[Federal Register: June 24, 2005 (Volume 70, Number 121)]
[Rules and Regulations]
[Page 36524-36533]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn05-22]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0155; FRL-7720-2]
Trifloxystrobin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of trifloxystrobin in or on soybean, forage; soybean,
hay; and soybean, seed. This action is in response to EPA's granting of
an emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on soybeans. This regulation establishes a maximum permissible level
for residues of trifloxystrobin in this food commodity. The tolerances
will expire and are revoked on December 31, 2009.
DATES: This regulation is effective June 24, 2005. Objections and
requests for hearings must be received on or before August 23, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
[[Page 36525]]
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
identification (ID) number OPP-2005-0155. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket/.
Although listed in the index, some information is not publicly
available, i.e., Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically in
EDOCKET or in hard copy at the Public Information and Records Integrity
Branch (PIRIB), Room 119, Crystal Mall 2, 1801 S. Bell St.,
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.
FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 306-0327; fax number: (703) 308-5433; e-mail address:
rodia.carmen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 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 Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), 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 on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for combined residues of the
fungicide trifloxystrobin, (benzeneacetic acid, (E,E)-[alpha]-
(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)phenyl] ethylidene]
amino]oxy]methyl]-,methylester) and the free form of its acid
metabolite CGA-321113 ((E,E)-methoxyimino-[2-[1-(3-
trifluoromethylphenyl) ethylideneaminooxymethyl]-phenyl] acetic acid)
in or on soybean, forage at 4.0 parts per million (ppm); soybean, hay
at 6.5 ppm; and soybean, seed at 0.04 ppm. These tolerances will expire
and are revoked on December 31, 2009. EPA will publish a document in
the Federal Register to remove the revoked tolerances from the Code of
Federal Regulations (CFR).
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related tolerances to set binding precedents for the
application of section 408 of FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of 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 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 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. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by the Food Quality Protection Act of 1996 (FQPA). EPA has
established regulations governing such emergency exemptions in 40 CFR
part 166.
III. Emergency Exemption for Trifloxystrobin on Soybeans and FFDCA
Tolerances
Multiple States throughout the United States have petitioned the
Agency requesting an emergency exemption for use of trifloxystrobin to
control soybean rust under the provisions of section 18 of FIFRA. The
soybean rust pathogen (Phakopsora pachyrhizi) was recently identified
in the continental United States. Soybean rust has been designated as a
biosecurity threat by action of the U.S. Congress and; therefore, it is
important that control measures be available to soybean growers in the
United States. Accordingly, EPA has expedited review under section 18
of FIFRA to authorize the use of trifloxystrobin on soybeans for
control of soybean rust for requesting states in the United States,
having concluded that emergency conditions exist regarding this
chemical use.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of trifloxystrobin in or on
soybeans. In doing so, EPA considered the safety standard in section
408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under
section 408(l)(6) of FFDCA would be consistent with the safety standard
and with section 18 of FIFRA. Consistent with the need to move quickly
on the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
[[Page 36526]]
comment as provided in section 408(l)(6) of FFDCA. Although these
tolerances will expire and are revoked on December 13, 2009, under
section 408(l)(5) of FFDCA, residues of the pesticide not in excess of
the amounts specified in the tolerance remaining in or on poultry,
soybeans, or swine after that date will not be unlawful, provided the
pesticide is applied in a manner that was lawful under FIFRA, and the
residues do not exceed a level that was authorized by these tolerances
at the time of that application. EPA will take action to revoke these
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether
trifloxystrobin meets EPA's registration requirements for use on
soybeans or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of trifloxystrobin by a
State for special local needs under section 24(c) of FIFRA. Nor do
these tolerances serve as the basis for any State that has not been
specifically authorized by EPA to use this pesticide on this crop under
section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 of FIFRA as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for trifloxystrobin, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of 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).
