80 FR 46816 - Fluazifop-P-Butyl; Pesticide Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 151 (August 6, 2015)

Page Range		46816-46822
FR Document		2015-18825

This regulation amends a tolerance for residues of fluazifop- P-butyl in or on sweet potato, roots. Syngenta Crop Protection requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 80 Issue 151 (Thursday, August 6, 2015)

[Federal Register Volume 80, Number 151 (Thursday, August 6, 2015)]
[Rules and Regulations]
[Pages 46816-46822]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-18825]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0441; FRL-9930-99]

Fluazifop-P-Butyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends a tolerance for residues of fluazifop-
P-butyl in or on sweet potato, roots. Syngenta Crop Protection
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective August 6, 2015. Objections and
requests for hearings must be received on or before October 5, 2015,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0441, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0441 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 5, 2015. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0441, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or

[[Page 46817]]

other information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

In the Federal Register of September 5, 2014 (79 FR 53009) (FRL-
9914-98), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4F8262) by Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC
27419-8300. The petition requested that 40 CFR 180.411 be amended by
amending the established tolerance for residues of the herbicide
fluazifop-P-butyl in or on sweet potato, roots from 0.05 parts per
million (ppm) to 1.5 ppm. That document referenced a summary of the
petition prepared by Syngenta, the registrant, which is available in
the docket, http://www.regulations.gov. No FFDCA-related comments were
received on the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

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. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA 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 and to make a
determination on aggregate exposure for fluazifop-P-butyl including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fluazifop-P-
butyl 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.
Fluazifop-P-butyl is the R enantiomer of fluazifop-butyl [(R,S)-2-
(4-((5-(trifluoromethyl)-2-pyridinyl)oxy)phenoxy)propanoic acid, butyl
ester]. The toxicology database for fluazifop-P-butyl consists of
studies conducted using fluazifop-butyl (racemic mixture) and its
enriched R-isomer, fluazifop-P-butyl. Comparison studies have shown
similar toxicities from both compounds. Metabolism studies have been
conducted in the rat with fluazifop-butyl, and absorption, excretion,
and confirmatory metabolism studies in the dog with fluazifop-butyl,
and hamster with fluazifop-P-butyl. Comparative metabolism studies in
the rat show that both fluazifop-P-butyl and fluazifop-butyl mixed
isomers are rapidly hydrolyzed to fluazifop acid and the [S] enantiomer
is rapidly converted to the [R] enantiomer in the blood, yielding
similar toxicities. In vivo, the S-isomer quickly converts to the R-
isomer.
Oral dog and female rat studies show similar results, while male
rats show greater toxicity. Fluazifop-butyl is rapidly absorbed through
the gut after oral dosing and the ester linkage is hydrolyzed to
produce the fluazifop acid in the blood. No parent fluazifop-ester was
detected in plasma at any time. Male rats show similar fluazifop acid
excretion to the female, but excretion is slower, because fluazifop is
excreted in the bile and results in a higher percentage in the feces.
The liver and kidney are its target organs expressed for the most
part as liver toxicity in the presence of peroxisome proliferation and
exacerbation of age-related kidney toxicity. These data are reasonably
consistent among the rat with fluazifop-butyl and fluazifop-P-butyl,
dog with fluazifop-butyl, and hamster with fluazifop-P-butyl.
Fluazifop-P-butyl shows similar toxicity by both the inhalation and
oral routes.
Although the liver and kidney were the organs most consistently
affected, other findings were used as endpoints for selection of the
points of departure. A rat developmental study exhibiting diaphragmatic
hernia effects was used as the basis to select the acute dietary
endpoint for females 13-49 years of age. The short-term incidental oral
and children's dermal endpoints were selected based upon a maternal
body weight gain decrement exhibited in the developmental toxicity
studies performed on rats. The chronic dietary (all populations),
intermediate-term dermal and inhalation, as well as the intermediate-
term incidental oral endpoints, were selected from the 2-generation
reproduction study in rats. This study was significant in exhibiting
decreased testes and epididymal weights in males, along with decreased
uterine and pituitary weights in females. In regard to the short-term
dermal for adults and inhalation endpoints used in this assessment, the
developmental toxicity studies performed on rats were used as the basis
for endpoint selection. These studies were notable in exhibiting
decreased fetal weights, as well as hydroureter and delayed
ossification effects. An additional endpoint was chosen that was
specific for short-term dermal exposure to children, as a developmental
effect is generally protective of pregnant women and fetuses. In this
case, the maternal toxicity (body weight gain decrement) was chosen to
be protective of children.
Indications of possible neurotoxicity were observed in the acute
neurotoxicity study, including clinical signs indicative of toxicity
(reduced activity, decreased rearing, hunched posture and/or
piloerection), decreased body temperature, and decreased motor activity
(total distance and number of rearings). No signs of neurotoxicity were
observed in the subchronic neurotoxicity test at doses up to 70 mg/kg/
day in males and 328 mg/kg/day in females. There was no observed
immunotoxicity resulting from fluazifop-P-butyl exposure in the
submitted study. There was no carcinogenicity observed in acceptable
studies in the rat with fluazifop-butyl or in the hamster for
fluazifop-P-butyl. The hamster was selected for cancer study, because
liver peroxisome proliferation more closely resembled what was found
for human liver cells. There was no mutagenicity observed for
fluazifop-butyl or fluazifop-P-butyl.

