
[Federal Register Volume 82, Number 186 (Wednesday, September 27, 2017)]
[Rules and Regulations]
[Pages 44936-44942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20748]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0878; FRL-9966-67]


Fluazifop-P-Butyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluazifop-p-butyl in or multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective September 27, 2017. Objections and 
requests for hearings must be received on or before November 27, 2017, 
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-2014-0878, 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: Michael Goodis, 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-2014-0878 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 
November 27, 2017. 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-2014-0878, 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 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 April 6, 2015 (80 FR 18327) (FRL-9924-
00), 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 
4E8328) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the herbicide fluazifop-p-butyl 
in or on the raw agricultural commodities lettuce, head and leaf at 5.0 
parts per million (ppm); strawberry at 3.0 ppm; onion, green at 1.5 
ppm; caneberry subgroup 13-07A at 0.05 ppm; bushberry subgroup 13-07B 
at 0.3 ppm; tuberous and corm vegetables (except for potato) subgroup 
1D at 1.5 ppm; small fruit vine climbing, except for fuzzy kiwifruit 
subgroup 13-07F at 0.03 ppm; and onion, bulb subgroup 3-07A at 0.5 ppm 
as well as tolerances with regional registration for grass hay at 15 
ppm; and grass forage at 4.0 ppm. Upon the approval of the 
aforementioned tolerances, IR-4 requested removal of the existing 
tolerances for grape at 0.01 ppm; onion, bulb at 0.5 ppm; and sweet 
potato, roots at 0.05 ppm; and also requested amend the existing 
tolerance for rhubarb from 0.5 ppm to 0.4 ppm. That document referenced 
a summary of the petition prepared by Syngenta Crop Protection, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which tolerances are being established for some 
commodities. The reasons for these changes are explained in Unit IV.C.

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.''

[[Page 44937]]

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.
    The toxicity profile shows that the principal toxic effects of 
fluazifop-P-butyl are changes in the liver and kidney following 
exposure via the oral route. Liver toxicity is observed in rats, 
hamster, and dogs, while kidney toxicity is observed in rats.
    Other adversely effected organs included the testes and eyes in 
rats and hamsters. Adrenal fatty vacuolation and increased incidence of 
thymic involution were noted in the chronic dog study. Gall bladder 
stones and ovarian cell hyperplasia were noted in the carcinogenicity 
study in hamsters. From the toxicity studies, the lowest LOAELs were 
observed in long-term studies, suggesting progression of toxicity with 
duration of treatment.
    Quantitative sensitivity of the fetus was observed in the rat 
developmental studies in which no maternal toxicity was observed. 
Developmental toxicity in the rat was generally related to incomplete 
ossification. At higher doses, decreased fetal body weight and an 
increased incidence of diaphragmatic hernia were observed. In the 
rabbit, maternal and developmental toxicity were observed at the same 
dose. Maternal toxicity included abortions, weight loss, and death, and 
fetal toxicity included abortions, skeletal effects, and fetuses that 
were small and/or had cloudy eyes. In the rat reproduction and 
fertility study, maternal (increased liver weight, bile duct 
hyperplasia, geriatric nephropathy) and offspring (decreased pup 
viability, decreased pup body weight, and hydronephrosis) toxicity were 
observed at the same dose level, and decreased female fertility was 
observed at the highest dose.
    No immunotoxicity was observed at the highest dose tested in the 
immunotoxicity study in rats. Although other studies indicated effects 
on the immune system organs (e.g., thymus effects in the dog), all 
points of departure (PODs) are protective of any possible immunotoxic 
response. Delayed neurotoxicity was not observed in hens, and there was 
no evidence of toxicity in the subchronic neurotoxicity study. In the 
acute neurotoxicity study at the lowest dose tested (500 milligrams/
kilogram (mg/kg)), where a bolus dose is administered by gavage, 
clinical signs indicative of toxicity (reduced activity, decreased 
rearing, hunched posture, and/or piloerection) were observed, as well 
as decreased motor activity (total distance and number of rearings) in 
both sexes. There was no evidence of carcinogenicity or mutagenicity in 
the toxicity profile.
    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 the document title ``Fluazifop-P-butyl. Human-
Health Risk Assessment for New Uses on Lettuce (Leaf and Head), 
Rhubarb, Green Onion, Strawberry, Caneberry Subgroup 13-07A, Bushberry 
Subgroup 13-07B, Fescue Grasses (Grown for Seed); and for Amendments to 
Existing Tolerances [Subgroups 1D, 3-07A, and 13-07F]'' on page 42 in 
docket ID number EPA-HQ-OPP-2014-0878.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD)s 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for fluazifop-P-butyl used 
for human risk assessment is shown in the Table of this unit.

