Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Rules and Regulations 38199 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 93 

Determining Conformity of Federal 

Actions to State or Federal 

Implementation Plans 

CFR Correction 

■ In Title 40 of the Code of Federal 

Regulations, parts 87 to 95, revised as of 

July 1, 2011, on page 579, in § 93.118, 

paragraph (e)(2) is corrected to read as 

follows: 

§ 93.118 Criteria and procedures: Motor 

vehicle emissions budget. 

* * * * * 

(e) * * * 

* * * * * 

(2) If EPA has not declared an 

implementation plan submission’s 

motor vehicle emissions budget(s) 

adequate for transportation conformity 

purposes, the budget(s) shall not be 

used to satisfy the requirements of this 

section. Consistency with the previously 

established motor vehicle emissions 

budget(s) must be demonstrated. If there 

are no previously approved 

implementation plans or 

implementation plan submissions with 

adequate motor vehicle emissions 

budgets, the interim emissions tests 

required by § 93.119 must be satisfied. 

* * * * * 

[FR Doc. 2012–15869 Filed 6–26–12; 8:45 am] 

BILLING CODE 1505–01–D 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0397; FRL–9350–9] 

Propiconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of propiconazole 

in or on multiple commodities which 

are identified and discussed later in this 

document. This regulation additionally 

removes an established tolerance on 

stone fruit crop group 12, as it will be 

superseded by the new tolerance for 

stone fruit crop group 12, except plum. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective June 

27, 2012. Objections and requests for 

hearings must be received on or before 

August 27, 2012, 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–2011–0397, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Andrew Ertman, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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://ecfr.gpoaccess.gov/cgi/t/ 

text/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–2011–0397 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 27, 2012. 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–2011–0397, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 28221T, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

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

Additional instructions on 

commenting or visiting the docket, 


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along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerances 

In the Federal Register of July 20, 

2011 (76 FR 43231) (FRL–8880–1), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1E7855) by IR–4,500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.434 be 

amended by establishing tolerances for 

residues of the fungicide propiconazole, 

1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3- 

dioxolan-2-yl] methyl]-1H-1,2,4-triazole 

and its metabolites determined as 2,4,- 

dichlorobenzoic acid (DCBA) and 

expressed as parent compound, in or on 

bean, snap at 0.8 ppm; bean, succulent 

shelled at 0.15 ppm; bean, dry seed at 

0.3 ppm; legume, foliage at 25 ppm; 

tomato at 2.5 ppm; fruit, citrus, group 

10–10 at 8.0 ppm; fruit, stone, group 12, 

except plum at 7.0 ppm; and plum at 1.0 

ppm. The petition also requested that 

the existing tolerance for stone fruit 

group 12 at 1.0 ppm be removed upon 

establishment of the requested 

tolerances. That notice referenced a 

summary of the petition prepared by 

Syngenta, 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 tolerances 

are being set for various commodities as 

well as some commodity definitions. 

The reason for these changes is 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue.* * *’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for propiconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with propiconazole 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. 

Propiconazole has low to moderate 

toxicity in experimental animals by the 

oral, dermal and inhalation routes. It is 

moderately irritating to the eyes, and 

minimally irritating to the skin. It is a 

dermal sensitizer. Propiconazole is 

readily absorbed by the rat skin with 

40% absorption within 10 hours of 

dermal application. 

The primary target organ for 

propiconazole toxicity in animals is the 

liver. Increased liver weights were seen 

in mice after subchronic or chronic oral 

exposures to propiconazole at doses 

greater than 50 milligrams/kilograms/ 

day (mg/kg/day). Liver lesions such as 

vacuolation of hepatocytes, ballooned 

liver cells, foci of enlarged hepatocytes, 

hypertrophy and necrosis are 

characteristic of propiconazole toxicity 

in rats and mice. Mice appear to be 

more susceptible to its toxicity than rats. 

Decreased body weight gain in 

experimental animals was seen in 

subchronic, chronic, developmental and 

reproductive studies. Dogs appeared to 

be more sensitive to the localized 

toxicity of propiconazole as manifested 

by stomach irritation at 6 mg/kg/day 

and above. 

In rabbits, developmental toxicity 

occurred at a higher dose than the 

maternally toxic dose, while in rats, 

developmental toxicity occurred at 

lower doses than the maternally toxic 

doses. Increased incidences of 

rudimentary ribs occurred in rat and 

rabbit fetuses. Increased cleft palate 

malformations were noted in two 

studies in rats. In one published study 

in rats, developmental effects 

(incomplete ossification of the skull, 

caudal vertebrae and digits, extra 14th 

rib and missing sternebrae, 

malformations of the lung and kidneys) 

were reported at doses that were not 

maternally toxic. 

