Document ID: EPA-HQ-OPP-2014-0470-0010
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Difenoconazole
Posted Date: 2015-08-26T04:00Z

[Federal Register Volume 80, Number 165 (Wednesday, August 26, 2015)]
[Rules and Regulations]
[Pages 51732-51739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21078]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0470; FRL-9929-61]

Difenoconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

[[Page 51733]]

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
difenoconazole in or on artichoke, globe; ginseng; fruit, stone, group 
12-12; and nut, tree, group 14-12. This regulation additionally removes 
existing tolerances in or on fruit, stone, group 12; nut, tree, group 
14; and pistachio. Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective August 26, 2015. Objections and 
requests for hearings must be received on or before October 26, 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-2014-0470, 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 
Printing Office's e-CFR 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-2014-0470 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 
October 26, 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-2014-0470, 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 
4E8274) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. The petition requested that 40 CFR part 180 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]-1H-1,2,4-triazole, in or on ginseng at 0.50 parts per million 
(ppm); artichoke, globe at 1.5 ppm; fruit, stone, group 12-12 at 2.5 
ppm; and nut, tree, group 14-12 at 0.03 ppm. That document referenced a 
summary of the petition prepared on behalf of IR-4 by Syngenta Crop 
Protection, LLC, the registrant, which is available in the docket, 
http://www.regulations.gov. Comments were received on the notice of 
filing. EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance in or on ginseng. The reason for this 
change is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with 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

[[Page 51734]]

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 (e.g. hepatocellular hypertrophy, liver necrosis, fatty 
changes in the liver). No systemic toxicity was observed at the limit 
dose in the most recently submitted rat dermal toxicity study.
    The available toxicity studies indicated no increased 
susceptibility of rats or rabbits from in utero or postnatal exposure 
to difenoconazole. In prenatal developmental toxicity studies in rats 
and rabbits and in the 2-generation reproduction study in rats, fetal 
and offspring toxicity, when observed, occurred at equivalent or higher 
doses than in the maternal and parental animals.
    In a rat developmental toxicity study, developmental effects were 
observed at doses higher than those which caused maternal toxicity. 
Developmental effects in the rat included increased incidence of 
ossification of the thoracic vertebrae and thyroid, decreased number of 
sternal centers of ossification, increased number of ribs and thoracic 
vertebrae, and decreased number of lumbar vertebrae. In the rabbit 
study, developmental effects (increases in post-implantation 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 and offspring, when observed, occurred at equivalent or 
higher doses than in the maternal and parental animals.
    In an acute neurotoxicity study in rats, reduced fore-limb grip 
strength was observed on day one in males at the lowest-observed-
adverse-effect-level (LOAEL), and clinical signs of neurotoxicity were 
observed in females only at the highest dose tested. In a subchronic 
neurotoxicity study in rats, decreased hind limb strength was observed 
in males only at the mid- and high-doses. The effects observed in acute 
and subchronic neurotoxicity studies were considered transient. 
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 nonlinear reference dose (RfD) 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 carcinoma tumors were only induced at 
excessively-high doses. Adenomas (benign tumors) and liver necrosis 
only were seen at 300 ppm (46 and 58 milligram/kilogram/day (mg/kg/day) 
in males and females, respectively). Based on excessive toxicity 
observed at the two highest doses in the mouse carcinogenicity 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 no-observed-adverse-
effect-level (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). EPA has concluded that a nonlinear RfD approach is 
appropriate for assessing cancer risk to difenoconazole and a separate 
quantitative cancer exposure assessment is unnecessary since the 
chronic dietary risk estimate will be protective of potential cancer 
risk.
    Specific information on the studies received and the nature of the 
adverse effects caused by difenoconazole as well as the NOAEL and the 
LOAEL from the toxicity studies can be found at http://www.regulations.gov in document, ``Difenoconazole: Human Health Risk 
Assessment for Proposed New Foliar Uses on Globe Artichoke, Ginseng and 
Greenhouse Grown Cucumbers and Conversion of the Established Foliar 
Uses/Tolerances for Stone Fruit Group 12 and Tree Nut Crop Group 14 to 
Stone Fruit Group 12-12 and Tree Nut Group 14-12.'' at pp. 36-43 in 
docket ID number EPA-HQ-OPP-2014-0470.

