53174 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations 

* * * * * 

[FR Doc. E9–25055 Filed 10–15–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0076; FRL–8794–4] 

Azoxystrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

established tolerances for residues of 

azoxystrobin in or on barley bran; barley 

grain; and barley straw. Interregional 

Research Project Number 4 (IR-4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

October 16, 2009. Objections and 

requests for hearings must be received 

on or before December 15, 2009, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0076. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2009–0076 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before December 15, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0076, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of April 8, 

2009 (74 FR 15971) (FRL–8407–4), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 8E7474) by 

Interregional Research Project Number 4 

(IR-4), IR-4 Project Headquarters, 500 

College Rd. East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.507 be 

amended by increasing established 

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 barley, grain from 0.1 parts per 

million (ppm) to 3.0 ppm and barley, 

straw from 4.0 ppm to 7.0 ppm. That 

notice referenced a summary of the 

petition prepared on behalf of IR-4 by 

Syngenta Crop Protection, Inc., the 

registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting these petitions, EPA has 

determined that the currently 

established tolerance in or on barley 

bran should also be increased and has 


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Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations 53175 

determined that the tolerance 

expression should be revised. The 

reasons for these changes are 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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of azoxystrobin 

on barley bran at 6.0 ppm; barley grain 

at 3.0 ppm; and barley straw at 7.0 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing tolerances 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Azoxystrobin has a 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 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 document 

‘‘Azoxystrobin. Human Health Risk 

Assessment for a Section 3 Amendment 

to Reduce the Preharvest Interval for 

Barley Grain and Straw and to Add Seed 

Treatment Uses on Head and Stem 

Brassica Vegetables (Subgroup 5A) and 

Sorghum, Grain.’’, pages 48–51 in 

docket ID number EPA–HQ–OPP–2009– 

0076. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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 can be found at 

http://www.regulations.gov in document 

‘‘Azoxystrobin. Human Health Risk 

Assessment for a Section 3 Amendment 

to Reduce the Preharvest Interval for 

Barley Grain and Straw and to Add Seed 

Treatment Uses on Head and Stem 

Brassica Vegetables (Subgroup 5A) and 

Sorghum, Grain.’’, pages 19–20 in 

docket ID number EPA–HQ–OPP–2009– 

0076. 

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. 


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In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used tolerance-level 

residues and assumed 100 percent crop 

treated (PCT). 

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, EPA 

used tolerance-level residues, 

incorporated PCT data for some existing 

uses and assumed 100 PCT for the 

remaining crops including barley. 

iii. Cancer. Based on the absence of 

carcinogenicity in two adequate rodent 

carcinogenicity studies, EPA has 

classified azoxystrobin as ‘‘not likely to 

be carcinogenic to humans;’’ therefore, a 

quantitative exposure assessment to 

evaluate cancer risk is unnecessary. 

iv. Percent crop treated (PCT) 

information. 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 used PCT information as 

follows: 

Almonds, 25%; apricot, 15%; 

artichoke, 25%; asparagus, 2.5%; 

blackberries, 5%; blueberries, 10%; 

broccoli, 5%; cabbage, 5%; cantaloupes, 

10%; carrot, 10%; cauliflower, 2.5%; 

celery, 10%; cherry, 5%; cottonseed, 

5%; cucumber, 15%; dried beans/peas, 

1%; field corn, 2.5%; filbert (hazelnut), 

5%; garlic, 60%; grape, 5%; grapefruit, 

25%; green beans, 5% lettuce, 2.5%; 

mustard greens, 15%; onion, 10%; 

orange, 5%; green peas, 2.5%; peach, 

5%; peanut, 15%; pecan, 2.5%; pepper, 

15%; pistachio, 20%; potato, 30%; 

pumpkin, 20%; raspberry, 5%; rice, 

35%; soybean, 2.5%; spinach, 10%; 

squash, 15%; strawberry, 30%; sugar 

beets, 5%; sweet corn, 10%; tangerine, 

20%; tomato, 15%; walnut, 1%; 

watermelon, 20%; and wheat, 2.5%. 

