24094 Federal Register / Vol. 78, No. 79 / Wednesday, April 24, 2013 / Rules and Regulations 

■ 25. Revise sections 4.1 and 5.2.2.2 to 

Appendix A to Subpart UUUUU of Part 

63 to read as follows: 

Appendix A to Subpart UUUUU—Hg 

Monitoring Provisions 

* * * * * 

4.1 Certification Requirements. All Hg 

CEMS and sorbent trap monitoring systems 

and the additional monitoring systems used 

to continuously measure Hg emissions in 

units of the applicable emissions standard in 

accordance with this appendix must be 

certified in a timely manner, such that the 

initial compliance demonstration is 

completed no later than the applicable date 

in § 63.9984(f). 

* * * * * 

5.2.2.2 The same RATA performance 

criteria specified in Table A–2 for Hg CEMS 

also apply to the annual RATAs of the 

sorbent trap monitoring system. 

* * * * * 

■ 26. Revise section 3.1.2.1.3 and the 

heading to section 5.3.4 to Appendix B 

to Subpart UUUUU of Part 63 to read as 

follows: 

Appendix B to Subpart UUUUU—HCl 

and HF Monitoring Provisions 

* * * * * 

3.1.2.1.3 For the ASTM D6348–03 test 

data to be acceptable for a target analyte, 

%R must be 70% ≤ R ≤ 130%; and 

* * * * * 

5.3.3 Conditional Data Validation 

* * * 

* * * * * 

[FR Doc. 2013–07859 Filed 4–23–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0282; FRL–9384–2] 

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 

discussed later in this document. 

Syngenta Crop Protection, LLC 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

24, 2013. Objections and requests for 

hearings must be received on or before 

June 24, 2013, 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 these 

actions, identified by docket 

identification (ID) number EPA–HQ– 

OPP–2012–0282, is available at http:// 

www.regulations.gov or at the Office of 

Pesticide Programs Regulatory Public 

Docket (OPP Docket) in the 

Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Erin 

Malone, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–0253; email address: 

Malone.Erin@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s eCFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0282 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before June 24, 2013. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0282, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of April 4, 

2012 (77 FR 20336) (FRL–9340–4), 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 1E7945) 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 an import 

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- 


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cyanophenoxy)pyrimidin-4- 

yloxy)phenyl)-3-methoxyacrylate] in or 

on ginseng extract (red ginseng extract 

and ginseng extract) at 0.5 parts per 

million (ppm). That document 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

LLC, the registrant, which is available in 

the docket EPA–HQ–OPP–2012–0041, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Additionally, in the Federal Register 

of May 23, 2012 (77 FR 30484) (FRL– 

9347–8), EPA issued a document 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing the filing 

of pesticide petitions (PP 2F7976 and PP 

2F7984) by Syngenta Crop Protection, 

LLC, P.O. Box 18300, Greensboro, NC 

27419–8300. The petitions requested 

that 40 CFR 180.507 be amended by: 

• Establishing tolerances 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)pyrimidin-4- 

yloxy)phenyl)-3-methoxyacrylate], in or 

on oats, forage at 4 parts per million 

(ppm); oats, hay at 7 ppm; oats, straw at 

3 ppm; oats, grain at 1 ppm; rye, forage 

at 4 ppm; rye, straw at 0.8 ppm; rye, 

grain at 0.07 ppm; poultry, meat at 0.01 

ppm; poultry, liver at 0.2 ppm; poultry, 

fat at 0.01 ppm; egg at 0.1 ppm; cattle, 

liver at 0.5 ppm; cattle, kidney at 0.1 

ppm; hog, liver at 0.2 ppm; hog, kidney 

at 0.03 ppm (PP 2F7976); 

• Amending established tolerances 

for barley, hay from 15 ppm to 7 ppm; 

barley, straw from 7 ppm to 8 ppm; 

barley, grain from 3 ppm to 2 ppm; 

wheat, forage from 25 ppm to 10 ppm; 

wheat, straw from 4 ppm to 6 ppm; 

wheat, hay from 15 ppm to 20 ppm; 

grain aspirated fractions from 420 ppm 

to 460 ppm; cattle, fat from 0.03 ppm to 

0.3 ppm; hog, fat from 0.01 ppm to 0.1 

ppm; hog, meat from 0.01 ppm to 0.02 

ppm; (PP 2F7984). 