[[Page 44938]]



     Table--Summary of Toxicological Doses and Endpoints for Fluazifop-P-Butyl for Use in Human Health Risk
                                                   Assessment
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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 (General population  LOAEL = 500 mg/kg/    Acute RfD = 0.50 mg/ Acute neurotoxicity--rat.
 including infants and children     day.                  kg/day.             LOAEL = 500 mg/kg, based on
 and females 13-49 years of age).  UFA = 10x...........  aPAD = 0.50 mg/kg/    clinical signs indicative of
                                   UFH = 10x...........   day.                 toxicity (reduced activity,
                                   FQPA SF (UFL) = 10x.                        decreased rearing, hunched
                                                                               posture and/or piloerection), and
                                                                               decreased motor activity (total
                                                                               distance and number of rearings)
                                                                               in both sexes.
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Chronic dietary (All populations)  NOAEL = 0.51 mg/kg/   Chronic RfD =        Combined chronic toxicity/
                                    day.                  0.0051 mg/kg/day.    carcinogenicity--rat.
                                   UFA = 10x...........  cPAD = 0.0051 mg/kg/ LOAEL = 4.15 mg/kg/day, based on
                                   UFH = 10x...........   day.                 increased mortality associated
                                   FQPA SF = 1x........                        with increased severity of
                                                                               nephropathy during the first year
                                                                               in males.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL = 5.8 mg/kg/    LOC for MOE = 100..  Reproduction--rat.
 30 days).                          day.                                      Offspring LOAEL = 17.5 mg/kg/day,
                                   UFA = 10x...........                        based on decreased pup viability
                                   UFH = 10x...........                        (both generations), decreased pup
                                   FQPA SF = 1x........                        weights ([darr]15%) in the F2-
                                                                               generation, and hydronephrosis in
                                                                               the F1 pups.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)   Oral study NOAEL =    LOC for MOE = 100..  Developmental toxicity--rat.
 (General population except         2.0 mg/kg/day                             Developmental LOAEL = 5.0 mg/kg/
 children).                         (dermal absorption                         day based on delayed ossification
                                    rate = 9%).                                in skull bones, sternebrae
                                   UFA = 10x...........                        bipartite, sternebrae partially
                                   UFH = 10x...........                        ossified and calcenum unossified
                                   FQPA SF = 1x........                        in fetuses and litters.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)   Dermal study NOAEL =  LOC for MOE = 100..  21-Day dermal toxicity in rabbits.
 (Children only).                   100 mg/kg/day.                            Offspring LOAEL = 500 mg/kg/day
                                   UFA = 10x...........                        based on death in 1/10 males.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Oral study NOAEL =    LOC for MOE = 1,000  Developmental toxicity--rat.
 days).                             2.0 mg/kg/day                             Developmental LOAEL = 5.0 mg/kg/
                                    (inhalation                                day based on delayed ossification
                                    absorption rate =                          in skull bones, sternebrae
                                    100%).                                     bipartite, sternebrae partially
                                   UFA = 10x...........                        ossified and calcenum unossified
                                   UFH = 10x...........                        in fetuses and litters.
                                   FQPA SF (UFDB) = 10x
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)                     Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL.

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 tolerances 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 2003-2008 food consumption information 
from the U.S. Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, EPA assumed 100 percent crop treated 
(PCT) and tolerance level residues with a ratio adjustment for 
additional metabolites of concern.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data from the USDA's 
NHANES/WWEIA. As to residue levels in food, the Agency used 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.

