v=/EPA
United States Prevention, Pesticides EPA 738-R-05-005
Environmental Protection and Toxic Substances September 2005
Agency (7508C)
Report of the Food Quality Protection Act
(FQPA) Tolerance Reassessment Progress
and Risk Management Decision (TRED) for
Fluazifop-P-butyl
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is the Environmental Protection Agency's (hereafter referred to as EPA or the Agency)
"Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk
Management Decision for Fluazifop-P-butyl," which was approved on September 13, 2005. This
document is also known as a Tolerance Reassessment Decision, or TRED. A Notice of Availability of
this tolerance reassessment decision published in the Federal Register. Because relatively few
comments were received in previous public comment opportunities, no additional comment period is
planned. The TRED, supporting risk assessments, and response to comments for fluazifop-P-butyl are
available to the public in EPA's Pesticide Docket OPP-2004-0347 at: http ://www. epa.gov/edockets.
The fluazifop-P-butyl TRED was developed through EPA's public participation process,
published in the Federal Register on May 14, 2004, which provides opportunities for public involvement
in the Agency's pesticide tolerance reassessment and reregistration programs. Developed in partnership
with USDA and with input from EPA's advisory committees and others, the public participation process
encourages public involvement starting early and continuing throughout the pesticide risk assessment and
risk mitigation decision making process. The public participation process encompasses full, modified,
and streamlined versions that enable the Agency to tailor the level of review to the level of refinement of
the risk assessments, as well as to the amount of use, risk, public concern, and complexity associated
with each pesticide. Through the public participation process, EPA is making a commitment to both
involve the public and meet statutory deadlines.
Background
The Federal Food, Drug and Cosmetic Act (FFDCA), as amended by FQPA, requires EPA to
reassess all the tolerances for registered chemicals in effect on or before the enactment of FQPA on
August 3, 1996. In reassessing these tolerances, the Agency must consider, among other things,
aggregate risks from non-occupational sources of pesticide exposure, whether there is increased
susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism
of toxicity. Once a safety finding has been made, the tolerances are considered reassessed. Existing
tolerances associated with fluazifop-P-butyl must be reassessed in accordance with FFDCA, as
amended by FQPA.
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There are 37 tolerances established under 40 CFR 180.411 for residues of fluazifop-butyl,
fluazifop-P-butyl, and free and conjugated fluazifop. There are currently no active products containing
fluazifop or free and conjugated fluazifop. Fluazifop-P-butyl (Case Number 2285, active ingredient
number 122809) is the resolved isomer of fluazifop-butyl. Because fluazifop-butyl has been canceled
and fluazifop-P-butyl is the only registered active ingredient supported for reregistration, only fluazifop-
P-butyl is addressed in this TRED document. In addition, the Agency is establishing a tolerance on
cotton gin byproducts. The current tolerance expressions will be consolidated and expressed as
"fluazifop."
Table 1. Chemicals in Case Number 2285
PC Code
122805
122809
Chemical Name
fluazifop, a.k.a. fluazifop-butyl
fluazifop-P-butyl, a.k.a. propanoic acid,
2-(4-((5-(trifluoromethyl)-2-pyridinyl)oxy)phenoxy)-,
butyl ester, (R)-]
Status
Canceled
Active
Fluazifop-P-butyl is a selective, post-emergent herbicide registered for the control of perennial
and annual grass weeds. Fluazifop-P-butyl is currently registered for food/feed use on asparagus,
carrot, coffee, cotton, endive (escarole), garlic, macadamia nut, onion, pecan, pepper, rhubarb,
soybeans, stone fruits, sweet potato, and yam. It is also registered for use on lawns/turf. The estimated
total domestic use (annual average) is approximately 250,000 Ibs. active ingredient per year. More than
90% of fluazifop-P-butyl's total usage is on cotton and soybeans. Fluazifop-P-butyl is typically applied
as a broadcast, banded, directed or spot treatment with groundboom sprayers and aerial equipment.
Applications are made as pre-plant, at-plant, post-emergence foliar or soil applications, and/or post-
harvest applications to the plant.
EPA has completed its review of the dietary and residential risks and is issuing its risk
management decision for fluazifop-P-butyl.