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 an 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.B. of the final rule 
published in the Federal Register of April 2, 2015 (80 FR 17697) (FRL-
9923-82).

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) National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, EPA assumed

[[Page 51735]]

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 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, 
average PCT for some commodities, and 100 PCT for the remaining 
commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use 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 
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%; cucumber, 5%; garlic, 5%; grape, 5%; 
grapefruit, 2.5%; onion, 5%; orange, 2.5%; peach, 1%; pecan, 2.5%; 
pepper, 2.5%; pistachio, 2.5%; pumpkin, 2.5%; squash, 5%; strawberry, 
2.5%; sugar beet, 15%; tangerine, 2.5%; tomato, 25%; walnut, 2.5%; 
watermelon, 5%; and wheat, 10%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
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 drinking water 
assessment was performed using a total toxic residue method, which 
considers both parent difenoconazole and its major metabolite, CGA 
205375, in surface and groundwater. Therefore, the Agency used 
screening level water exposure models in the dietary exposure analysis 
and risk assessment for difenoconazole and its major metabolite in 
drinking water. These simulation models take into account data on the 
physical, chemical, and fate/transport characteristics of 
difenoconazole and CGA 205375. 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 Surface Water Concentration Calculator (SWCC), Screening 
Concentration in Ground Water (SCI-GROW), and Pesticide Root Zone Model 
Ground Water (PRZM GW) models, the combined estimated drinking water 
concentrations (EDWCs) of difenoconazole and CGA 205375 are estimated 
to be 20.0 parts per billion (ppb) for surface water and 1.77 ppb for 
ground water. For chronic exposure assessments, EDWCs are estimated to 
be 13.6 ppb for surface water; EDWCs were not detected for ground water 
for chronic assessments.
    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 non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control,

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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 mixing, loading, and applying difenoconazole on 
ornamentals (gardens and trees). For residential post-application 
exposures, short-term dermal exposure is expected for both adults and 
children from post-application activities in treated residential 
landscapes.
    The scenarios used in the aggregate assessment were those that 
resulted in the highest exposures. The highest exposures consist of the 
short-term dermal exposure to adults from post-application activities 
in treated gardens and short-term dermal exposure to children 6 to 11 
years old from post-application 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/science/residential-exposure-sop.html.
    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). This document may be found at 
EPA's Web site at http://www.epa.gov/oppfead1/trac/science/cumulativeguidance.pdf.
    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 difenoconazole, EPA conducted 
a human health risk assessment for exposure to 1,2,4-triazole, 
triazolylalanine, and triazolylacetic acid resulting from the use of 
all current and pending uses of any triazole-derived fungicide. The 
risk assessment is a highly conservative, screening-level evaluation in 
terms of hazards associated with common metabolites (e.g., use of a 
maximum combination of uncertainty factors) and potential dietary and 
non-dietary exposures (i.e., high end estimates of both dietary and 
non-dietary exposures). In addition, the Agency retained the additional 
10X Food Quality Protection Act Safety Factor (FQPA 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 may be found in the 
propiconazole reregistration docket at http://www.regulations.gov, 
docket ID Number EPA-HQ-OPP-2005-0497. The Agency's latest complete 
risk assessment for the triazole-containing metabolites was finalized 
on April 9, 2015 and is entitled, ``Common Triazole Metabolites: 
Updated Dietary (Food + Water) Exposure and Risk Assessment to Address 
The New Section 3 Registrations For Use of Propiconazole on Tea, Dill, 
Mustard Greens, Radish, and Watercress; Use of Difenoconazole on Globe 
Artichoke, Ginseng and Greenhouse Grown Cucumbers and Conversion of the 
Established Foliar Uses/Tolerances for Stone Fruit and Tree Nut Crop 
Groups to Fruit, Stone, Group 12-12 and the Nut, Tree, Group 14-12.; 
and Use of Flutriafol on Hops.'' The assessment may be found in the 
propiconazole reregistration docket at http://www.regulations.gov, 
docket ID number EPA-HQ-OPP-2014-0470.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA SF. In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology database for difenoconazole includes rat and rabbit prenatal 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. 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 post-implantation 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 exposure in multiple species in the 
difenoconazole

