45730 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0727; FRL–9966–09] 

Fluoxastrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluoxastrobin 

in or on multiple commodities which 

are identified and discussed later in this 

document. Arysta LifeScience North 

America, LLC requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 2, 2017. Objections and 

requests for hearings must be received 

on or before December 1, 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–2015–0727, 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–2015–0727 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 December 1, 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– 

2015–0727, 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 March 16, 

2016 (81 FR 14030) (FRL–9942–86), 

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 5F8406) by Arysta 

LifeScience North America, LLC, 15401 

Weston Parkway, Suite 150, Cary, North 

Carolina, 27513. The petition requested 

that 40 CFR 180.609 be amended by 

establishing tolerances for residues of 

the fungicide fluoxastrobin, (1E)-[2-[[6- 

(2-chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]oxy]phenyl] (5,6-dihydrol,4,2-dioxazin-3-yl)methanone Omethyloxime, and its Z isomer, (1Z)-[2- 

[[6-(2chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]oxy]phenyl] (5,6-dihydrol,4,2-dioxazin-3-yl)methanone Omethyloxime, in or on avocado at 0.9 

parts per million (ppm); barley, grain at 

0.4 ppm; barley, hay at 15 ppm; barley, 

straw at 15 ppm; rapeseed subgroup 

20A at 0.8 ppm; and dried shelled pea 

and bean (except soybean) subgroup 6C 

at 0.2 ppm. No comments were 

submitted on this notice of filing. Based 

on data submitted with the petition, the 

tolerances established by the Agency in 

this action differ slightly from what the 

petitioner requested. The reasons for 

these deviations are discussed 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.’’ 

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 


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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 fluoxastrobin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluoxastrobin 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. 

In mammals, the liver and kidney 

were the main target organs. Liver 

effects (cholestasis) were observed in 

dogs following subchronic and chronic 

oral exposures. Dogs were the more 

sensitive species, with liver effects in 

dogs occurring at a 35-fold lower dose 

than elicited adverse effects in other 

species. Kidney effects were observed in 

rats and dogs following subchronic 

exposures, but not following chronic 

exposures. In rats, effects were also 

observed in the adrenal glands, urinary 

bladder, and urethra. There were doserelated changes in the liver and kidneys 

of mice, however, the changes were not 

considered to be adverse. 

There was no evidence of increased 

quantitative or qualitative fetal or 

offspring susceptibility in the 

developmental toxicity studies in rats or 

rabbits or the two-generation 

reproduction toxicity study in rats. 

There were no maternal or 

developmental effects in the rat 

developmental study. In the 

developmental toxicity study in rabbits, 

maternal effects (cold ears, transient 

body-weight loss, and decreased food 

consumption) occurred in the absence 

of fetal toxicity. In the two-generation 

reproduction study in rats, offspring 

effects (decreased body weights, delayed 

preputial separation, and incomplete 

ossification) occurred at the same dose 

as parental toxicity (decreased 

premating absolute body weight and 

body-weight gain). 

Fluoxastrobin has low acute toxicity 

via the oral, dermal, and inhalation 

routes of exposure. Overall, it is mildly 

irritating to the eyes, but is neither a 

dermal irritant nor a dermal sensitizer. 

There were no signs of neurotoxicity or 

immunotoxicity in the database. 

Fluoxastrobin is classified as ‘‘Not 

Likely to be Carcinogenic to Humans’’ 

based on the absence of treatmentrelated tumors in two adequate rodent 

carcinogenicity studies. There was no 

concern for mutagenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluoxastrobin as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Human Health Risk Assessment in 

Support of Application to Avocado, 

Barley, Rapeseed subgroup 20A, and 

Dried Shelled Pea and Bean on pages 14 

and 15 in docket ID number EPA–HQ– 

OPP–2015–0727. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for fluoxastrobin used for 

human risk assessment is shown in the 

Table of this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUOXASTROBIN 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 (All Populations) No appropriate toxicological effect attributable to a single dose was observed. Therefore, a dose and endpoint 

were not identified for this risk assessment. 

Chronic dietary (All populations) NOAEL = 1.5 mg/kg/ 

day.

UFA = 10x ................

UFH = 10x ................

FQPA SF = 1x .........

Chronic RfD = 0.015 

mg/kg/day.

cPAD = 0.015 mg/ 

kg/day.

Chronic Toxicity Study in Dogs. 

LOAEL = M/F 8.1/7/7 mg/kg/day based on body weight reductions and hepatocytomegaly and cytoplasmic changes associated with increased serum liver alkaline phosphatase indicative of cholestasis. 