In the 2-generation reproduction 

study in rats, offspring toxicity occurred 

at a higher dose than the parentally 

toxic dose, suggesting lower 

susceptibility of the offspring to the 

toxic doses of propiconazole in this 

study. 

Propiconazole was negative for 

mutagenicity in the in vitro BALB/C 

3T3 cell transformation assay, bacterial 

reverse mutation assay, Chinese hamster 

bone marrow chromosomal aberration 

assay, unscheduled DNA synthesis 

studies in human fibroblasts and 

primary rat hepatocytes, mitotic gene 

conversion assay and the dominant 

lethal assay in mice. Hepatocellular 

proliferation studies in mice suggest 

that propiconazole induces cell 

proliferation followed by treatmentrelated hypertrophy in a manner similar 

to the known hypertrophic agent 

phenobarbital. 

Propiconazole was carcinogenic to 

male mice. Propiconazole was not 

carcinogenic to rats or to female mice. 

The Agency classified propiconazole as 

a possible human carcinogen and 

recommended that, for the purpose of 

risk characterization, the reference dose 

(RfD) approach be used for 

quantification of human risk. 

Propiconazole is not genotoxic and this 

fact, together with special mechanistic 

studies, indicates that propiconazole is 

a threshold carcinogen. Propiconazole 

produced liver tumors in male mice 

only at a high dose that was toxic to the 

liver. At doses below the RfD, liver 

toxicity is not expected; therefore, 

tumors are also not expected. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by propiconazole 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 in docket ID 

number EPA–HQ–OPP–2011–0397 on 

pages 43–49 of the document titled 

‘‘Propiconazole Human Health Risk 

Assessment for a Section 3 Registration 

on Snap beans, Succulent shelled beans, 

Dry Beans, and Post-harvest use on 

Tomato, Citrus Fruit, and Stone fruit.’’ 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 


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toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for propiconazole used for 

human risk assessment is discussed in 

Unit B of the final rule published in the 

Federal Register of Wednesday, May 11, 

2011 (76 FR 27261) (FRL–8873–2). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to propiconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing propiconazole tolerances in 40 

CFR 180.434. EPA assessed dietary 

exposures from propiconazole 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 

propiconazole. 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 levels and 100 percent crop 

treated (PCT) for all existing and 

proposed uses. 

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 levels and 100 PCT for 

all existing and proposed uses. 

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 nonlinear 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 to propiconazole. Cancer 

risk was assessed using the same 

exposure estimates as discussed in Unit 

III.C.1.ii., chronic exposure. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for propiconazole. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for propiconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

propiconazole. 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 

propiconazole for acute exposures are 

estimated to be 55.78 parts per billion 

(ppb) for surface water and 0.64 ppb for 

ground water, for chronic exposures for 

non-cancer assessments are estimated to 

be 21.61 ppb for surface water and 0.64 

ppb for ground water and for chronic 

exposures for cancer assessments are 

estimated to be 13.24 ppb for surface 

water and 0.64 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 55.8 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 21.6 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). 

Propiconazole is currently registered for 

the following uses that could result in 

residential exposures: turf, ornamentals, 

and in paint. EPA assessed residential 

exposure using the following 

assumptions: Short-term risk to toddlers 

was assessed for incidental oral and 

dermal exposure. The highest incidental 

oral and dermal exposure scenarios are 

expected from residential use on turf. 

Short-term risk to adults was assessed 

for dermal and inhalation residential 

handler exposure as well as from postapplication dermal exposure. Adult 

handlers have some inhalation 

exposure; however, based on the low 

vapor pressure of propiconazole, 

negligible post application inhalation 

exposure is anticipated to occur. The 

highest post application exposure from 

residential use on turf was used to 

assess risk to short-term aggregate 

exposures. 

The only residential use scenario that 

will result in potential intermediateterm exposure to propiconazole is 

dermal and incidental oral post 

application exposure to children from 

wood treatment (antimicrobial use). 

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.’’ 

Propiconazole is a member of the 

conazole 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 


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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. 