Consistent with section 408(b)(2)(D) of 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
trifloxystrobin and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of FFDCA, for a time-limited
tolerance for combined residues of trifloxystrobin in or on soybean,
forage at 4.0 ppm; soybean, hay at 6.5 ppm; and soybean, seed at 0.04
ppm. EPA's assessment of the dietary exposures and risks associated
with establishing the tolerance follows.
A. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10x to account for interspecies differences and 10x
for 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 over risk to children's health, 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 (SF).
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10x to account for interspecies differences and 10x for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x10-\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 36527]]
Table 1.--Summary of Toxicological Dose and Endpoints for Trifloxystrobin for Use in Human Risk Assessment
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FQPA SF* and level of
Exposure/scenario Dose used in risk concern for risk Study and toxicological
assessment, UF assessment effects
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Acute dietary NOAEL = 250 milligram/ FQPA SF = 1x Developmental toxicity--
(Females 13-49 years of age)......... kilogram/day (mg/kg/ aPAD = acute RfD/FQPA rat
day) SF = 2.5 mg/kg/day. LOAEL = 500 mg/kg/day
UF = 100.............. based on increased
Acute RfD = 2.5 mg/kg/ fetal skeletal
day. anomalies.
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Acute Dietary There were no appropriate toxicological effects attributable to a single
(General U.S. population, including exposure (dose) observed in oral toxicity studies including maternal
infants and children). effects in developmental studies in rats and rabbits. Therefore, a dose
and endpoint were not identified for this risk assessment.
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Chronic dietary Parental NOAEL = 3.8 mg/ FQPA SF = 1x 2-Generation
(All populations).................... kg/day cPAD = chronic RfD/FQPA reproduction study--
UF = 100.............. SF = 0.038 mg/kg/day. rat
Chronic RfD = 0.038 mg/ LOAEL = 55.3 mg/kg/day
kg/day. based on decreases in
body weight, body
weight gains, reduced
food consumption, and
histopathological
lesions in the liver,
kidneys, and spleen.
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Short- (1 to 30 days) and Offspring NOAEL = 3.8 LOC for MOE = 100 2-Generation
intermediate-term (1-6 months) mg/kg/day (residential, includes reproduction study--
Oral................................. FQPA SF). rat
LOAEL = 55.3 mg/kg/day
based on reduced pup
body weights during
lactation.
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Short- (1 to 30 days) and Dermal study NOAEL = LOC for MOE = 100 28-Day dermal toxicity
intermediate-term (1-6 months) 100 mg/kg/day (occupational)......... study--rat
Dermal............................... LOC for MOE = 100...... LOAEL = 1,000 mg/kg/day
(residential, includes based on increases in
FQPA SF). mean absolute and
relative liver and
kidney weights.
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Long-term (> 6 months) Oral study NOAEL = 3.8 LOC for MOE = 100 2-Generation
Dermal............................... mg/kg/day (occupational)......... reproduction study--
(dermal absorption rate LOC for MOE = 100...... rat
= 33%). (residential, includes LOAEL = 55.3 mg/kg/day
FQPA SF). based on decreases in
body weight, body
weight gains, reduced
food consumption, and
histopathological
lesions in the liver,
kidneys, and spleen.
----------------------------------------------------------------------------------------------------------------
Short- (1 to 30 days), intermediate- Oral study NOAEL = 3.8 LOC for MOE = 100 2-Generation
(1-6 months), and long-term (> 6 mg/kg/day (occupational)......... reproduction study--
months) (inhalation absorption LOC for MOE = 100...... rat
Inhalation........................... rate = 100%). (residential, includes LOAEL = 55.3 mg/kg/day
FQPA SF). based on decreases in
body weight, body
weight gains, reduced
food consumption, and
histopathological
lesions in the liver,
kidneys, and spleen.