In most cases, EPA uses available data 

from USDA/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 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 

one. 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) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

azoxystrobin for surface water are 

estimated to be 173 parts per billion 

(ppb) for acute exposures 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: Turf grass, 

ornamentals, indoor surfaces, and 

treated paints (preservative 

incorporation). EPA assessed residential 

exposure using the following 

assumptions: Adults were assessed for 

short-term inhalation exposures when 

mixing, loading and applying 

azoxystrobin. For short-term and 

intermediate-term postapplication 

exposures, toddlers and children were 

assessed for incidental oral exposure 

(hand-to-mouth exposure, object-tomouth exposure and exposure through 

incidental ingestion of soil) from contact 

with treated foliage and surfaces. Adults 

were not assessed for intermediate-term 

risk, as intermediate-term residential 

handler scenarios are not expected to 

occur. A dermal exposure assessment 

was not conducted for residential 

handlers or for postapplication activities 

because no dermal endpoint was 

identified. 

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 


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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 website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicity 

database for azoxystrobin 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 reduced the 

FQPA SF 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. EPA has determined that 

reliable data show that it would be safe 

for infants and children to reduce the 

FQPA safety factor to 1X. 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, intermediateterm, and chronic risk assessment based 

on the following considerations: 

i. The concern is low for the use of a 

LOAEL to extrapolate a NOAEL, given 

the relatively insignificant nature of the 

effect (transient diarrhea seen in the rat); 

the fact that diarrhea was only seen in 

studies involving gavage dosing in the 

rat but not in repeat dosing through 

dietary administration in rats, mice, 

rabbits, and dogs; the very high dose 

level needed to reach the acute oral 

lethal dose (LD)50 (>5000 milligrams/ 

kilogram (mg/kg)), and the overall low 

toxicity of azoxystrobin. NOAELs were 

used for short-term, intermediate-term, 

and chronic risk assessments. 

ii. The toxicity database for 

azoxystrobin is complete except for 

immunotoxicity testing. Recent 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, 

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 for potential immunotoxicity does 

not need to be applied. 

iii. 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. 

iv. 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. 

v. The acute and chronic dietary 

exposure assessments were performed 

based on tolerance-level residues. 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 postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by azoxystrobin. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to azoxystrobin 

will occupy 70% of the aPAD for 

children 1–2 years old, the population 

group receiving the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to azoxystrobin 

from food and water will utilize 9.6% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of azoxystrobin is not expected. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-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 and 

intermediate-term residential exposure 

and the Agency has determined that it 


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53178 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations 

is appropriate to aggregate chronic 

exposure through food and water with 

short-term and intermediate-term 

residential exposures to azoxystrobin. 

Using the exposure assumptions 

described in this unit for short-term and 

intermediate-term exposures, EPA has 

concluded the combined short-term 

food, water, and residential exposures 

result in an aggregate MOE of 240 for 

children 1–2 years old (the population 

group receiving the greatest exposure), 

and has concluded the combined 

intermediate-term food, water, and 

residential exposures result in an 

aggregate MOE of 340 for children 1–2 

years old (the population group 

receiving the greatest intermediate-term 

exposure). As the aggregate MOEs for 

short-term and intermediate-term 

exposure are greater than 100 (the LOC) 

for all population subgroups assessed, 

short-term and intermediate-term 

aggregate exposures to azoxystrobin are 

not of concern to EPA. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in mice and 

rats in two adequate carcinogenicity 

studies, azoxystrobin was classified as 

‘‘not likely to be carcinogenic to 

humans,’’ and is not expected to pose a 

cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 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 method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

Codex Maximum Residue Limits 

(MRLs) have been established for 

azoxystrobin in or on barley grain at 0.5 

ppm; and straw and fodder of cereal 

grains (except maize) at 15 ppm. The 

Codex MRLs for barley grain and straw 

are based on field trials conducted in 

Europe and on residues present at a 35– 

42 day pre-harvest interval (PHI). The 

recommended U.S. tolerances on barley 

grain (3.0 ppm) and straw (7.0 ppm) are 

based on residues present at a 14–day 

PHI. The U.S. tolerance for barley grain 

is higher due to the shorter PHI; thus, 

the barley grain tolerance and MRLs 

cannot be harmonized between the U.S. 