Propiconazole 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 

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 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 complete risk assessment is 

found in the propiconazole 

reregistration docket at http:// 

www.regulations.gov, Docket 

Identification (ID) Number EPA–HQ– 

OPP–2005–0497, and an update to 

assess the addition of the commodities 

included in this action may be found in 

docket ID number EPA–HQ–OPP–2011– 

0397, in the document titled ‘‘Common 

Triazole Metabolites: Updated Dietary 

(Food + Water) Exposure and Risk 

Assessment to Address The Amended 

Propiconazole Section 3 Registration to 

Add Uses on Snap beans, succulent 

shelled beans, dry beans, tomato (postharvest, citrus (post-harvest), and stone 

fruit (post-harvest), Difenoconazole, and 

Flutriafol.’’ 

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. 

In the developmental toxicity study in 

rats, fetal effects observed in this study 

at a dose lower than that evoking 

maternal toxicity are considered to be 

quantitative evidence of increased 

susceptibility of fetuses to in utero 

exposure to propiconazole. In the 

developmental toxicity study in rabbits, 

neither quantitative nor qualitative 

evidence of increased susceptibility of 

fetuses to in utero exposure to 

propiconazole was observed in this 

study. In the 2-generation reproduction 

study in rats, neither quantitative nor 

qualitative evidence of increased 

susceptibility of neonates (as compared 

to adults) to prenatal and/or postnatal 

exposure to propiconazole was 

observed. There is no evidence of 

neuropathology or abnormalities in the 

development of the fetal nervous system 

from the available toxicity studies 

conducted with propiconazole. In the 

rat acute neurotoxicity study, there was 

evidence of mild neurobehavioral 

effects at 300 mg/kg/day, but no 

evidence of neuropathology from 

propiconazole administration. Although 

there was quantitative evidence of 

increased susceptibility of the young 

following exposure to propiconazole in 

the developmental rat study, the Agency 

determined there is a low degree of 

concern for this finding and no residual 

uncertainties because the increased 

susceptibility was based on minimal 

toxicity at high doses of administration, 

clear NOAELs and LOAELs have been 

identified for all effects of concern, and 

a clear dose-response has been well 

defined. 

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 

propiconazole is complete except for the 

lack of immunotoxicity and subchronic 

neutotoxicity studies. In the absence of 

specific immunotoxicity studies, EPA 

has evaluated the available 

propiconazole toxicity data to determine 

whether an additional database 

uncertainty factor is needed to account 

for potential immunotoxicity. There was 

no evidence of adverse effects on the 

organs of the immune system in any 

propiconazole study. In addition, 

propiconazole does not belong to a class 

of chemicals (e.g., the organotins, heavy 

metals, or halogenated aromatic 

hydrocarbons) that would be expected 

to be immunotoxic. Based on the 

considerations in this Unit, EPA does 

not believe that conducting a special 

Harmonized Guideline 870.7800 

immunotoxicity study will result in a 

POD less than the NOAEL of 10.0 mg/ 

kg/day used in calculating the cPAD for 

propiconazole, and therefore, an 

additional database uncertainty factor is 

not needed to account for potential 

immunotoxicity. 

In the absence of the subchronic 

neurotoxicity study, EPA has evaluated 

the available propiconazole toxicity data 

to determine whether an additional 

database uncertainty factor is needed to 

account for potential neurotoxicity after 

repeated exposures. With the exception 

of the developmental studies in the rat, 

there were no indications in any of the 

repeated dose studies that 

propiconazole is neurotoxic. In the 

developmental studies in the rat, there 

were some clinical signs of 

neurotoxicity at 300 mg/kg/day but not 

at lower doses. Further, there is no 

evidence of neuropathology or 

abnormalities in the development of the 

fetal nervous system from the available 

toxicity studies conducted with 

propiconazole. In the rat acute 

neurotoxicity study, there was evidence 

of mild neurobehavioral effects at 300 

mg/kg, but no evidence of 

neuropathology from propiconazole 

administration. Based on the 

considerations in this Unit, EPA does 

not believe that conducting a 

Harmonized Guideline 870.6200b 

subchronic neurotoxicity study will 

result in a POD less than the NOAEL of 

10 mg/kg/day used in calculating the 


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cPAD for propiconazole, and therefore, 

an additional database uncertainty 

factor is not needed to account for 

potential neurotoxicity from repeated 

exposures. 

iii. Although an apparent increased 

quantitative susceptibility was observed 

in fetuses and offspring, for the reasons 

noted in this Unit residual uncertainties 

or concerns for prenatal and/or 

postnatal toxicity are minimal. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

propiconazole 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 propiconazole. 

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 

propiconazole will occupy 77% of the 

aPAD for children 1 to 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 propiconazole 

from food and water will utilize 63% of 

the cPAD for children 1 to 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 

propiconazole 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). 