----------------------------------------------------------------------------------------------------------------
Cancer Classification: ``Not Likely Human Carcinogen,'' based on the lack of
(Oral, dermal, and inhalation)....... evidence of carcinogenicity in mouse and rat cancer studies.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to FQPA.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.555) for the combined residues of
trifloxystrobin, in or on a variety of raw agricultural commodities
(RACs). Specifically, tolerances for almonds, barley, carrots, celery,
citrus, field corn, fruiting vegetables, hops, pecans, potatoes, rice,
stone fruits, sugar beets, and wheat. Risk assessments were conducted
by EPA to assess dietary exposures from trifloxystrobin in food as
follows:
i. Acute exposure. Acute dietary (food only) exposure assessments
are performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1 day or single exposure. The Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-FCID\TM\),
Version 1.3, which incorporates the individual food consumption data as
reported by respondents in the United States Department of Agriculture
(USDA) 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake
by Individuals (CSFII) and accumulated exposure to the chemical for
each commodity. The acute dietary (food only) exposure analysis for
trifloxystrobin is unrefined, assuming 100% crop treated and tolerance
level residues. No additional data were used to refine the analysis.
The acute dietary endpoint is applicable to the population subgroup
females, 13-49 years only. An acute dietary endpoint for the general
U.S. population, including infants and children, was not identified.
The estimated dietary (food only) exposure for females, 13-49 years old
occupies less than 1% of the aPAD and does not exceed EPA's level of
concern.
ii. Chronic exposure. In conducting this chronic dietary (food
only) exposure assessment, EPA used the DEEM-FCID\TM\ software,
incorporating the individual food consumption data as reported by
respondents in the USDA 1994-1996 and 1998 CSFII and accumulated
exposure to the chemical for each commodity. The chronic dietary (food
only) exposure analysis for trifloxystrobin is unrefined, assuming 100%
crop treated and tolerance level residues. The chronic dietary endpoint
applies to all population subgroups, including infants and children.
Risk
[[Page 36528]]
estimates for all population subgroups are below EPA's level of concern
(100% of the cPAD).
iii. Cancer. EPA's previous reviews of data (May 1999) related to
trifloxystrobin have determined that trifloxystrobin should be
classified as a ``Not Likely Human Carcinogen.'' Accordingly, no
additional cancer risk assessment was performed for trifloxystrobin.
iv. Anticipated residue and percent crop treated (PCT) information.
Established and recommended tolerances were used in the acute and
chronic dietary (food only) exposure assessments for trifloxystrobin.
The metabolite L7a (taurine conjugate of trifloxystrobin) was also
included in the exposure assessment for liver, based on the amount
found in the ruminant metabolism study. EPA did not apply PCT data for
this assessment. DEEM-FCID\TM\ default concentration factors were used
except for tomato juice, puree, paste, and catsup. Processing data show
no concentration in these fractions.
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 are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of trifloxystrobin.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis modeling system (PRZM/EXAMS)
to produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentration in Ground Water modeling system (SCI-GROW)
is used to predict pesticide concentrations in shallow ground water.
For a screening-level assessment for surface water, EPA will generally
use FIRST (a tier 2 model) before using PRZM/EXAMS (a tier 2 model).
The FIRST model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. While both FIRST and
PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to trifloxystrobin, they are
further discussed in Unit IV.D., aggregate risk.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of
trifloxystrobin for acute exposures are estimated to be 48 parts per
billion (ppb) for surface water and 3.4 ppb for ground water. The EECs
for chronic exposures are estimated to be 140 ppb for surface water and
3.4 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Trifloxystrobin is currently registered for use in turf grass and
ornamentals. No new residential uses are proposed in this action.
Because FQPA requires consideration of aggregate exposure to all likely
non-occupational uses, this assessment uses non-occupational post-
application contact with trifloxystrobin following potential use on
turf grass as the most common and worst case contributor to such
exposures. The current registered use of trifloxystrobin on turf grass
and ornamentals may only be applied by a Certified Pest Control
Operator (PCO); therefore, an assessment of dermal or inhalation
exposure for residential handlers is not required and was not
performed.
