41284 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Rules and Regulations 

costs on tribal governments or preempt 

tribal law. 

B. Submission to Congress and the 

Comptroller General 

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). 

C. Petitions for Judicial Review 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by September 11, 2012. 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 

finalizing the limited approval of the 

Pennsylvania Regional Haze SIP may 

not be challenged later in proceedings to 

enforce its requirements. See section 

307(b)(2) of the CAA. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Nitrogen dioxide, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Dated: June 15, 2012. 

W.C. Early, 

Acting Regional Administrator, Region III. 

40 CFR part 52 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 NN— Pennsylvania 

■ 2. In § 52.2520, the table in paragraph 

(e) is amended by adding an entry for 

Regional Haze Plan at the end of the 

table to read as follows: 

§ 52.2020 Identification of plan. 

* * * * * 

(e)* * * 

Name of non-regulatory SIP 

revision Applicable geographic area 

State 

submittal 

date 

EPA approval date Additional explanation 

*******

Regional Haze Plan ................. Statewide ................................ 12/20/10 7/13/12 [Insert page number 

where the document begins].

§ 52.2042; Limited Approval. 

[FR Doc. 2012–16428 Filed 7–12–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0398; FRL–9352–2] 

Azoxystrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of azoxystrobin 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) and Syngenta 

Crop Protection requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

13, 2012. Objections and requests for 

hearings must be received on or before 

September 11, 2012, 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–2011–0398; 

FRL–9352–2, is available either 

electronically through http:// 

www.regulations.gov or in hard copy at 

the OPP Docket in the Environmental 

Protection Agency Docket Center (EPA/ 

DC), located in EPA West, 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: 

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; email address: 

ertman.andrew@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. 


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Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Rules and Regulations 41285 

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–2011–0398 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 September 11, 2012. 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 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0398, 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), Mail Code: 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 

Tolerances 

In the Federal Register of July 20, 

2011 (76 FR 43231) (FRL–8880–1), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1E7851) by Interregional 

Research Project Number 4 (IR–4), 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.507 be 

amended by: 

• Establishing tolerances for residues 

of the fungicide azoxystrobin, (methyl 

(E)-2-[2-[6-(2-cyanophenoxy)pyrimidin4-yloxy]phenyl]-3-methoxyacrylate) and 

the Z isomer of azoxystrobin, (methyl 

(Z)-2-[2-[6-(2-cyanophenoxy)pyrimidin4-yloxy]pheny1]-3-methoxyacrylate) in 

or on onion, bulb subgroup 3–07A at 1.0 

parts per million (ppm); onion, green 

subgroup 3–07B, at 7.5 ppm; caneberry 

subgroup 13–07A, at 5.0 ppm; 

bushberry subgroup 13–07B, at 3.0 ppm; 

small fruit vine climbing subgroup, 

except fuzzy kiwifruit, 13–07F, at 1.0 

ppm; low growing berry subgroup 13– 

07G, except cranberry, at 10.0 ppm; 

vegetable, fruiting, subgroup 8–10A, at 

0.2 ppm; vegetable, fruiting, subgroups 

8–10B, at 2.0 ppm; fruit, citrus, group 

10–10, at 10.0 ppm; rapeseed subgroup 

20A, at 1.0 ppm; sunflower subgroup 

20B, at 0.5 ppm; cottonseed subgroup 

20C, at 0.6 ppm; wasabi, at 50.0 ppm; 

and dragon fruit, at 2.0 ppm; 

