Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 50893 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: July 18, 2011. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraph (c)(354)(i)(A)(5) to 

read as follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(354) * * * 

(i) * * * 

(A) * * * 

(5) Rule 1113, ‘‘Architectural 

Coatings,’’ amended on July 13, 2007. 

* * * * * 

[FR Doc. 2011–20842 Filed 8–16–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0725; FRL–8884–4] 

Fluoxastrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of fluoxastrobin in 

or on squash/cucumber subgroup 9B. 

Arysta LifeScience North America, LLC 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 17, 2011. Objections and 

requests for hearings must be received 

on or before October 17, 2011, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0725. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(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 in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Heather Garvie, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0034; e-mail address: 

garvie.heather@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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–2010–0725 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before October 17, 2011. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0725, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 


Emcdonald on DSK2BSOYB1PROD with RULES
50894 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of September 

23, 2010 (75 FR 57942) (FRL–8845–4), 

EPA issued a notice pursuant to section 

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

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

pesticide petition (PP 0F7726) 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 a tolerance 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 raw agricultural 

commodities listed under crop squash/ 

cucumber subgroup 9B at 0.50 parts per 

million (ppm). That notice 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. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has made 

the following changes to the proposed 

fluoxastrobin tolerance. A minor change 

has been made to the commodity name 

to conform to the Agency’s Food and 

Feed Commodity Vocabulary. 

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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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. 

Fluoxastrobin has a low order of acute 

toxicity via the oral, dermal and 

inhalation routes of exposure. 

Fluoxastrobin is a moderate eye irritant 

but is neither a dermal irritant nor a 

skin sensitizer. 

Fluoxastrobin appears to have mild or 

low toxicity following repeated 

administration in all tested species 

other than the dog. In both the 90-day 

and 1-year oral feeding dog studies, 

there was liver toxicity in the form of 

cholestasis as evidenced by 

hepatocytomegaly and cytoplasmic 

granular changes associated with 

increased liver weight and increased 

serum liver alkaline phosphatase (ALP). 

In addition, several phase I and phase 

II liver drug metabolizing enzymes were 

induced. 

In the rat and rabbit developmental 

toxicity studies and the 2-generation 

reproduction rat study, there was no 

increased susceptibility to prenatal or 

postnatal exposure to fluoxastrobin and 

no effects on reproduction. 

Fluoxastrobin is not acutely 

neurotoxic in rats up to a single high 

dose of 2,000 milligrams/kilogram/day 

(mg/kg/day) or by repeated dietary 

feeding in the rat subchronic 

neurotoxicity screening study where the 

top dose was nearly half the limit dose 

of 1,000 mg/kg/day. Other studies in 

rats including the subchronic, chronic 

toxicity/carcinogenicity, 2-generation 

reproduction, and developmental 

toxicity were tested to or above the limit 

dose with no indication of clinical 

signs, histopathology or other signs of 

toxicity that could be attributed to 

neurotoxicity. Also, in both the 90-day 

and 1-year dog studies, neurologic 

examinations, including mental status/ 

behavior, gait characteristics, postural 

status and reactions, and spinal/cranial 

reflexes, were carried out and were 

found to be within normal limits. 

Fluoxastrobin is not immunotoxic 

based on repeated dosing studies in rats 

and mice. In the 90-day oral toxicity rat 

study, there was no difference between 

the controls and treated animals in 

spleen cell count, macrophage activities 

after phorbol myristate acetate (PMA) 

stimulation and plaque-forming cell 

assay after challenge with sheep 

erythrocytes. Slight decreases were 

noted in immunoglobulin G 

concentration in the high dose males 

but not females. An unacceptable 

subchronic immunotoxicity study in 

mice found no apparent decrease on 

B-cell activated, T-cell mediated 

immunoglobulin M (IgM) response to 

sheep red blood cell (SRBC) at doses as 

high as 2,383 mg/kg/day. 

Fluoxastrobin and major metabolites 

were negative in a battery of 

genotoxicity tests. The carcinogenic 

potential of fluoxastrobin was 

adequately tested in rats and mice of 

both sexes. The results demonstrated a 

lack of treatment-related increase in 

tumor incidence in rats or mice. There 

was no mutagenicity concern and no 

structure activity relationship alert. It 

was concluded that there was no 

incidence of carcinogenicity for 

fluoxastrobin. 

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 are discussed in the 

final rule published in the Federal 

Register of September 16, 2005 (70 FR 

54640) (FRL–7719–9). 

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 


Emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 50895 

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. 

TABLE 1—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 (Females 13–50 

years of age).

None: There was no indication of an adverse effect attributable to a single dose. An aRfD was not established. 

Acute dietary (General population 

including infants and children).

None: There was 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 in the 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 

to 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 (800 

ppm) 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 (1000 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 rate = 2.3%).