Regulatory Decision
EPA has evaluated the dietary and residential risks from the supported registered uses and has
determined that there is a reasonable certainty that no harm to any population subgroup will result from
exposure to fluazifop-P-butyl. The acute dietary exposure estimates (food + water) for the U.S.
population and all population subgroups are <1% of the acute Population Adjusted Dose (aPAD) and
are below the Agency's level of concern at the 95th exposure percentile. The chronic dietary exposure
estimates (food + water) for the U.S. population are 15% of the chronic Population Adjusted Dose
(cPAD) and for the most highly exposed population subgroup, children 1-2 years of age are, 46%
cPAD and are below the Agency's level of concern at the 95th exposure percentile. This assessment is
considered conservative since tolerance level residues and screening level water estimates were included
in the dietary assessment.
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The current tolerances established at 40 CFR 180.411 for residues of fluazifop-P-butyl in/on
raw agricultural commodities are now considered reassessed under section 408(q) of the FFDCA (see
Table 6).
Cumulative Risk Assessment
FQPA requires that EPA consider "available information" concerning the cumulative effects of a
particular pesticide's residues and "other substances that have a common mechanism of toxicity." The
Agency considers other substances because low-level exposures to multiple chemical substances that
cause a common toxic effect by a common mechanism could lead to the same adverse health effect, as
would a higher level of exposure to any of the other substances individually.
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
fluazifop-P-butyl and any other substances, and fluazifop-P-butyl does not appear to produce a toxic
metabolite that is also produced by other substances. For the purposes of this tolerance action,
therefore, EPA has not assumed that fluazifop-P-butyl has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a common mechanism on EPA's
website at http://www.epa.gov/pesticides/cumulative/.
Human Health Effects
(For a complete discussion, see section 4:1 of the "Fluazifop-P-butyl: Revised HED Chapter of the
TRED, " dated August 29, 2005.)
The database for fluazifop-butyl and fluazifop-P-butyl is adequate for FQPA evaluation.
Acceptable developmental toxicity studies in rats and rabbits on fluazifop-P-butyl are available in
addition to an acceptable two-generation reproduction study in rats. There is no need for a special
FQPA safety factor (i.e., reduced to IX) given the robust database and since there are no residual
uncertainties for pre-and/or post-natal toxicity. The Agency has determined that the exposure estimates
are conservative and unlikely to underestimate the potential exposure or risk for infants and children.
Fluazifop-P-butyl has low acute toxicity (Toxicity Category HI) by the oral, dermal and
inhalation routes, is mildly irritating (Toxicity Category IV) to the eye and skin, and is not a skin
sensitizer. Available data in rats show that the kidney and liver are the target organs. Toxicity is
expressed as exacerbation of age-related kidney toxicity and liver toxicity in the presence of
peroxasome proliferation.
In accordance with EPA's Guidelines for Carcinogen Risk Assessment, Fluazifop-P-butyl is
classified as "not likely to be carcinogenic to humans." No mutagenic potential was observed in
adequate in vivo and in vitro studies with fluazifop-P-butyl.
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There is evidence of pre/post-natal toxicity resulting from exposure to fluazifop-butyl and
fluazifop-P-butyl. There was quantitative evidence of increased susceptibility in the fetuses of rats
exposed in utero to fluazifop-butyl and fluazifop-P-butyl. Developmental toxicity, characterized as
delays in skeletal ossifications, was seen in the absence of maternal toxicity consistently in two strains of
rats. There was no evidence (quantitative or qualitative) of increased susceptibility following in utero
exposures to rabbits or following pre-and/or post-natal exposure in the two-generation reproduction
toxicity study in rats. The degree of concern is low for the increased susceptibility seen in the rats based
on the following considerations: the endpoint of concern (delayed ossifications) is considered to be a
developmental delay as opposed to a malformation or variation which is considered to be more serious
in nature; there were considerable variations in the incidences among the five studies; the NOAEL and
LOAEL were well defined and consistent across these studies; and a developmental endpoint of
concern (diaphragmatic hernia) is used for assessing acute dietary risk. Therefore, there is no residual
uncertainty for pre and/or post natal toxicity.
The acute dietary endpoint for females 13-49 is based on diaphragmatic hernia observed in a rat
developmental toxicity study at the LOAEL of 200 mg/kg/day. The NOAEL in this study was 50
mg/kg/day. An uncertainty factor of 100 (1 OX for inter-species extrapolation and 10X for intra-species
variation) was applied to the NOAEL resulting in an acute Reference Dose (aRfD) of 0.50 mg/kg/day.