The notices referenced summaries of 

the petitions prepared by Syngenta Crop 

Protection, LLC, the registrant, which is 

available in the dockets EPA–HQ–OPP– 

2012–0282 and EPA–HQ–OPP–2012– 

0283, http://www.regulations.gov. There 

were no comments received in response 

to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA is 

establishing tolerances that vary from 

what the petitioner requested. 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 

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. 

The toxicological profile for 

azoxystrobin has not changed since the 

final rule published in the Federal 

Register of July 13, 2012 (77 FR 41285) 

(FRL–9352–2). See that rule for a 

summary of the toxicological profile and 

references to supporting Agency 

documents that discuss specific 

information on the toxicity 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). 

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 discussed in 

Unit III.B. of the final rule published in 

the Federal Register of July 13, 2012 (77 

FR 41286) (FRL–9352–2). 

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’s (USDA) 

National Health and Nutrition 

Examination Survey, What We Eat in 


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America (NHANES/WWEIA) conducted 

from 2003 to 2008. As to residue levels 

in food, the acute dietary exposure 

assessment of azoxystrobin is partially 

refined by using highest residue values 

for citrus fruits and assuming tolerancelevel residues for all other existing and 

proposed commodities. One hundred 

percent of the crops were assumed 

treated with azoxystrobin and DEEM 

(Dietary Exposure Evaluation Model) 

version 7.81 default processing factors 

were used except 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’s 

(NHANES/WWEIA) conducted from 

2003 to 2008, as well. As to residue 

levels in food, a slightly refined chronic 

dietary analysis for azoxystrobin was 

conducted using tolerance-level 

residues and average percent crop 

treated estimates when available. DEEM 

version 7.81 default processing factors 

were assumed except for where 

tolerances were established for 

processed commodities or when 

processing studies show no 

concentration. An updated screening 

level usage analysis (SLUA) of 

azoxystrobin from 2011 was used for 

percent crop treated. 

iii. Cancer. The rat and the mouse 

carcinogenicity studies on azoxystrobin 

do not show an increase in tumor 

incidence. Azoxystrobin is classified as 

‘‘not likely to be carcinogenic to 

humans.’’ Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

iv. Anticipated or actual residues 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 CallIns 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%; and wheat, 2.5%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/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 First Index Reservoir 

Screening Tool (FIRST), the highest 

estimated drinking water concentrations 

(EDWCs) of azoxystrobin for acute 

exposures are estimated to be 173 parts 

per billion (ppb) for surface water and 

33 ppb for chronic exposures for noncancer assessments. Based on the 

Screening Concentration in 

Groundwater, version 2.3, August 8, 

2003 (SCI-GROW), the EDWC for ground 

water is 3.1 ppb for all exposures. 

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 

value of 33 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 


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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, azoxystrobin is registered 

for uses on indoor carpets/other 

surfaces, and in treated paints 

(preservative incorporation). EPA 

assessed residential exposure using the 

following assumptions: 

• Residential uses will result in shortterm (1 to 30 days) handler exposure; 

residential handlers are assumed to be 

wearing short-sleeved shirts, short 

pants, shoes, and socks during the 

application; and because there was no 

dermal endpoint chosen for 

azoxystrobin, residential handler risk 

from exposure 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. Residential postapplication inhalation exposure in 

outdoor settings is considered 

negligible; however, residential postapplication inhalation exposure in 

indoor settings has been assessed for 

adults and children. 

Further information regarding EPA’s 

standard assumptions and generic 

inputs for residential exposures may be 

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

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found 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 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 regards to prenatal 

and/or postnatal toxicity. 

3. Conclusion. 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 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 (LD)50

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

and the overall low toxicity of 

azoxystrobin. 