Incidental oral short-term (1–30 

days) and Intermediate-term 

(1–6 months).

NOAEL = 3.0 mg/kg/ 

day.

UFA = 10x ................

UFH = 10x ................

FQPA SF = 1x .........

LOC for MOE = 

<100.

90-Day Toxicity in Dogs. 

LOAEL = 24 mg/kg/day based on reductions in body-weight 

gain and food efficiency, liver effects (cholestasis), and kidney effects (increased relative weights in females, degeneration of proximal tubular epithelium in males). 


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45732 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUOXASTROBIN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Dermal short-term (1–30 days) 

and intermediate-term (1–6 

months).

Oral study NOAEL = 

3.0 mg/kg/day 

(dermal absorption 

rate = 2.3%.

UFA = 10x ................

UFH = 10x ................

FQPA SF = 1x .........

Residential LOC for 

MOE = <100.

Occupational LOC 

for MOE = <100.

90-Day Toxicity in Dog. 

LOAEL = 24 mg/kg/day based on reductions in body-weight 

gain and food efficiency, liver effects (cholestasis), and kidney effects (increased relative weights in females, degeneration of proximal tubular epithelium in males). 

Inhalation short and Intermediate-Term.Oral study NOAEL = 

3.0 mg/kg/day (inhalation toxicity is 

considered equivalent to oral toxicity).

UFA = 10x ................

UFH = 10x ................

FQPA SF = 1x .........

Residential LOC for 

MOE = <100.

Occupational LOC 

for MOE = <100.

90-Day Toxicity in Dogs. 

LOAEL = 24 mg/kg/day based on reductions in body-weight 

gain and food efficiency, liver effects (cholestasis), and kidney effects (increased relative weights in females, degeneration of proximal tubular epithelium in males). 

Cancer (Oral, dermal, inhalation).Classification: Fluoxastrobin is classified as ‘‘not likely to be carcinogenic to humans’’ based on the absence of 

treatment-related tumors in two adequate rodent carcinogenicity studies. 

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). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluoxastrobin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fluoxastrobin tolerances in 40 

CFR 180.609. EPA assessed dietary 

exposures from fluoxastrobin 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. No such effects were 

identified in the toxicological studies 

for fluoxastrobin; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEM–FCID, Version 

3.16, food consumption data from the 

2003–2008 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 tolerance-level residues 

for livestock commodities, average field 

trial residues for some crop 

commodities, and percent crop treated 

(PCT) and percent crop treated for new 

use (PCTn) estimates for some 

commodities. DEEM version 7.81 

default processing factors were 

assumed, except for tolerances that were 

established for processed commodities 

or when processing studies showed no 

concentration. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fluoxastrobin does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of the FFDCA authorizes 

EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

408(f)(1) that data be provided 5 years 

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. In addition, the 

Agency must provide for periodic 

evaluation of any estimates used. To 

provide for the periodic evaluation of 

the estimate of PCT as required by 

FFDCA section 408(b)(2)(F), EPA may 

require registrants to submit data on 

PCT. 

The Agency estimated the PCT for 

existing uses as follows: corn, 1.0%; 

peanuts, 2.5%; peppers, 2.5%; potatoes, 

1.0%; soybeans, 1.0%; and wheat, 2.5%. 

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 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 


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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 estimated the PCT for 

new uses as follows: avocado, 12%; 

barley, 16%; canola, 9%; and dry beans/ 

peas, 14%. 

EPA estimates percent crop treated for 

new uses (PCTn) of fluoxastrobin based 

on the PCT of the dominant pesticide 

(i.e., the one with the greatest PCT) used 

on that crop over the three most recent 

years of available data. Comparisons are 

only made among pesticides of the same 

pesticide types (i.e., the dominant 

fungicide on the crop is selected for 

comparison with a new fungicide). The 

PCTs included in the analysis may be 

for the same pesticide or for different 

pesticides since the same or different 

pesticides may dominate for each year. 

Typically, EPA uses USDA/NASS as the 

source for raw PCT data because it is 

publicly available and does not have to 

be calculated from available data 

sources. When a specific use site is not 

surveyed by USDA/NASS, EPA uses 

proprietary market research data or 

other publicly available state data when 

80% or more of the crop acreage is 

grown in that state and calculates the 

PCTn. 