There is no aRfD for the general population because an endpoint attributable to a single dose was not
seen in the database including the developmental toxicity studies.
The chronic dietary endpoint for all populations is based on decreased spleen, testes, and
epididymal weights in males and decreased uterine and pituitary weights in females observed in a two-
generation reproduction study in rats at the LOAEL of 5.8 mg/kg/day in males and 7.1 mg/kg/day in
females. The NOAEL in this study was 0.74 mg/kg/day. An uncertainty factor of 100 (10X for inter-
species extrapolation and 10X for intra-species variation) was applied to the NOAEL resulting in a
cRfD of 0.0074 mg/kg/day.
A summary of the lexicological dose and endpoints for fluazifop-P-butyl that were used in the
dietary risk assessment is shown below in Table 2.
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Table 2. Toxicological Dose and Endpoints used in the Dietary Risk Assessment
Exposure
Scenario
Acute Dietary
(Females 13-49 years of
age)
Acute Dietary
(General population
including infants and
children)
Chronic Dietary
(All populations)
Dose Used in
Risk
Assessment,
UF
NOAEL = 50
mg/kg/day
UF = 100
Acute RfD =
0.50 mg/kg
Special FQPA SF*
and Level of Concern
for Risk Assessment
FQPA SF = IX
aPAD = acute RfD
FQPA SF
= 0.50 mg/kg
Study and Toxicological Effects
Developmental Toxicity in rats
LOAEL = 200 mg/kg/day based on
diaphragmatic hernia
An appropriate endpoint attributable to a single dose was not identified in the available studies
including the developmental toxicity studies.
NOAEL= 0.74
mg/kg/day
UF = 100
Chronic RfD =
0.0074 mg/kg/day
FQPA SF = IX
cPAD =
chronic RfD
FQPA SF
= 0.0074 mg/kg/day
Two-Generation Reproduction in rats
LOAEL = 5.8 mg/kg/day in males and 7.1 in
females based on decreased spleen, testes &
epididymal weights in males and uterine &
pituitary weights in females
Drinking Water Exposure and Risk Assessment
(For a complete discussion, see the "Tier 2 Drinking Water Assessment, " dated May 11, 2005.)
Drinking water exposure to pesticides can occur through ground and surface water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks and uses
either modeling or actual monitoring data, if available, to estimate those risks. Since limited monitoring
data were available for fluazifop-P-butyl, estimated drinking water environmental concentrations
(EDWECs) were calculated from models. The EDWECs were incorporated directly into the acute and
chronic dietary exposure assessment model (DEEM-FCID™) for fluazifop-P-butyl. The EDWECs are
based on application methods, rates and use sites that would likely yield the highest drinking water
concentrations.
Fluazifop-P-butyl is rapidly (less than one day) degraded in soil to fluazifop acid, which is much
more stable in soil and water environments than the parent. EPA used the physical properties of
fluazifop acid in its modeling because it is the form expected to be present in drinking water. The tree
fruit scenarios were modeled in the drinking water assessment because they have the highest labeled use
rates.
Surface Water - In the Tier 2 surface water assessment, maximum application rates, minimum
application intervals, and the default percent cropped area (PCA) factor of 87%, were incorporated into
the PRZM-EXAMS model to yield the EDWECs in raw (untreated) drinking water, using the Index
Reservoir scenario.
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Ground Water - In the Tier 1 ground water assessment, maximum application rates, minimum
application intervals, and the default PCA factor of 87%, were incorporated into SCIGROW model to
yield the EDWECs in raw (untreated) drinking water. The model predicts the impact on ground water
from a single season's use of a chemical.
Table 3. Estimated Drinking Water Environmental Concentrations for Fluazifop Acid
Fluazifop Acid
Duration of Exposure
Acute
Chronic (non-cancer)a
Surface Water EDWECs
7.5 ppb
3.0 ppb
Ground Water EDWECs
0.1 ppb
0.02 ppb
a Values represent l-in-10 year return frequencies
Acute and Chronic Dietary (Food + Water) Exposure and Risk Assessment
(For a complete discussion, see section 6:1 of the "Fluazifop-P-butyl: Revised HED Chapter of the
TRED, " dated August 29, 2005.)
