20100 Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations 

EPA-APPROVED NEW HAMPSHIRE SOURCE SPECIFIC REQUIREMENTS

Name of source Permit No. 

State 

effective 

date 

EPA approval date 2 Explanations 

*******

Waste Management ........................ ARD–01–001 4/27/2012 11/5/2012, 77 FR 66388 ................ Single source NOX RACT order for 

facility in Rochester, NH. 

* * * * * * * 

2 In order to determine the EPA effective date for a specific provision listed in this table, consult the FEDERAL REGISTER notice cited in this column for the particular provision. 

* * * * * 

[FR Doc. 2014–07729 Filed 4–10–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0576; FRL–9907–46] 

Fluoxastrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluoxastrobin 

in or on wheat, grain; and revises 

tolerances for milk; and milk, fat. Arysta 

LifeScience, North America, LLC, 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

11, 2014. Objections and requests for 

hearings must be received on or before 

June 10, 2014, 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–2012–0576, 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), EPA West 

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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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://ecfr.gpoaccess.gov/cgi/t/

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0576 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 June 10, 2014. 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– 

2012–0576, 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.htm. 

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 February 

27, 2013 (78 FR 13296) (FRL–9380–2), 

EPA issued a document pursuant to 

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Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations 20101 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 2F8130) by Arysta 

LifeScience, North America, LLC, 15401 

Weston Pkwy., Suite 150, Cary, NC 

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-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, and its Z-isomer, (1Z)-[2- 

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

pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, in or on wheat, grain at 

0.15 parts per million (ppm). The 

petition also requested that 40 CFR 

180.609 be amended by revising 

tolerances for milk from 0.02 ppm to 

0.03 ppm; and milk, fat from 0.50 ppm 

to 0.75 ppm. That document referenced 

a summary of the petition prepared by 

Arysta LifeScience, North America LLC, 

the registrant, which is available in the 

docket, http://www.regulations.gov. 

Comments were received on the notice 

of filing. EPA’s response to these 

comments is 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 

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. 

Following repeated exposure, 

fluoxastrobin has mild or low toxicity in 

all tested species except for the dog. 

Repeated oral administration to dogs 

resulted in adverse liver toxicity at 

considerably lower doses than those 

noted in other species. Based on species 

sensitivity, the effects observed in the 

dog were used as endpoints for risk 

assessment. In both the 90-day and oneyear oral feeding studies in dogs, the 

liver appeared to be the target organ. In 

dogs, mice, and rats, the kidney was 

another target organ. There was no 

indication of an adverse effect 

attributable to a single dose. Based on 

developmental toxicity studies (rat and 

rabbit) and a two-generation 

reproduction study (rat), there was 

neither increased susceptibility of pre-/ 

postnatal exposure to fluoxastrobin, nor 

adverse effects on reproduction. 

Furthermore, acute neurotoxic effects 

were not seen in an acute neurotoxicity 

study in rats up to the limit dose of 

2,000 milligrams/kilogram/day (mg/kg/

day). In a subchronic neurotoxicity 

study in rats, fluoxastrobin did not elicit 

any neurotoxic effects. Repeated dose 

studies of fluoxastrobin in the database 

did not show immunotoxic effects in 

rats. Results of genotoxicity testing were 

negative and there were no treatmentrelated carcinogenicity findings in 

adequately performed carcinogenicity 

studies in rats and mice. Therefore, 

fluoxastrobin is classified as ‘‘not likely 

to be carcinogenic to humans.’’ Specific 

information on the studies received and 

the nature of the adverse effects caused 

by fluoxastrobin as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http://

www.regulations.gov in document, 

‘‘Fluoxastrobin. Aggregate Human 

Health Risk Assessment for the 

Proposed New Uses on Melon Subgroup 

9A and Sorghum, Along with 

Establishment of Permanent Tolerances 

on Wheat, and Amendments to 

Established Tolerances on Milk and 

Milk Fat’’ on pages 26–31 in docket ID 

number EPA–HQ–OPP–2012–0576. 

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 the NOAEL and the 

LOAEL are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for fluoxastrobin used for 

human risk assessment is shown in 

Table 1 of this unit. 

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20102 Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUOXASTROBIN FOR USE IN DIETARY, NONOCCUPATIONAL, AND OCCUPATIONAL 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.None: There is no indication of an adverse effect attributable to a single dose. An aRfD was not established. 