This estimated PCTn, based on the 

average PCT of the market leader, is 

appropriate for use in the chronic 

dietary risk assessment. This method of 

estimating a PCT for a new use of a 

registered pesticide or a new pesticide 

produces a high-end estimate that is 

unlikely, in most cases, to be exceeded 

during the initial five years of actual 

use. The predominant factors that bear 

on whether the estimated PCTn could 

be exceeded are (1) the extent of pest 

pressure on the crops in question; (2) 

the pest spectrum of the new pesticide 

in comparison with the market leaders 

as well as whether the market leaders 

are well-established for this use; and (3) 

resistance concerns with the market 

leaders. EPA has examined the relevant 

data and determined that it is unlikely 

that the actual PCT with fluoxastrobin 

on avocado, barley, canola (rapeseed 

subgroup 20A) and dried shelled pea 

and bean (crop subgroup 6C) will 

exceed the PCTn within the next five 

years. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT and PCTn 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 fluoxastrobin 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 fluoxastrobin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fluoxastrobin. 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. 

The estimated drinking water 

concentrations (EDWCs) in surface 

water resulting from the proposed 

fluoxastrobin uses were calculated using 

the pesticide water calculator (PWC). 

Groundwater EDWCs for fluoxastrobin 

were derived for the proposed and 

existing uses using PRZM-Groundwater 

(PRZM GW). Based on PRZM GW, the 

EDWCs of fluoxastrobin for chronic 

exposures for non-cancer assessments 

are estimated to be 47.8 ppb for surface 

water and 182 ppb for ground water. 

The more conservative modeled 

estimate of drinking water 

concentrations (182 ppb) was directly 

entered into the dietary exposure model 

to assess the contribution to drinking 

water and chronic dietary risk. 

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). 

Fluoxastrobin is currently registered 

for the following uses that could result 

in residential exposures: Broadcast 

control of diseases on turf, including 

lawns and golf courses. EPA assessed 

residential exposure using the following 

assumptions: 

i. Residential Handler Exposure: All 

registered fluoxastrobin product labels 

with residential use sites (e.g., turf and 

ornamentals) require that handlers wear 

specific clothing (e.g., long sleeve shirt/ 

long pants) and/or use personalprotective equipment (PPE). Therefore, 

the Agency has made the assumption 

that these products are not intended for 

homeowner use, and has not conducted 

a quantitative residential handler 

assessment. 

ii. Residential Post-Application 

Exposure: Adults and children 

performing physical activities on turf 

and ornamentals during postapplication activities (e.g., high-contact 

lawn activities, mowing, and gardening) 

may receive dermal exposure to 

fluoxastrobin residues. Young children 

1 to <2 years old may also receive 

incidental oral post-application 

exposure to fluoxastrobin from treated 

turf. Residential post-application 

exposure is expected to be short-term in 

duration. Intermediate-term exposures 

are not likely because of the intermittent 

nature of exposure to homeowners. 

Post-application dermal and hand-tomouth exposure scenarios were 

combined for children 1 <2 years old. 

This combination was considered a 

protective estimate of children’s 

exposure. Further information regarding 

EPA standard assumptions and generic 

inputs for residential exposures may be 

found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/ 

standard-operating-proceduresresidential-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 fluoxastrobin to 

share a common mechanism of toxicity 

with any other substances, and 

fluoxastrobin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that fluoxastrobin does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 


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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. 

As discussed in Unit III.A., there is no 

evidence of quantitative or qualitative 

fetal or offspring susceptibility in the 

developmental toxicity studies in rats or 

rabbits nor in two-generation 

reproduction studies in rats. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

fluoxastrobin is complete. 

ii. There is no indication that 

fluoxastrobin is a neurotoxic chemical, 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

fluoxastrobin results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the two-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. A 

partially refined chronic aggregate 

dietary (food and drinking water) 

exposure and risk assessments were 

conducted. The assumptions of the 

dietary assessment include tolerancelevel residues for livestock 

commodities, average field-trial residues 

for some crop commodities, and PCT 

and PCTn estimates for some 

commodities. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to fluoxastrobin in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by fluoxastrobin. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, fluoxastrobin is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluoxastrobin 

from food and water will utilize 31% of 

the cPAD for the general U.S population 

and 77% of the cPAD for all infants <1- 

year-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 

fluoxastrobin 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). Fluoxastrobin 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 fluoxastrobin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 150 for adults and 100 for 

children (1–2 years old). The Agency 

does not have concern if the MOEs are 

equal to or greater than 100. 

Furthermore, many conservative 

assumptions were incorporated into the 

assessment, so the actual exposure and 

risk are likely to be considerably lower 

than the estimates in the Agency 

assessment. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). An 

intermediate-term adverse effect was 

identified; however, fluoxastrobin is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm 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 

fluoxastrobin. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fluoxastrobin 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 fluoxastrobin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectrometry) is available to enforce the 

tolerance expression. Method No. 00604 

is available for plant commodities and 

Method No. 00691 is available for 

livestock commodities. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

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 


jstallworth on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations 45735 

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 a MRL for fluoxastrobin. 