Acute and chronic dietary risk assessments for fluazifop-P-butyl were conducted using the
Dietary Exposure Evaluation Model DEEM-FCID™, Version 2.03, which uses food consumption data
from the USDA's Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and
1998.
An acute dietary exposure analysis (food + water) was performed to determine the acute
exposure and risks which result from the registered uses of fluazifop-P-butyl. Tolerance level residues
with a ratio adjustment for additional metabolites of concern, 100% crop treated (CT), and default
processing factors were used in this assessment. A screening level point estimate was used to assess the
dietary exposure and risks from residues in water. No refinements were included for the acute dietary
exposure analysis; therefore this is considered to be a conservative assessment. Dietary risk estimates
are provided for the only population subgroup with an acute dietary endpoint, females 13-49 years of
age. This assessment concludes that for all supported registered commodities, the acute dietary risk
estimates are below the Agency's level of concern for the U.S. population and all population subgroups
(<1 % aPAD) at the 95th exposure percentile.
A chronic dietary exposure analyses was performed to determine the chronic exposure and risks
which result from the registered uses of fluazifop-P-butyl. Tolerance levels with a ratio adjustment for
additional metabolites of concern, percent crop treated estimates, and default processing factors were
used in the chronic assessment. A screening level point estimate was used to assess the dietary
exposure and risks from residues in water. No additional refinements were included. Dietary risk
estimates are provided for the U.S. population (total) and various population subgroups. The chronic
dietary exposure estimates (food + water) for the U.S. population (15% cPAD) and the most highly
exposed population subgroup, children 1-2 years of age (46% cPAD), are below the Agency's level of
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concern at the 95th exposure percentile.
Fluazifop-P-butyl is classified as "not likely to be carcinogenic to humans;" therefore, no dietary
cancer assessment was performed. Results of the dietary exposure and risk assessment are listed
below.
Table 4. Summary of Dietary (Food + Water) Exposure and Risk for Fluazifop-P-butyl
Population Subgroup*
General U.S. Population
Children 1-2 years old
Females 13-49 years old
Acute Dietary
Dietary Exposure
(mg/kg/day)
NA
0.004638
% aPAD
NA
<1
Chronic Dietary
Dietary Exposure
(mg/kg/day)
0.001085
0.003410
<1
% cPAD
15
46
11
Residential Risk
(For a complete discussion, see section 6.3 of the "Fluazifop-P-butyl: Revised HED Chapter of the
TRED, " dated August 29, 2005.)
At this time, products containing fluazifop-P-butyl are registered for residential use on turfgrass
and broadleaf ornamentals; for total grass weed control for lawn renovations; and around driveways,
fence lines, sidewalks, and similar areas. Exposure to residential handlers can occur when they mix, load
or apply fluazifop-P-butyl for use in a low pressure hand wand, hose-end sprayer or ready-to-use
sprayer. In the residential handler scenarios assessed, margins of exposure (MOEs) ranged from 240 to
4300 and do not exceed the Agency's level of concern. Intermediate- and long-term exposures are not
anticipated for residential handlers.
EPA assessed short-term dermal and inhalation risks using a NOAEL of 2 mg/kg/day based on
an endpoint of reduced fetal weight, hydroureter and delayed ossification at the LOAEL of 5 mg/kg/day
in a rat developmental toxicity study. Selecting a short-term dermal (non cancer) endpoint from an oral
study requires the use of a dermal absorption factor. Based on a dermal absorption study in humans, the
Agency determined that a dermal absorption factor of 9% should be used to assess risks from low
exposures (e.g., golfing or mowing residential lawns) and a dermal absorption factor of 2% should be
used to assess risks from high exposure activities. Although a 21-day rabbit dermal toxicity study was
available with a NOAEL of 100 mg/kg/day and a LOAEL of 500 mg/kg/day, the Agency chose to use
the rat developmental study with a lower NOAEL of 2 mg/kg/day and the dermal absorption rates noted
above for the residential short-term dermal risk assessment because the effects observed in the rat
developmental toxicity study would not be observable in the 21-day rabbit dermal toxicity.