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 dog 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 to 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 subchronic dog LOAEL = M/F 24.8/24.2 mg/kg/day 

based on dose-related reductions in net body weight 

gain and food efficiency in addition to toxicity findings in 

the liver (cholestasis) in both sexes, and kidneys (increased relative weights in females and degeneration of 

the proximal tubular epithelium in males). 

Dermal short-term (1 to 30 days) ........... None: There were no systemic or dermal toxicity findings in a 28-day dermal toxicity study in the rat 

up to the limit dose (1,000 mg/kg/day) and there were no developmental or neurotoxicity concerns 

raised in other studies. 

Dermal intermediate-term (1 to 6 

months).

NOAEL = 3.0 mg/

kg/day.

dermal absorption 

factor = 2.3%. 

Residential LOC 

for MOE = 100.

Occupational LOC 

for MOE = 100. 

90-day subchronic dog LOAEL = M/F 24.8/24.2 mg/kg/day 

based on dose-related reductions in net body weight 

gain and food efficiency in addition to toxicity findings in 

the liver (cholestasis) in both sexes, and kidneys (increased relative weights in females and degeneration of 

the proximal tubular epithelium in males). 

Inhalation b Short-Term (1–30 days) and 

Intermediate-Term (1–6 months).

NOAEL = 3.0 mg/

kg/day.

Residential LOC 

for MOE = 100.

Occupational LOC 

for MOE = 100. 

90-day subchronic dog LOAEL = M/F 24.8/24.2 mg/kg/day 

based on dose-related reductions in net body weight 

gain and food efficiency in addition to toxicity findings in 

the liver (cholestasis) in both sexes, and kidneys (increased relative weights in females and degeneration of 

the proximal tubular epithelium in males). 

Cancer (Oral, dermal, inhalation) ........... Classification: ‘‘Not likely to be Carcinogenic to Humans.’’ 

a ‘‘Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.’’ NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH

= potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population 

adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. bToxicity by the oral route is assumed to be equivalent to the inhalation route. A subchronic inhalation toxicity study is not required for 

fluoxastrobin at this time. Although no subchronic inhalation data is available EPA has waived the data requirement. In determining the need for 

a subchronic inhalation study, EPA’s weight of evidence decision process included both hazard and exposure considerations as well as incorporation of a presumed 10X Database Uncertainty Factor (UFdb) for the lack of this study. Specifically, with regard to exposure considerations, the 

Agency’s Level of Concern in the evaluating the need for the subchronic inhalation study is a Margin of Exposure (MOE) of 1,000 for inhalation 

exposure, which includes the 10X inter-species extrapolation factor, 10X intra-species variation factor, and the 10X UFdb. For fluoxystrobin, residential inhalation exposures resulted in MOEs higher than the LOC of 1,000 when using an oral Point of Departure (POD). This indicates that the 

lack of an inhalation study does not reduce the overall confidence in the risk assessment or result in an uncertainty (i.e., the study will not provide a POD sufficiently low to result in a risk of concern). Because EPA’s decision to waive the subchronic inhalation study essentially incorporates an additional 10X UFdb (i.e. the study was only waived because risks were at least 10X lower than required by use of the inter- and 

intraspecies safety factors), a second additional 10X FQPA safety factor is not being retained for the protection of infants and children due to the 

absence of this study. 

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. A slightly 

refined chronic dietary exposure 

assessment was performed for 

fluoxastrobin using tolerance-level 

residues, average field trial residues, 

and 100 percent crop treated (PCT). This 

risk assessment was conducted using 

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the DEEM–FCID Version 3.16. This 

model uses 2003–2008 food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). 

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. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for fluoxastrobin. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

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://www.epa.gov/

oppefed1/models/water/index.htm. In 

addition to evaluating the EDWCs from 

the proposed uses, EDWCs were 

reevaluated for all existing uses with 

Pesticide Root Zone Model Ground 

Water (PRZM–GW), which models 

continued use of fluoxastrobin over 

many years. For the chronic dietary 

assessment, the most conservative 

EDWC (137 mg/L) was based on an 

existing turf use modeled with a 100 

year simulation of 100 years of repeated 

applications, using the highest single 

maximum application rate and the 

highest yearly application rate. 

