Federal Register / Vol. 76, No. 115 / Wednesday, June 15, 2011 / Rules and Regulations 34877 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0296; FRL–8876–4] 

Difenoconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

difenoconazole in or on aspirated grain 

fractions; carrot; chickpea; fruits, stone, 

group 12; soybean, hulls; soybean, seed; 

strawberry; and turnip greens. Syngenta 

Crop Protection, Inc., requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). This 

regulation also increases the existing 

tolerances for cattle, liver; goat, liver; 

hog, liver; horse, liver; sheep, liver; and 

decreases the existing tolererance for 

egg and revises the tolerance expression 

for animal commodities. 

DATES: This regulation is effective June 

15, 2011. Objections and requests for 

hearings must be received on or before 

August 15, 2011, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0296. 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: Rose 

Mary Kearns, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5611; e-mail address: 

kearns.rosemary@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0296 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 August 15, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0296, 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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of August 4, 

2010 (75 FR 46924) (FRL–8834–9), 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 9F7676) by 

Syngenta Crop Protection, Inc., P.O. Box 

18300, Greensboro, NC 27419–8300. 

The petition requested that 40 CFR 

180.475 be amended by establishing 

tolerances for residues of the fungicide 

difenoconazole, in or on carrot at 0.45 

parts per million (ppm); chickpeas at 

0.05 ppm; fruits, stone, group 12 at 2.5 

ppm; soybean, seed, at 0.2 ppm; 

soybean, aspirated grain fraction at 95 

ppm; strawberry at 2.5 ppm; turnip 

greens at 35 ppm; and increasing the 

existing milk tolerance from 0.01 to 0.08 

ppm. Comments were received on the 

notice of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has: 

Increased the proposed tolerance for 

carrot from 0.45 ppm to 0.50 ppm, and 

for chickpea from 0.05 ppm to 0.08 

ppm; decreased the proposed soybean, 

seed tolerance from 0.20 ppm to 0.15 

ppm; established a tolerance that was 

not proposed for soybean, hulls at 0.20 

ppm; changed the proposed tolerance 

terminology for ‘‘soybean, aspirated 

grain fractions’’ to ‘‘aspirated grain 

fractions;’’ revised the tolerance 

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expression for animal commodities; 

increased the existing animal tolerances 

from 0.20 ppm to 0.40 ppm for the livers 

of cattle, goat, hog, horse, and sheep; 

decreased the existing tolerance for eggs 

from 0.10 ppm to 0.02 ppm; not granted 

the proposed tolerance increase for milk 

from 0.01 to 0.08 ppm. The reasons for 

these changes are explained in Unit 

IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

Consistent with 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 difenoconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with difenoconazole 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. 

Difenoconazole possesses low acute 

toxicity by the oral, dermal and 

inhalation routes of exposure. It is not 

an eye or skin irritant and is not a 

sensitizer. Subchronic and chronic 

studies with difenoconazole in mice and 

rats showed decreased body weights, 

decreased body weight gains and effects 

on the liver. In an acute neurotoxicity 

study in rats, reduced fore-limb grip 

strength was observed on day 1 in males 

and clinical signs of neurotoxicity were 

observed in females at the limit dose of 

2,000 milligrams/kilograms (mg/kg). In a 

subchronic neurotoxicity study in rats, 

decreased hind limb strength was 

observed in males only at the mid- and 

high-doses. However, the effects 

observed in acute and subchronic 

neurotoxicity studies are transient, and 

the dose-response is well characterized 

with identified no observed adverse 

effect level (NOAELs). No systemic 

toxicity was observed at the limit dose 

in the most recently submitted 28-day 

rat dermal toxicity study. 

There is no concern for increased 

qualitative and/or quantitative 

susceptibility after exposure to 

difenoconazole based on developmental 

toxicity studies in rats and rabbits, and 

a reproduction study in rats as fetal/ 

offspring effects occurred in the 

presence of maternal toxicity. There are 

no indications in the available studies 

that organs associated with immune 

function, such as the thymus and 

spleen, are affected by difenoconazole. 

