Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 5941 

TABLE 1 TO SUBPART DDDDDD OF PART 63—EMISSION LIMITS AND STANDARDS FOR EXISTING AFFECTED SOURCES— 

Continued 

For this type of emission 

point . . . And for this air pollutant . . . And for an affected source producing this type of PVC resin . . . 

You must meet this emission 

limit . . . 

Stripped resin ................................. Vinyl chloride ................................ Bulk resin ...................................... 7.1 parts per million by weight 

(ppmw). 

Dispersion resin ............................ 1,500 ppmw. 

Suspension resin .......................... 36 ppmw. 

Suspension blending resin ........... 140 ppmw. 

Copolymer resin ........................... 790 ppmw. 

Total non-vinyl chloride organic 

HAP.

Bulk resin ...................................... 170 ppmw. 

Dispersion resin ............................ 320 ppmw. 

Suspension resin .......................... 36 ppmw. 

Suspension blending resin ........... 500 ppmw. 

Copolymer resin ........................... 1,900 ppmw. 

Process Wastewater ...................... Vinyl chloride ................................ All resin types ............................... 2.1 ppmw. 

aEmission limits at 3-percent oxygen, dry basis. 

bAffected sources have the option to comply with either the total hydrocarbon limit or the total organic HAP limit. 

■ 3. Table 2 to Subpart DDDDDD of Part 

63 is revised to read as follows: 

TABLE 2—TO SUBPART DDDDDD OF PART 63—EMISSION LIMITS AND STANDARDS FOR NEW AFFECTED SOURCES

For this type of emission 

point . . . And for this air pollutant . . . And for an affected source producing this type of PVC resin . . . 

You must meet this emission 

limit . . . 

PVC-only process vents a .............. Vinyl chloride ................................ All resin types ............................... 5.3 parts per million by volume 

(ppmv). 

Total hydrocarbons ....................... All resin types ............................... 46 ppmv measured as propane. 

Total organic HAPb ...................... All resin types ............................... 140 ppmv. 

Dioxins/furans (toxic equivalency 

basis).

All resin types ............................... 0.13 nanograms per dry standard 

cubic meter (ng/dscm). 

PVC-combined process vents a ..... Vinyl chloride ................................ All resin types ............................... 0.56 ppmv. 

Total hydrocarbons ....................... All resin types ............................... 2.3 ppmv measured as propane. 

Total organic HAPb ...................... All resin types ............................... 29 ppmv. 

Dioxins/furans (toxic equivalency 

basis).

All resin types ............................... 0.076 ng/dscm. 

Stripped resin ................................. Vinyl chloride ................................ Bulk resin ...................................... 7.1 parts per million by weight 

(ppmw). 

Dispersion resin ............................ 1,500 ppmw. 

Suspension resin .......................... 36 ppmw. 

Suspension blending resin ........... 140 ppmw. 

Copolymer resin ........................... 790 ppmw. 

Total non-vinyl chloride organic 

HAP.

Bulk resin ...................................... 170 ppmw. 

Dispersion resin ............................ 320 ppmw. 

Suspension resin .......................... 36 ppmw. 

Suspension blending resin ........... 500 ppmw. 

Copolymer resin ........................... 1,900 ppmw. 

Process Wastewater ...................... Vinyl chloride ................................ All resin types ............................... 2.1 ppmw. 

aEmission limits at 3 percent oxygen, dry basis. 

bAffected sources have the option to comply with either the total hydrocarbon limit or the total organic HAP limit. 

[FR Doc. 2015–01922 Filed 2–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0151; FRL–9920–98] 

Difenoconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

difenoconazole in or on rapeseed 

subgroup 20A, and dragon fruit. 