• Changing the tolerance for 

vegetable, tuberous and corm, subgroup 

1C from 0.03 ppm to 6.0 ppm; and 

• Upon approval of the tolerances 

above, by removing the established 

tolerances for onion, bulb at 1.0 ppm; 

onion, green at 7.5 ppm; caneberry 

subgroup 13–A at 5.0 ppm; bushberry 

subgroup 13B at 3.0 ppm; Juneberry at 

3.0 ppm; lingonberry at 3.0 ppm; salal 

at 3.0 ppm; grape at 1.0 ppm; strawberry 

at 10.0 ppm; tomato at 0.2 ppm; 

vegetable, fruiting, group 8 except 

tomato at 2.0 ppm; fruit, citrus, group 10 

at 10.0 ppm; canola, seed at 1.0 ppm; 

cotton, undelinted seed at 0.6 ppm; 

crambe, seed at 0.5 ppm; flax, seed at 

0.5 ppm; mustard, field, seed at 0.5 

ppm; mustard, Indian, seed at 0.5 ppm; 

mustard, seed at 0.5 ppm; rapeseed, 

Indian at 0.5 ppm; rapeseed, seed at 0.5 

ppm; safflower, seed at 0.5 ppm; 

sunflower, seed at 0.5 ppm; potato at 

0.03 ppm. 

In the Federal Register of November 

9, 2011 (76 FR 69690) (FRL–9325–1), 

EPA issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1F7891) by Syngenta Crop 

Protection, LLC., P.O. Box 18300, 

Greensboro, NC 27419–8300. The 

petition requested that 40 CFR 180.507 

be amended by establishing a tolerance 

for residues of the fungicide 

azoxystrobin, (methyl (E)-2-[2-[6-(2- 

cyanophenoxy)pyrimidin-4- 

yloxy]phenyl]-3-methoxyacrylate) and 

the Z isomer of azoxystrobin, (methyl 

(Z)-2-[2-[6-(2-cyanophenoxy)pyrimidin4-yloxy]phenyl]-3-methoxyacrylate) in 

or on sugarcane at 0.2 ppm. 

The notices referenced summaries of 

the petitions prepared by Syngenta, the 

registrant, which are available in the 

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

There were no comments received in 

response to these notices of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the levels at which tolerances 

are being established for various 

commodities. The reason for these 

changes is explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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 


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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. 

Dietary administration 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, increases in alkaline 

phosphatase and gama 

glutamyltransferase, decreases in 

albumin, 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 

including the lowest-observed-adverseeffect-level (LOAEL). Decreased body 

weight/weight gain and food utilization 

was noted in the rat subchronic 

neurotoxicity study. There were no 

consistent indications of treatmentrelated 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 at 

acceptable dose levels. 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 LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2011–0398 on 

pages 38–40 of the document titled 

‘‘Azoxystrobin: Human Health Risk 

Assessment for Proposed Uses on 

Dragon Fruit, Wasabi, and Tuberous and 

Corm Vegetables (Subgroup 1C), and 

from the Revisions to Various Crop 

Groups (Onion Subgroups 3–07 A, B; 

Fruiting Vegetable Subgroups 8–10 A, B; 

Small Fruit and Berry Subgroups 13–07 

A, B, F, G, Oilseeds Subgroups A, B, C; 

and Citrus Fruit Group 10–10).’’ 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for azoxystrobin used for 

human risk assessment is shown in the 

following Table. 

TABLE—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 UFL

Acute RfD = 0.67 mg/kg/day ........

aPAD = 0.67 mg/kg/day 

Acute Neurotoxicity—Rat. LOAEL 

= 200 mg/kg/day based on diarrhea at 2-hours post dose at all 

dose levels up to and including 

to LOAEL. 

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).

NOAEL= 25 mg/kg/day .................

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... Prenatal Developmental Oral Toxicity—Rat. LOAEL = 100 mg/kg/ 

day based on increased maternal diarrhea, urinary incontinence, and salivation. 


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

ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Inhalation short-term (1 to 30 

days).

Oral study NOAEL= 25 mg/kg/day 

(inhalation absorption rate = 

100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... Prenatal Developmental Oral Toxicity—Rat. LOAEL = 100 mg/kg/ 

day based on increased maternal diarrhea, urinary incontinence, and salivation. 