[[Page 46818]]

In a dermal absorption and pharmacokinetic study in humans, most of
the applied dose appeared to be in the stratum corneum and easily
removed (the unrecovered test material was speculated to be in the
outer layers of the skin). Peak plasma levels were shown to occur 24 to
31 hours after application in these men. The one half-life for
excretion was about 18 hours. Specific information on the studies
received and the nature of the adverse effects caused by fluazifop-P-
butyl as well as the no-observed-adverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at http://www.regulations.gov in document ``Fluazifop-P-
Butyl. Human-Health Risk Assessment for Sweet Potato Label Amendment
and Resulting Tolerance Increase.'' at pages 28-36 in docket ID number
EPA-HQ-OPP-2014-0441.

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for fluazifop-P-butyl used
for human risk assessment is shown in Table 1 of this unit.

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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (Females 13-49 NOAEL = 50 mg/kg/day Acute RfD = 0.50 mg/ MRIDs: 00088857, 92067047,
years of age). UFA = 10x........... kg/day. 00088858, 92067048, Rat
UFH = 10x........... developmental.
FQPA SF = 1x........ Developmental LOAEL = 200 mg/kg/
day based on diaphragmatic
hernia.
Acute dietary (General population .................... ................... An appropriate endpoint for the
including infants and children). general population attributable
to a single dose was not
identified in the available
studies.
Chronic dietary (All populations) NOAEL = 0.74 mg/kg/ Chronic RfD = cPAD MRIDs: 00088859, 92067050, Rat
day. = 0.0074 mg/kg/day. reproduction study; reproductive
UFA = 10x........... LOAEL = 5.8 mg/kg/day based on
UFH = 10x........... decreased testes and epididymal
FQPA SF = 1x........ weights.
Incidental oral short-term (1 to NOAEL = 100 mg/kg/ Residential LOC for MRIDs: 46082913, 46158401, Rat
30 days). day. MOE = 100. developmental study; maternal
UFA = 10x........... LOAEL = 300 mg/kg/day based on
UFH = 10x........... maternal body weight gain
FQPA SF = 1x........ decrement during GD 7-16.
Dermal short-term (1 to 30 days: NOAEL = 100 mg/kg/ Residential LOC for MRIDs: 46082913, 46158401, Rat
Children). day. MOE = 100. developmental study; maternal.
DAF= 9% (low LOAEL = 300 mg/kg/day based on
exposure) or 2% maternal body weight gain
(high exposure).. decrement during GD 7-16.
UFA = 10x...........
UFH = 10x...........
FQPA SF = 1x........
Dermal short-term (1 to 30 days: NOAEL = 2.0 mg/kg/ Residential LOC for MRIDs: 46082903, 46082013, Rat
Adults). day. MOE = 100. developmental study;
DAF = 9% (low Developmental
exposure) or 2% LOAEL = 5.0 mg/kg/day based on
(high exposure).. fetal weight decrement,
UFA = 10x........... hydroureter, and delayed
UFH = 10x........... ossification.
FQPA SF = 1x........
Inhalation short-term (1 to 30 Inhalation (or oral) Residential LOC for MRIDs: 46082903, 46082013, Rat
days). study NOAEL = 2.0 MOE = 100. developmental study;
mg/kg/day Developmental
(inhalation LOAEL = 5.0 mg/kg/day based on
absorption rate = fetal weight decrement,
100%). hydroureter, and delayed
UFA = 10x........... ossification.
UFH = 10x...........
FQPA SF = 1x........
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[[Page 46819]]