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 (800 

ppm) 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 short-term (1 to 30 

days) and intermediate-term (1 

to 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 (800 

ppm) 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.’’ 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account 

for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = 

acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 


Emcdonald on DSK2BSOYB1PROD with RULES
50896 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluoxastrobin, EPA 

considered exposure under the 

petitioned-for tolerance 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 food consumption data 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Surveys of Food Intake 

by Individuals (CSFII). As to residue 

levels in food, EPA conducted a 

conservative dietary exposure 

assessment for fluoxastrobin. The 

assumptions of this dietary assessment 

included tolerance level residues and 

100 percent crop treated (PCT). 

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. 

2. Dietary exposure from drinking 

water. Based on laboratory studies, 

fluoxastrobin persists in soils for several 

months to several years and is slightly 

to moderately mobile in soil. 

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. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

fluoxastrobin for chronic exposures for 

non-cancer assessments are estimated to 

be 52.9 parts per billion (ppb) for 

surface water and 0.23 ppb for ground 

water. Modeled estimates of drinking 

water concentrations were directly 

entered into the dietary exposure model. 

For chronic dietary risk assessment, the 

water concentration of value 53 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). 

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: Because of 

the potential for application four times 

per year, exposure duration is expected 

to be short-term and intermediate-term. 

A short-term dermal endpoint was not 

identified; therefore, only intermediateterm dermal risks as well as short-and 

intermediate-term inhalation risks were 

assessed. Homeowner residential 

applicators are expected to be adults. 

There is also the 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. 

While it is assumed that most 

residential use will result in short-term 

(1 to 30 days) post-application 

exposures, it is believed that 

intermediate-term exposures (greater 

than 30 days up to 180 days) are also 

possible. Further information regarding 

EPA standard assumptions and generic 

inputs for residential exposures may be 

found at: http://www.epa.gov/ 

pesticides/trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found 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 toxicity database for fluoxastrobin, 

including acceptable developmental 

toxicity studies in rats and rabbits, as 

well as a 2-generation reproductive 

toxicity study, provides no indication of 

prenatal and/or postnasal sensitivity. 

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 except for a 

functional immunotoxicity study as 

required by the recent changes to the 

pesticide data requirements. The 

Agency does have an immunotoxicity 

study for fluoxastrobin but it has 

deficiencies that make it unacceptable at 

this time. Nonetheless, the Agency does 

not believe that conducting a new 

immunotoxicity study will result in a 

lower NOAEL than the regulatory dose 

for risk assessment. First, the available 

data do not indicate that fluoxastrobin 

results in primary immune system 

effects; a NOAEL for decreased spleen 

weight in the absence of 

histopathological findings (male rats) 

was 53 mg/kg/day. Secondly, no 

apparent decrease in B-cell activated, Tcell mediated IgM response to SRBC 

was seen in mice at doses as high as 


Emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 50897 

2,383 mg/kg/day. The Agency therefore 

believes that no additional safety factor 

is needed to account for the lack of this 

study, but the registrant will be required 

to upgrade it. 

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. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The chronic dietary food exposure 

assessment utilized tolerance-level 

residues and 100 PCT information for 

all commodities. Use of these screeninglevel assessment values helps ensure 

that chronic exposures and risks will 

not be underestimated. EPA 

additionally 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 

residential post-application exposure of 

children as well as incidental oral 

exposure of toddlers to fluoxastrobin. 

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 aPAD and 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 47% 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 

fluoxastrobin is not expected. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure take into account short- and 

intermediate-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 both short- and intermediateterm residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short- and intermediate-term residential 

exposures of adults and children 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 short-term incidental oral 

and intermediate-term 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- and intermediate-term 

food, water, and residential exposures 

result in aggregate MOEs of 630 for 

adults; 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; e-mail 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 U.N. 

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 currently no established 

Mexican, Canadian, or Codex maximum 

residue limits (MRLs) or tolerances for 

fluoxastrobin on the squash/cucumber 

subgroup 9B. 

C. Revisions to Petitioned-For 

Tolerances 

EPA converted ‘‘crop subgroup 9B 

squash/cucumbers’’ to ‘‘squash/ 

cucumber subgroup 9B’’ to conform it to 

the Agency’s Food and Feed Commodity 

Vocabulary. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of 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, including its metabolites 


Emcdonald on DSK2BSOYB1PROD with RULES
50898 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 

and degradates, in or on squash/ 

cucumber subgroup 9B at 0.50 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 

104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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 10, 2011. 

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. Section 180.609 is amended by 

alphabetically adding the following 

commodity to the table in paragraph 

(a)(1) to read as follows: 

§ 180.609 Fluoxastrobin; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Squash/cucumber subgroup 9B 0.50 

* * * * * 

* * * * * 

[FR Doc. 2011–20835 Filed 8–16–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0621; FRL–8882–7] 

Metconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of metconazole 

in or on the bushberry subgroup 13–07B 

and the tuberous and corm vegetable 

subgroup 1C. The Interregional Research 

Project No. 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 17, 2011. Objections and 

requests for hearings must be received 

on or before October 17, 2011, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0621. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(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 in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@epa.gov. 


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