Propiconazole 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 propiconazole. 

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 130 for toddlers (children 1 to 

2 years old), between 110 and 1700 for 

adults from handler activities and 290 

for adults from post-application 

activities. Because EPA’s level of 

concern for propiconazole 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). 

Propiconazole is currently registered 

for uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to propiconazole. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 74 for toddlers 

(children 1 to 2 years old). The aggregate 

MOE is 74, which is less than the target 

MOE of 100. However, this aggregate 

MOE is based on 100 PCT and 

tolerance-level residues concerning food 

exposure, conservative (protective) 

assumptions in the ground and surface 

water modeling, and similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. Additional refinements 

incorporating average field trial and/or 

percent crop treated information would 

result in MOEs well above the target 

MOE of 100. Therefore, this scenario is 

not of concern. 

5. Aggregate cancer risk for U.S. 

population. The Agency considers the 

chronic aggregate risk assessment, 

making use of the cPAD, to be protective 

of any aggregate cancer risk. 

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 

propiconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

a high performance liquid 

chromatography with ultraviolet 

detection method (HPLC/UV Method 

AG–671A) is available to enforce the 

tolerance expression. 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 not established an 

MRL for propiconazole for any of the 

subject commodities in this document. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the Agency’s evaluation of 

the residue data submitted with the 

petition, for all proposed commodities, 

with the exception of the level for the 

citrus fruit group 10–10 (8.0 ppm), the 

Agency has modified the levels for 

which tolerances are being established. 

The proposed tolerances for snap bean, 

succulent shelled beans, stone fruit 

group 12 except plum, and plum are 

being reduced to 0.70 ppm, 0.10 ppm, 

4.0 ppm, and 0.60 ppm, respectively. 

The proposed tolerances for foliage of 

legume foliage, dry bean seed, and 

tomato are being increased to 30 ppm, 

0.40 ppm, and 3.0 ppm, respectively, 

and the commodity definition for 

legume foliage is being changed to 

‘‘vegetable, foliage of legume, group 7.’’ 

Lastly, a tolerance for citrus oil is being 

established at 1000 ppm. The Agency 

revised these tolerance levels based on 

analysis of the residue field trial data 


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38204 Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Rules and Regulations 

using the Agency’s Tolerance 

Spreadsheet in accordance with the 

Agency’s Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data. 

V. Conclusion 

Therefore, tolerances are established 

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

(2,4-dichlorophenyl)-4-propyl-1,3- 

dioxolan-2-yl] methyl]-1H–1,2,4- 

triazole) and its metabolites determined 

as 2,4-dichlorobenzoic acid and 

expressed as parent compound, in or on 

bean, snap at 0.70 ppm; bean, succulent 

shelled at 0.10 ppm; vegetable, foliage of 

legume, group 7 at 30 ppm; bean, dry 

seed at 0.40 ppm; tomato at 3.0 ppm; 

fruit, citrus, group 10–10 at 8.0 ppm; 

fruit, stone, group 12, except plum at 4.0 

ppm; plum at 0.60 ppm; and citrus, oil 

at 1000 ppm. Additionally, the 

established tolerance is removed for 

fruit, stone, group 12 at 1.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (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 

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 8, 2012. 

Lois Rossi, 

Director, Registration Division. 

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 § 180.434, the table in paragraph 

(a) is amended as follows: 

■ i. Remove the entry ‘‘fruit, stone, 

group 12’’ and 

■ ii. Add, alphabetically, the following 

commodities to read as follows: 

§ 180.434 Propiconazole; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Bean, dry seed ........................... 0.40 

Bean, snap ................................. 0.70 

Bean, succulent shelled ............. 0.10 

* * * * * 

Citrus, oil ..................................... 1000 

* * * * * 

Fruit, citrus, group 10–10 ........... 8.0 

Fruit, stone, group 12, except 

plum ........................................ 4.0 

* * * * * 

Plum ............................................ 0.60 

* * * * * 

Tomato ........................................ 3.0 

* * * * * 

Vegetable, foliage of legume, 

group 7 .................................... 30 

* * * * * 

[FR Doc. 2012–15539 Filed 6–26–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0029; FRL–9352–5] 

Cyflufenamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of cyflufenamid 

in or on multiple commodities which 

are identified and discussed later in this 

document. Nippon Soda Co., Ltd., c/o 

Nisso America, Inc. requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

27, 2012. Objections and requests for 


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