24824 Federal Register / Vol. 80, No. 84 / Friday, May 1, 2015 / Rules and Regulations 

in any other area where EPA or an 

Indian tribe has demonstrated that a 

tribe has jurisdiction. In those areas of 

Indian country, the rule does not have 

tribal implications and will not impose 

substantial direct costs on tribal 

governments or preempt tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by June 30, 2015. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this action for 

the purposes of judicial review nor does 

it extend the time within which a 

petition for judicial review may be filed, 

and shall not postpone the effectiveness 

of such rule or action. This action may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

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

Dated: April 14, 2015. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, chapter I, title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 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)(458) to read as 

follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(458) New and amended regulations 

for the following APCDs were submitted 

on December 29, 2014 by the Governor’s 

designee. 

(i) Incorporation by Reference. 

(A) South Coast Air Quality 

Management District. 

(1) Rule 1325, Rule 1325, ‘‘Federal 

PM2.5 New Source Review Program’’ 

adopted on December 5, 2014. 

[FR Doc. 2015–10239 Filed 4–30–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0248; FRL–9926–24] 

Azoxystrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of azoxystrobin 

in or on coffee, green bean; pear, Asian; 

and tea, dried. Syngenta Crop 

Protection, LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA) to 

cover residues of azoxystrobin in coffee, 

Asian pear, and tea imported into the 

United States; there are currently no 

U.S. registrations for pesticides 

containing azoxystrobin that are used on 

coffee, Asian pear, or tea. 

DATES: This regulation is effective May 

1, 2015. Objections and requests for 

hearings must be received on or before 

June 30, 2015, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0248, 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: 

Susan Lewis, 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 Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

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

Title40/40tab_02.tpl 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0248 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 

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Federal Register / Vol. 80, No. 84 / Friday, May 1, 2015 / Rules and Regulations 24825 

before June 30, 2015. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0248, 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. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of May 23, 

2014 (79 FR 29729) (FRL–9910–29), 

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 3E8228) by 

Syngenta Crop Protection, LLC, P.O. 

Box 18300, Greensboro, NC 27419. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for residues of the fungicide 

azoxystrobin, in or on coffee, bean, 

green at 0.03 parts per million (ppm); 

pear, Asian at 0.07 ppm and tea at 10 

ppm. That document referenced a 

summary of the petition prepared by 

Syngenta Crop Protection, LLC, the 

petitioner, which is available in the 

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

comment was received on the notice of 

filing. EPA’s response to this comment 

is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

increased the tolerance on tea from what 

the petitioner requested. The reason for 

this change is explained in Unit IV.D. 

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 azoxystrobin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with azoxystrobin 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. 

Azoxystrobin has low acute toxicity 

via the oral, dermal, and inhalation 

routes of exposure. It is not an eye or 

skin irritant and is not a skin sensitizer. 

Repeated oral dosing of azoxystrobin to 

rats resulted in decreased body weights, 

decreased food intake and utilization, 

increased diarrhea, and other clinical 

toxicity observations (increased urinary 

incontinence, hunched postures, and 

distended abdomens). In addition, liver 

effects characterized by increased liver 

weights, increase in alkaline 

phosphatase and gamma 

glutamyltransferase, decrease in 

albumin, and gross and histological 

lesions in the liver and bile ducts, were 

seen in rats. In dogs, effects on liver/

biliary function were found after oral 

administration. 

In the acute neurotoxicity study in 

rats, increased incidence of diarrhea 

was observed at all dose levels tested. 

Decreases in body weight and food 

utilization were noted in the rat 

subchronic neurotoxicity study. There 

were no indications of treatment-related 

neurotoxicity in either the acute or 

subchronic neurotoxicity studies. 

In the rat developmental toxicity 

study, diarrhea, urinary incontinence, 

and salivation were observed in 

maternal animals; in the rabbit 

developmental toxicity study, maternal 

animals exhibited decreased body 

weight gain. No adverse treatmentrelated developmental effects were seen 

in either study. In the rat reproduction 

study, offspring and parental effects 

(decreased body weights and increased 

adjusted liver weights) were observed at 

the same dose. 