Cancer (Oral, dermal, inhalation) Not likely to be carcinogenic to humans.
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Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to
extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the
absence of key data (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor. PAD = population adjusted
dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A =
not applicable. DAF = dermal absorption factor.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluazifop-P-butyl, EPA considered exposure under the
petitioned-for tolerance as well as all existing fluazifop-P-butyl
tolerances in 40 CFR 180.411. EPA assessed dietary exposures from
fluazifop-P-butyl in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for fluazifop-P-butyl. In estimating acute dietary exposure, EPA used
food consumption information from the United States Department of
Agriculture (USDA) 2003-2008 National Health and Nutrition Survey/What
We Eat in America (NHANES/WWEIA) database. The acute dietary analysis
was conducted using 100% crop treated assumptions and tolerance-level
residues, adjusted as appropriate using factors from the metabolism
studies, to account for residues of concern not measured by the
analytical method.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA database. As to residue levels in food, the chronic
dietary analysis was conducted assuming mean residue levels from crop
field trials with a ratio adjustment for additional metabolites of
concern, average percent crop treated estimates, and experimentally-
determined processing factors.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluazifop-P-butyl does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit
data on PCT.
The Agency estimated the PCT for existing uses as follows: For the
acute dietary analysis, 100 PCT was assumed for all crops. The
following average percent crop treated estimates were used in the
chronic dietary risk assessments for the following crops that are
currently registered for fluazifop-P-butyl: Apricots, 2.5%; asparagus,
2.5%; carrots, 15%; cherries, 1%; cotton, 1%; dry beans/peas. 1%;
garlic, 10%; grapefruit, 15%; grapes, 2.5%; nectarines, 1%; onions,
10%; oranges, 2.5%; peaches, 2.5%; peanuts, 1%; pecans, 1%; peppers,
2.5%; plums, 2.5%; potatoes, 1%; prunes, 2.5%; soybeans, 2.5%; and
sugar beets, 1%; 100 PCT was assumed for sweet potatoes and all other
registered crops not listed above.
To determine PCT values, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for each chemical/crop combination from the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account

[[Page 46820]]

