore, it is not
expected that the upper bound residential exposure scenario would occur
on the same day as an upper bound recreational exposure scenario.
Exposure from these two exposure scenarios are not aggregated. Rather,
the residential risk estimate should serve as an upper bound for both
residential and recreational exposure.
    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 (adults and
children) and oral exposure (children only) during postapplication
activities. Four postapplication exposure scenarios resulting from lawn
treatment were assessed. Postapplication exposure and risk estimates
for adults and children resulted in MOE's that were above 100 and all
risks were considered below EPA's level of concern.
    iv. Other exposure sources. Spray drift is always a potential
source of exposure to residents nearby to spraying operations. This is
particularly the case with aerial application, but, to a lesser extent,
could also be a potential source of exposure from the groundboom
application. The Agency has been working with the Spray Drift Task
Force, EPA Regional Offices and State Lead Agencies for pesticide
regulation and other parties to develop the best spray drift management
practices. The Agency is now requiring interim mitigation measures for
aerial applications that must be placed on product labels/labeling. The
Agency has completed its evaluation of the new database submitted by
the Spray Drift Task Force, a membership of U.S. pesticide registrants,
and is developing a policy on how to appropriately apply the data and
the AgDRIFT computer model to its risk assessments for pesticides
applied by air, orchard airblast and ground hydraulic methods. After
the policy is in place, the Agency may impose further refinements in
spray drift management practices to reduce off-target drift and risks
associated with aerial as well as other application types where
appropriate.
    4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider "available information" concerning the cumulative effects of
a particular pesticide's residues and "other substances that have a
common mechanism of toxicity." Trifloxystrobin belongs to a new class
of fungicides, the MAEs (beta-methoxyacryl esters), which are synthetic
analogs of strobilurin A, an antifungal secondary metabolite of the
fungus Strobilurus tenacellus. Trifloxystrobin works by interfering
with respiration in plant pathogenic fungi. The site of action of
strobilurin compounds is located in the mitochondrial respiration
pathway between cytochromes b and c1 at the level of the hydroquinone
binding site. As a result of this mode of action, trifloxystrobin is a
potent inhibitor of fungal spore germination and mycelial growth.
Trifloxystrobin can be referred to more specifically as an
oximinoacetate.
    EPA does not have, at this time, available data to determine
whether trifloxystrobin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
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 efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997).
D. Safety Factor for Infants and Children
    EPA determined the 10x safety factor for the protection of infants
and children should be removed for the following reasons:
    1. The toxicology database is complete for FQPA assessment.
    2. There is no indication of increased susceptibility of rat or
rabbits to trifloxystrobin. In the developmental and reproductive
toxicity studies, effects in the fetuses/offspring were observed only
at or above treatment levels which resulted in evidence of parental
toxicity.
    3. It was determined that a developmental neurotoxicity study in
rats is not required.
    4. The exposure assessments will not underestimate the potential
dietary (food and drinking water) or nondietary exposures for infants
and children from the use of trifloxystrobin.
E. Aggregate Risks and Determination of Safety
    Acute and chronic aggregate risk estimates were calculated in this
risk assessment. Acute aggregate risk was calculated by comparing acute
drinking water levels of concern (DWLOCs) to potential drinking water
exposure to trifloxystrobin. Similarly, chronic aggregate risk was
calculated by comparing chronic DWLOCs to potential drinking water
exposure.
    Short-term aggregate risk estimates were also calculated. Short-
term risk is based on exposures occurring over 1 to 30 days. Short-term
aggregate risk was calculated by combining risk estimates for high-end
residential oral and/or dermal exposures with chronic food and drinking
water risks. Intermediate-term risk is based on 30 to 180 days of
exposure (1 to 6 months). Intermediate-term exposure is not expected to
occur based on the short soil half-life (about 2 days). Chronic non-
dietary aggregate risk was not calculated as chronic dermal and oral
exposures (from residential treatment) are not expected. Cancer
aggregate risk was not calculated because trifloxystrobin is classified
as "not likely human carcinogen."
    1. Acute risk (food + drinking water). The acute aggregate risk
assessment takes into account exposure estimates from dietary
consumption of trifloxystrobin from food and drinking water sources.
The acute risk estimate for Females 13-50 years, resulting from
aggregate exposure to trifloxystrobin in food and drinking water is
below EPA's level of concern. Acute aggregate risk was not calculated
for the U.S. population including infants and
children or other population subgroups as EPA did not identify an
endpoint for risk assessment for those groups.
    The surface and groundwater EECs were used to compare against back-
calculated DWLOCs for aggregate risk assessments. To calculate the
DWLOC for acute exposure relative to an acute toxicity endpoint, the
acute dietary food exposure (from DEEM) was subtracted from
the aPAD to obtain the acceptable acute exposure to trifloxystrobin in
drinking water. The acute DWLOCs are listed in the following Table 4:
Table 4.--DWLOCs for Acute Dietary Exposure to Trifloxystrobin
Population Subgroup1
Acute PAD
(mg/kg/day)
Food Exposure
(mg/kg/day)
Max. Water Exposure (mg/kg/day)2
Rice Surface Water (µg/L)3
Ground Water (µg/L)3
DWLOC (µg/L)4
Females (13–50 years)
2.5
0.012
2.5
48
3.4
75,000
1 Within each of these subgroups, the subpopulation with the highest (acute) food exposure having an adequately representative number of samples was selected EPA default body weight is 60 kg for females (13+ years old).