In accordance with the Agency’s 

current policy, difenoconazole is 

classified as ‘‘Suggestive Evidence of 

Carcingenic Potential’’ and EPA is using 

the Margin of Exposure (MOE) approach 

to assess cancer risk. Difenoconazole is 

not mutagenic, and no evidence of 

carcinogenicity was seen in rats. 

Evidence for carcinogenicity was seen 

in mice (liver tumors), but these tumors 

were only induced at doses which were 

considered to be excessively high for 

carcinogenicity testing. Based on 

excessive toxicity observed at the two 

highest doses in the study, the absence 

of tumors at the study’s lower doses, 

and the absence of genotoxic effects, 

EPA has concluded that the chronic 

point of departure (POD) from the 

chronic mouse study will be protective 

of any cancer effects. The POD from this 

study is the NOAEL of 30 ppm (4.7 and 

5.6 mg/kg/day in males and females, 

respectively) which was chosen based 

upon only those biological endpoints 

which were relevant to tumor 

development (i.e., hepatocellular 

hypertrophy, liver necrosis, fatty 

changes in the liver and bile stasis). 

Specific information on the studies 

received and the nature of the adverse 

effects caused by difenoconazole as well 

as the NOAEL and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Difenoconazole Human Health Risk 

Assessment for Amended Section 3 

Registration to Add Uses on Carrots, 

Chickpeas, Soybeans, Stone Fruits 

(Group 12), Strawberries, Turnip Greens 

and Golf Course Turf Grass,’’ pp. 13–19 

in docket ID number EPA–HQ–OPP– 

2010–0296. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological 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 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 

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 chemical name used for 

human risk assessment is shown in the 

Table of this unit. 

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TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIFENOCONAZOLE 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—General population including infants and 

children.

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

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.25 mg/ 

kg/day.

aPAD = 0.25 mg/kg/ 

day 

Acute Neurotoxicity study in Rats LOAEL = 200 mg/kg/day based 

on reduced fore-limb grip strength in males on day 1. 

Chronic dietary—All 

populations.

NOAEL= 0.96 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.01 

mg/kg/day.

cPAD = 0.01 mg/kg/ 

day 

Combined chronic toxicity/carcinogenicity (rat; dietary) LOAEL = 

24.1/32.8 mg/kg/day based on cumulative decreases in bodyweight gains. 

Incidental oral shortterm—1 to 30 days.NOAEL= 1.25 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = < 100 Reproduction and fertility Study (rat; dietary) Parental/Offspring 

LOAEL = 12.5 mg/kg/day based on decreased pup weight in 

males on day 21 and reduction in body-weight gain of F0 females 

prior to mating, gestation and lactation. 

Inhalation short- and 

intermediate-term 

inhalation and oral 

absorption assumed 

equivalent.

Inhalation (or oral) study 

NOAEL = 1.25 mg/kg/ 

day inhalation absorption rate = 100%.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = < 100 Reproduction and fertility study (rat; dietary) Parental/Offspring 

LOAEL = 12.5 mg/kg/day based on decreased pup weight in 

males on day 21 and reduction in body-weight gain of F0 females 

prior to mating, gestation and lactation. 

Cancer, Oral, dermal, 

inhalation.

Difenoconazole is classified ‘‘Suggestive Evidence of Carcinogenic Potential’’ with a non-linear (MOE) approach for 

human risk characterization. 

POD = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation 

to determine risk associated with lower environmentally relevant human exposures. NOAEL = No observed adverse effect level. LOAEL = lowest 

observed adverse effect level. 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. UFS = use of a short-term study 

for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to difenoconazole. EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing difenoconazole tolerances in 40 

CFR 180.475. EPA assessed dietary 

exposures from difenoconazole 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 difenoconazole. 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 assumed 

tolerance-level residues, 100 percent 

crop treated (PCT), and the available 

empirical or dietary exposure evaluation 

model (DEEMTM) (ver. 7.81) default 

processing factors. 

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 

assumed tolerance-level residues for 

some commodities, average field trial 

residues (i.e., anticipated residues) for 

the majority of commodities, and the 

available empirical or DEEMTM (ver. 