Syngenta Crop Protection requested the 

rapeseed subgroup 20A tolerance, and 

Dragonberry/YW International Produce 

requested the dragonfruit tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 4, 2015. Objections and 

requests for hearings must be received 

on or before April 6, 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–2013–0151, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 


tkelley on DSK3SPTVN1PROD with RULES
5942 Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 

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; 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 Printing Office’s e-CFR 

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

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2013–0151 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 April 6, 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– 

2013–0151, 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 June 5, 2013 

(78 FR 33785) (FRL–9386–2), 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 2F8134) by Syngenta Crop 

Protection, LLC, P.O. Box 18300, 

Greensboro, NC 27419–8300. The 

petition requested that 40 CFR 180.475 

be amended by establishing a tolerance 

for residues of the fungicide 

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

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

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

in or on rapeseed subgroup 20A at 0.1 

parts per million (ppm). That document 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

the registrant, which was inadvertently 

missing from the docket in http://

www.regulations.gov. Because the 

summary of the petition was missing 

from the docket, the announcement was 

republished in the Federal Register of 

December 17, 2014 (79 FR 75107) (FRL– 

9918–90), with a new comment period. 

There were no comments received in 

response to the original notice of filing, 

but one comment was received on the 

republished notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

In the Federal Register of December 

17, 2014 (79 FR 75107) (FRL–9918–90), 

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 (4E8296) by 

Dragonberry/YW International Produce, 

Inc., 386 S. Sequoia Parkway, Canby, 

Oregon 97013. The petition requested 

that 40 CFR 180.475 be amended by 

establishing tolerances for residues of 

the fungicide difenoconazole, [1-[2-[2- 

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

methyl-1,3-dioxolan-2-ylmethyl]1H1,2,4-triazole, in or on dragon fruit at 1.5 

ppm. That document referenced a 

summary of the petition prepared by 

Dragonberry/YW International Produce, 

Inc, 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 

changed the requested rapeseed 

subgroup 20A tolerance from 0.1 ppm to 

0.10 ppm, and is also removing the 

current tolerance for canola, seed. The 

reason 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 


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Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 5943 

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. 

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-adverseeffects-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 ppm (46 

and 58 milligrams/kilograms/day (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 mid-dose, 

the absence of tumors at the study’s 

lower dose, 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 are found in the 

document, ‘‘Difenoconazole: Human 

Health Risk Assessment for New Foliar 

Use and Tolerance in/on Rapeseed 

subgroup 20A and New Foliar Use on 

Imported Dragonfruit’’ in docket ID 

number EPA–HQ–OPP–2013–0151. 

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 

LOAEL are identified. 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 discussed in 

Unit III of the final rule published in the 

Federal Register of June 15, 2011 (76 FR 

34877) (FRL–8876–4). 

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 used 

tolerance-level residues and 100 percent 

crop treated (PCT). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food EPA 

used tolerance-level residues for some 

commodities, average field trial residues 

for the majority of commodities, and the 

available empirical or Dietary Exposure 

Evaluation Model (DEEM) (ver. 7.81) 

default processing factors, and 100 PCT. 

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 percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 


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5944 Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 

information in the dietary assessment 

for difenoconazole. EPA used average 

field trial residues for some 

commodities, tolerance level residues 

for the other commodities, and 100 PCT. 

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. 

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 Pesticide Root Zone Model/ 

Exposure Analysis Modeling System 

(PRZM/EXAMS) for registered and 

proposed new uses as well as Pesticide 

Root Zone Model for Groundwater 

(PRZM–GW) and Screening 

Concentration In Ground Water (SCI– 

GROW) models the maximum estimated 

drinking water concentrations (EDWCs) 

of difenoconazole for acute exposures 

are estimated to be 20.0 parts per billion 

(ppb) for surface water and 2.24 ppb for 

ground water. Chronic exposures for 

non-cancer assessments are estimated to 

be 13.6 ppb for surface water and 0.82 

ppb 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 

assess the water concentration 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: Ornamentals 

and golf course turf. EPA assessed 

residential exposure using the following 

assumptions: Adults may be exposed to 

difenoconazole from its currently 

registered use on ornamentals. 