through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
reliable information on the regional consumption of food to which
fluazifop-P-butyl may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluazifop-P-butyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of fluazifop-P-butyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Estimated drinking water concentrations (EDWCs) in ground water
were modeled using Tier I SCIGROW (version 2.3) and surface water EDWCs
were modeled using Tier II PRZM (Pesticide Root Zone Model) and EXAMS
(Exposure Analysis Modeling System). Modeled estimates of drinking
water concentrations were directly entered into the dietary exposure
model. For the acute dietary risk assessment, the surface water
concentration value of 33.4 ppb was used to assess the contribution
from drinking water. For the chronic dietary risk assessment, the
surface water concentration value of 6.6 ppb was used to assess the
contribution from drinking 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).
Fluazifop-P-butyl is currently registered for the following uses
that could result in residential exposures: Non-agricultural outdoor
buildings, building foundations, curbs, driveways, fencerows, non-
agricultural areas (wildlife refuge), non-crop areas, ornamentals
(lawns, flowering shrubs, flowering plants, gardens, ground covers,
plants, trees, turf, and woody shrubs), patios, pathways, rights-of-
way, sidewalks, and storage yards. EPA assessed residential exposure
using the following assumptions. For handlers, there is a potential for
short-term inhalation and dermal exposure. Residential handler exposure
scenarios include handwand, hose and sprayer, backpack, sprinkler can,
and RTU hose end sprayer.
There is also the potential for short-term post-application
exposure for dermal exposure to all groups: Adult and child (1 to <2
years) turf-high contact; adult and youth (11-16 years) mowing; adult,
child (6 to <11 years) and youth (11-16 years) golfing; adult and child
(6 to <11 years) garden. Two separate dermal absorption values were
used: 9% is used for assessing dermal exposures while golfing or mowing
a lawn, since these are representative of low exposure activities
(i.e., the Agency assumes that 9% of dermal exposures will be
absorbed), whereas 2% is used for assessing dermal exposures from high-
contact lawn activities, since these are representative of high-
exposure activities (i.e., the Agency assumes that 2% of dermal
exposures will be absorbed). In addition, there is potential for short-
term post-application incidental oral exposure for children (1 to <2
years). Chemical-specific dislodgeable foliar residue (DFR) data are
available and were used for the residential post application exposure
assessment for gardens. Since Turf Transferable Residue (TTR) data are
not available for fluazifop-P-butyl, default TTR values were used for
the residential post application exposure assessment for turf. Given
the conservatisms associated with default TTR values and the potential
compounding nature of conservatisms in the turf assessment, EPA is able
to rely upon the calculated exposure estimates with confidence that
exposure is not being underestimated. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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.'' EPA has not found
fluazifop-P-butyl to share a common mechanism of toxicity with any
other substances, and fluazifop-P-butyl does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fluazifop-P-butyl
does not have 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity. No increased offspring
sensitivity over parent was seen in the rabbit pre-natal developmental
studies or the rat post-natal reproduction study, and no evidence of
neurotoxicity was observed. Several rat developmental toxicity studies
conducted on both fluazifop-butyl and fluazifop-P-butyl indicate fetal
effects (ranging from delayed ossification, fetal weight decrements,
increased incidence of small fetuses, cervical arches and centrum in
fetuses and litters at levels from 5 to 20 mg/kg/day to diaphragmatic
hernia at 200 mg/kg/day) in the absence of maternal toxicity.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for assessing potential prenatal and
postnatal toxicity of fluazifop-P-butyl to infants and children is
complete.
ii. As there is limited indication of developmental neurotoxicity
resulting from exposure to fluazifop-P-butyl with the current data
sets, there is no need for a developmental neurotoxicity study. There
were no developmental or central nervous system malformations seen in
any of the developmental toxicity studies with rats or rabbits and

[[Page 46821]]

no evidence of neurotoxicity or neuropathology in adult animals in the
available studies. The toxicological significance of the marginal
increases in brain weights at high doses is unknown in the absence of
corroborative histopathological lesions. EPA therefore concludes that
there is not a concern for developmental neurotoxicity resulting from
exposure to fluazifop-butyl or fluazifop-P-butyl.
iii. While there was quantitative evidence of increased
susceptibility in the fetuses of rats exposed in utero to fluazifop-
butyl and fluazifop-P-butyl, EPA concludes that there is no residual
uncertainty for prenatal or postnatal toxicity that would warrant an
additional 10X safety factor. The available studies clearly identify
well-defined NOAELs and LOAELs that are consistent across the five
developmental rat toxicity studies. In addition, the Agency has
selected, based on these studies, a developmental endpoint of concern
(diaphragmatic hernia) for assessing acute dietary risk. As this
endpoint is relevant to single exposures, the acute risk assessment
based on this endpoint will be protective of any fetal effects
resulting from a single exposure. Further, the Agency has selected,
based these studies, a developmental endpoint of concern (delayed
ossifications) for repeat exposure scenarios, which will be protective
of any developmental effects in those scenarios.
iv. There are no residual uncertainties identified in the exposure
databases. There is an adequate toxicity database for fluazifop-P-butyl
and exposure data are complete. The dietary and residential assessments
are based on reliable data and will not underestimate exposure/risk.
EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to fluazifop-P-butyl in
drinking water. EPA used similarly conservative assumptions to assess
post application exposure of children as well as incidental oral
exposure of toddlers. Although EPA has required additional data on
transferable residues from treated turf for fluazifop-P-butyl, EPA is
confident that it has not underestimated turf exposure due to the
conservativeness of the default turf transfer value and conservative
assumptions in the short-term turf assessment procedures (e.g.,
assuming residues do not degrade over the thirty day assessment period
and assuming high-end activities on turf for every day of the
assessment period). The additional data on transferable turf residues
have been required in case refinement of exposure assessments is needed
in the future and to further EPA's general understanding of the
availability of turf transferable pesticide residues. These assessments
will not underestimate the exposure and risks posed by fluazifop-P-
butyl.