There was no evidence of 

carcinogenicity in rats and mice. As a 

result, EPA has classified azoxystrobin 

as ‘‘not likely to be carcinogenic to 

humans.’’ Azoxystrobin induced a weak 

mutagenic response in the mouse 

lymphoma assay, but the activity 

expressed in vitro is not expected to be 

expressed in whole animals. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by azoxystrobin 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 Aggregate Risk 

Assessment for Permanent Tolerances 

on Imported Asian Pear, Imported Tea, 

and Imported Coffee; Establishment of 

Permanent Tolerances on Ti Palm and 

for Crop Group Conversions for Stone 

Fruits Group 12–12 and Tree Nut Group 

14–12 Crop Groups’’ on page 5 in docket 

ID number EPA–HQ–OPP–2014–0248. 

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 

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24826 Federal Register / Vol. 80, No. 84 / Friday, May 1, 2015 / Rules and Regulations 

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 azoxystrobin used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR AZOXYSTROBIN 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) LOAEL = 200 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

Acute RfD = 0.67mg/

kg/day.

aPAD = 0.67 mg/kg/

day 

Acute Neurotoxicity—Rat. 

LOAEL = 200 mg/kg/day based on diarrhea at two-hours post 

dose at all dose levels tested. 

Chronic dietary (All populations) NOAEL = 18 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.18 

mg/kg/day.

cPAD = 0.18 mg/kg/

day 

Combined Chronic Toxicity/Carcinogenicity Feeding Study— 

Rat. 

LOAEL = 82.4/117 mg/kg/day (M/F) based on reduced body 

weights in both sexes and bile duct lesions in males. 

Incidental oral short-term ..........

(1 to 30 days) & intermediateterm 

(1 to 6 months) 

NOAEL = 35 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 2-Generation Reproduction Study—Rat. 

LOAEL = 165 mg/kg/day based on decreased pup weights in 

both males and females (↓8–21%). 

Dermal .......................................

(All durations) 

No hazard was identified for this exposure 

scenario. 

21-Day Repeated Dose Dermal Study—Rat. No dermal or systemic toxicity was seen at the limit dose (1,000 mg/kg/day). 

Inhalation 1 ................................

short-term 

(1 to 30 days) & intermediateterm 

(1 to 6 months) 

NOAEL = 35 mg/kg/

day 2.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 2-Generation Reproduction Study—Rat. 

LOAEL = 165 mg/kg/day based on decreased pup weights in 

both males and females (↓8–21%). 

Cancer (Oral, dermal, inhalation).Azoxystrobin is classified as ‘‘Not Likely’’ to be carcinogenic to humans. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. 

NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty 

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

(intraspecies). 1To protect for the body weight decreases seen in the pups, a 69 kg body weight was used for estimating short- and intermediate-term inhalation doses because the pup body weight decrease also influenced by the maternal health. 2Toxicity via the inhalation route is assumed to be equivalent to the oral route. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to azoxystrobin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing azoxystrobin tolerances in 40 

CFR 180.507. EPA assessed dietary 

exposures from azoxystrobin in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

Such effects were identified for 

azoxystrobin. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

Nationwide Health and Nutrition 

Examination Survey, What We Eat In 

America (NHANES/WWEIA) conducted 

from 2003–2008. As to residue levels in 

food, the acute dietary assessment 

incorporated tolerance-level residues for 

all commodities except for citrus fruits 

(which used the highest residues from 

residue trials); 100 percent crop treated 

(PCT); and Dietary Exposure Evaluation 

Model (DEEM) (ver. 3.16) default 

processing factors, except for where 

tolerances were established for 

processed commodities or when 

processing studies showed no 

concentration. Field trial data were 

translated from the representative 

commodities to the non-representative 

commodities according to HED SOP 

2000.1‘‘Guidance for Translation of 

Field Trial Data from Representative 

Commodities in the Crop Group 

Regulation to other Commodities in 

Each Crop Group/Subgroup.’’ 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s (NHANES/WWEIA) 

conducted from 2003–2008. As to 

residue levels in food, the chronic 

dietary analysis incorporated tolerancelevel residues for all commodities, 

average PCT estimates when available 

and DEEM (ver. 3.16) default processing 

factors, except for where tolerances 

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Federal Register / Vol. 80, No. 84 / Friday, May 1, 2015 / Rules and Regulations 24827 

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 azoxystrobin should be 

classified as ‘‘not likely’’ to be 

carcinogenic to humans. Therefore a 

cancer risk assessment is unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