However, 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 short-term, 

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. 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 that would be 

expected to be immunotoxic. Based on 

the above considerations, 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 for potential immunotoxicity does 

not need to be applied. 

ii. Clinical signs, including transient 

diarrhea and decreased body weight, 

body weight gain, and food utilization, 

were noted in the acute and subchronic 

neurotoxicity studies, but were not 

considered indicative of neurotoxicity. 

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. There are no residual uncertainties 

in the azoxystrobin exposure database. 

While some refinements were 

incorporated into the dietary exposure 

calculations, EPA is confident that the 

aggregate risk from exposure to 

azoxystrobin in food, drinking water, 

and residential pathways will not be 

underestimated. The acute dietary 

(food) exposure assessment utilized 

conservative upper-bound inputs 

including 100% of the proposed and 

registered crops treated, and tolerancelevel residues for all existing and 

proposed 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 

tolerance-level residues for all 

commodities and PCT estimates when 

available (SLUA, 07/13/11). Although 

the acute and chronic assessments 

included minor refinements, the use of 


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field trial and PCT estimates ensures 

that actual exposures/risks from 

residues in food will not be 

underestimated. The drinking water 

assessment utilized water concentration 

values generated by models and 

associated modeling parameters which 

are designed to produce conservative, 

health protective, high-end estimates of 

water concentrations which are not 

likely to be exceeded. The dietary (food 

and drinking water) exposure 

assessment does not underestimate the 

potential exposure for infants, children, 

or women of child-bearing age. 

In addition, the residential exposure 

assessment is based on the updated 

2012 Residential SOPs employing 

surrogate study data, including 

conservative exposure assumptions 

based on Day 0 dermal/oral contact to 

turf and surfaces treated at the 

maximum application rate. These data 

are reliable and are not expected to 

underestimate risks to adults or 

children. The Residential SOPs are 

based upon reasonable ‘‘worst-case’’ 

assumptions and are not expected to 

underestimate risk. 

E. Aggregate Risks and Determination of 

Safety. 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the aPAD and cPAD. For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-, intermediate-, and chronic-term 

risks are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute aggregate risk 

would be equivalent to the acute dietary 

exposure from food and water to 

azoxystrobin will occupy 41% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

azoxystrobin is not expected. Therefore, 

the chronic aggregate risk would be 

equivalent to the chronic dietary 

exposure estimate and was 17% of the 

cPAD for the most highly exposed 

subgroup, children 1–2 years old. 

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 920 for general U.S. population 

and 190 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). 

Azoxystrobin is not registered for any 

use patterns that would result in 

intermediate-term residential exposure. 

Therefore, EPA relies on chronic dietary 

exposure to evaluate intermediate-term 

aggregate risk. 

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 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 not established MRLs 

for azoxystrobin on oat, forage; oat, hay; 

rye, forage; barley, hay; wheat, forage; 

wheat, hay; and grain aspirated 

fractions. 

The Codex has established MRLs for 

azoxystrobin in or on ginseng, dried 

including red ginseng at 0.5 ppm; rye, 

grain at 0.2 ppm and wheat, grain at 0.2 

ppm. These MRLs are the same as the 

tolerances established for azoxystrobin 

in the United States. 

The Codex has established MRLs for 

azoxystrobin in or on oats, grain at 0.5 

ppm and barley, grain at 0.5 ppm. These 

MRLs are different than the tolerances 

established for azoxystrobin in the 

United States. The U.S. tolerance on oat 

grain (1.5 ppm) and barley grain (3 ppm) 

could not be harmonized since the 

Codex MRLs are lower. Setting the U.S. 

tolerance to be consistent with the 

Codex MRLs might lead to residues in 

excess of the tolerance, despite legal use 

of the pesticide in accordance with the 

registered label. 

C. Revisions to Petitioned-For 

Tolerances 

The tolerance levels requested by the 

petitioners are based on residue data 

submitted using lower application rates 

than are found on the registered label; 

therefore, EPA used the proportionality 

principle (JMPR Report 2011) to 

estimate residue values that reflect the 

higher application rates on the 

registered label. In doing this exercise, 

EPA determined that an adjustment to 

the wheat, grain tolerance was required 

to reflect the application rates for the 

pesticide. 