[[Page 51737]]

study 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 uncertainty factors 
(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 utilized tolerance level 
residues and 100 PCT for the acute assessment; the chronic assessment 
was refined by using 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 89% 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 
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 intermediate-term 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 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. Based on the data 
summarized 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

    Adequate enforcement methodology, gas chromatography with nitrogen 
phosphorus detection (GC/NPD) method AG-575B, is available for the 
determination of residues of difenoconazole per se in or on plant 
commodities. Liquid chromatography with tandem 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 methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint 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 a MRL in or on artichoke, globe. 
Codex has established the following MRLs for difenoconazole: Ginseng at 
0.08 ppm; dried and red ginseng at 0.2 ppm; ginseng extracts at 0.6 
ppm; cherry and plum, including prune at 0.2 ppm; nectarine and peach 
at 0.5 ppm; and tree nut at 0.03 ppm. The MRL for tree nut at 0.03 ppm 
is the same as the tolerance being established for difenoconazole in 
the United States for nut, tree, group 14-12 at 0.03 ppm. Based on the 
data reviewed in conjunction with this action, harmonization with Codex 
MRLs is not possible for ginseng and stone fruit

[[Page 51738]]

commodities (including cherry, nectarine, peach, plum, and prune). The 
data supporting the EPA petition support the establishment of tolerance 
levels that are higher than the established Codex MRLs. The U.S. 
tolerances are being recommended by EPA are as follows: Ginseng at 1.0 
ppm; and fruit, stone, group 12-12 at 2.5 ppm.

C. Response to Comments

    Several comments were received in response to the notice of filing. 
All but one were concerned with potential environmental impacts, and 
were not specifically related to the difenoconazole action. EPA notes 
that these comments address potential environmental concerns; however, 
the safety standard for approving tolerances under section 408 of the 
FFDCA focuses on potential harms to human health and does not permit 
consideration of effects on the environment.
    One additional comment was received that did not specifically 
address the difenoconazole action, but that raised concerns about the 
toxicity of pesticides and requested that no tolerance be established. 
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 persons 
seeking such tolerances or exemptions have demonstrated 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. EPA has found 
that there is a reasonable certainty of no harm to humans after 
considering the toxicological studies and the exposure levels of humans 
to difenoconazole.

D. Revisions to Petitioned-for Tolerances

    Based on the data supporting the petition, EPA determined that the 
proposed tolerance in or on ginseng at 0.50 ppm should be established 
at 1.0 ppm. Residues of difenoconazole appeared to increase 
significantly with a pre-harvest interval (PHI) longer than the 
proposed 0-day PHI. Average per-trial residues increased by a factor of 
as much as 2.3x between the 0- and 21-day PHIs and based on this 
finding, EPA determined that average per-trial residues of 
difenoconazole for trials reflecting a 0-day PHI should be adjusted by 
a factor of 2.3x to account for the maximum demonstrated increase in 
difenoconazole residues resulting from PHIs longer than the proposed 0-
day PHI. Therefore, the adjusted residues were used in the Organization 
for Economic Cooperation and Development (OECD) tolerance calculation 
procedures, resulting in the recommend tolerance in or on ginseng at 
1.0 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of 
difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-
dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on artichoke, globe at 
1.5 ppm; ginseng at 1.0 ppm; fruit, stone, group 12-12 at 2.5 ppm; and 
nut, tree, group 14-12 at 0.03 ppm. Additionally, this regulation 
removes the established tolerances for residues of difenoconazole in or 
on fruits, stone group 12 at 2.5 ppm; nut, tree, group 14 at 0.03 ppm; 
and pistachio at 0.03 ppm.

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: August 13, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.475:

[[Page 51739]]

0
a. Remove the entries ``Fruits, stone, group 12''; ``Nut, tree, group 
14''; and ``Pistachio'' from the table in paragraph (a)(1).
0
b. Add alphabetically the following commodities to the table in 
paragraph (a)(1).
    The amendments read as follows:

Sec.  180.475  Difenoconazole; tolerances for residues.

    (a)(1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Artichoke, globe..........................................          1.5
 
                                * * * * *
Fruit, stone, group 12-12.................................          2.5
Ginseng...................................................          1.0
 
                                * * * * *
Nut, tree, group 14-12....................................          0.03
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-21078 Filed 8-25-15; 8:45 am]
 BILLING CODE 6560-50-P