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). UFL = use of a LOAEL to extrapolate a NOAEL. mg/kg/day = milligrams/kilogram/day. 

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 U.S. Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII). As 

to residue levels in food, the acute 

dietary assessment used tolerance levels 

for all commodities, except citrus fruits 

where the highest residue from crop 

field trials was used, and 100 percent 

crop treated (PCT) for all commodities. 

Default processing factors were assumed 

except for where tolerances were 

established for processed commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, the 

chronic dietary analysis for 

azoxystrobin was conducted using 

tolerance levels and average PCT 

estimates when available. Default 

processing factors were assumed except 

for where tolerances were established 

for processed commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that azoxystrobin does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

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

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

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

and authorized under FFDCA section 

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

submitted no later than 5 years from the 

date of issuance of these tolerances. 

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

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

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

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for 

existing uses as follows: 

Almonds, 25%; apricots, 10%; 

artichokes, 25%; asparagus, 2.5%; green 

beans, 10%; blackberries, 5%; 

blueberries, 10%; broccoli, 5%; cabbage, 

10%; cantaloupes, 10%; carrots, 10%; 

cauliflower, 2.5%; celery, 10%; cherries, 

5%; corn, 2.5%; cotton, 5%; cucumbers, 

20%; dry beans/peas, 1%; garlic, 60%; 

grapefruit, 20%; grapes, 5%; hazelnuts 

(filberts), 5%; lettuce, 2.5%; onions, 

10%; oranges, 5%; peaches, 5%; 

peanuts, 15%; green peas, 2.5%; pecans, 

2.5%; peppers, 15%; pistachios, 15%; 

potatoes, 35%; prunes, 2.5%; pumpkins, 

20%; raspberries, 5%; rice, 35%; 

soybeans, 2.5%; spinach, 10%; squash, 

15%; strawberries, 30%; sugar beets, 

5%; sweet corn, 10%; tangerines, 15%; 

tomatoes, 15%; walnuts, 1%; 

watermelon, 20%; wheat, 2.5%. 

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 


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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 First Index Reservoir 

Screening Tool (FIRST), Screening 

Concentration in Ground Water (SCIGROW), the Pesticide Root Zone Model 

(PRZM) and the Exposure Analysis 

Modeling System (EXAMS) models, the 

estimated drinking water concentrations 

(EDWCs) of azoxystrobin for acute 

exposures are estimated to be 173 parts 

per billion (ppb) and 33 ppb for chronic 

exposures. For ground water, the 

estimated drinking water concentration 

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 173 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 33 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). EPA 

assessed residential exposure using the 

new 2012 updated residential standard 

operating procedures (SOPs) that are 

now used in all human health 

assessments. For residential handler 

exposure, the Agency assumed that 

most residential use will result in shortterm (1 to 30 days) dermal and 

inhalation exposures. The worst-case 

scenario used was painting with an 

airless sprayer. Residential handlers are 

assumed to be wearing short-sleeved 

shirts, short pants, shoes and socks 

during application of azoxystrobin. 

Because there was no dermal endpoint 

chosen for azoxystrobin, residential 

handler risk from exposure to 

azoxystrobin was assessed for the 

inhalation route only. 

The Agency assumed that postapplication exposure in residential 

settings is expected to be short-term in 

duration only. No dermal endpoint was 

chosen for azoxystrobin; therefore, a 

dermal post-application risk assessment 

was not conducted. Residential postapplication inhalation exposure in 

outdoor settings is considered 

negligible; however, residential postapplication inhalation exposure has 

been assessed. The scenarios evaluated 

were short-term post-application 

inhalation (indoor), short-term 

incidental oral ingestion from treated 

indoor surfaces (hand-to-mouth vinyl/ 

hard surfaces and carpet/textile 

surfaces), and short-term incidental oral 

ingestion from treated turf (hand-tomouth, mouthing grass, and soil 

ingestion). 