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

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

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

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for the 

chronic dietary exposure assessment for 

existing uses as follows: Almonds, 20%; 

apricots, 10%; artichokes, 20%; 

asparagus, <2.5%; barley, <2.5%; green 

beans, 15%; blueberries, 15%; broccoli, 

10%; cabbage, 10%; cane berries, 5%; 

cantaloupes, 20%; carrots, 10%; 

cauliflower, <2.5%; celery, 10%; corn, 

<2.5%; cotton, <2.5%; cotton (seed 

treatment), 25%; cucumbers, 20%; dry 

beans/peas, <2.5%; eggplant, 30%; 

garlic, 70%; grapefruit, 20%; grapes, 

5%; hazelnuts, 5%; lemons, <2.5%; 

lettuce, <2.5%; nectarines, <2.5%; 

onions, 5%; oranges, 5%; peaches, 5%; 

peanuts, 20%; peanuts (seed treatment), 

30%; green peas, <2.5%; pecans, 5%; 

peppers, 20%; pistachios, 5%; plums/

prunes, <2.5%; potatoes, 40%; potatoes 

(seed treatment), <1%; pumpkins, 20%; 

rice, 40%; soybeans, 5%; soybeans (seed 

treatment), <1%; spinach, 10%; squash, 

20%; strawberries, 25%; sugar beets, 

10%; sugar beets (seed treatment), 

<2.5%; sweet corn, 15%; tangelos, 25%; 

tangerines, 10%; tobacco, 15%; 

tomatoes, 25%; walnuts, >2.5%; 

watermelons, 15%; wheat, 5%; wheat 

seed (seed treatment), <1%. 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (NASS), proprietary 

market surveys, and the National 

Pesticide Use Database for the chemical/ 

crop combination for the most recent 6– 

7 years. EPA uses an average PCT for 

chronic 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 

1%. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which azoxystrobin 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 azoxystrobin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

azoxystrobin. 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 Screening Concentration 

in Ground Water (SCI–GROW) model 

and Pesticide Root Zone Model Ground 

Water (PRZM GW), for surface water, 

the estimated drinking water 

concentrations (EDWCs) of azoxystrobin 

for acute exposures are estimated to be 

70.2 parts per billion (ppb) and for 

chronic exposures are estimated to be 

48.5 ppb. For ground water, the 

estimated drinking water concentration 

for both acute and chronic exposure 

scenarios is 3.1 ppb. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 70.2 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 48.5 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). 

Azoxystrobin is currently registered for 

the following uses that could result in 

residential exposures: Outdoor 

residential (lawns, ornamentals, flower 

gardens, vegetables, fruit and nut trees, 

berries and vines) and recreational (golf 

courses, parks and athletic fields) sites. 

Additionally, it is registered for use on 

indoor carpets/other surfaces by noncommercial applicators, and in treated 

paints (preservative incorporation). 

The proposed uses do not impact the 

aggregate risk assessment; however, the 

scenarios that do impact the aggregate 

assessment have been re-evaluated in 

this assessment to reflect the revised 

incidental oral and inhalation PODs. 

Using those new PODs, EPA assessed 

residential exposure using the 2012 

updated residential standard operating 

procedures (SOPs) that are now used in 

all human health assessments. 

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24828 Federal Register / Vol. 80, No. 84 / Friday, May 1, 2015 / Rules and Regulations 

For the adult aggregate assessment, 

the Agency used inhalation exposure 

from adult handlers applying treated 

paint via airless sprayers; for the 

aggregate assessment for children, the 

Agency used post-application inhalation 

exposure from space-trays and hand-tomouth exposures from indoor 

applications to treated carpets for 

children 1 to <2 years old. 

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 azoxystrobin to 

share a common mechanism of toxicity 

with any other substances, and 

azoxystrobin does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that azoxystrobin 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 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 prenatal and postnatal toxicity 

database for azoxystrobin includes 

prenatal developmental toxicity studies 

in rats and rabbits and a 2-generation 

reproduction study in young rats. In 

these studies, there is no evidence that 

azoxystrobin results in increased 

quantitative sensitivity to developing 

fetuses. Also in the reproduction study, 

the offspring and the parental effects 

occurred at the same dose level. 

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 for all exposure 

scenarios except acute exposure. For 

assessing acute dietary risk, EPA is 

retaining an FQPA factor of 3X to 

account for the use of a LOAEL from the 

acute neurotoxicity study to derive an 

acute reference dose. The Agency 

believes that a 3X FQPA SF (as opposed 

to a 10X) will be adequate to extrapolate 

a NOAEL in assessing acute risk based 

on the following considerations: 

• The LOAEL is based on a transient 

effect (diarrhea in rats) expected to be 

relatively insignificant in nature. This 

effect is also seen in other chemicals of 

the same class. 