7.81) default processing factors, and 100 

PCT. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. Based on the 

data summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk difenoconazole. However, 

EPA determined that a quantitative 

cancer exposure assessment is 

unnecessary since the NOAEL (4.7 and 

5.6 mg/kg/day in males and females, 

respectively) to assess cancer risk is 

higher than the NOAEL (0.96 and 1.27 

mg/kg/day in males and females, 

respectively) to assess chronic risks and 

the cancer exposure assessment would 

not exceed the chronic exposure 

estimate. Therefore, the chronic dietary 

risk estimate will be protective of 

potential cancer risk. 

Cancer risk was assessed using the 

same exposure estimates as discussed in 

Unit III.C.1.ii. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use PCT information in the dietary 

assessment of difenoconazole. EPA used 

anticipated residues including average 

field trial residues for the majority of 

commodities, the available empirical or 

DEEMTM (ver. 7.81) default processing 

factors; and 100 PCT information in the 

chronic dietary assessment for 

difenoconazole. 

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 

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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. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for difenoconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

difenoconazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models the estimated drinking 

water concentrations (EDWCs) of 

difenoconazole for surface water are 

estimated to be 15.8 parts per billion 

(ppb) for acute exposures and 10.4 ppb 

for chronic exposures. For ground 

water, the EDWCs are estimated to be 

0.0128 ppb for both acute and chronic 

exposures. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. The 

water concentration of 15.8 ppb and 

10.4 ppb were used to assess the 

contribution to drinking water in the 

acute and chronic dietary risk 

assessments, respectively. 

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). 

Difenoconazole is currently registered 

for the following uses that could result 

in residential exposures: Application to 

ornamentals. There is a potential for 

exposure to difenoconazole during 

mixing, loading, and application 

activities through the dermal and 

inhalation routes. Difenoconazole 

products are applied by homeowners 

using handheld spray equipment. 

Exposure duration is considered shortterm (1–30 days). In addition, 

residential post-application exposure to 

treated golf course turf is possible for 

recreational golfers. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http:// 

www.epa.gov/pesticides/trac/science/ 

trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

Difenoconazole is a member of the 

triazole-containing class of pesticides. 

Although conazoles act similarly in 

plants (fungi) by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between their pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same, sequence of 

major biochemical events (EPA, 2002). 

With triazole type fungicides however, 

a variable pattern of toxicological 

responses is found. Some are 

hepatotoxic and hepatocarcinogenic in 

mice. Some induce thyroid tumors in 

rats. Some induce developmental, 

reproductive, and neurological effects in 

rodents. Furthermore, the conazoles 

produce a diverse range of biochemical 

events including altered cholesterol 

levels, stress responses, and altered 

DNA methylation. It is not clearly 

understood whether these biochemical 

events are directly connected to their 

toxicological outcomes. Thus, there is 

currently no evidence to indicate that 

conazoles share common mechanisms of 

toxicity and EPA is not following a 

cumulative risk approach based on a 

common mechanism of toxicity for the 

conazoles. For information regarding 

EPA’s procedures for cumulating effects 

from substances found to have a 

common mechanism of toxicity, see 

EPA’s Web site at http://www.epa.gov/ 

pesticides/cumulative. 

Difenoconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and two triazole conjugates 

(triazolylalanine and triazolylacetic 

acid). To support existing tolerances 

and to establish new tolerances for 

triazole-derivative pesticides, including 

difenoconazole, EPA conducted a 

human health risk assessment for 

exposure to 1,2,4-triazole, 

triazolylalanine, and triazolylacetic acid 

resulting from the use of all current and 

pending uses of any triazole-derived 

fungicide. The risk assessment is a 

highly conservative, screening-level 

evaluation in terms of hazards 

associated with common metabolites 

(e.g., use of a maximum combination of 

uncertainty factors) and potential 

dietary and non-dietary exposures (i.e., 

high end estimates of both dietary and 

non-dietary exposures). In addition, the 

Agency retained the additional 10x 

FQPA safety factor for the protection of 

infants and children. The assessment 

includes evaluations of risks for various 

subgroups, including those comprised 

of infants and children. The Agency’s 

complete risk assessment is found in the 

reregistration docket at http:// 

www.regulations.gov, docket ID number 

EPA–HQ–OPP–2005–0497. 