C. Revisions to Petitioned-For 

Tolerances 

EPA is establishing tolerance levels 

for the following commodities that 

differ from what the petitioner 

requested: Avocado from 0.9 ppm to 1.0 

ppm; barley, grain from 0.4 ppm to 0.40 

ppm; rapeseed subgroup 20A from 0.8 

ppm to 0.70 ppm; pea and bean, dried 

shelled, except soybean, subgroup 6C 

from 0.2 ppm to 0.20 ppm. The 

tolerances for avocado and rapeseed 

subgroup 20A differ because the Agency 

used different inputs for determining 

those tolerance levels. Although the 

petitioner and the Agency both used the 

Organization for Economic Co-operation 

and Development (OECD) calculation 

procedures to obtain tolerance levels, 

the Agency determined that some of the 

trials were not independent. In addition, 

if a higher residue value was observed 

at a preharvest interval (PHI) longer 

than the minimum labeled PHI, then the 

Agency used the highest value. 

The Agency added a significant figure 

to the tolerances for barley, grain and 

pea and bean, dried shelled, except 

soybean to conform to current Agency 

policy on significant figures. In 

addition, the Agency has modified the 

commodity definition for dried shelled 

pea and bean (crop subgroup 6C) to pea 

and bean, dried shelled, except soybean, 

subgroup 6C in order for consistency 

with the Agency’s food and feed 

commodity vocabulary. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluoxastrobin, and its Zisomer in or on avocado at 1.0 ppm; 

barley, grain at 0.40 ppm; barley, hay at 

15 ppm; barley, straw at 15 ppm; 

rapeseed subgroup 20A at 0.70 ppm; 

and pea and bean, dried shelled, except 

soybean, subgroup 6C at 0.20 ppm. 

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 31, 2017. 

Michael 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 § 180.609, add alphabetically 

‘‘avocado’’, ‘‘barley, grain’’; ‘‘barley, 

hay’’; ‘‘barley, straw’’; ‘‘pea and bean, 

dried shelled, except soybean, subgroup 

6C’’; and ‘‘rapeseed, subgroup 20A’’ to 

the table in paragraph (a)(1) to read as 

follows: 

§ 180.609 Fluoxastrobin; tolerances for 

residues. 

(a) * * * (1) * * * 

Commodity Parts per 

million 

Avocado ...................................... 1.0 

Barley, grain ............................... 0.40 

Barley, hay .................................. 15 

Barley, straw ............................... 15 

* * * * * 

Pea and bean, dried shelled, except soybean, subgroup 6C .... 0.20 

* * * * * 

Rapeseed, subgroup 20A ........... 0.70 

* * * * * 


jstallworth on DSKBBY8HB2PROD with RULES
45736 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations 

* * * * * 

[FR Doc. 2017–21113 Filed 9–29–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 261 

[EPA–R06–RCRA–2017–0254; FRL–9968– 

61–Region 6] 

Hazardous Waste Management 

System; Identification and Listing of 

Hazardous Waste 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is granting a petition 

submitted by Samsung Austin 

Semiconductor (Samsung) to exclude 

from hazardous waste control (or delist) 

a certain solid waste. This final rule 

responds to the petition submitted by 

Samsung to have the copper filter cake 

from the electroplating process 

excluded, or delisted from the definition 

of a hazardous waste. The Copper filter 

cake is listed as F006, wastewater 

treatment sludges from electroplating 

operations. The basis of the listing is 

cadmium, hexavalent chromium, nickel, 

and cyanide (complexed). After careful 

analysis and evaluation of comments 

submitted by the public, the EPA has 

concluded that the petitioned wastes are 

not hazardous waste when disposed of 

in Subtitle D landfills. This exclusion 

applies to the copper filter cake 

generated at Samsung Austin 

Semiconductor’s Austin, Texas facility. 

Accordingly, this final rule excludes the 

petitioned waste from the requirements 

of hazardous waste regulations under 

the Resource Conservation and 

Recovery Act (RCRA) when disposed of 

in Subtitle D landfills, but imposes 

testing conditions to ensure that the 

future-generated wastes remain 

qualified for delisting. 