• The diarrhea was only seen in 

studies using gavage dosing in the rat, 

but not in studies using repeat dosing 

through dietary administration in rats or 

mice, and not through gavage dosing in 

rabbits. 

• The very high dose level needed to 

reach the acute oral lethal dose (LD)50 (≤ 

5000 mg/kg), and the overall low 

toxicity of azoxystrobin. 

The decision to reduce the FQPA 

safety factor to 1X for the assessment of 

the remaining exposure scenarios is 

based on the following findings: 

i. The toxicity database for 

azoxystrobin is complete. 

ii. There is no indication that 

azoxystrobin is a neurotoxic chemical. 

Although clinical signs were observed 

in the acute and subchronic 

neurotoxicity studies which included 

transient diarrhea, decreased body 

weight, body weight gain, and food 

utilization, no other effects were seen in 

those studies that would be considered 

indicative of neurotoxicity. Therefore, 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

azoxystrobin 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. In the reproduction 

study, the offspring and the parental 

effects occurred at the same dose level. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary (food) exposure 

assessments utilized conservative 

upper-bound inputs including assuming 

100% CT and tolerance-level residues 

for all commodities except citrus fruits 

where the highest field trial residue was 

used as a refinement. The chronic 

dietary exposure assessment was 

partially refined, and used tolerancelevel residues for all commodities and 

PCT information for selected crops. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to azoxystrobin in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by azoxystrobin. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

azoxystrobin will occupy 40% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to azoxystrobin 

from food and water will utilize 15% 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 azoxystrobin 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). 

Azoxystrobin 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 azoxystrobin. 

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 2,400 for adults and 280 for 

children 1–2 years old. Because EPA’s 

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Federal Register / Vol. 80, No. 84 / Friday, May 1, 2015 / Rules and Regulations 24829 

level of concern for azoxystrobin is a 

MOE of 100 or below, these MOEs are 

not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because no intermediate-term adverse 

effect was identified, azoxystrobin is not 

expected to pose an intermediate-term 

risk. Therefore, the intermediate-term 

aggregate risk would be equivalent to 

the chronic dietary exposure estimate. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

azoxystrobin 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 azoxystrobin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography with a nitrogenphosphorus detector (GC/NPD) method, 

RAM 243/04) is available to enforce the 

tolerance expression for residues of 

azoxystrobin and its Z-isomer in crop 

commodities. This method (designated 

RAM 243, dated 5/15/98) has been 

submitted to FDA for inclusion in the 

Pesticide Analytical Manual (PAM), 

Volume II. 

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. 

The Codex has established a MRL for 

azoxystrobin in or on coffee, bean at 

0.03 ppm. The US tolerance for coffee 

is harmonized with the Codex MRL. The 

Codex has not established a MRL for 

Asian pear or tea. 

C. Response to Comments 

One comment was received in 

response to the notice of filing of 

Syngenta Crop Protection’s petition. The 

commenter objected to the increase of 

chemical residues generally and 

expressed additional concerns about the 

carcinogenic effects of chemicals in 

general on humans. The Agency 

understands the commenter’s concerns 

regarding toxic chemicals and their 

potential effects on humans. Pursuant to 

its authority under the FFDCA, and as 

discussed further in this preamble, EPA 

conducted a comprehensive assessment 

of azoxystrobin, which included an 

assessment on the carcinogenic 

potential of azoxystrobin. Based on its 

assessment of the available data, the 

Agency has concluded that azoxystrobin 

is not likely to be a carcinogen and that 

there is a reasonable certainty that no 

harm will result from aggregate 

exposure to residues of azoxystrobin. 

D. Revisions to Petitioned-For 

Tolerances 

The tolerance on tea has been revised 

from what was proposed in the initial 

petition. EPA is increasing the proposed 

tolerance for tea from 10 ppm to 20.0 

ppm. The proposed tolerance of 10 ppm 

for tea is insufficient, as the trials were 

conducted at 50% of the label maximum 

rate. Correction by proportionality to the 

maximum label rate provides a 

tolerance recommendation of 20.0 ppm. 

Also, because magnitude of residue data 

used to determine the appropriate 

tolerance level were provided for dried 

tea only, EPA is only establishing a 

tolerance for dried tea at this time. 