2 Maximum Water Exposure (mg/kg/day) = Acute PAD (mg/kg/day) - Acute Food Exposure.
3 Estimate for the highest use rate was chosen.
4 DWLOC (μg/L) = [Maximum water Exposure (mg/kg/day) x body wt (kg)] ÷ [(10-3 mg/μg) x water consumed daily (L/day)]. μg/L = parts per billion. EPA default daily drinking rate is 2 L/day for adults.
    For the acute aggregate risk scenario, food and drinking water
exposures were taken into account. DWLOCs were calculated for females
(13-50 years old) the only subgroup to which the acute dietary endpoint
applies. The DWLOC was 75,000 ppb for females. This value is well above
the EECs for drinking water, and therefore, acute aggregate risk is
below EPA's level of concern.
    2. Short-term risk (food + drinking water + residential). The
short-term aggregate risk assessment estimates risks likely to result
from 1- to 30-day exposure to trifloxystrobin residues are from food,
drinking water, and residential pesticide uses. High-end estimates of
residential exposure are used in the short-term assessment, while
average values are used for food and drinking water exposure (i.e.
chronic exposures).
    A short-term risk assessment is required for adults because there
is a residential exposure scenario (postapplication only). In addition,
a short-term risk assessment is required for infants and children
because there are residential post-application dermal and oral exposure
scenarios. Toddlers' incidental oral exposure is assumed to include
hand-to-mouth exposure, object-to-mouth exposure and exposure through
incidental ingestion of soil.
    Different endpoints were identified by EPA for short-term
incidental oral and dermal risk assessment. The basis for the oral
endpoint is reduced pup body weights and the dermal endpoint is based
on increases in liver and kidney weights. Therefore, it is not possible
to combine the exposure from both dietary/oral exposure with that from
dermal exposure.
    For the short-term aggregate risk scenario, food, drinking water
and residential exposures are taken into account. DWLOCs were
calculated for the U.S. population, males (13-19 years old), all
infants (less than 1 year old) and females (13-50 years old). DWLOCs
ranged from 170 ppb for all infants to 1,200 pbb for the U.S.
population and males (13-19 years old). These values are above the EECs
for drinking water and therefore, short-term aggregate risk is below
EPA's level of concern.
    3. 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. High-end estimates of
residential exposure are used in the short-term assessment, while
average values are used for food and drinking water exposure (i.e.
chronic exposures).
    Intermediate-term exposure is not expected to occur based on the
short soil half-life (about 2 days). Therefore, an intermediate-term
aggregate risk assessment was not performed.
    4. Chronic risks. The chronic aggregate risk assessment takes into
account exposure estimates from dietary consumption of trifloxystrobin
from food and drinking water sources. Chronic risk estimates resulting
from aggregate exposure to trifloxystrobin in food and drinking water
are below EPA's level of concern from all population subgroups.
    The surface and groundwater EECs were used to compare against back-
calculated DWLOCs for aggregate risk assessments. To calculate DWLOCs
for chronic exposure relative to a chronic toxicity endpoint, the
chronic dietary food exposure (from DEEM) was subtracted from
the cPAD to obtain the acceptable chronic exposure to trifloxystrobin
in drinking water. The chronic DWLOCs are listed in the following Table 5:
Table 5.--DWLOCs for Chronic Dietary Exposure to Trifloxystrobin.
Population Subgroup1
Acute PAD
(mg/kg/day)
Food Exposure
(mg/kg/day)
Max. Water Exposure (mg/kg/day)2
Rice Surface Water (μg/L)3
Ground Water (μg/L)3
DWLOC (μg/L)4
U.S. Population
0.038
0.00503
0.033
140
3.4
1,200
Males (13–19 years)
0.038
0.0035
0.035
140
3.4
1,200
All Infants ( < 1 year)
0.038
0.015
0.023
140
3.4
230
Females (13–50 years)
0.038
0.0036
0.034
140
3.4
1,000
1 Within each of these subgroups, the subpopulation with the highest food exposure having an adequately representative number of samples was selected EPA default body weights are: General U.S. Population, 70 kg; Females (13+ years old), 60 kg; and, All Infants/Children, 10 kg.
2 Maximum Water Exposure (mg/kg/day) = Chronic PAD (mg/kg/day) - Chronic Food Exposure.
3Estimate for the highest use rate was chosen.
    Chronic DWLOCs for all population subgroups are above the estimated
concentrations of trifloxystrobin and its metabolites in drinking
water, and are therefore not of concern.
    5. Aggregate cancer risk. Not applicable. There is no evidence of
carcinogenicity.
    6. Determination of safety. EPA concludes with reasonable certainty
that aggregate exposure from trifloxystrobin will not result in harm to
the adult U.S. population or infants and children.
