[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Rules and Regulations]
[Pages 17697-17703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07354]

[[Page 17697]]



40 CFR Part 180

[EPA-HQ-OPP-2014-0149; FRL-9923-82]

Difenoconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
difenoconazole in or on multiple commodities which are identified and 
discussed later in this document. Syngenta Crop Protection requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 

DATES: This regulation is effective April 2, 2015. Objections and 
requests for hearings must be received on or before June 1, 2015, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0149, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].


I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing Office's 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-2014-0149 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
June 1, 2015. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0149, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of September 5, 2014 (79 FR 53009) (FRL-
9914-98), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
4F8231) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR part 180 be amended 
by establishing tolerances for residues of the fungicide, 
difenoconazole in or on pea, and bean, dried shelled, except soybean, 
subgroup 6C at 0.2 parts per million (ppm); pea, vine at 10 ppm; pea, 
hay at 40 ppm; and bushberry, subgroup 13-07B at 3.0 ppm. The petition 
also requested that the existing tolerance for chickpea be removed. 
That document referenced a summary of the petition prepared by 
Syngenta, the registrant, which is available in the docket identified 
by docket ID number EPA-HQ-OPP-2014-0373, http://www.regulations.gov. 
Comments were received on the notice of filing. EPA's response to these 
comments is discussed in Unit IV.C.
    In the Federal Register of February 11, 2015 (80 FR 7559) (FRL-
9921-94), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3F8209) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR part 180 be amended 
by increasing existing tolerances for residues of the fungicide, 
difenoconazole in or on fruit, pome, group 11-10 from 1.0 to 3.0 ppm, 
and apple, wet pomace from 4.5 to 7.5 ppm. That document referenced a 
summary of the petition prepared by Syngenta Crop Protection, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which some of the tolerances are being 
established. The reason for these changes are explained in Unit IV.D.

[[Page 17698]]

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for difenoconazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with difenoconazole 

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 
    Subchronic and chronic studies with difenoconazole in mice and rats 
showed decreased body weights, decreased body weight gains and effects 
on the liver.
    In an acute neurotoxicity study in rats, reduced fore-limb grip 
strength was observed on 1-day in males and clinical signs of 
neurotoxicity were observed in females at the limit dose of 2,000 
milligrams/kilograms (mg/kg). In a subchronic neurotoxicity study in 
rats, decreased hind limb strength was observed in males only at the 
mid- and high-doses. However, the effects observed in acute and 
subchronic neurotoxicity studies are transient, and the dose-response 
is well characterized with identified no-observed-adverse effects-
levels (NOAELs). No systemic toxicity was observed at the limit dose in 
the most recently submitted 28-day rat dermal toxicity study.
    There is no concern for increased qualitative and/or quantitative 
susceptibility after exposure to difenoconazole in developmental 
toxicity studies in rats and rabbits, and a reproduction study in rats 
as fetal/offspring effects occurred in the presence of maternal 
toxicity. Although there is some evidence that difenoconazole affects 
antibody levels at doses that cause systemic toxicity, there are no 
indications in the available studies that organs associated with immune 
function, such as the thymus and spleen, are affected by 
    EPA is using the non-linear (reference dose) approach to assess 
cancer risk. Difenoconazole is not mutagenic, and no evidence of 
carcinogenicity was seen in rats. Evidence for carcinogenicity was seen 
in mice (liver tumors), but statistically significant carcinomas tumors 
were only induced at excessively-high doses. Adenomas (benign tumors) 
and liver necrosis only were seen at 300 parts per million (ppm) (46 
and 58 mg/kg/day in males and females, respectively). Based on 
excessive toxicity observed at the two highest doses in the study, the 
presence of only benign tumors and necrosis at the mid-dose, the 
absence of tumors at the study's lower doses, and the absence of 
genotoxic effects, EPA has concluded that the chronic point of 
departure (POD) from the chronic mouse study will be protective of any 
cancer effects. The POD from this study is the NOAEL of 30 ppm (4.7 and 
5.6 mg/kg/day in males and females, respectively) which was chosen 
based upon only those biological endpoints which were relevant to tumor 
development (i.e., hepatocellular hypertrophy, liver necrosis, fatty 
changes in the liver and bile stasis).
    Specific information on the studies received and the nature of the 
adverse effects caused by difenoconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov on page 44 of the document titled ``Difenoconazole: 
Human Health Risk Assessment for proposed new foliar uses on legume 
subgroup 6C and bushberry subgroup 13-07B; post-harvest uses on pome 
fruit group 11-10; and ornamental plants and vegetable transplants 
grown in both indoor and outdoor production facilities'' in docket ID 
number EPA-HQ-OPP-2014-0149.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological POD and levels of concern to use in evaluating 
the risk posed by human exposure to the pesticide. For hazards that 
have a threshold below which there is no appreciable risk, the 
toxicological POD is used as the basis for derivation of reference 
values for risk assessment. PODs are developed based on a careful 
analysis of the doses in each toxicological study to determine the dose 
at which no adverse effects are observed (the NOAEL) and the lowest 
dose at which adverse effects of concern are identified (the LOAEL). 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for difenoconazole used 
for human risk assessment is shown in Table 1 of this unit.