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. 

EPA determined that the available data 

indicated no increased susceptibility of 

rats or rabbits to in utero and/or 

postnatal exposure to difenoconazole. In 

the prenatal developmental toxicity 

studies in rats and rabbits and the 2- 

generation reproduction study in rats, 

toxicity to the fetuses/offspring, when 

observed, occurred at equivalent or 

higher doses than in the maternal/ 

parental animals. In the prenatal 

developmental toxicity study in rats, 

maternal toxicity was manifested as 

decreased body weight gain and food 

consumption at the LOAEL of 85 mg/kg/ 

day; the NOAEL was 16 mg/kg/day. The 

developmental toxicity was manifested 

as alterations in fetal ossifications at 171 

mg/kg/day; the developmental NOAEL 

was 85 mg/kg/day. In a developmental 

toxicity study in rabbits, maternal and 

developmental toxicity were seen at the 

same dose level (75 mg/kg/day). 

Maternal toxicity in rabbits were 

manifested as decreased in body weight 

gain and decreased in food 

consumption, while developmental 

toxicity was manifested as decreased 

fetal weight. In a 2-generation 

reproduction study in rats, there were 

decreases in maternal body weight gain 

and decreases in body weights of F1

males at the LOAEL of 12.5 mg/kg/day; 

the parental systemic and off spring 

toxicity NOAEL was 1.25 mg/kg/day. 

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3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1x. That decision is 

based on the following findings: 

i. The toxicity database for 

difenoconazole is adequate for 

conducting a FQPA risk assessment. At 

this time, an immunotoxicity study is 

not available. However, the toxicology 

database for difenoconazole does not 

show any evidence of treatment-related 

effects on the immune system. The 

overall weight of evidence suggests that 

this chemical does not directly target 

the immune system. An immunotoxicity 

study is now required as a part of new 

data requirements in the 40 CFR part 

158 for conventional pesticide 

registration; however, the Agency does 

not believe that conducting a functional 

immunotoxicity study will result in a 

lower POD than that currently in use for 

overall risk assessment, and therefore, a 

database uncertainty factor (UFDB) is 

not needed to account for lack of this 

study. 

ii. The acute and subchronic 

neurotoxicity studies in rats are 

available. These data show that 

difenoconazole exhibits some evidence 

of neurotoxicity in the database, but the 

effects are transient or occur at doses 

exceeding the limit dose. EPA 

concluded that difenoconazole is not a 

neurotoxic compound. Based on the 

toxicity profile, and lack of 

neurotoxicity, a developmental 

neurotoxicity study in rats is not 

required nor is an additional database 

uncertainty factor needed to account for 

the lack of this study. 

iii. There is no evidence that 

difenoconazole results in increased 

susceptibility of rats or rabbit fetuses to 

in utero and/or postnatal exposure in 

the developmental and reproductive 

toxicity data. 

iv. There are no residual uncertainties 

identified in the exposure databases. A 

conservative dietary food exposure 

assessment was conducted. Acute 

dietary food exposure assessments were 

performed based on tolerance-level 

residues, 100 PCT, and the available 

empirical or DEEMTM (ver. 7.81) default 

processing factors. 

Chronic dietary exposure assessments 

were based on tolerance-level residues 

for some commodities, average field 

trial residues for the majority of 

commodities, the available empirical or 

DEEMTM (ver. 7.81) default processing 

factors, and 100 PCT. These are 

conservative approaches and are 

unlikely to understate the residues in 

food commodities. 

EPA also made conservative 

(protective) assumptions in the ground 

water and surface water modeling used 

to assess exposure to difenoconazole in 

drinking water. Post-application 

exposure of children as well as 

incidental oral exposure of toddlers is 

not expected. These assessments will 

not underestimate the exposure and 

risks posed by difenoconazole. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from 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 difenoconazole 

will occupy 19% 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 difenoconazole 

from food and water will utilize 49% of 

the cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. 

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). Difenoconazole 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 difenoconazole. 

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 260. Because EPA’s level of 

concern for difenoconazole is a MOE of 

100 or below, these MOEs are not of 

concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit III.A and the toxicological 

endpoints described in Unit III.B, EPA 

has concluded that the cPAD is 

protective of possible cancer effects; 

therefore, given the results of the 

chronic risk assessment described in 

this unit, cancer risk resulting from 

exposure to difenoconazole is not of 

concern. 

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 

difenoconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement method, gas 

chromatography/nitrogen- phosphorus 

detection (GC/NPD) method AG–575B, 

is available for the determination of 

residues of difenoconazole per se in/on 

plant commodities. An adequate 

enforcement method, liquid 

chromatography mass spectrometry (LC/ 

MS/MS) method REM 147.07b, is 

available for the determination of 

residues of difenoconazole and CGA– 

205375 in livestock commodities. 

Adequate confirmatory methods are also 

available. This is the first 

difenoconazole petition since the new 

livestock method (147.07b) was 

approved by the Agency and this new 

method has lower level of quantitation 

than the previous enforcement method. 

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 U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

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34882 Federal Register / Vol. 76, No. 115 / Wednesday, June 15, 2011 / Rules and Regulations 

requires that EPA explain the reasons 

for departing from the Codex level. 

Codex maximum residue levels 

(MRLs) for residues of difenoconazole 

per se have been established at 0.2 ppm 

for carrot; 0.02 ppm for soya bean (dry); 

0.2 ppm for cherries and plums 

(including prunes); and 0.5 ppm for 

nectarines and peaches. Canadian and 

Mexican MRLs have been established 

for difenoconazole; however, no MRLs 

have been established for the 

commodities included in the current 

petition. Codex MRLs for residues of 

difenoconazole and its metabolite CGA– 

205375, expressed as difenoconazole 

have been established at 0.2 ppm for 

edible offal (mammalian) and 0.01 for 

eggs. Also, Canadian MRLs have been 

established for difenoconazole at 0.05 

ppm for meat byproducts of cattle, 

goats, hogs, and sheep and at 0.05 ppm 

in eggs. Based on the submitted/ 

available magnitude of the residue data, 

harmonization with established Codex 

MRLs is not possible for carrots, soya 

bean (dry), cherries, plums (including 

prunes), nectarines, peaches, edible 

offal (mammalian), and eggs because the 

Codex MRLs are too low, due to 

differences in the use patterns, called 

Good Agricultural Practices or GAPs. 

Harmonization with the established 

Canadian MRLs for eggs and meat 

byproducts of cattle, goats, hogs, and 

sheep is not possible due to differences 

in the regulated residue expression. 

C. Response to Comments 

One anonymous comment was 

received on August 7, 2010. This 

commenter opposes the establishment 

of any numerical tolerance other than 

zero. No information was submitted to 

support the commenter’s position. 

D. Revisions to Petitioned-For 

Tolerances 

1. Tolerances for carrot, chickpea, and 

soybean, seed were corrected to use the 

recommendation from the EPA 

tolerance spreadsheet (January 2008 

version). 

2. No tolerance proposal was made for 

soybean, hulls, which is a regulated 

commodity. A tolerance is being 

established for this commodity, because 

difenoconazole residues concentrate in 

this commodity. 

3. Commodity names for proposed 

tolerances are being corrected to be 

consistent with EPA’s standard 

commodity vocabulary definitions: 

‘‘Chickpeas’’ to ‘‘Chickpea;’’ ‘‘Soybean, 

aspirated grain fractions’’ to ‘‘Aspirated 

Grain Fractions;’’ ‘‘Fruits, stone, group 

12’’ to ‘‘Fruit, stone, group 12’’. 

4. The animal commodity tolerance 

expression is being changed slightly to 

express the metabolite CGA 205375 as a 

difenoconazole stoichoimetric 

equivalent. 

5. There are a number of livestock 

feedstuffs associated with the proposed 

uses and currently established livestock 

tolerances were reassessed. Due 

primarily to the significant change in 

the beef diet from the proposed use on 

soybeans and the residues of 

difenoconazole found in/on soybean 

aspirated grain fractions, the tolerance 

levels for residues of concern in liver of 

cattle, goat, hog, horse, and sheep need 

to be increased from 0.20 ppm to 0.40 

ppm. 

6. Although there was little change in 

the poultry diet from the proposed new 

uses, due to the lower level of 

quantitation from the new animal 

commodity enforcement analytical 

method (method 147.07b), the tolerance 

level for residues of concern in egg 

needs to be decreased from 0.10 ppm to 

0.02 ppm. Furthermore, the existing 

commodity name for ‘‘eggs’’ is being 

corrected to ‘‘egg’’ consistent with EPA’s 

standard commodity vocabulary 

definition. 

7. The proposed increased tolerance 

for milk is not needed because the 

calculations for changes in the dietary 

burden due to the new uses indicate no 

change is needed. 

V. Conclusion 

Therefore, tolerances are established 

for residues of difenoconazole, 1-([2-[2- 

chloro-4-(4-chlorophenoxy)phenyl]-4- 

methyl-1,3-dioxolan-2-yl]methyl)-1H1,2,4-triazole, in or on: Aspirated grain 

fractions at 95 ppm; carrot at 0.50 ppm; 

chickpea at 0.08 ppm; fruit, stone, group 

12 at 2.5 ppm; soybean, hulls at 0.20; 

soybean, seed at 0.15; strawberry at 2.5 

ppm; turnip greens at 35 ppm. The 

existing animal commodity tolerance 

expression is being revised, and 

tolerances are being increased for liver 

of cattle/goat/hog/horse/sheep from 0.20 

ppm to 0.40 ppm. The existing egg 

tolerance is being decreased from 0.10 

ppm to 0.02 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal governments, 

on the relationship between the national 

government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

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Federal Register / Vol. 76, No. 115 / Wednesday, June 15, 2011 / Rules and Regulations 34883 

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: June 7, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.475 is amended as 

follows: 

■ i. In the table to paragraph (a)(1), by 

alphabetically adding the following 

commodities; and 

■ ii. In paragraph (a)(2), by revising the 

introductory text and the following 

commodities in the table. 

The amendments read as follows: 

§ 180.475 Difenoconazole; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Aspirated grain fractions ............. 95 

* * * * * 

Carrot .......................................... 0 .50 

Chickpea ..................................... 0 .08 

* * * * * 

Fruits, stone, group 12 ............... 2 .5 

* * * * * 

Soybean, hulls ............................ 0 .20 

Soybean, seed ............................ 0 .15 

Strawberry .................................. 2 .5 

Turnip, greens ............................ 35 

* * * * * 

(2) Tolerances are established for 

residues of difenoconazole, including its 

metabolites and degradates, in the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring the sum of difenoconazole, 

1-[2-[2-chloro-4-(4- 

chlorophenoxy)phenyl]-4-methyl-1,3- 

dioxolan-2-ylmethyl]-1H-1,2,4-triazole, 

and its metabolite, CGA–205375, 1-[2- 

chloro-4-(4-chloro-phenoxy)phenyl]-2- 

[1,2,4]triazol-1-yl-ethanol, calculated as 

the stoichiometric equivalent of 

difenoconazole, in the following 

commodities: 

Commodity Parts per 

million 

* * * * * 

Cattle, liver .................................... 0.40 

* * * * * 

Egg ............................................... 0.02 

* * * * * 

Goat, liver ..................................... 0.40 

* * * * * 

Hog, liver ...................................... 0.40 

* * * * * 

Horse, liver ................................... 0.40 

* * * * * 

Sheep, liver ................................... 0.40 

* * * * * 

* * * * * 

[FR Doc. 2011–14770 Filed 6–14–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–1081; FRL–8875–4] 

Pesticide Tolerances; Technical 

Amendments 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA has reviewed its 

pesticide regulations and is making 

changes in a number of areas. These 

changes will correct cross-references, 

remove expired tolerances, ‘‘reserve’’ 

paragraphs within sections that no 

longer have any tolerances listed due to 

the removal of expired tolerances, and 

remove sections that no longer have any 

tolerances due to the removal of expired 

tolerances. These changes have no 

substantive impact on any requirements. 

As such, notice and public comment 

procedures are unnecessary. 

DATES: This final rule is effective June 

15, 2011. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–1081. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. 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 

WReier-Aviles on DSKGBLS3C1PROD with RULES