The proposed tolerance on ginseng 

extract (red ginseng extract and ginseng 


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Federal Register / Vol. 78, No. 79 / Wednesday, April 24, 2013 / Rules and Regulations 24099 

extract) is not needed because the 

tolerance on ginseng will cover the 

expected residues in these processed 

commodities. 

The proposed amended tolerance for 

grain aspirated fractions is not needed 

due to the current tolerance being 

sufficient. EPA is not establishing the 

tolerances as proposed for livestock 

commodities as there was no increased 

dietary burden on livestock with the 

new uses, the existing tolerances were 

sufficient. 

The tolerance expression in 40 CFR 

180.507(a)(2) is incorrect and was 

revised. 

V. Conclusion 

Therefore, tolerances are established 

for residues of 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)pyrimidin-4- 

yloxy)phenyl)-3-methoxyacrylate], in or 

on oat, forage at 5.0 ppm; oat, hay at 

10.0 ppm; oat, straw at 3.0 ppm; oat, 

grain at 1.5 ppm; rye, forage at 7.0 ppm; 

rye, straw at 1.5 ppm; rye, grain at 0.2 

ppm; barley, hay at 10.0 ppm; barley, 

straw 15.0 ppm; wheat, forage from at 

15.0 ppm; wheat, straw at 10.0 ppm; 

wheat, hay at 30.0 ppm; and wheat, 

grain at 0.2 ppm. In conjunction with 

establishment of the wheat grain 

tolerance at 0.2 ppm, the existing 

tolerance on wheat bran needs to be 

deleted from 40 CFR 180.507(a)(1). 

Also, EPA is establishing a tolerance 

for residues of 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)pyrimidin-4- 

yloxy)phenyl)-3-methoxyacrylate], in or 

on ginseng at 0.5 ppm. Although, as of 

the date of publication of this rule, there 

are no U.S. registrations for use of 

azoxystrobin on ginseng, this tolerance 

will allow for imports of treated ginseng 

meeting this tolerance level. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 12, 2013. 

Daniel J. Rosenblatt, 

Acting 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. Revise the entries for ‘‘Barley, hay’’, 

‘‘Barley, straw’’, ‘‘Wheat, grain’’, 

‘‘Wheat, hay’’, ands ‘‘Wheat, straw’’ in 

the table in paragraph (a)(1); 

■ b. Add alphabetically the entries for 

‘‘Ginseng’’, ‘‘Oats, forage’’, ‘‘Oats, 

grain’’, ‘‘Oats, hay’’, ‘‘Oats, straw’’, 

‘‘Rye, forage’’, ‘‘Rye, grain’’, ‘‘Rye, 

straw’’ to the table in paragraph (a)(1); 

■ c. Remove the entry in the table in 

paragraph (a)(1) for ‘‘Wheat, bran’’; 

■ d. Add footnote 1 to the table in 

paragraph (a)(1); and 

■ e. Revise the introductory text of 

paragraph (a)(2) 

The revisions and additions read as 

follows: 

§ 180.507 Azoxystrobin; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Barley, hay ................................ 10.0 

Barley, straw ............................. 15.0 

* * * * * 

Ginseng 1 .................................. 0.5 

* * * * * 

Oats, forage .............................. 5.0 

Oats, grain ................................ 1.5 

Oats, hay .................................. 10.0 

Oats, straw ............................... 3.0 

* * * * * 

Rye, forage ............................... 7.0 

Rye, grain ................................. 0.2 

Rye, straw ................................. 1.5 


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Commodity Parts per 

million 

* * * * * 

Wheat, grain ............................. 0.2 

Wheat, hay ............................... 30.0 

Wheat, straw ............................. 10.0 

1There are no United States registrations 

for use of azoxystrobin on ginseng. 

(2) Tolerances are established for 

residues of the fungicide, azoxystrobin, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

table is to be determined by measuring 

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

cyanophenoxy) pyrimidin-4- 

yloxy)phenyl)-3-methoxyacrylate] in or 

on the commodity. 

* * * * * 

[FR Doc. 2013–09701 Filed 4–23–13; 8:45 am] 

BILLING CODE 6560–50–P 


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