Postapplication exposure can occur when individuals are in or near a residential area that has
been previously treated with fluazifop-P-butyl (e.g., home lawns). The postapplication scenarios
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assessed for adults included activities such as lawn renovation, mowing or golfing, MOEs ranged from
380 to 26,000. The postapplication scenario assessed for children age 10-12 was golfing, the MOEs
ranged from 8,600 to 10,000. The postapplication scenarios for toddlers were assessed for separate
postapplication activities (i.e. dermal contact, oral hand to mouth, oral object to mouth, and oral
incidental soil ingestion); MOEs ranged from 260 to 26,000,000. In addition, the separate
postapplication scenarios for toddlers were assessed as if all those activities occurred simultaneously (i.e.
dermal contact + oral hand to mouth + oral object to mouth + oral incidental soil ingestion = combined
MOE); MOEs ranged from 250 to 32,000. All postapplication scenarios for adults, children and
toddlers had MOEs that do not exceed the Agency's level of concern.
Aggregate Risk
(For a complete discussion, see section 7:0 of the "Fluazifop-P-butyl: Revised HED Chapter of the
TRED, " dated August 29, 2005.)
In accordance with the FQPA, EPA must consider and aggregate pesticide exposures and risks
from all potential sources including food, drinking water, and residential exposures. In an aggregate
assessment, exposures are combined and compared to quantitative estimates of hazard (e.g., aNOAEL
or PAD). When aggregating exposures and risks from various sources, EPA considers both the route
and duration of exposure. In general, exposures from various sources are aggregated only when the
toxic effects determined by the endpoint selected for that route, are the same. In the case of fluazifop-P-
butyl, an aggregate assessment was performed using high-end exposures and conservative endpoints.
Further refinements would have been incorporated into the risk assessment if exposures of concern had
been identified. Since the screening level aggregate assessment did not show risks of concern, the
Agency concludes with reasonable certainty that combined residues of fluazifop-P-butyl from food,
drinking water and residential exposures would not likely result in an aggregate risk of concern to any
population subgroup.
Acute aggregate risk estimates include contributions to exposures from acute dietary (food +
water) only. The estimated acute dietary risk is <1 % of the aPAD for females 13-49 years of age and
does not exceed the Agency's level of concern for any population sub-group. No acute dietary
endpoint was selected for the U.S. population and therefore, no dietary risk assessment was conducted
for that population.
Short-term aggregate risk estimates include contributions to exposures from chronic dietary
(food + water) and short-term residential sources for adult, children and toddlers from dermal, oral and
inhalation exposures. The estimated short-term aggregate risk (MOEs) ranged from 150 to 250 and do
not exceed the Agency's level of concern for any population sub-group.
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Table 5. Short-Term Aggregate Risk
Population
U.S. Pop.
Adult Female
Child
EPA's
Aggregate
LOG1
100
100
100
Short-Term Scenario
MOE
food +
water2
92,000
119,000
29,000
MOE
incidental
oral3
NA
NA
5,500
MOE
dermal4
150
150
260
MOE
inhalation5
14,000
14,000
NA
Aggregate MOE
(food + water +
residential)6
150
150
250
1 Level of Concern (LOC) is 100 based on 1 OX for inter-species extrapolation and 1 OX for intra-species variation.
2 MOE food + water = [(short-term oral NOAEL 100 mg/kg/day)/(chronic dietary exposure)]
Chronic dietary exposure: U.S. Pop. =0.0011 mg/kg/day; Females 13-49yrs = 0.00084 mg/kg/day; Children 1-2
yrs. = 0.0034 mg/kg/d
3 MOE incidental oral = [(short-term incidental oral NOAEL 100 mg/kg/day )/(child residential exposure)]
Child residential exposure: Hand-to-mouth = 0.015 mg/kg/day; Object-to-mouth = 0.0037 mg/kg/day; Incidental soil ingestion =
0.000049 mg/kg/day
4 MOE dermal = [(short-term dermal NOAEL 2 mg/kg/day)/(high-end dermal residential exposure)]
Dermal exposure: Adults = handler 0.0081 mg/kg/day + postapp 0.0053 mg/kg/day; Child = 0.0076 mg/kg/day
5 MOE inhalation = [(inhalation NOAEL 2 mg/kg/day)/(high-end inhalation residential exposure)]
Inhalation exposure: Adult = handler 0.00014 mg/kg/day
6 Aggregate MOE (food + water + residential) = l-[ [(1-MOE food+water) + (KMOE incidental oral) + (KMOE dermal) +
(1-MOE inhalation)]]
Intermediate-term aggregate risk estimates were not calculated because no intermediate-term
residential exposures are expected.