and Codex. Codex MRLs for forages, 

straws and the like are set on a dryweight basis, whereas U.S. tolerances 

are set on an as-fed basis; therefore, the 

U.S. tolerance on barley straw cannot be 

harmonized with the Codex MRL for 

straw and fodder of cereal grains 

(including barley, oats, rice and wheat 

data) at this time. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA has revised 

the existing tolerance for barley bran 

from 0.2 ppm to 6.0 ppm. Based on 

previously-submitted wheat processing 

data, a tolerance for barley bran was 

established at 0.2 ppm; however, the 

proposed PHI reduction for barley grain 

results in higher residues in barley grain 

and the potential for increased residues 

in barley bran. Using the highest average 

field trial data for barley grain harvested 

at the 14–day PHI (1.85 ppm) and the 

concentration factor for wheat bran (3x), 

expected residues in barley bran would 

be 5.55 ppm. The expected barley bran 

residues exceed the proposed tolerance 

increase for barley grain at 3.0 ppm and 

the existing tolerance for barley bran at 

0.2 ppm. Therefore, the Agency is 

increasing the established tolerance for 

azoxystrobin in or on barley bran from 

0.2 ppm to 6.0 ppm. 

Additionally, EPA has revised the 

tolerance expression to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

azoxystrobin not specifically 

mentioned; and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

This change was made to both the 

tolerance expressions for plant 

commodities and animal commodities 

because it makes no substantive change 

to the meaning of the tolerance but 

rather only clarifies the existing 

language. 

V. Conclusion 

Therefore, established tolerances are 

amended 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 barley, bran at 6.0 ppm; barley, grain 

at 3.0 ppm; and barley, straw at 7.0 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 


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Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations 53179 

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) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: October 7, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.507 is amended in 

paragraph (a)(1) by revising the 

introductory text and by revising the 

entries for ‘‘Barley, bran’’; ‘‘Barley, 

grain’’; and ‘‘Barley, straw’’ in the table; 

and in paragraph (a)(2) by revising the 

introductory text to read as follows: 

§ 180.507 Azoxystrobin; tolerances for 

residues. 

(a) General. (1) 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 the sum 

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 the commodity. 

Commodity Parts per million 

* * * * * 

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

* * * * * 

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

* * * * * 

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

* * * * * 

(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 the sum 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)pyrimidin-4- 

yloxy)phenyl)-3 methoxyacrylate] in or 

on the commodity. 

* * * * * 

[FR Doc. E9–24813 Filed 10–15–09; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2008–0020; Internal 

Agency Docket No. FEMA–8099] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities, where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP), that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. 

DATES: Effective Dates: The effective 

date of each community’s scheduled 

suspension is the third date (‘‘Susp.’’) 

listed in the third column of the 

following tables. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact David Stearrett, 

Mitigation Directorate, Federal 

Emergency Management Agency, 500 C 

Street, SW., Washington, DC 20472, 

(202) 646–2953. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

flood insurance which is generally not 

otherwise available. In return, 

communities agree to adopt and 

administer local floodplain management 

aimed at protecting lives and new 

construction from future flooding. 

Section 1315 of the National Flood 

Insurance Act of 1968, as amended, 42 

U.S.C. 4022, prohibits flood insurance 

coverage as authorized under the NFIP, 

42 U.S.C. 4001 et seq.; unless an 

appropriate public body adopts 

adequate floodplain management 

measures with effective enforcement 

measures. The communities listed in 

this document no longer meet that 

statutory requirement for compliance 

with program regulations, 44 CFR part 

59. Accordingly, the communities will 

be suspended on the effective date in 

the third column. As of that date, flood 

insurance will no longer be available in 

the community. However, some of these 

communities may adopt and submit the 

required documentation of legally 

enforceable floodplain management 

measures after this rule is published but 

prior to the actual suspension date. 

These communities will not be 

suspended and will continue their 

eligibility for the sale of insurance. A 

notice withdrawing the suspension of 

the communities will be published in 

the Federal Register. 

In addition, FEMA has identified the 

Special Flood Hazard Areas (SFHAs) in 

these communities by publishing a 

Flood Insurance Rate Map (FIRM). The 


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