Residential pesticide handlers may be 

exposed to short-term duration (1–30 

days) only. The dermal and inhalation 

(short-term) residential exposure was 

assessed for homeowner’s mixer/loader/ 

applicator wearing short pants and 

short-sleeved shirts as well as shoes 

plus socks using garden hose-end 

sprayer, pump-up compressed air 

sprayer, and backpack sprayer. 

Residential post-application exposure 

may occur from use of difenoconazole 

on golf course turf. Short-term dermal 

exposure was assessed for postapplication exposure to golf course turf. 

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 events 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 

procedure s for cumulating effects from 

substances found to have a common 

mechanism of toxicity, see EPA’s Web 

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

cumulative and http://www.epa.gov/

fedrgstr/EPA_PEST/2002/January/

Day16/. 

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 pesticide, including 

difenoconazole, EPA conducted a 

human health risk assessment for 

exposure to 1,2,4-triazole, 

triazolylanine, 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 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 

Food Quality Protection Act (FQPA) 

safety factor (SF) 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 

most recent update for the triazoles is 

found in the docket for this rapeseed 

action at http://www.regulations.gov, 

Docket ID Number EPA–HQ–OPP– 

2013–0151. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 


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Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 5945 

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 the 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 post-implantation loss and 

resorptions and decreased 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. 

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 as well as 

incidental oral exposure of toddlers. 

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 29% 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 78% 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 160. Because EPA’s level of 

concern (LOC) for difenoconazole is 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). 

Because no intermediate-term adverse 

effect was identified, difenoconazole is 

not expected to pose an intermediateterm risk. 

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, 

Gas chromatography/NitrogenPhosphorus Detector (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. 

A Codex MRL is established for 

residues of difenoconazole in or/on 

rapeseed at 0.05 mg/kg based on data 

reflecting foliar use of difenoconazole, 

but with a significantly longer preharvest intervals than currently 

proposed in the U.S. The Codex MRL 


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5946 Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 

would not be adequate to cover residues 

expected from the proposed use in the 

U.S., therefore, harmonization with 

Codex is not possible at this time. 

There is no Codex MRLs for 

difenoconazole in/on dragonfruit. 

C. Response to Comments 

EPA received one comment to the 

republished Notice of Filing for the 

petition requesting that EPA establish a 

rapeseed subgroup 20A tolerance that 

stated, in part, that no residue should be 

allowed for difenoconazole. The Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that pesticides should be banned 

on agricultural crops. However, the 

existing legal framework provided by 

section 408 of the FFDCA states that 

tolerances may be set when the Agency 

determines that the pesticide meets the 

safety standard imposed by that statute. 

This citizen’s comment appears to be 

directed at the underlying statute and 

not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. 

D. Revisions to Petitioned-For 

Tolerances 

EPA has changed the requested 

rapeseed subgroup 20A tolerance from 

0.1 to 0.10 ppm to be consistent with 

the tolerance setting procedures which 

involve using two significant numbers 

after the decimal point. EPA is also 

removing the current tolerance for 

canola, seed at 0.01 ppm because canola 

is included in the Rapeseed subgroup 

20A crops and the tolerance being 

established for this group at 0.10 ppm 

will supersede the lower tolerance for 

canola seed treatment. 

V. Conclusion 

Therefore, tolerances are established 

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

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

4methyll-[1,3]dioxolan-2-ylmethyl]-1H- 

[1,2,4]triazole, in or on rapeseed 

subgroup 20A at 0.10 ppm, and 

dragonfruit which is imported, at 1.5 

ppm. Also, the current tolerance for 

canola, seed is being removed. 

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 

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: January 28, 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 Section 180.475: 

■ a. Remove the entry for ‘‘Canola, 

seed’’. 

■ b. Add alphabetically the following 

commodities to the table to paragraph 

(a)(1). 

§ 180.475 Difenoconazole; Tolerance for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

* * * * * 

Dragonfruit 1 .......................... 1.5 

* * * * * 

Rapeseed subgroup 20A ...... 0.10 

* * * * * 

1There are no U.S. registrations. 

* * * * * 

[FR Doc. 2015–02170 Filed 2–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0482; FRL–9922–06] 

Flutriafol; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 


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