Long-term (non cancer) aggregate risk estimates were calculated based on the contribution from
chronic dietary sources alone (food + water), since no long-term or chronic residential exposures are
expected. The chronic dietary exposure estimates (food + water) for the U.S. population (15% cPAD)
and the most highly exposed population subgroup, children 1-2 years of age (46% cPAD) are below the
Agency's level of concern at the 95th exposure percentile.
Aggregate cancer risk was not assessed because fluazifop-P-butyl is classified as "not likely to
be carcinogenic to humans."
Tolerance Reassessment Summary
Tolerances for the residues of fluazifop butyl, fluazifop-P-butyl, and free and conjugated fluazifop
are established under 40 CFR 180.411. Because the resolved isomer of fluazifop butyl is the only
registered active ingredient, the tolerance expressions, which are currently expressed in terms of mixture
of isomers for some commodities and in terms of the resolved isomer for other commodities, will be
consolidated as tolerances for residues of the herbicide fluazifop-P-butyl,
butyl(R)-2-[4-[[5-(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate, and the free and conjugated
forms of the resolved isomer of fluazifop, (R)-2-[4-[[5-
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(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoic acid, expressed as fluazifop. A summary of the
fluazifop-P-buytl tolerance reassessment is presented in Table 6.
Table 6. Tolerance Reassessment Summary for Fluazifop-P-Butyl
Commodity
Current
Tolerance (ppm)
Range of
Residues (ppm)
Tolerance
Reassessment (ppm)
Comment/ [Correct
Commodity Definition]
Tolerances Listed Under 40 CFR §180.411(a)(l):
Cattle, fat
Cattle, meat
Cattle, meat byproducts
Cotton, undelinted seed
Cotton, oil
Egg
Goat, fat
Goat, meat
Goat, meat byproducts
Hog, fat
Hog, meat
Hog, meat byproducts
Horse, fat
Horse, meat
Horse, meat byproducts
Milk
Poultry, fat
Poultry, meat
Poultry, meat byproducts
Sheep, fat
Sheep, meat
Sheep, meat byproducts
Soybean
Soybean, meal
Soybean, refined oil
0.05
0.05
0.05
0.1
0.2
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
1.0
2.0
2.0
—
—
—
—
-
-
-
-
-
-
-
—
—
—
—
—
—
-
-
-
-
-
-
-
—
0.05 2
0.05 2
0.05 2
0.10 2
0.20 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
0.05 2
1.0
2.0 2
2.0 2
Tolerances Listed Under 40 CFR §180.411(a)(2):
Carrots, roots
Endive
Fruit, stone
Nut, macadamia
Onion (bulb)
Pecans
2.0
6.0
0.05
0.1
0.5
0.05
—
—
0.03
<0.1
-
<0.03
2.0 3
TBD1
0.05 2
0.10
0.50
0.05
Fruit, stone, group 12
Onion, dry bulb
Pecan
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Commodity
Spinach
Sweet potato, roots
Current
Tolerance (ppm)
6.0
0.5
Range of
Residues (ppm)
--
•0.5
Tolerance
Reassessment (ppm)
Revoke
0.50 3
Comment/ [Correct
Commodity Definition]
There are currently no
registered uses on spinach.
Tolerances to Be Proposed under 40 CFR 180.411(a):
Cotton, gin byproducts
—
—
TBD1
Tolerances Listed Under 40 CFR §180.411(c)(l):
Pepper, tabasco
1.0
—
1.0
Tolerances Listed under 40 CFR 180.41 l(c)(2):
Asparagus
Coffee, bean
Rhubarb
3.0
0.1
0.5
0.14-2.7
<0.1
0.5
TBD1
0.10
0.50 3
1 To be determined when additional crop field trial data have been submitted.
2 Tentative until additional information is received to upgrade the existing data.
3 Confirmatory data are required.
Additional Generic Data Requirements
Table 7 lists the generic data requirements for fluazifop-P-butyl. For a detailed description of
the following data requirements, refer to the Residue Chemistry chapter dated August 11, 2004 and the
HIARC Report dated June 15, 2004. In addition, the Agency has no data to assess exposures from
applications using a sprinkling can, therefore, Outdoor Residential Exposure Task Force (ORETF)
hose-end data were used in the assessment.