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: Spot treatment 

and/or broadcast control of diseases on 

turf, including lawns and golf courses. 

EPA assessed residential exposure using 

the following assumptions: Residential 

handler exposure for adults is expected 

to be short-term only. Intermediate-term 

and chronic exposures are not likely 

because of the intermittent nature of 

applications by homeowners. Since 

there are no toxicity findings for the 

short-term dermal route of exposure up 

to the limit dose, the residential handler 

assessment only includes the inhalation 

route of exposure. There is also 

potential for homeowners and their 

families (of varying ages) to be exposed 

as a result of entering areas that have 

previously been treated with 

fluoxastrobin. Exposure might occur on 

areas such as lawns used by children or 

recreational areas such as golf courses 

used by adults and youths. Potential 

routes of exposure include dermal 

(adults and children) and incidental oral 

ingestion (children). Since no acute 

hazard has been identified, an 

assessment of episodic granular 

ingestion was not conducted. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www.epa.gov/pesticides/science/

residential-exposure-sop.html. 

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 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The available studies used to evaluate 

pre- and postnatal exposure 

susceptibility do not indicate increased 

susceptibility of rats or rabbits to 

fluoxastrobin. These studies include the 

following: 

i. Developmental toxicity studies in 

rats. 

ii. Developmental toxicity studies in 

rabbits. 

iii. A 2-generation reproduction study 

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. EPA waived 

the requirement for a subchronic 

inhalation data based on, among other 

things, its conclusion that even if an 

additional 10X safety factor was 

applied, inhalation exposure would not 

raise a risk of concern. 

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 2-generation 

reproduction study. The rat 

developmental study was tested up to 

the limit dose (1,000 mg/kg/day), and 

the rabbit developmental study was 

tested up to 400 mg/kg/day (highest 

dose tested). At the highest dose tested, 

there were decreases in food 

consumption and body weight in the 

maternal animals, but there were no 

developmental effects. Furthermore, in 

the rat reproduction study, there was no 

sensitivity in the offspring of the pups 

relative to the parental animals. 

iv. The exposure databases are 

estimated based on data that reasonably 

account for potential exposures. The 

chronic dietary food exposure 

assessment was conservatively based on 

100 PCT assumptions, tolerance-level 

residues, and conservative ground and 

surface drinking water modeling 

estimates. New 2012 Residential 

Standard Operating Procedures (SOPs) 

were used to assess post-application 

exposure to children including 

incidental oral exposure. The residential 

post-application assessment assumes 

maximum application rates and 

conservative day zero hand-to-mouth 

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activities. Although EPA has required 

additional data on transferable residues 

from treated turf for fluoxastrobin, EPA 

is confident that it has not 

underestimated turf exposure due to the 

conservativeness of the default turf 

transfer value and conservative 

assumptions in the short-term turf 

assessment procedures (e.g., assuming 

residues do not degrade over the thirty 

day assessment period and assuming 

high-end activities on turf for every day 

of the assessment period). All of the 

exposure estimates for fluoxastrobin are 

based on conservative high-end 

assumptions and are not likely to result 

in underestimated risk. 

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 30% of 

the cPAD for the general population, 

and 66% of the cPAD for all infants <1 

year old, the population subgroup with 

the highest estimated chronic dietary 

exposure to fluoxastrobin. 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- and intermediate-term risk. 

Short- and intermediate-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. Because all 

short- and intermediate-term 

quantitative hazard assessments (via the 

dermal and incidental oral routes) for 

fluoxastrobin are based on the same 

endpoint, a screening-level, 

conservative aggregate risk assessment 

was conducted that combined the shortterm incidental oral and intermediateterm exposure estimates (i.e., the 

highest exposure estimates) in the risk 

assessments for adults. The Agency 

believes that most residential exposure 

will be short-term, based on the use 

pattern. 

There is potential short- and 

intermediate-term exposure to 

fluoxastrobin via the dietary (which is 

considered background exposure) and 

residential (which is considered 

primary) pathways. For adults, these 

pathways lead to exposure via the oral 

(background), and dermal and 

inhalation (primary) routes. For 

children, these pathways lead to 

exposure via the oral (background), and 

incidental oral and dermal (primary) 

routes. 