[[Page 44939]]

    iii. Cancer. 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 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 average PCT for existing uses as follows:
    Asparagus, 2.5%; carrots, 15%; 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%; plums, 2.5%; potatoes, 
1%, prunes, 2.5%; soybeans, 2.5%; and sugar beets, 1%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS) and proprietary market surveys for the chemical/crop 
combination for the most recent 6-7 years. EPA uses an average PCT for 
chronic dietary risk analysis and a maximum PCT for acute 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 2.5%. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 6 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5%, except for situations in which the maximum PCT is less than 
2.5%. In cases where the estimated value is less than 2.5% but greater 
than 1%, the average and maximum PCT used are 2.5%. If the estimated 
value is less than 1%, 1% is used as the average PCT and 2.5% is used 
as the maximum PCT.
    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 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Surface Water Concentration Calculator (SWCC) model 
and the Pesticide Root Zone Model Ground Water (PRZM-GW) model, the 
estimated drinking water concentrations (EDWCs) of fluazifop-P-butyl 
for acute exposures are estimated to be 56.6 parts per billion (ppb) 
for surface water and 6.8 ppb for ground water and for chronic 
exposures are estimated to be 4.41 ppb for surface water and 3.39 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 56.6 ppb was used to 
assess the contribution to drinking water. For the chronic dietary risk 
assessment, the water concentration of value 4.41 ppb was used to 
assess the contribution to 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: Lawns/turf and ornamentals. 
EPA assessed residential exposure using the following assumptions: For 
handlers, exposure is expected as a result of application to turf and 
ornamentals. Post-application exposure is also expected as a result of 
being in an environment that has been previously treated with 
fluazifop-P-butyl.
    For adult handlers, risk estimates are presented as an aggregated 
risk index (ARI) since the PODs for dermal and inhalation routes of 
exposure are based on the same study/effects, but have different LOCs 
(dermal LOC = 100 and inhalation LOC = 1000). The target ARI is 1; ARIs 
of less than 1 are risk estimates of concern. None of the residential 
handler scenarios resulted in a risk estimate of concern (i.e., all 
ARIs >=1).
    For post-application, only dermal and incidental oral (for kids 
only) exposures were assessed. Since the PODs for these routes are 
based on the same effects and have the same LOC, risk estimates can be 
combined. All residential post-application MOEs are greater than the 
LOC of 100, and are therefore not of concern.
    The Agency used the worst-case exposure scenarios for all 
population subgroups for recommendation for inclusion in the aggregate 
assessment. The residential exposure scenario used in the adult 
aggregate assessment is dermal and inhalation handler exposure

[[Page 44940]]

