44936 Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations 

* * * * * 

[FR Doc. 2017–20598 Filed 9–26–17; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

SUMMARY: This regulation establishes 

tolerances for residues of fluazifop-pbutyl 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/textidx?&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-pbutyl 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.’’ 


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Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations 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-Pbutyl 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-effectlevel (NOAEL) and the lowest-observedadverse-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-andassessing-pesticide-risks/assessinghuman-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. 


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44938 Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUAZIFOP-P-BUTYL FOR USE IN HUMAN HEALTH

RISK ASSESSMENT

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (General population including infants and 

children and females 13–49 

years of age).

LOAEL = 500 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF (UFL) = 

10x 

Acute RfD = 0.50 

mg/kg/day.

aPAD = 0.50 mg/kg/ 

day 

Acute neurotoxicity—rat. 

LOAEL = 500 mg/kg, based on clinical signs indicative of toxicity (reduced activity, decreased rearing, hunched posture 

and/or piloerection), and decreased motor activity (total distance and number of rearings) in both sexes. 

Chronic dietary (All populations) NOAEL = 0.51 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 

0.0051 mg/kg/day.

cPAD = 0.0051 mg/ 

kg/day 

Combined chronic toxicity/carcinogenicity—rat. 

LOAEL = 4.15 mg/kg/day, based on increased mortality associated with increased severity of nephropathy during the first 

year in males. 

Incidental oral short-term (1 to 

30 days).

NOAEL = 5.8 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Reproduction—rat. 

Offspring LOAEL = 17.5 mg/kg/day, based on decreased pup 

viability (both generations), decreased pup weights (↓15%) in 

the F2-generation, and hydronephrosis in the F1 pups. 

Dermal short-term (1 to 30 

days) (General population except children).

Oral study NOAEL = 

2.0 mg/kg/day 

(dermal absorption 

rate = 9%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Developmental toxicity—rat. 

Developmental LOAEL = 5.0 mg/kg/day based on delayed ossification in skull bones, sternebrae bipartite, sternebrae partially ossified and calcenum unossified in fetuses and litters. 

Dermal short-term (1 to 30 

days) (Children only).

Dermal study 

NOAEL = 100 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 21-Day dermal toxicity in rabbits. 

Offspring LOAEL = 500 mg/kg/day based on death in 1/10 

males. 

Inhalation short-term (1 to 30 

days).

Oral study NOAEL = 

2.0 mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF (UFDB) = 

10x 

LOC for MOE = 

1,000.

Developmental toxicity—rat. 

Developmental LOAEL = 5.0 mg/kg/day based on delayed ossification in skull bones, sternebrae bipartite, sternebrae partially ossified and calcenum unossified in fetuses and litters. 

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. 


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Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations 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-assessingpesticide-risks/about-water-exposuremodels-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 nonoccupational, 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 postapplication 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 


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44940 Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations 

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-scienceand-assessing-pesticide-risks/standardoperating-procedures-residentialpesticide. 

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-andassessing-pesticide-risks/cumulativeassessment-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 fluazifopP-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 (≈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 postnatal 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 highend estimates of dietary food exposure. 


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Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations 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-Pbutyl 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-Pbutyl 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 intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm 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-Pbutyl 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 


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44942 Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations 

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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.411: 

■ 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); 

■ b. Remove the commodity ‘‘Grape’’ in 

the table in paragraph (a); 

■ c. Add alphabetically the 

commodities ‘‘Lettuce, head’’ and 

‘‘Lettuce, leaf’’ to the table in paragraph 

(a); 

■ d. Remove the commodity ‘‘Onion, 

bulb’’ in the table in paragraph (a); 

■ e. Add alphabetically the 

commodities ‘‘Onion, bulb, subgroup 3– 

07A’’; ‘‘Onion, green’’; ‘‘Rhubarb’’; and 

‘‘Strawberry’’; 

■ f. Remove the commodity ‘‘Sweet 

potato, roots’’ in the table in paragraph 

(a); 

■ g. Add alphabetically the commodity 

‘‘Vegetable, tuberous and corm, except 

potato, subgroup 1D’’ to the table in 

paragraph (a); 

■ h. Add alphabetically the 

commodities ‘‘Fescue, forage’’; and 

‘‘Fescue, hay’’ to the table in paragraph 

(c); and 

■ i. Remove the commodity ‘‘Rhubarb’’ 

from the table in paragraph (c). 

The additions read as follows: 

§ 180.411 Fluazifop-P-butyl; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Bushberry subgroup 13–07B ...... 0.30 

Caneberry subgroup 13–07A ..... 0.08 

* * * * * 

Fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13– 

07F .......................................... 0.03 

* * * * * 

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) * * * 

Commodity Parts per 

million 

* * * * * 

Fescue, forage ............................ 4.0 

Fescue, hay ................................ 15 

* * * * * 

* * * * * 

[FR Doc. 2017–20748 Filed 9–26–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2016–0049; FRL–9966–68] 

Oxathiapiprolin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 


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