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 610 for adults and 170 for 

children (1–2 years old). Because EPA’s 

level of concern for fluoxastrobin is a 

MOE of 100 or below, these MOEs are 

not of concern. 

4. 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. 

5. 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/mass spectrometry) is 

available to enforce the tolerance 

expression. Method No. 00604 is 

available for plant commodities and 

Method No. 00691 is available for 

animal 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 

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. 

There are no Codex MRLs established 

for fluoxastrobin. However, there are 

Canadian MRLs established on sorghum 

and milk at 0.02 ppm, milk fat at 0.15 

ppm, wheat bran at 0.15 ppm, and 

wheat grain at 0.1 ppm. Furthermore, 

the Canadian tolerance expression is not 

harmonized with the US tolerance 

expression. For plants and livestock, the 

Canadian tolerance expression does not 

include the Z-isomer. 

C. Response to Comments 

Two comments were received to the 

docket from members of the public. 

Both comments were the same. The 

commenters objected to the proposed 

tolerance on the ground that it would 

result in fluoride being added to treated 

crops. The commenters offered no basis 

for this claim. 

The Agency reviewed all plant, 

livestock, and environmental 

degradation data and determined that 

the fluorine will not be released into the 

environment when applied to crops or 

non-agricultural areas. Neither free 

fluorine nor de-fluorinated 

fluoxastrobin was observed in food or 

water in any of the metabolism, 

degradation, and magnitude of residue 

studies. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluoxastrobin, in or on 

wheat, grain at 0.15 ppm; and tolerances 

are revised for milk and milk, fat at 0.03 

ppm and 0.75 ppm respectively. 

Additionally, the established tolerance 

for wheat bran at 0.15 ppm is no longer 

needed and should be revoked because 

the recommended tolerance of 0.15 ppm 

for wheat, grain will cover expected 

residues in wheat bran. 

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Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations 20105 

VI. Statutory and Executive Order 

Reviews 

This final rule 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule 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 final rule 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 final rule 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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(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 of 1995 

(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: March 28, 2014. 

Lois Rossi, 

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: 

■ a. Remove ‘‘Wheat, bran’’ from the 

table in paragraph (a)(1). 

■ b. Add ‘‘Wheat, grain’’ in alphabetical 

order to the table in paragraph (a)(1). 

■ c. Revise ‘‘Milk’’ and ‘‘Milk, fat’’ in 

the table in paragraph (a)(2). 

The amendments read as follows: 

§ 180.609 Fluoxastrobin; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Wheat, grain ......................... 0.15 

* * * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Milk ....................................... 0.03 

Milk, fat ................................. 0.75 

* * * * * 

* * * * * 

[FR Doc. 2014–07820 Filed 4–10–14; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 90 

[WT Docket No. 96–86; DA 12–1942] 

Service Rules Governing Public Safety 

Narrowband Operations in the 769– 

775/799–805 MHz Bands 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the 

Commission amends its rules to change 

the date of the ‘‘substantial service’’ 

benchmarks applicable to 700 MHz 

narrowband State licenses. This is 

intended to conform the dates used for 

the substantial service benchmarks 

under the Commission rules to the 

deadlines specified in the Commission’s 

July 2011 Declaratory Ruling. 

DATES: Effective April 11, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Difie Osborne, Esq., Policy and 

Licensing Division, Public Safety and 

Homeland Security Bureau, (202) 418– 

3627, or by email at Difie.Osborne@

fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Order in WT Docket No. 

96–86, DA 12–1942, adopted on 

December 2, 2012, and released on 

December 3, 2012. The document is 

available for download at http:// 

fjallfoss.fcc.gov/edocs_public/. The 

complete text of this document is also 

available for inspection and copying 

during normal business hours in the 

FCC Reference Information Center, 

Portals II, 445 12th Street SW., Room 

CY–A257, Washington, DC 20554. To 

request materials in accessible formats 

for people with disabilities (Braille, 

large print, electronic files, audio 

format), send an email to FCC504@

fcc.gov or call the Consumer & 

Governmental Affairs Bureau at 202– 

418–0530 (voice), 202–418–0432 (TTY). 

1. In 1998, the Commission 

established the initial band plan and 

service rules for the 24 megahertz of 

public safety spectrum in the 700 MHz 

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