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fluazifop will occupy 14% of the aPAD for females 13-49 years old,
the only relevant population subgroup for the acute dietary endpoint.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluazifop-P-butyl from food and water will utilize 64% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
fluazifop-P-butyl is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Fluazifop-P-
butyl is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to Fluazifop-P-butyl.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 210 for adults
and 3100 for children. Because EPA's level of concern for fluazifop-P-
butyl is a MOE of 100 or below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
An intermediate-term adverse effect was identified; however,
fluazifop-P-butyl is not registered for any use patterns that would
result in intermediate-term residential exposure. Intermediate-term
risk is assessed based on intermediate-term residential exposure plus
chronic dietary exposure. Because there is no intermediate-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess intermediate-term risk), no
further assessment of intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for fluazifop-P-butyl.
5. Aggregate cancer risk for U.S. population. Fluazifop-P-butyl has
been classified as ``Not likely to be carcinogenic to humans'';
therefore, EPA concludes that fluazifop-P-butyl will not pose a cancer
risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fluazifop-P-butyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (High Performance Liquid
Chromatography/Ultra-Violet Spectrometry (HPLC/UV)) is available to
enforce the tolerance expression. The method is available in Pesticide
Analytical Methods (PAM), Volume II: Method I for animal tissues and
milk and Method II for crops. The stated detection limits are 0.02-0.05
ppm for crops, 0.01 ppm for milk, and 0.02 ppm for animal tissues.
Improved enforcement methods based on liquid chromatography and tandem
mass spectroscopy, LC/MS/MS, are available as Method GRM044.01A and
Method GRM044.02A. Both of these methods have been validated at 0.01
ppm on a wide variety of crop matrices.

B. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).

[[Page 46822]]

The Codex Alimentarius is a joint United Nations Food and Agriculture
Organization/World Health Organization food standards program, and it
is recognized as an international food safety standards-setting
organization in trade agreements to which the United States is a party.
EPA may establish a tolerance that is different from a Codex MRL;
however, FFDCA section 408(b)(4) requires that EPA explain the reasons
for departing from the Codex level.
The Codex has not established a MRL for fluazifop-P-butyl.

V. Conclusion

Therefore, the tolerance is amended for residues of fluazifop-P-
butyl in or on sweet potato, roots from 0.05 ppm to 1.5 ppm.

VI. Statutory and Executive Order Reviews

This action amends 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 action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), 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).
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.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: July 23, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
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. In Sec. 180.411, revise the commodity ``Sweet potato, roots'' in
the table in paragraph (a) to read as follows:

Sec. 180.411 Fluazifop-P-butyl; tolerances for residues.