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 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 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 prenatal and postnatal toxicity 

database for azoxystrobin is complete 

and includes prenatal developmental 

toxicity studies in rats and rabbits and 

a 2-generation reproduction study in 

rats. In these studies, offspring toxicity 

was observed at equivalent or higher 

doses than those resulting in parental 

toxicity; thus, there is no evidence of 

increased susceptibility and there are no 

residual uncertainties with regard to 

prenatal and/or postnatal toxicity. 

3. Conclusion. EPA has determined 

that reliable data show that it would be 

safe for infants and children to reduce 

the FQPA safety factor to 1X for shortterm, intermediate term, and chronic 

risk assessment. This determination is 

based on the following considerations: 

i. The toxicity database for 

azoxystrobin is complete except for 

immunotoxicity testing. Changes to 

40 CFR part 158 make immunotoxicity 

testing (OPPTS Guideline 870.7800) 

required for pesticide registration; 

however, the existing data are sufficient 

for endpoint selection for exposure/risk 

assessment scenarios, and for evaluation 

of the requirements under the FQPA. 

There are no indications in the available 

studies that organs associated with 

immune function, such as the thymus 

and spleen, are affected by azoxystrobin 

and azoxystrobin does not belong to a 

class of chemicals (e.g., the organotins, 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Rules and Regulations 41289 

heavy metals, or halogenated aromatic 

hydrocarbons) that would be expected 

to be immunotoxic. Based on the above 

considerations in this unit, EPA does 

not believe that conducting the 

immunotoxicity study will result in a 

dose less than the point of departure 

already used in this risk assessment, 

and an additional database uncertainty 

factor (UF) for potential immunotoxicity 

does not need to be applied. 

ii. Clinical signs noted in the acute 

and subchronic neurotoxicity studies 

were not considered treatment related 

because of a lack of dose-response, 

inconsistency of observations at 

different time points, variability of 

pretreatment values and/or small 

magnitude of response. 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 to in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. The acute dietary exposure 

assessment was performed based on 

tolerance-level residues for all crops 

except citrus, and the chronic dietary 

exposure assessment was performed 

based on tolerance level residues for all 

crops. The acute dietary assessment 

incorporated 100 PCT information, and 

the chronic dietary exposure assessment 

was somewhat refined using 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. 

Despite these considerations 

supporting removal of the FQPA SF, 

EPA has retained the FQPA SF, reduced 

to 3X, in assessing acute dietary risk. An 

additional safety factor is needed for 

acute risk assessment to account for the 

use of a LOAEL from the acute 

neurotoxicity study in rats in deriving 

the acute reference dose used for 

assessing acute dietary exposure for all 

populations including infants and 

children. To account for the use of a 

LOAEL from the acute neurotoxicity 

study in rats, the Agency believes that 

a 3X FQPA SF (as opposed to a 10X) 

will be adequate to extrapolate a 

NOAEL in assessing acute risk and that 

no additional safety factor is needed for 

short-term, intermediate-term, and 

chronic risk assessment based on the 

following considerations: 

• The effect seen (transient diarrhea 

seen in the rat) is of a nature that is 

relatively insignificant; 

• The diarrhea was only seen in 

studies involving gavage dosing in the 

rat but not in repeat dosing through 

dietary administration in rats and mice, 

and not through gavage dosing in 

rabbits; and 

• The very high dose level needed to 

reach the acute oral lethal dose (LD50) 

(>5,000 milligrams/kilogram (mg/kg)), 

and the overall low toxicity of 

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 42% of the 

aPAD for children 1 to 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 16% of 

the cPAD for children 1 to 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 460 for adult males, 470 for 

females 13 to 49 years old and 200 for 

children 1 to 2 years old. Because EPA’s 

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). 

An intermediate-term adverse effect 

was identified; however, azoxystrobin is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

azoxystrobin. 