from applications to gardens/trees using a backpack sprayer. The 
residential exposure scenario used in the youth (11 to <16 years) 
aggregate assessment is dermal post-application exposure from golfing 
on treated turf. The residential exposure scenario used in the child (6 
to <11 years) aggregate assessment is dermal post-application exposure 
from activities in treated gardens. The residential exposure scenario 
used in the child (1 to <2 years) aggregate assessment reflects 
combined dermal plus hand-to-mouth post-application exposure from high 
contact activities on treated turf. The PODs for the adult dermal and 
inhalation routes of exposure are based on the same study and based on 
the same effects; however, the LOCs are different (dermal LOC = 100 and 
inhalation LOC = 1000). Therefore, a total aggregated risk index (ARI) 
was used to combine risk estimates. The aggregate risk index (ARI) is 
calculated as follows:
    Aggregate Risk Index (ARI) = 1 / [(Dermal LOC / Dermal MOE) + 
(Inhalation LOC / Inhalation MOE)]. The target ARI is 1; ARIs of less 
than 1 are risk estimates of concern. Further information regarding EPA 
standard assumptions and generic inputs for residential exposures may 
be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 (FQPA 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. Quantitative sensitivity of 
the fetus was observed in the rat developmental studies in which no 
maternal toxicity was observed. Developmental toxicity in the rat was 
generally related to incomplete ossification. At higher doses, 
decreased fetal body weight and an increased incidence of diaphragmatic 
hernia were observed. In the rabbit, maternal and developmental 
toxicity were observed at the same dose. Maternal toxicity included 
abortions, weight loss, and death, and fetal toxicity included 
abortions, skeletal effects, and fetuses that were small and/or had 
cloudy eyes. In the rat reproduction and fertility study, maternal 
(increased liver weight, bile duct hyperplasia, geriatric nephropathy) 
and offspring (decreased pup viability, decreased pup body weight, and 
hydronephrosis) toxicity were observed at the same dose level, and 
decreased female fertility was observed at the highest dose.
    3. Conclusion. For acute dietary and inhalation short-term exposure 
scenarios, the Agency is retaining the FQPA safety factor of 10x for 
the use of a LOAEL to extrapolate a NOAEL (acute dietary) and to 
account for the lack of a subchronic inhalation toxicity study 
(inhalation short-term). 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 for the chronic dietary, incidental oral, 
and dermal short-term exposure scenarios. That decision is based on the 
following findings:
    i. The toxicity database for fluazifop-P-butyl for assessing these 
scenarios is complete.
    ii. Possible signs of neurotoxicity were observed at 500 mg/kg in 
the acute neurotoxicity study. The clinical signs observed included 
reduced activity, decreased rearing, hunched posture and/or 
piloerection, and decreased motor activity (total distance and number 
of rearings) in both sexes. However, considering that this was a bolus 
(gavage) dose at half the limit dose, the nature of the observations 
and the lack of neuropathology suggests that the findings were a result 
of generalized toxicity rather than neurotoxicity.
    Slight increases in absolute (2.5%) and relative (1.6%) brain 
weights were seen in both sexes at 3,000 ppm ([ap]194 mg/kg/day) at 
termination in the carcinogenicity study in hamsters. Slight increases 
in brain weights were seen in female rats (2.9%) at 100 mg/kg/day and 
in male hamsters (4%) at 120 mg/kg/day after subchronic exposures with 
fluazifop-P-butyl. The toxicological significance of the marginal 
increases in brain weights at high doses is unknown in the absence of 
corroborative histopathological lesions.
    The Agency concluded that there was not a concern for neurotoxicity 
resulting from exposure to fluazifop-P-butyl at relevant exposure 
levels. The only indication of potential neurotoxicity was due to a 
large (500 mg/kg) bolus dose (gavage) in the acute neurotoxicity study. 
No developmental or central nervous system malformations were seen in 
any of the developmental toxicity studies with rats or rabbits. No 
increased offspring sensitivity over parent was seen in the rabbit pre-
natal developmental studies or in the rat post-natal reproduction 
study, and no evidence of neurotoxicity or neuropathology was observed 
in adult animals. Although malformed fetuses were seen at high dose 
levels in the absence of maternal toxicity in the rat developmental 
toxicity studies, the definitive developmental endpoint in five 
developmental studies was selected based on delayed ossification and 
fetal weight decrement at much lower doses (100-fold lower). Therefore, 
the conditions were not met for requiring a developmental neurotoxicity 
study.
    iii. There was no indication of fetal or offspring susceptibility 
in rabbit developmental or rat reproduction studies. Quantitative 
sensitivity of the fetus was noted in the rat developmental studies as 
described above. However, the selected PODs are protective for all 
exposure scenarios where the developing fetus is of concern. Therefore, 
the degree of concern is low.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments include assumptions 
that result in high-end estimates of dietary food exposure.

[[Page 44941]]

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. 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-P-butyl will occupy 42% of the aPAD for children 1-2 years 
old, the population group receiving the greatest exposure.
    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 49% 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 ARIs of 2.1 for adults, 
51 for youths 11-16 years old, 13 for children 6-11 years old, and 1.7 
for children 1-2 years old. Because EPA's level of concern for 
fluazifop-P-butyl is an ARI of 1 or below, these ARIs 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).
    Intermediate-term adverse effects were 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. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fluazifop-P-butyl is not expected to pose a cancer risk to 
humans.
    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.

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). 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 any MRLs for fluazifop-P-butyl.