Table 7. Data Requirements for Fluazifop-P-butyl
Guideline
870.3465
860.1200
860.1300
860.1300
860.1340
860.1380
860.1480
860.1500
Study Title
28-Day Inhalation Toxicity
Directions for Use
Nature of the Residue - Plants
Nature of the Residue - Livestock
Residue Analytical Method
Storage Stability Data
Magnitude of the Residue - Meat, Milk, Poultry, Eggs
Crop Field Trials: carrot, sweet potato, endive, rhubarb, asparagus,
cotton seed and gin byproducts
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860.1520
860.1650
860.1850
Processed Food/Feed: coffee, soybean
Submittal of Analytical Reference Standards
Confined Accumulation in Rotational Crops
Required Label Changes
The following label amendments are needed. In addition, the registrant must submit translated
copies of labels for all foreign uses of fluazifop-P-butyl on coffee destined for import into the U.S.
• All product labels that contain use directions for Florigraze perennial peanuts must be
amended to refer to this crop as "'Florigraze' rhizoma peanuts" or "'Florigraze'
perennial (rhizoma) peanuts."
• All labels that include uses on nonbearing ginseng, olive, and/or small fruits must be
modified to specify that the crop may not be harvested for food/feed use within one year
of treatment.
• All labels that include uses for soybean must specify a maximum seasonal application
rate of 0.5 Ib ai/A to soybeans.
• All labels that include uses for pecans must specify a 30-day PFfl for pecans.
For EPA Reg. No. 100-1071 and 100-1116, the rotational crop restriction that
prohibits the grazing of rotated small grain crops and the harvesting of these crops for
livestock forage and straw is impractical and must be removed.
This document summarizes the Agency's decision on the tolerance reassessment for fluazifop-P-
butyl. A generic data call-in (DCI) and product-specific DCI including instructions for submitting the
necessary label changes will be issued as soon as possible after publication of this TRED. Please
contact Lance Wormell of my staff with any questions regarding this decision. He may be reached by
phone at (703) 603-0523 or by e-mail at wormell.lance@,epa.gov.
Sincerely,
Debra Edwards, Ph.D., Director
Special Review and Reregistration Division
Page 12 of 13
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Technical Support Documents
for the Fluazifop-P-Butyl TRED
1. Diana Locke (USEPA/OPPTS/OPP/HED). Fluazifop-P-butyl: Revised HED Chapter of the
Tolerance Reassessment Eligibility Document (TRED). August 29, 2005
2. Sherrie L. Kinard (USEPA/OPPTS/OPP/HED). Fluazifop-P-butyl. REVISED TRED-
Report on FQPA Tolerance Reassessment Progress and Interim Risk Management Decisions.
Residue Chemistry Considerations. Case No. 2285. August 17, 2005.
3. Sherrie L. Kinard (USEPA/OPPTS/OPP/HED). Fluazifop-p-butyl. Revised Acute and
Chronic Dietary Exposure Assessments for the Tolerance Reassessment Eligibility Decision
(TRED). August 18, 2005.
4. William P. Eckel (USEPA/OPPTS/OPP/EFED). Tier 2 Drinking Water Assessment for
Fluazifop-P-butyl and its Major Degradate Fluazifop-acid: Response to Phase 3 Comments.
May 11,2005.
5. Ken Dockter (USEPA/OPPTS/OPP/HED). Fluazifop-P-butyl. List B Reregistration Case
2285. PC Code 122809. Product Chemistry Chapter for the Reregistration Eligibility Decision
[RED] Document. February 25, 2004.
6. David G Anderson (USEPA/OPPTS/OPP/HED). Fluazifop-butyl/Fluazifop-P-butyl - Report
of the Hazard Identification Assessment Review Committee. June 15, 2004.
7. Sherrie L. Kinard (USEPA/OPPTS/OPP/HED). Fluazifop-P-butyl. Report of the Metabolism
Assessment Review Committee. July 8, 2004.
8. Margarita Collantes (USEPA/OPPTS/OPP/HED). Fluazifop-P-butyl: REVISED Residential
Exposure Assessment and Recommendations for the Tolerance Reassessment Eligibility
Decision (TRED) Document August 10, 2004.
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