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 methodologies 

are available to enforce the tolerance 

expression and have been submitted to 

FDA for inclusion in the Pesticide 

Analytical Manual (PAM) Volume II: A 

gas chromatography method with 

nitrogen-phosphorus detection (GC/ 

NPD), RAM 243/04, for the enforcement 

of tolerances for residues of 

azoxystrobin and its Z-isomer in crop 

commodities; and a GC/NPD method, 

RAM 255/01, for the enforcement of 

tolerances of azoxystrobin in livestock 

commodities. The methods may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 


tkelley on DSK3SPTVN1PROD with RULES
41290 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Rules and Regulations 

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

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize 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 following tolerances being 

established by this document are in 

harmony with the equivalent Codex 

MRLs are harmonized (Codex 

commodities in brackets): Caneberry 

subgroup 13–07A (berries and other 

small fruits, except cranberry, grapes 

and strawberry); berry, low growing, 

subgroup 13–07G, except cranberry 

(strawberries); sunflower subgroup 20B 

(sunflower seed); bushberry, subgroup 

13–07B (berries and other small fruits, 

except cranberry, grapes and 

strawberry); cottonseed, subgroup 20C 

(cotton seed); fruit, citrus, group 10–10 

(citrus fruits); fruit, small vine climbing, 

except fuzzy kiwifruit, 13–07F (grape); 

and pepper/eggplant subgroup 8–10B 

(fruiting vegetables other than cucurbits 

except mushrooms and sweet corn). The 

following tolerances could not be 

harmonized with Codex MRLs: Berry, 

low growing subgroup 13–07G, except 

cranberry (berries and other small fruits, 

except cranberry, grapes and 

strawberry); dragon fruit (mango); 

onion, bulb and green subgroups 3–07A 

& B (bulb vegetables); tomato subgroup 

8–10A (fruiting vegetables other than 

cucurbits except mushrooms and sweet 

corn); vegetable, tuberous and corm 

subgroup 1C (root and tuber vegetables); 

and wasabi fresh and dry (herbs, fresh 

and dry). The disharmony is caused by 

various issues, including different 

Codex classification for crop grouping, 

different calculation procedures for 

establishing MRLs, different use 

patterns, and different data sets. There 

are no Codex MRLs) for residues of 

azoxystrobin and its Z-isomer for 

sugarcane. 

C. Revisions to Petitioned-For 

Tolerances 

Several of the tolerances have been 

revised from what was proposed in the 

initial petition. EPA is increasing the 

proposed crop group tolerances for 

bushberry, subgroup 13–07B; cottonseed 

subgroup 20C; citrus fruit, group 10–10; 

fruit, small vine climbing, except fuzzy 

kiwifruit subgroup 13–07F, and pepper/ 

eggplant subgroup 8–10B to harmonize 

the numerical portion of the tolerance 

with the Codex MRL. Also, based on the 

Organization for Economic Cooperation 

and Development (OECD) calculation 

procedures for the current post-harvest 

potato use data, EPA increased the 

requested tolerance for vegetable, 

tuberous and corm, subgroup 1C from 

6.0 ppm to 8.0 ppm. It should be noted 

that there is an existing tolerance on 

potato at 0.03 ppm that is based on 

foliar use. The substantial increase from 

0.03 ppm to 8.0 ppm results from the 

post-harvest use, as opposed to the 

previous foliar-only use. 

EPA is also revising some of the 

commodity definitions in the tolerance 

table to be consistent with EPA’s 

preferred terms for food and feed. 

