
[Federal Register Volume 80, Number 151 (Thursday, August 6, 2015)]
[Rules and Regulations]
[Pages 46816-46822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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