EPA calculated MOEs for exposure scenarios involving potential
residential exposure resulting from the currently registered uses of
the chemical. The lowest MOE was 800 for children resulting from direct
dermal contact with treated lawns (this represents the exposure
scenario with the highest exposure; conversely, the adult dermal MOE
was 1,300). The highest MOE for children was 220,000 from ingestion of
soil from treated lawns. All calculated non-occupational post-
application MOEs are greater than 100 on the day of application and;
therefore, did not exceed EPA's level of concern.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
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 OPP
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/.
C. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional ten-fold margin of safety for infants and children in the
case of threshold effects to account for prenatal and post-natal
toxicity and the completeness of the data base on toxicity and
exposure, unless EPA determines that a different margin of safety will
be safe for infants and children. Margins of safety are incorporated
into EPA risk assessments either directly through use of an MOE
analysis or through using UFs in calculating a dose level that poses no
appreciable risk to humans.
2. Discussion. There is no indication of an increased
susceptibility of rat or rabbit fetuses/pups to pre- and/or post-natal
exposure to trifloxystrobin. In the developmental and reproduction
[[Page 36529]]
toxicity studies, effects in the fetuses/pups were observed only at or
above treatment levels, which resulted in evidence of parental
toxicity. As a result, the Agency determined that a developmental
neurotoxicity (DNT) study in rats is not required.
The acute and chronic dietary (food only) 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.
Additionally, 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.
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. The
residential post-application assessment is based upon the residential
standard operating procedures (SOPs) and 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.
3. Conclusion. EPA has evaluated the potential for increased
susceptibility of infants and children from exposure to
trifloxystrobin. 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. The Agency
has concluded that there are no residual uncertainties for pre- and/or
post-natal toxicity. Further, based on existing hazard data and the
quality of exposure data for trifloxystrobin, EPA has determined that
traditional 10x safety factors are adequately protective for all
populations, and the special FQPA SF need not be applied (e.g., it has
been reduced from 10x to 1x).
D. Aggregate Risks and Determination of Safety
1. General discussion. To estimate total aggregate exposure to a
pesticide from food, drinking water, and residential uses, the Agency
calculates DWLOCs which are used as a point of comparison against the
model estimates of a pesticide's concentration in water (EECs). DWLOC
values are not regulatory standards for drinking water. DWLOCs are
theoretical upper limits on a pesticide's concentration in drinking
water in light of total aggregate exposure to a pesticide in food and
residential uses. In calculating a DWLOC, the Agency determines how
much of the acceptable exposure (i.e., the PAD) is available for
exposure through drinking water [e.g., allowable chronic water exposure
(mg/kg/day) = cPAD - (average food + chronic non-dietary, non-
occupational exposure)]. This allowable exposure through drinking water
is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's 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 trifloxystrobin 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 trifloxystrobin on drinking water as a part of the aggregate risk
assessment process.
2. Summary of aggregate risk analysis. Acute and chronic aggregate
risk estimates were calculated in this risk assessment. Acute aggregate
risk was calculated by comparing acute DWLOCs to potential drinking
water exposure to trifloxystrobin. Similarly, chronic aggregate risk
was calculated by comparing chronic DWLOCs to potential drinking water
exposure. The surface and ground water EECs were used to compare
against back-calculated DWLOCs for aggregate risk assessments.
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 exposure (1 to 6 months) to
the parent trifloxystrobin is not expected to occur in residential
settings due to its short half-life (about 2 days based on soil and
aquatic metabolism studies). Therefore, an intermediate-term aggregate
risk assessment was not performed. 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 has been classified as a ``not
likely human carcinogen.''
Acute, short-term and chronic aggregate risk estimates resulting
from aggregate exposure to trifloxystrobin in food and drinking water
were assessed, and are below EPA's level of concern.
3. Acute risk. The acute aggregate risk assessment takes into
account exposure estimates from dietary consumption of trifloxystrobin
from food and drinking water sources. Acute aggregate risk was not
calculated for the general U.S. population (including infants and
children or other population subgroups) as hazard endpoints have not
been identified for those groups.