(a) * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------

* * * * *
Sweet potato, roots.......................................... 1.5
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-18825 Filed 8-5-15; 8:45 am]
BILLING CODE 6560-50-P

46816 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations

EPA-APPROVED MISSOURI NONREGULATORY SIP PROVISIONS—Continued
Applicable geo-
Name of nonregulatory SIP graphic or nonattain- State submittal date EPA approval date Explanation
provision ment area

(60) Section 128 Declaration: Statewide ................ 8/08/12 .................... 6/21/13; 78 FR [EPA–R07–OAR–2013–0208; FRL–
Missouri Air Conservation 37457 9825–7].
Commission Representation
and Conflicts of Interest Pro-
visions; Missouri Revised
Statutes (RSMo) RSMo
105.450, RSMo 105.452,
RSMo 105.454, RSMo
105.462, RSMo 105.463,
RSMo 105.466, RSMo
105.472, and RSMo
643.040.2.
(61) Section 110(a)(2) Infra- Statewide ................ 12/20/11 .................. 8/19/14, 79 FR [EPA–R07–OAR–2014–0290; FRL–
structure Requirements for 48994 9915–28-Region 7] This action ad-
the 2008 Pb NAAQS. dresses the following CAA elements:
110(a)(2)(A), (B), (C), (D), (E), (F), (G),
(H), (J), (K), (L), and (M).
(62) Implementation Plan for the City of 4/18/13 .................... 10/20/14, 79 FR [EPA–R07–OAR–2014–0448; FRL–
2008 Lead NAAQS. Herculaneum, MO. 62574 9918–18-Region-7]

[FR Doc. 2015–19092 Filed 8–5–15; 8:45 am] Public Reading Room is (202) 566–1744, site at http://www.ecfr.gov/cgi-bin/text-
BILLING CODE 6560–50–P and the telephone number for the OPP idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Docket is (703) 305–5805. Please review 40tab_02.tpl.
the visitor instructions and additional
ENVIRONMENTAL PROTECTION C. How can I file an objection or hearing
information about the docket available
AGENCY request?
at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Under FFDCA section 408(g), 21
40 CFR Part 180 U.S.C. 346a, any person may file an
Susan Lewis, Registration Division
[EPA–HQ–OPP–2014–0441; FRL–9930–99] (7505P), Office of Pesticide Programs, objection to any aspect of this regulation
Environmental Protection Agency, 1200 and may also request a hearing on those
Fluazifop-P-Butyl; Pesticide Tolerance Pennsylvania Ave. NW., Washington, objections. You must file your objection
DC 20460–0001; main telephone or request a hearing on this regulation
AGENCY: Environmental Protection in accordance with the instructions
Agency (EPA). number: (703) 305–7090; email address:
provided in 40 CFR part 178. To ensure
ACTION: Final rule. RDFRNotices@epa.gov.
proper receipt by EPA, you must
SUPPLEMENTARY INFORMATION: identify docket ID number EPA–HQ–
SUMMARY: This regulation amends a
I. General Information OPP–2014–0441 in the subject line on
tolerance for residues of fluazifop-P-
the first page of your submission. All
butyl in or on sweet potato, roots. A. Does this action apply to me? objections and requests for a hearing
Syngenta Crop Protection requested this
You may be potentially affected by must be in writing, and must be
tolerance under the Federal Food, Drug,
this action if you are an agricultural received by the Hearing Clerk on or
and Cosmetic Act (FFDCA).
producer, food manufacturer, or before October 5, 2015. Addresses for
DATES: This regulation is effective
pesticide manufacturer. The following mail and hand delivery of objections
August 6, 2015. Objections and requests and hearing requests are provided in 40
list of North American Industrial
for hearings must be received on or CFR 178.25(b).
Classification System (NAICS) codes is
before October 5, 2015, and must be In addition to filing an objection or
not intended to be exhaustive, but rather
filed in accordance with the instructions hearing request with the Hearing Clerk
provides a guide to help readers
provided in 40 CFR part 178 (see also as described in 40 CFR part 178, please
determine whether this document
Unit I.C. of the SUPPLEMENTARY submit a copy of the filing (excluding
applies to them. Potentially affected
INFORMATION). any Confidential Business Information
entities may include:
ADDRESSES: The docket for this action, • Crop production (NAICS code 111). (CBI)) for inclusion in the public docket.
identified by docket identification (ID) • Animal production (NAICS code Information not marked confidential
number EPA–HQ–OPP–2014–0441, is 112). pursuant to 40 CFR part 2 may be
available at http://www.regulations.gov • Food manufacturing (NAICS code disclosed publicly by EPA without prior
or at the Office of Pesticide Programs 311). notice. Submit the non-CBI copy of your
Regulatory Public Docket (OPP Docket) • Pesticide manufacturing (NAICS objection or hearing request, identified
in the Environmental Protection Agency code 32532). by docket ID number EPA–HQ–OPP–
mstockstill on DSK4VPTVN1PROD with RULES