V. Conclusion 

Therefore, tolerances are established 

for residues of azoxystrobin, (methyl 

(E)-2-[2-[6-(2-cyanophenoxy)pyrimidin4-yloxy]phenyl]-3-methoxyacrylate) and 

the Z isomer of azoxystrobin, (methyl 

(Z)-2-[2-[6-(2-cyanophenoxy)pyrimidin4-yloxy]phenyl]-3-methoxyacrylate) in 

or on onion, bulb, subgroup 3–07A at 

1.0 ppm; onion, green, subgroup 3–07B 

at 7.5 ppm; tomato subgroup 8–10A at 

0.2 ppm; pepper/eggplant subgroup 8– 

10B at 3.0 ppm; fruit, citrus, group 10– 

10 at 15.0 ppm; caneberry subgroup 13– 

07A at 5.0 ppm; bushberry subgroup 

13–07B at 5.0 ppm; fruit, small vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F at 2.0 ppm; berry, low 

growing, subgroup 13–07G, except 

cranberry at 10.0 ppm; rapeseed 

subgroup 20A at 1.0 ppm; sunflower 

subgroup 20B at 0.5 ppm; cottonseed 

subgroup 20C at 0.7 ppm; wasabi, fresh 

at 50 ppm; wasabi, dry at 260 ppm; 

dragon fruit at 2.0 ppm; vegetable, 

tuberous and corm, subgroup 1C at 8.0 

ppm, and sugarcane, cane at 0.2 ppm. 

And lastly, due to the tolerances 

established above by this document, the 

following existing tolerances are 

removed as unnecessary: Onion, bulb; 

onion, green; caneberry subgroup 13A; 

bushberry subgroup 13B; Juneberry; 

lingonberry; salal; grape; strawberry; 

tomato; vegetable, fruiting, group 8 

except tomato; fruit, citrus, group 10; 

canola, seed; cotton, undelinted seed; 

crambe, seed; flax, seed; mustard, field, 

seed; mustard, Indian, seed; mustard, 

seed; rapeseed, Indian; rapeseed, seed; 

safflower, seed; sunflower, seed; potato; 

okra. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to petitions 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Rules and Regulations 41291 

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 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: July 3, 2012. 

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 § 180.507 revise the table in 

paragraph (a)(1) to read as follows: 