IV. Other Considerations
A. Metabolism in Plants and Animals
    1. For plants. The qualitative nature of the residue in plants is
adequately understood for fruits, fruiting vegetables, cucurbit
vegetables and peanuts, based on acceptable metabolism studies
conducted on apples, cucumbers, peanuts, and a supplementary study on
wheat. For the current petition, Bayer submitted two sugar beet
trifloxystrobin metabolism studies. As result of these studies the
nature of trifloxystrobin in/on sugar beets is adequately understood.
The sugar beet metabolism studies, however, do not fulfill the wheat
metabolism data requirement because the two crops are too dissimilar.
    2. For animals. No livestock data were submitted. The qualitative
nature of the residue in livestock is adequately understood based on
acceptable studies conducted on goats and laying hens. The EPA has
determined that the total toxic residues for livestock, both for
regulatory and risk assessment purposes, is trifloxystrobin and the
free form of its acid metabolite CGA-321113. Additionally, metabolite
L7a (taurine conjugate of trifloxystrobin) in the liver should be
included in the risk assessment.
B. Analytical Method for Plants and Livestock
    EPA has completed a method validation trial of AG-659A on apples,
wet apple pomace, grapes, summer squash, peanut hay, peanuts, cow
liver, cow milk and raisins, and concluded that AG-659A is suitable for
enforcement of trifloxystrobin and the free form of its acid metabolite
in plant and livestock commodities. The enforcement method has been
submitted to the Food and Drug Administration for publication in the
Pesticides Assessment Manual II.
    The analytical methods, AG-659A or AG-659A/REM 177.04, are adequate
for collecting data for residues of trifloxystrobin and its acid
metabolite CGA-321113 in/on all crops associated with this petition.
C. International Residue Limits
    There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) established for trifloxystrobin. Harmonization is thus not an
issue at this time.
V. Conclusion
    Therefore, tolerances are established for combined residues of
trifloxystrobin and the free form of its acid metabolite CGA-321113 in/
on fruit, stone, group at 2 ppm; nut, tree, group at 0.04 ppm;
pistachio at 0.04 ppm; corn, field, grains at 0.05 ppm; corn, field,
forage at 0.2 ppm; corn, field, stover at 7 ppm; corn, field, refined
oil at 0.1 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 7
ppm; rice, grain at 3.5 ppm; rice, hulls at 8 ppm; rice, straw at 7.5
ppm; citrus, dried pulp at 0.8 ppm; citrus oil at 30 ppm; fruit,
citrus, grroup at 0.3 ppm; egg at 0.04 ppm; poultry, fat at 0.04 ppm;
poultry, meat at 0.04 ppm; poultry, meat by products at 0.04 ppm.
VI. Objections and Hearing Requests
    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to "object" to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-2002-0052 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 July 22,
2002.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
You may also deliver your request to the Office of the Hearing Clerk in
Room M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission be 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, 401 M St., SW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A. of
this preamble, you should also send a copy of your request to the PIRB
for its inclusion in the official record that is described in Unit
I.B.2. of this preamble. Mail your copies, identified by docket number
OPP-2002-0052, to: Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PRIB described in Unit I.B.2. of this preamble. 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 6.1/8.1 file format 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 EPA, 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. Regulatory Assessment Requirements
    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), 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 FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this rule does not have any "tribal
implications" as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure "meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications." "Policies that have tribal implications" is
defined in the Executive order to include regulations that have
"substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes." This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VIII. Submission to Congress and the Comptroller General
    The Congressional Review Act, 5 U.S.C. 801 et seq.,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: May 13, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
    1. The authority citation for part 180 continues to read as
follows:
    Authority: 21 U.S.C. 321(q), 346(a), and 374.
    2. Section 180.555 is amended by alphabetically adding commodities
to the table in paragraph (a) to read as follows:
Sec. 180.555  Trifloxystrobin; tolerances for residues.
    (a) *  *  *
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
                   *      *      *      *      *
Citrus, dried pulp...........................................        0.8
Citrus, oil..................................................       30
Corn, field, forage..........................................        0.2
Corn, field, grain...........................................        0.05
Corn, field, stover..........................................        7
Corn, field, refined oil.....................................        0.1
Corn, pop, grain.............................................        0.05
Corn, pop, stover............................................        7
                   *      *      *      *      *
Egg..........................................................        0.04
Fruit, citrus, group.........................................        0.3
Fruit, stone, group..........................................        2
                   *      *      *      *      *
Nut, tree, group.............................................        0.04
                   *      *      *      *      *
Pistachio....................................................        0.04
                   *      *      *      *      *
Poultry, fat.................................................        0.04
Poultry, meat................................................        0.04
Poultry, meat byproducts.....................................        0.04
                   *      *      *      *      *
Rice, grain..................................................        3.5
Rice, hulls..................................................        8
Rice, straw..................................................        7.5
                   *      *      *      *      *
------------------------------------------------------------------------
* * * * *
[FR Doc. 02-12850 Filed 5-21-99; 8:45 am]