In addition, EPA is altering the 

commodity name for ‘‘coffee, green 

bean’’ from the petitioned-for name 

(‘‘coffee, bean, green’’) to be consistent 

with the general food and feed 

commodity vocabulary EPA uses for 

tolerances and exemptions. 

V. Conclusion 

Therefore, tolerances are established 

for residues of azoxystrobin, in or on 

coffee, green bean at 0.03 ppm; pear, 

Asian at 0.07 ppm; and tea, dried at 20.0 

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 

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24830 Federal Register / Vol. 80, No. 84 / Friday, May 1, 2015 / Rules and Regulations 

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: April 23, 2015. 

Susan Lewis, 

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 § 180.507: 

■ a. Add alphabetically the entries for 

‘‘Coffee, green bean’’; 1 ‘‘Pear, Asian’’,1

‘‘Tea, dried’’ 1 to the table in paragraph 

(a)(1). 

■ b. Revise footnote 1 at the end of the 

table in paragraph (a)(1). 

The additions and revision read as 

follows: 

§ 180.507 Azoxystrobin; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Coffee, green bean 1 ................. 0.03 

* * * * * 

Pear, Asian 1 ............................. 0.07 

* * * * * 

Tea, dried 1 ............................... 20.0 

Commodity Parts per 

million 

* * * * * 

1There are no United States registrations 

for use of azoxystrobin on coffee, green bean; 

ginseng; pear, Asian and tea, dried. 

* * * * * 

[FR Doc. 2015–10149 Filed 4–30–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2015–0001; Internal 

Agency Docket No. FEMA–8381] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. Also, information 

identifying the current participation 

status of a community can be obtained 

from FEMA’s Community Status Book 

(CSB). The CSB is available at http://

www.fema.gov/fema/csb.shtm. 

DATES: The effective date of each 

community’s scheduled suspension is 

the third date (‘‘Susp.’’) listed in the 

third column of the following tables. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact Bret Gates, Federal 

Insurance and Mitigation 

Administration, Federal Emergency 

Management Agency, 500 C Street SW., 

Washington, DC 20472, (202) 646–4133. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

Federal flood insurance that is not 

otherwise generally available from 

private insurers. In return, communities 

agree to adopt and administer local 

floodplain management measures aimed 

at protecting lives and new construction 

from future flooding. Section 1315 of 

the National Flood Insurance Act of 

1968, as amended, 42 U.S.C. 4022, 

prohibits the sale of NFIP flood 

insurance unless an appropriate public 

body adopts adequate floodplain 

management measures with effective 

enforcement measures. The 

communities listed in this document no 

longer meet that statutory requirement 

for compliance with program 

regulations, 44 CFR part 59. 

Accordingly, the communities will be 

suspended on the effective date in the 

third column. As of that date, flood 

insurance will no longer be available in 

the community. We recognize that some 

of these communities may adopt and 

submit the required documentation of 

legally enforceable floodplain 

management measures after this rule is 

published but prior to the actual 

suspension date. These communities 

will not be suspended and will continue 

to be eligible for the sale of NFIP flood 

insurance. A notice withdrawing the 

suspension of such communities will be 

published in the Federal Register. 

In addition, FEMA publishes a Flood 

Insurance Rate Map (FIRM) that 

identifies the Special Flood Hazard 

Areas (SFHAs) in these communities. 

The date of the FIRM, if one has been 

published, is indicated in the fourth 

column of the table. No direct Federal 

financial assistance (except assistance 

pursuant to the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act not in connection with a 

flood) may be provided for construction 

or acquisition of buildings in identified 

SFHAs for communities not 

participating in the NFIP and identified 

for more than a year on FEMA’s initial 

FIRM for the community as having 

flood-prone areas (section 202(a) of the 

Flood Disaster Protection Act of 1973, 

42 U.S.C. 4106(a), as amended). This 

prohibition against certain types of 

Federal assistance becomes effective for 

the communities listed on the date 

shown in the last column. The 

Administrator finds that notice and 

public comment procedures under 5 

U.S.C. 553(b), are impracticable and 

unnecessary because communities listed 

in this final rule have been adequately 

notified. 

Each community receives 6-month, 

90-day, and 30-day notification letters 

addressed to the Chief Executive Officer 

stating that the community will be 

suspended unless the required 

floodplain management measures are 

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