§ 180.507 Azoxystrobin; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

Acerola ........................................ 2.0 

Almond, hulls .............................. 4.0 

Animal feed, nongrass, group 

18, forage ................................ 45 

Animal feed, nongrass, group 

18, hay .................................... 120 

Commodity Parts per 

million 

Artichoke, globe .......................... 4.0 

Asparagus ................................... 0.04 

Atemoya ...................................... 2.0 

Avocado ...................................... 2.0 

Banana ....................................... * 

Barley, bran ................................ 6.0 

Barley, forage ............................. 25 

Barley, grain ............................... 3.0 

Barley, hay .................................. 15.0 

Barley, straw ............................... 7.0 

Berry, low growing, subgroup 

13–07G, except cranberry ...... 10.0 

Biriba ........................................... 2.0 

Brassica, head and stem, subgroup 5A ................................. 3.0 

Brassica, leafy greens, subgroup 

5B ............................................ 25 

Bushberry subgroup 13–07B ...... 5.0 

Caneberry subgroup 13–07A ..... 5.0 

Canistel ....................................... 2.0 

Cherimoya .................................. 2.0 

Cilantro, leaves ........................... 30.0 

Citrus, dried pulp ........................ 20.0 

Citrus, oil ..................................... 40.0 

Corn, field, forage ....................... 12.0 

Corn, field, grain ......................... 0.05 

Corn, field, refined oil ................. 0.3 

Corn, field, stover ....................... 25.0 

Corn, pop, grain .......................... 0.05 

Corn, pop, stover ........................ 25.0 

Corn, sweet, forage .................... 12.0 

Corn, sweet, kernel plus cob 

with husks removed ................ 0.05 

Corn, sweet, stover .................... 25.0 

Cotton, gin byproducts ............... 45 

Cottonseed subgroup 20C ......... 0.7 

Cranberry .................................... 0.50 

Custard apple ............................. 2.0 

Dragon fruit ................................. 2.0 

Feijoa .......................................... 2.0 

Fruit, citrus, group 10–10 ........... 15.0 

Fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13– 

07F .......................................... 2.0 

Fruit, stone, group 12 ................. 1.5 

Grain, aspirated fractions ........... 420 

Grass, forage .............................. 15 

Grass, hay .................................. 20 

Guava ......................................... 2.0 

Herb Subgroup 19A, dried 

leaves ...................................... 260 

Herb Subgroup 19A, fresh 

leaves ...................................... 50 

Hop, dried cones ........................ 20.0 

Ilama ........................................... 2.0 

Jaboticaba .................................. 2.0 

Jackfruit ...................................... 2.0 

Longan ........................................ 2.0 

Loquat ......................................... 2.0 

Lychee ........................................ 2.0 

Mango ......................................... 2.0 

Nut, tree, group 14 ..................... 0.02 

Onion, bulb, subgroup 3–07A .... 1.0 

Onion, green, subgroup 3–07B .. 7.5 

Papaya ........................................ 2.0 

Passionfruit ................................. 2.0 

Pawpaw ...................................... 2.0 

Pea and bean, dried shelled, except soybean, subgroup 6C .... 0.5 

Pea and bean, succulent 

shelled, subgroup 6B .............. 0.5 

Peanut ........................................ 0.2 

Peanut, hay ................................ 15.0 

Commodity Parts per 

million 

Peanut, refined oil ...................... 0.6 

Pepper/eggplant subgroup 8– 

10B .......................................... 3.0 

Peppermint, tops ........................ 30 

Persimmon .................................. 2.0 

Pistachio ..................................... 0.50 

Pulasan ....................................... 2.0 

Rambutan ................................... 2.0 

Rapeseed subgroup 20A ............ 1.0 

Rice, grain .................................. 5.0 

Rice, hulls ................................... 20 

Rice, straw .................................. 12 

Rice, wild, grain .......................... 5.0 

Sapodilla ..................................... 2.0 

Sapote, black .............................. 2.0 

Sapote, mamey .......................... 2.0 

Sapote, white .............................. 2.0 

Sorghum, grain, forage ............... 25 

Sorghum, grain, grain ................. 11 

Sorghum, grain, stover ............... 40 

Soursop ...................................... 2.0 

Soybean, hay .............................. 55.0 

Soybean, hulls ............................ 1.0 

Soybean, seed ............................ 0.5 

Spanish lime ............................... 2.0 

Spearmint, tops .......................... 30 

Spice Subgroup 19B, except 

black pepper ........................... 38 

Star apple ................................... 2.0 

Starfruit ....................................... 2.0 

Sugar apple ................................ 2.0 

Sugarcane, cane ........................ 0.2 

Sunflower subgroup 20B ............ 0.5 

Tamarind ..................................... 2.0 

Tomato, paste ............................. 0.6 

Tomato subgroup 8–10A ............ 0.2 

Turnip, greens ............................ 25 

Vegetable, cucurbit, group 9 ...... 0.3 

Vegetable, foliage of legume, 

group 7 .................................... 30.0 

Vegetable, leafy, except brassica, group 4 ........................... 30.0 

Vegetable, leaves of root and 

tuber, group 2 ......................... 50.0 

Vegetable, legume, edible podded, subgroup 6A, except soybean ........................................ 3.0 

Vegetable, root, subgroup 1A .... 0.5 

Vegetable, tuberous and corm, 

subgroup 1C ........................... 8.0 

Wasabi, dry ................................. 260 

Wasabi, fresh .............................. 50 

Watercress .................................. 3.0 

Wax jambu .................................. 2.0 

Wheat, bran ................................ 0.20 

Wheat, forage ............................. 25 

Wheat, grain ............................... 0.10 

Wheat, hay ................................. 15 

Wheat, straw ............................... 4.0 

* 2.0 (of which not more than 0.1 is contained in the pulp) 

* * * * * 

[FR Doc. 2012–17021 Filed 7–12–12; 8:45 am] 

BILLING CODE 6560–50–P 


tkelley on DSK3SPTVN1PROD with RULES