Docket Center (EPA/DC), West William 2014–0441, by one of the following
Jefferson Clinton Bldg., Rm. 3334, 1301 B. How can I get electronic access to methods:
Constitution Ave. NW., Washington, DC other related information? • Federal eRulemaking Portal: http://
20460–0001. The Public Reading Room You may access a frequently updated www.regulations.gov. Follow the online
is open from 8:30 a.m. to 4:30 p.m., electronic version of EPA’s tolerance instructions for submitting comments.
Monday through Friday, excluding legal regulations at 40 CFR part 180 through Do not submit electronically any
holidays. The telephone number for the the Government Printing Office’s e-CFR information you consider to be CBI or

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Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations 46821

no evidence of neurotoxicity or EPA’s general understanding of the exposure to food and water (considered
neuropathology in adult animals in the availability of turf transferable pesticide to be a background exposure level).
available studies. The toxicological residues. These assessments will not An intermediate-term adverse effect
significance of the marginal increases in underestimate the exposure and risks was identified; however, fluazifop-P-
brain weights at high doses is unknown posed by fluazifop-P-butyl. butyl is not registered for any use
in the absence of corroborative patterns that would result in
E. Aggregate Risks and Determination of
histopathological lesions. EPA therefore intermediate-term residential exposure.
Safety
concludes that there is not a concern for Intermediate-term risk is assessed based
developmental neurotoxicity resulting EPA determines whether acute and on intermediate-term residential
from exposure to fluazifop-butyl or chronic dietary pesticide exposures are exposure plus chronic dietary exposure.
fluazifop-P-butyl. safe by comparing aggregate exposure Because there is no intermediate-term
iii. While there was quantitative estimates to the acute PAD (aPAD) and residential exposure and chronic dietary
evidence of increased susceptibility in chronic PAD (cPAD). For linear cancer exposure has already been assessed
the fetuses of rats exposed in utero to risks, EPA calculates the lifetime under the appropriately protective
fluazifop-butyl and fluazifop-P-butyl, probability of acquiring cancer given the cPAD (which is at least as protective as
EPA concludes that there is no residual estimated aggregate exposure. Short-, the POD used to assess intermediate-
uncertainty for prenatal or postnatal intermediate-, and chronic-term risks term risk), no further assessment of
toxicity that would warrant an are evaluated by comparing the intermediate-term risk is necessary, and
additional 10X safety factor. The estimated aggregate food, water, and EPA relies on the chronic dietary risk
available studies clearly identify well- residential exposure to the appropriate assessment for evaluating intermediate-
defined NOAELs and LOAELs that are PODs to ensure that an adequate MOE term risk for fluazifop-P-butyl.
consistent across the five developmental exists. 5. Aggregate cancer risk for U.S.
rat toxicity studies. In addition, the 1. Acute risk. Using the exposure population. Fluazifop-P-butyl has been
Agency has selected, based on these assumptions discussed in this unit for classified as ‘‘Not likely to be
studies, a developmental endpoint of acute exposure, the acute dietary carcinogenic to humans’’; therefore,
concern (diaphragmatic hernia) for exposure from food and water to EPA concludes that fluazifop-P-butyl
assessing acute dietary risk. As this fluazifop will occupy 14% of the aPAD will not pose a cancer risk.
endpoint is relevant to single exposures, for females 13–49 years old, the only 6. Determination of safety. Based on
the acute risk assessment based on this relevant population subgroup for the these risk assessments, EPA concludes
endpoint will be protective of any fetal acute dietary endpoint. that there is a reasonable certainty that
effects resulting from a single exposure. 2. Chronic risk. Using the exposure
no harm will result to the general
Further, the Agency has selected, based assumptions described in this unit for
population, or to infants and children