The acute risk estimate for females, 13-49 years, resulting from
aggregate exposure to trifloxystrobin in food and drinking water, is
below EPA's level of concern. DWLOCs were calculated for females 13-49
years, the only subgroup to which the acute dietary endpoint applies.
Surface and ground water 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-FCID\TM\) was subtracted from
the aPAD to obtain the acceptable acute exposure to trifloxystrobin in
drinking water.
The DWLOC was 75,000 ppb for females, 13-49 years, a value that is
well above the EECs for drinking water. Therefore, acute aggregate risk
is below EPA's level of concern. EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in Table 2 of this unit:
[[Page 36530]]
Table 2.--Aggregate Risk Assessment for Acute Exposure to Trifloxystrobin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg/day) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-49 years 2.5 < 1 92 (turf) 3.4 75,000
48 (rice)
----------------------------------------------------------------------------------------------------------------
4. Chronic risk. For the chronic aggregate risk scenario, potential
food and drinking water exposures were analyzed. Chronic exposure in
residential settings is not expected. The surface and ground water EECs
were used to compare against back-calculated DWLOCs for aggregate risk
assessments. To calculate DWLOCs for chronic exposure relative to an
chronic toxicity endpoint, the chronic dietary food exposure (from
DEEM-FCID\TM\) was subtracted from the cPAD to obtain the acceptable
chronic exposure to trifloxystrobin in drinking water.
DWLOCs were calculated for the general U.S. population, children
aged 1-2 years, females aged 13-49 years and adults aged 50 years and
older. DWLOCs ranged from 170 ppb for children to 1,200 ppb for adults
aged 50 years and older. These values are above the EECs for drinking
water. Therefore, chronic aggregate risk is below EPA's level of
concern. EPA does not expect the aggregate exposure to exceed 100% of
the cPAD, as shown in Table 3 of this unit:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Trifloxystrobin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population subgroup cPAD (mg/ % cPAD Water EEC Water EEC Chronic
kg/day) (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.038 15 140 (rice) 3.4 1,100
50 (turf)
------------------------------------------------ ------------- ------------
Children 1-2 years 54 170
----------------------------------------------------------------------------------------------------------------
5. 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). Though residential
exposure could occur with the use of trifloxystrobin, the potential
short-term exposures were not aggregated with chronic dietary food and
water exposures because the toxic effects are different. Different
endpoints have been identified 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, based on the best available data and
current policies, potential risks do not exceed EPA's level of concern.
A short-term risk assessment was not required for adults, because
no incidental oral exposure is expected for adults. A short-term risk
assessment was performed for infants and children because of
residential post-application oral exposure scenarios. Incidental oral
exposure for toddlers is assumed to include hand-to-mouth exposure,
object-to-mouth exposure and exposure through incidental ingestion of
soil.
DWLOCs were calculated for the general U.S. population, children
aged 1-2 years, females aged 13-49 years and adults 50 years and older.
DWLOCs ranged from 130 ppb for children to 1,200 ppb for adults aged 50
years and older. Although the surface water EEC for rice (140 ppb)
exceeds the DWLOC for children (130 ppb), EPA does not believe this is
a cause for concern, because the surface water estimate for rice is
considered to be a gross overestimate of the true value found in the
environment. EPA's careful analysis indicates that the turf grass
estimate (50 ppb) is a more realistic estimate of drinking water
residues. Thus, EPA does not consider short-term aggregate risk for
children to exceed the Agency's level of concern, as shown in Table 4
of this unit:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Trifloxystrobin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate MOE (Food + Aggregate Level of Surface Water EEC Ground Water EEC Short-Term DWLOC
Population subgroup Residential) Concern (LOC) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General U.S. population 690 100 140 (rice) 3.4 1,100
50 (turf)............
