[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Rules and Regulations]
[Pages 5941-5946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02170]



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

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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.


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. 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 
     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]1H-1,2,4-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

[[Page 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 

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 
    Difenoconazole possesses low acute toxicity by the oral, dermal and 
inhalation routes of exposure. It is not an eye or skin irritant and is 
not a sensitizer. Subchronic and chronic studies with difenoconazole in 
mice and rats showed decreased body weights, decreased body weight 
gains and effects on the liver. In an acute neurotoxicity study in 
rats, reduced fore-limb grip strength was observed on day 1 in males 
and clinical signs of neurotoxicity were observed in females at the 
limit dose of 2,000 milligrams/kilograms (mg/kg). In a subchronic 
neurotoxicity study in rats, decreased hind limb strength was observed 
in males only at the mid and high doses. However, the effects observed 
in acute and subchronic neurotoxicity studies are transient, and the 
dose-response is well characterized with identified no-observed-
adverse-effects-levels (NOAELs). No systemic toxicity was observed at 
the limit dose in the most recently submitted 28-day rat dermal 
toxicity study.
    There is no concern for increased qualitative and/or quantitative 
susceptibility after exposure to difenoconazole in developmental 
toxicity studies in rats and rabbits, and a reproduction study in rats 
as fetal/offspring effects occurred in the presence of maternal 
toxicity. Although there is some evidence that difenoconazole affects 
antibody levels at doses that cause systemic toxicity, there are no 
indications in the available studies that organs associated with immune 
function, such as the thymus and spleen, are affected by 
    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-observed-adverse-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-

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-

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

[[Page 5944]]

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 non-occupational, 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 post-application 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.

[[Page 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 
    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 
    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 
    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 
    Because no intermediate-term adverse effect was identified, 
difenoconazole is not expected to pose an intermediate-term 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 
    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/Nitrogen-
Phosphorus 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 
    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: 

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 pre-harvest intervals 
than currently proposed in the U.S. The Codex MRL

[[Page 5946]]

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:


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).

Sec.  180.475  Difenoconazole; Tolerance for residues.

    (a) General. * * *

                                                             Parts per
                        Commodity                             million
                                * * * * *
Dragonfruit \1\.........................................             1.5
                                * * * * *
Rapeseed subgroup 20A...................................            0.10
                                * * * * *
\1\ There are no U.S. registrations.

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