these studies, a developmental endpoint chronic exposure, EPA has concluded
from aggregate exposure to fluazifop-P-
of concern (delayed ossifications) for that chronic exposure to fluazifop-P-
butyl residues.
repeat exposure scenarios, which will butyl from food and water will utilize
be protective of any developmental 64% of the cPAD for children 1–2 years IV. Other Considerations
effects in those scenarios. old, the population group receiving the
A. Analytical Enforcement Methodology
iv. There are no residual uncertainties greatest exposure. Based on the
identified in the exposure databases. explanation in Unit III.C.3., regarding Adequate enforcement methodology
There is an adequate toxicity database residential use patterns, chronic (High Performance Liquid
for fluazifop-P-butyl and exposure data residential exposure to residues of Chromatography/Ultra-Violet
are complete. The dietary and fluazifop-P-butyl is not expected. Spectrometry (HPLC/UV)) is available to
residential assessments are based on 3. Short-term risk. Short-term enforce the tolerance expression. The
reliable data and will not underestimate aggregate exposure takes into account method is available in Pesticide
exposure/risk. EPA made conservative short-term residential exposure plus Analytical Methods (PAM), Volume II:
(protective) assumptions in the ground chronic exposure to food and water Method I for animal tissues and milk
and surface water modeling used to (considered to be a background and Method II for crops. The stated
assess exposure to fluazifop-P-butyl in exposure level). Fluazifop-P-butyl is detection limits are 0.02–0.05 ppm for
drinking water. EPA used similarly currently registered for uses that could crops, 0.01 ppm for milk, and 0.02 ppm
conservative assumptions to assess post result in short-term residential for animal tissues. Improved
application exposure of children as well exposure, and the Agency has enforcement methods based on liquid
as incidental oral exposure of toddlers. determined that it is appropriate to chromatography and tandem mass
Although EPA has required additional aggregate chronic exposure through food spectroscopy, LC/MS/MS, are available
data on transferable residues from and water with short-term residential as Method GRM044.01A and Method
treated turf for fluazifop-P-butyl, EPA is exposures to Fluazifop-P-butyl. GRM044.02A. Both of these methods
confident that it has not underestimated Using the exposure assumptions have been validated at 0.01 ppm on a
turf exposure due to the described in this unit for short-term wide variety of crop matrices.
conservativeness of the default turf exposures, EPA has concluded the
B. International Residue Limits
transfer value and conservative combined short-term food, water, and
assumptions in the short-term turf residential exposures result in aggregate In making its tolerance decisions, EPA
assessment procedures (e.g., assuming MOEs of 210 for adults and 3100 for seeks to harmonize U.S. tolerances with
residues do not degrade over the thirty children. Because EPA’s level of international standards whenever
mstockstill on DSK4VPTVN1PROD with RULES

day assessment period and assuming concern for fluazifop-P-butyl is a MOE possible, consistent with U.S. food
high-end activities on turf for every day of 100 or below, these MOEs are not of safety standards and agricultural
of the assessment period). The concern. practices. EPA considers the
additional data on transferable turf 4. Intermediate-term risk. international maximum residue limits
residues have been required in case Intermediate-term aggregate exposure (MRLs) established by the Codex
refinement of exposure assessments is takes into account intermediate-term Alimentarius Commission (Codex), as
needed in the future and to further residential exposure plus chronic required by FFDCA section 408(b)(4).

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Document Created: 2018-02-23 10:55:54
Document Modified: 2018-02-23 10:55:54

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective August 6, 2015. Objections and requests for hearings must be received on or before October 5, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 46816
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements