Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Rules and Regulations 17697 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0149; FRL–9923–82] 

Difenoconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

difenoconazole in or on multiple 

commodities which are identified and 

discussed later in this document. 

Syngenta Crop Protection requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

2, 2015. Objections and requests for 

hearings must be received on or before 

June 1, 2015, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0149, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

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

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0149 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before June 1, 2015. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0149, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

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

II. Summary of Petitioned-for Tolerance 

In the Federal Register of September 

5, 2014 (79 FR 53009) (FRL–9914–98), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 4F8231) by 

Syngenta Crop Protection, LLC., P.O. 

Box 18300, Greensboro, NC 27419– 

8300. The petition requested that 40 

CFR part 180 be amended by 

establishing tolerances for residues of 

the fungicide, difenoconazole in or on 

pea, and bean, dried shelled, except 

soybean, subgroup 6C at 0.2 parts per 

million (ppm); pea, vine at 10 ppm; pea, 

hay at 40 ppm; and bushberry, subgroup 

13–07B at 3.0 ppm. The petition also 

requested that the existing tolerance for 

chickpea be removed. That document 

referenced a summary of the petition 

prepared by Syngenta, the registrant, 

which is available in the docket 

identified by docket ID number EPA– 

HQ–OPP–2014–0373, http://

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

In the Federal Register of February 

11, 2015 (80 FR 7559) (FRL–9921–94), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 3F8209) by 

Syngenta Crop Protection, LLC., P.O. 

Box 18300, Greensboro, NC 27419– 

8300. The petition requested that 40 

CFR part 180 be amended by increasing 

existing tolerances for residues of the 

fungicide, difenoconazole in or on fruit, 

pome, group 11–10 from 1.0 to 3.0 ppm, 

and apple, wet pomace from 4.5 to 7.5 

ppm. That document referenced a 

summary of the petition prepared by 

Syngenta Crop Protection, the registrant, 

which is available 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 the petition, EPA has 

modified the levels at which some of the 

tolerances are being established. The 

reason for these changes are explained 

in Unit IV.D. 


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III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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. 

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 1-day 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 

effects-levels (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 in developmental 

toxicity studies in rats and rabbits, and 

a reproduction study in rats as fetal/

offspring effects occurred in the 

presence of maternal toxicity. Although 

there is some evidence that 

difenoconazole affects antibody levels at 

doses that cause systemic 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. 

EPA is using the non-linear (reference 

dose) 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 

statistically significant carcinomas 

tumors were only induced at 

excessively-high doses. Adenomas 

(benign tumors) and liver necrosis only 

were seen at 300 parts per million (ppm) 

(46 and 58 mg/kg/day in males and 

females, respectively). Based on 

excessive toxicity observed at the two 

highest doses in the study, the presence 

of only benign tumors and necrosis at 

the mid-dose, 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 no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov on page 44 of the 

document titled ‘‘Difenoconazole: 

Human Health Risk Assessment for 

proposed new foliar uses on legume 

subgroup 6C and bushberry subgroup 

13–07B; post-harvest uses on pome fruit 

group 11–10; and ornamental plants 

and vegetable transplants grown in both 

indoor and outdoor production 

facilities’’ in docket ID number EPA– 

HQ–OPP–2014–0149. 

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 no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for difenoconazole used for 

human risk assessment is shown in 

Table 1 of this unit. 


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TABLE 1—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 (All populations) .. NOAEL = 25 mg/kg/

day.

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 in males 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 (M/F) based on cumulative decreases in body-weight gains. 

Dermal Short-term (1–30 days) Oral NOAEL = 1.25 

mg/kg/day dermal 

absorption rate = 

6%.

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-term (1–30 

days).

Inhalation and oral absorption 

assumed equivalent.

Oral 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. 

Cancer (oral, dermal, inhalation).The Agency is using a non-linear approach based on the chronic POD to assess the carcinogenic potential of 

difenoconazole. 

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

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

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 2003–2008 

food consumption information from the 

United States Department of 

Agriculture’s (USDA) National Health 

and Nutrition Examination Survey, 

What We Eat in America, (NHANES/

WWEIA). As to residue levels in food, 

EPA assumed tolerance level residues 

and 100 percent crop treated (PCT) 

information. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s NHANES/WWEIA. As 

to residue levels in food, EPA used 

USDA Pesticide Data Program (PDP) 

monitoring data, average field trial 

residues for some commodities, 

tolerance level residues for the 

remaining commodities, and average 

percent crop treated for some 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to difenoconazole. 

Therefore, a separate quantitative cancer 

exposure assessment is unnecessary 

since the chronic dietary risk estimate 

will be protective of potential cancer 

risk. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

section 408(f)(1) that data be provided 5 

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

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

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

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

EPA may require registrants to submit 

data on PCT. 

For the chronic dietary exposure 

analysis, the Agency estimated the PCT 

for existing uses as follows: 

Almond 5%, cabbage 2.5%, 

cucumbers 5%, garlic 5%, grape 5%, 

grapefruit 2.5%, onions 5%, orange 

2.5%, pecan 2.5%, peach 1%, peppers 


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2.5%, pistachio 2.5%, pumpkin 2.5%, 

squash 5%, strawberry 2.5%, sugar 

beets 15%, tangerine 2.5%, tomatoes 

25%, walnut 2.5%, watermelon 5%, and 

wheat 10%. 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (NASS), proprietary 

market surveys, and the National 

Pesticide Use Database for the chemical/ 

crop combination for the most recent 6– 

7 years. EPA uses an average PCT for 

chronic dietary risk analysis. The 

average PCT figure for each existing use 

is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

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 difenoconazole 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 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. 

The drinking water assessment was 

performed using a total toxic residue 

(TTR) method which considers both 

parent difenoconazole and its major 

metabolite, CGA–205375, in surface and 

groundwater. 

Based on the surface water 

concentration calculator (SWCC) and 

screening concentration in ground water 

(SCI–GROW) and pesticide root zone 

model ground water (PRZM GW) 

models, the estimated drinking water 

concentrations (EDWCs) of 

difenoconazole for acute exposures are 

estimated to be 20.0 parts per billion 

(ppb) for surface water and 1.77 ppb for 

ground water and for chronic exposure 

assessments are estimated to be 13.6 

ppb for surface water and not detected 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 20.0 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 13.6 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). 

Difenoconazole is currently registered 

for the following uses that could result 

in residential exposures: Treatment of 

ornamental plants in commercial and 

residential landscapes and interior 

plantscapes. EPA assessed residential 

exposure using the following 

assumptions: For residential handlers, 

adult short-term dermal and inhalation 

exposure is expected from use on 

ornamentals (garden/trees). For 

residential post-application, short-term 

dermal exposure is expected for both 

adults and children from postapplication activities in treated gardens. 

The scenarios used in the aggregate 

assessment were those that resulted in 

the highest exposures. The highest 

exposures consist of the following: 

• Short-term dermal exposure to 

adults from post-application activities 

in treated gardens, and 

• Short-term dermal exposure to 

children (6–11 years old) from postapplication activities in treated gardens. 

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). 

In conazoles, 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 

propiconazole, 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 


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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 propiconazole 

reregistration docket at http://

www.regulations.gov, docket 

identification (ID) number EPA–HQ– 

OPP–2005–0497. 

The most recent update for the 

triazoles was conducted on October 24, 

2013. The requested new uses of 

difenoconazole did not significantly 

change the dietary exposure estimates 

for free triazole or conjugated triazoles. 

Therefore, an updated dietary exposure 

analysis was not conducted. The 

October 24, 2013 update for triazoles 

may be found in docket ID number 

EPA–HQ–OPP–2014–0149. 

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 

Food Quality Protection Act (FQPA) 

Safety Factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The available Agency guideline studies 

indicated no increased qualitative or 

quantitative 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 a rat developmental toxicity study 

developmental effects were observed at 

doses higher than those which caused 

maternal toxicity. In the rabbit study, 

developmental effects (increases in postimplantation loss and resorptions and 

decreases in fetal body weight) were 

also seen at maternally toxic doses 

(decreased body weight gain and food 

consumption). In 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. 

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 complete. 

ii. There are no clear signs of 

neurotoxicity following acute, 

subchronic or chronic dosing in 

multiple species in the difenoconazole 

database. The effects observed in acute 

and subchronic neurotoxicity studies 

are transient, and the dose-response is 

well characterized with identified 

NOAELs. Based on the toxicity profile, 

and lack of concern for neurotoxicity, 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

difenoconazole results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary risk assessment is 

conservative, using tolerance level 

residues and 100 PCT for the acute 

assessment while the chronic 

assessment used USDA PDP monitoring 

data, average field trial residues for 

some commodities, tolerance level 

residues for remaining commodities, 

and average PCT for some commodities. 

These assumptions will not 

underestimate dietary exposure to 

difenoconazole. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to difenoconazole in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children. 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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

difenoconazole will occupy 49% of the 

aPAD for all infants less than 1 year 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 88% 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 difenoconazole is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

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 170 for adults and 190 for 

children. Because EPA’s level of 

concern for difenoconazole is a MOE of 

100 or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, difenoconazole 

is not registered for any use patterns 

that would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 


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17702 Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Rules and Regulations 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

difenoconazole. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit III.A, 

the chronic dietary risk assessment is 

protective of any potential cancer 

effects. Based on the results of that 

assessment, EPA concludes that 

difenoconazole is not expected to pose 

a cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

difenoconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement method, 

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/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. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has an established MRL for 

the sum of difenoconazole and its 

metabolite, 1-[2-chloro-4-(4- 

chlorophenoxy)-phenyl]-2-(1,2,4- 

triazol)-1-yl-ethano), expressed as 

difenoconazole in or on milk at 0.02 

ppm, which is the same as the 

recommended U.S. tolerance. 

The Codex has not established an 

MRL for difenoconazole in or on pea 

and bean, dried shelled, except soybean, 

subgroup 6C; bushberry subgroup 13– 

07B; pea, field, hay; pea, field, vines; or 

apple, wet pomace. 

The Codex has an established MRL for 

difenoconazole in or on pome fruit at 

0.5 ppm for residues incurred from 

foliar uses of difenoconazole. This MRL 

differs from the recommended U.S. 

tolerance for difenoconazole in or on 

fruit, pome, group 11–10 at 5.0 ppm. 

The Codex MRL is not adequate to cover 

residues incurred from the proposed 

post-harvest uses in the United States; 

therefore, harmonization with Codex is 

not possible at this time. 

C. Response to Comments 

Several comments were received in 

response to the notice of filing, 

however, all were concerned with 

effects to bees and related to other 

petitions and chemicals contained in 

the same notice of filing, not 

difenoconazole. 

D. Revisions to Petitioned-for 

Tolerances 

The tolerance being established for 

the bushberry subgroup 13–07B is 4.0 

ppm, not 3.0 ppm as proposed. This is 

due to the independent field trial 

determination which resulted in the 

exclusion of one of the trials from the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures. The tolerance 

being established for the pea and bean, 

dried shelled, except soybean, subgroup 

6C tolerance is being set at 0.20 ppm, 

not 0.2 ppm, and is based on the current 

practice of setting tolerances to 2 

significant figures. The established 

tolerance in milk is being increased 

from 0.01 ppm to 0.02 ppm because of 

the new pea hay and vine feedstuffs 

which significantly increased the 

maximum reasonably balanced dietary 

estimate for dairy cattle. Furthermore, 

the Agency is establishing tolerances for 

the fruit, pome, group 11–10 and apple, 

wet pomace (5.0 ppm and 25 ppm, 

respectively) at higher levels than 

requested (3.0 ppm and 7.5 ppm, 

respectively). The established tolerances 

for fruit, pome, group 11–10 take into 

account maximum tolerance estimates 

that may result from post-harvest 

application techniques for pome fruit. 

The established tolerances for apple, 

wet pomace was calculated based on the 

highest average field trial residues in or 

on apples and the average processing 

factor for wet pomace. Lastly, some 

commodity terms were modified to be 

consistent with Agency’s preferred food 

and feed commodity vocabulary. 

V. Conclusion 

Therefore, tolerances are established 

for residues of difenoconazole, in or on 

bushberry subgroup 13–07B at 4.0 ppm; 

pea and bean, dried shelled, except 

soybean, subgroup 6C at 0.20 ppm; pea, 

field, hay at 40 ppm; and pea, field, 

vines at 10 ppm. Additionally, existing 

tolerances are modified as follows: 

Apple, wet pomace from 7.5 ppm to 25 

ppm; fruit, pome, group 11–10 from 3.0 

to 5.0 ppm; and milk from 0.01 to 0.02 

ppm. Lastly, the existing chickpea 

tolerance is removed as unnecessary 

since it is now covered by the pea and 

bean, dried shelled, except soybean, 

subgroup 6C tolerance. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Rules and Regulations 17703 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 25, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.475: 

■ i. Remove ‘‘Chickpea’’ from the table 

in paragraph (a)(1). 

ii. Add alphabetically the entries for 

‘‘Bushberry subgroup 13–07B’’, ‘‘Pea 

and bean, dried shelled, except soybean, 

subgroup 6C’’, ‘‘Pea, field, hay’’, and 

‘‘Pea, field, vines’’ to the table in 

paragraph (a)(1). 

■ iii. Revise the entries for ‘‘Apple, wet 

pomace’’ and ‘‘Fruit, pome, group 11– 

10’’ in the table in paragraph (a)(1). 

■ iv. Revise the entry for ‘‘Milk’’ in the 

table in paragraph (a)(2). 

The amendments read as follows: 

§ 180.475 Difenoconazole; tolerances for 

residues. 

(a) * * * (1) * * * 

Commodity Parts per 

million 

* * * * * 

Apple, wet pomace ..................... 25 

* * * * * 

Bushberry subgroup 13–07B ...... 4 .0 

* * * * * 

Fruit, pome, group 11–10 ........... 5 .0 

* * * * * 

Pea and bean, dried shelled, except soybean, subgroup 6C .... 0 .20 

Pea, field, hay ............................. 40 

Pea, field, vines .......................... 10 

* * * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Milk ............................................. 0 .02 

* * * * * 

* * * * * 

[FR Doc. 2015–07354 Filed 4–1–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–2014–0620; FRL–9924– 

66–OSWER] 

RIN 2050–AG76 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan (NCP); Amending the NCP for 

Public Notices for Specific Superfund 

Activities 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA or the Agency) is adding 

language to the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP) to broaden the 

methods by which the EPA can notify 

the public about certain Superfund 

activities. 

DATES: This final rule is effective on 

May 4, 2015. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–SFUND–2014–0620. All 

documents in the docket are listed in 

the www.regulations.gov index. 

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, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in 

www.regulations.gov or in hard copy at 

the Superfund Docket (Docket ID No. 

EPA–HQ–SFUND–2014–0620). This 

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

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

excluding legal holidays. The telephone 

number for the Reading Room is (202) 

566–1744 and the telephone number for 

the Superfund Docket is (202) 566– 

0276. The EPA Docket Center (EPA/DC) 

is located at WJC West Building, Room 

3334, 1301 Constitution Ave. NW., 

Washington, DC. 

FOR FURTHER INFORMATION CONTACT: 

General Information: Superfund, 

Toxics Release Inventory (TRI), 

Emergency Planning and Community 

Right-to-Know Act (EPCRA), Risk 

Management Program (RMP) and Oil 

Information Center at (800) 424–9346 or 

TDD (800) 553–7672 (hearing impaired). 

In the Washington, DC metropolitan 

area, call (703) 412–9810 or TDD (703) 

412–3323. 


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