------------------------------------------------------------ ----------------------
All infants < 1 year 190 180
------------------------------------------------------------ ----------------------
Children 1-2 years 150 130
------------------------------------------------------------ ----------------------
Females 13-49 years 970 1,000
------------------------------------------------------------ ----------------------
Adults > 50 years 950 1,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 36531]]
6. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term aggregate risk assessment (1 to 6 months
of exposure to trifloxystrobin residues from food, drinking water, and
residential pesticide uses) is not expected to occur based on the short
soil half-life of trifloxystrobin (about 2 days). Therefore, EPA did
not perform an intermediate-term aggregate risk assessment.
7. Aggregate cancer risk for U.S. population. EPA has concluded
that trifloxystrobin should be classified as a ``Not Likely Human
Carcinogen.'' Due to the classification, an aggregate cancer risk
assessment was not performed.
8. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general U.S. population, and to infants and children from
aggregate exposure to trifloxystrobin residues.
V. Other Considerations
A. Analytical Enforcement Methodology
EPA has completed a method validation trial of AG-659A on apples,
cow liver, cow milk, grapes, peanut hay, peanuts, raisins, summer
squash, and wet apple pomace 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 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 or on soybeans.
The regulable residue was tested in accordance with the Pesticide
Analytical Manual (PAM), Volume I, Appendix II. Trifloxystrobin gave
adequate responses through protocol C, and was completely recovered
from fortified apple samples when analyzed through protocols D and E.
Acid metabolite CGA-321113 was recoverable through protocol B and
residues from apples fortified with CGA-321113 were completely
recovered through Section 402 E2/C1 (extraction with methylene
chloride). The enforcement method has been forwarded to the Food and
Drug Administration (FDA) for inclusion in the PAM II.
Adequate enforcement methodology (example--gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Road, Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) established for trifloxystrobin. Harmonization is thus not an
issue at this time.
C. Conditions
There are no conditions for registration placed on these time-
limited tolerances.
VI. Conclusion
Therefore, tolerances are established for combined residues of
trifloxystrobin, (benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-
,methylester) and the free form of its acid metabolite CGA-321113
((E,E)-methoxyimino-[2-[1-(3-trifluoromethylphenyl)
ethylideneaminooxymethyl]-phenyl]acetic acid) in or on soybean, forage
at 4.0 ppm, soybean, hay at 6.5 ppm; and soybean, seed at 0.04 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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 FQPA,
EPA will continue to use those procedures, with appropriate
adjustments, until the necessary modifications can be made. The new
section 408(g) of 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 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-2005-0155 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 August
23, 2005.
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 part 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 part
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 (1900L),
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 Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. 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) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by the docket ID number OPP-2005-0155, 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 ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
[[Page 36532]]
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 part 178.32).
VIII. Statutory and Executive Order Reviews
This final rule establishes a time-limited tolerance under section
408 of FFDCA. 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 FIFRA
section 18 exemption under section 408 of 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.
IX. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 17, 2005.
Lois Rossi,
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), 346a and 371.
0
2. Section 180.555 is amended by adding text to paragraph (b) to read
as follows:
Sec. 180.555 Trifloxystrobin; tolerances for residues.
* * * * *
(b) * * * Time-limited tolerances are established for combined
residues of the fungicide trifloxystrobin, (benzeneacetic acid, (E,E)-
[alpha]-(methoxyimino)-2-[[[[1-[3- (trifluoromethyl)phenyl]
ethylidene]amino] oxy]methyl]-,methylester) and the free form of its
acid metabolite CGA-321113 ((E,E)-methoxyimino-[2-[1-(3-
trifluoromethylphenyl) ethylideneaminooxymethyl]-phenyl]acetic acid) in
connection with the use of the pesticide under FIFRA section 18
emergency exemptions granted by EPA. The tolerances will expire and are
revoked on the date specified in the table in this unit.
[[Page 36533]]
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Soybean, forage............................... 4.0 12/31/09
Soybean, hay.................................. 6.5 12/31/09
Soybean, seed................................. 0.04 12/31/09
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-12447 Filed 6-23-05; 8:45 am]
BILLING CODE 6560-50-S