DATES: This final rule is effective on 

October 2, 2017. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–R06–RCRA–2017–0254. All 

documents in the docket are listed on 

the http://www.regulations.gov Web 

site. Although listed in the index, some 

information is not publicly available, 

e.g., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available electronically through http://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: For 

technical information regarding the 

Samsung Austin Semiconductor 

petition, contact Michelle Peace at 214– 

665–7430 or by email at 

peace.michelle@epa.gov. 

SUPPLEMENTARY INFORMATION: The 

information in this section is organized 

as follows: 

I. Overview Information 

A. What action is EPA finalizing? 

B. Why is EPA approving this delisting? 

C. What are the limits of this exclusion? 

D. How will Samsung Austin 

Semiconductor manage the waste if it is 

delisted? 

E. When is the final delisting exclusion 

effective? 

F. How does this final rule affect states? 

II. Background 

A. What is a ‘‘delisting’’? 

B. What regulations allow facilities to 

delist a waste? 

C. What information must the generator 

supply? 

III. EPA’s Evaluation of the Waste Data 

A. What waste and how much did 

Samsung Austin Semiconductor petition 

EPA to delist? 

B. How did Samsung Austin 

Semiconductor sample and analyze the 

waste data in this petition? 

IV. Public Comments Received on the 

Proposed Exclusion 

Who submitted comments on the proposed 

rule? 

V. Statutory and Executive Order Reviews 

I. Overview Information 

A. What action is EPA finalizing? 

The EPA is finalizing: 

(1) The decision to grant Samsung 

Austin Semiconductor’s petition to have 

its copper filter cake excluded, or 

delisted, from the definition of a 

hazardous waste, subject to certain 

continued verification and monitoring 

conditions; and 

(2) To use the Delisting Risk 

Assessment Software v.3.0.35 to 

evaluate the potential impact of the 

petitioned waste on human health and 

the environment. The Agency used this 

model to predict the concentration of 

hazardous constituents released from 

the petitioned waste, once it is 

disposed. 

After evaluating the petition, EPA 

proposed a rule, on July 14, 2017, to 

exclude the Samsung Austin 

Semiconductor copper filter cake waste 

from the lists of hazardous wastes under 

§§ 261.31 and 261.32. There were no 

comments received on this rulemaking. 

B. Why is EPA approving this delisting? 

Samsung’s petition requests an 

exclusion from the F006 waste listing 

pursuant to 40 CFR 260.20 and 260.22. 

Samsung does not believe that the 

petitioned waste meets the criteria for 

which EPA listed it. Samsung also 

believes no additional constituents or 

factors could cause the waste to be 

hazardous. EPA’s review of this petition 

included consideration of the original 

listing criteria and the additional factors 

required by the Hazardous and Solid 

Waste Amendments of 1984 (HSWA). 

See section 3001(f) of RCRA, 42 U.S.C. 

6921(f), and 40 CFR 260.22 (d)(1)–(4) 

(hereinafter all sectional references are 

to 40 CFR unless otherwise indicated). 

In making the initial delisting 

determination, EPA evaluated the 

petitioned waste against the listing 

criteria and factors cited in 

§ 261.11(a)(2) and (3). Based on this 

review, EPA agrees with the petitioner 

that the waste is non-hazardous, with 

respect to the original listing criteria. If 

EPA had found, based on this review, 

that the waste remained hazardous 

based on the factors for which the waste 

was originally listed, EPA would have 

proposed to deny the petition. EPA 

evaluated the waste with respect to 

other factors or criteria to assess 

whether there is a reasonable basis to 

believe that such additional factors 

could cause the waste to be hazardous. 

EPA considered whether the waste is 

acutely toxic, the concentration of the 

constituents in the waste, their tendency 

to migrate and to bioaccumulate, their 

persistence in the environment once 

released from the waste, plausible and 

specific types of management of the 

petitioned waste, the quantities of waste 

generated, and waste variability. EPA 

believes that the petitioned waste does 

not meet the listing criteria and thus 

should not be a listed waste. EPA’s 

proposed decision to delist waste from 

Samsung is based on the information 

submitted in support of this rule, 

including descriptions of the wastes and 

analytical data from the Austin, Texas 

facility. 

C. What are the limits of this exclusion? 

This exclusion applies to the waste 

described in the petition only if the 

requirements described in Table 1 of 

part 261, appendix IX and the 

conditions contained herein are 

satisfied. The conditional exclusion 

applies to 750 cubic yards of copper 

filter cake sludge generated annually 

from the Samsung Austin 

Semiconductor facility in Austin, TX. 

D. How will Samsung Austin 

Semiconductor manage the waste if it is 

delisted? 

Storage containers of the copper filter 

cake will be transported to an 


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