C. Revisions to Petitioned-For Tolerances

    The petitioner requested a tolerance of 5.0 ppm for ``Lettuce, head 
and leaf''. This is not a standard commodity definition. Rather, the 
Agency is establishing separate tolerances for ``Lettuce, head'' and 
``Lettuce, leaf'' at 3.0 and 5.0 ppm, respectively, as determined by 
the Organization for Economic Cooperation and Development (OECD) MRL 
calculation procedures. The caneberry subgroup 13-07A tolerance is 
being established at 0.08 ppm instead of 0.05 ppm as requested since 
two of the raspberry trials were determined not to be independent. The 
requested tolerances for grass forage and hay is being established as 
fescue forage and hay because the use requested for the corresponding 
pesticide registration is limited to fescue grass varieties. In 
addition, where appropriate, EPA has modified the numerical expression 
of tolerance values in order to conform to current Agency policy on 
significant figures.

V. Conclusion

    Therefore, tolerances are established for residues of fluazifop-P-
butyl, butyl (2R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoate, including its metabolites and 
degradates, in or on the bushberry subgroup 13-07B at 0.30 ppm; 
caneberry subgroup 13-07A at 0.08 ppm; fescue, forage at 4.0 ppm 
(tolerance with regional registrations); fescue, hay at 15 ppm 
(tolerance with regional registrations); fruit, small vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F at 0.03 ppm; lettuce, head at 
3.0 ppm; lettuce, leaf at 5.0 ppm; onion, bulb, subgroup 3-07A at 0.50 
ppm; onion, green at 1.5 ppm; strawberry at 3.0 ppm; and vegetable, 
tuberous and corm, except potato, subgroup 1D at 1.5 ppm.
    Additionally, the existing tolerances for grape; onion, bulb; and 
sweet potato, roots are removed as unnecessary, since they are covered 
by the newly established crop group tolerances, and the tolerance with 
regional registrations for rhubarb at 0.5 ppm, currently under section 
180.411(c), will now be listed in

[[Page 44942]]

section 180.411(a) since it will now have a national registration.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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: August 30, 2017.
Michael L. Goodis,
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:
0
a. Add alphabetically the commodities ``Bushberry subgroup 13-07B''; 
``Caneberry subgroup 13-07A''; and ``Fruit, small vine climbing, except 
fuzzy kiwifruit, subgroup 13-07F'' to the table in paragraph (a);
0
b. Remove the commodity ``Grape'' in the table in paragraph (a);
0
c. Add alphabetically the commodities ``Lettuce, head'' and ``Lettuce, 
leaf'' to the table in paragraph (a);
0
d. Remove the commodity ``Onion, bulb'' in the table in paragraph (a);
0
e. Add alphabetically the commodities ``Onion, bulb, subgroup 3-07A''; 
``Onion, green''; ``Rhubarb''; and ``Strawberry'';
0
f. Remove the commodity ``Sweet potato, roots'' in the table in 
paragraph (a);
0
g. Add alphabetically the commodity ``Vegetable, tuberous and corm, 
except potato, subgroup 1D'' to the table in paragraph (a);
0
h. Add alphabetically the commodities ``Fescue, forage''; and ``Fescue, 
hay'' to the table in paragraph (c); and
0
i. Remove the commodity ``Rhubarb'' from the table in paragraph (c).
    The additions read as follows:


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

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Bushberry subgroup 13-07B...................................        0.30
Caneberry subgroup 13-07A...................................        0.08
 
                                * * * * *
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup        0.03
 13-07F.....................................................
 
                                * * * * *
Lettuce, head...............................................         3.0
Lettuce, leaf...............................................         5.0
 
                                * * * * *
Onion, bulb, subgroup 3-07A.................................        0.50
Onion, green................................................         1.5
 
                                * * * * *
Rhubarb.....................................................        0.50
 
                                * * * * *
Strawberry..................................................         3.0
Vegetable, tuberous and corm, except potato, subgroup 1D....         1.5
------------------------------------------------------------------------

* * * * *
    (c) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fescue, forage..............................................         4.0
Fescue, hay.................................................          15
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-20748 Filed 9-26-17; 8:45 am]
BILLING CODE 6560-50-P