[[Page 17699]]

Table 1--Summary of Toxicological Doses and Endpoints for Difenoconazole for Use in Human Health Risk Assessment
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
Acute dietary (All populations)..  NOAEL = 25 mg/kg/day  Acute RfD = 0.25 mg/ Acute neurotoxicity study in rats
                                   UFA = 10x...........   kg/day.             LOAEL= 200 mg/kg in males based on
                                   UFH = 10x...........  aPAD = 0.25 mg/kg/    reduced fore-limb grip strength
                                   FQPA SF = 1x........   day.                 in males on day 1.
Chronic dietary (All populations)  NOAEL= 0.96 mg/kg/    Chronic RfD = 0.01   Combined chronic toxicity/
                                    day.                  mg/kg/day.           carcinogenicity rat; dietary
                                   UFA = 10x...........  cPAD = 0.01 mg/kg/   LOAEL = 24.1/32.8 mg/kg/day (M/F)
                                   UFH = 10x...........   day.                 based on cumulative decreases in
                                   FQPA SF = 1x........                        body-weight gains.
Dermal Short-term (1-30 days)....  Oral NOAEL = 1.25 mg/ LOC for MOE = 100..  Reproduction and fertility Study
                                    kg/day dermal                              rat; dietary Parental/Offspring
                                    absorption rate =                         LOAEL = 12.5 mg/kg/day based on
                                    6%.                                        decreased pup weight in males on
                                   UFA = 10x...........                        day 21 and reduction in body-
                                   UFH = 10x...........                        weight gain of F0 females prior
                                   FQPA SF = 1x........                        to mating, gestation and
Inhalation short-term (1-30 days)  Oral NOAEL = 1.25 mg/ LOC for MOE = 100..  Reproduction and fertility Study
Inhalation and oral absorption      kg/day.                                    rat; dietary Parental/Offspring
 assumed equivalent.               UFA = 10x...........                       LOAEL = 12.5 mg/kg/day based on
                                   UFH = 10x...........                        decreased pup weight in males on
                                   FQPA SF = 1x........                        day 21 and reduction in body-
                                                                               weight gain of F0 females prior
                                                                               to mating, gestation and
Cancer (oral, dermal, inhalation)  The Agency is using a non-linear approach based on the chronic POD to assess
                                    the carcinogenic potential of difenoconazole.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to difenoconazole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing difenoconazole 
tolerances in 40 CFR 180.475. EPA assessed dietary exposures from 
difenoconazole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for difenoconazole. In estimating 
acute dietary exposure, EPA used 2003-2008 food consumption information 
from the United States Department of Agriculture's (USDA) National 
Health and Nutrition Examination Survey, What We Eat in America, 
(NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance 
level residues and 100 percent crop treated (PCT) information.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. As to residue levels in food, EPA used USDA Pesticide Data 
Program (PDP) monitoring data, average field trial residues for some 
commodities, tolerance level residues for the remaining commodities, 
and average percent crop treated for some commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk to difenoconazole. Therefore, a separate quantitative 
cancer exposure assessment is unnecessary since the chronic dietary 
risk estimate will be protective of potential cancer risk.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    For the chronic dietary exposure analysis, the Agency estimated the 
PCT for existing uses as follows:
    Almond 5%, cabbage 2.5%, cucumbers 5%, garlic 5%, grape 5%, 
grapefruit 2.5%, onions 5%, orange 2.5%, pecan 2.5%, peach 1%, peppers

[[Page 17700]]

2.5%, pistachio 2.5%, pumpkin 2.5%, squash 5%, strawberry 2.5%, sugar 
beets 15%, tangerine 2.5%, tomatoes 25%, walnut 2.5%, watermelon 5%, 
and wheat 10%.
    In most cases, EPA uses available data from USDA/National 
Agricultural Statistics Service (NASS), proprietary market surveys, and 
the National Pesticide Use Database for the chemical/crop combination 
for the most recent 6-7 years. EPA uses an average PCT for chronic 
dietary risk analysis. The average PCT figure for each existing use is 
derived by combining available public and private market survey data 
for that use, averaging across all observations, and rounding to the 
nearest 5%, except for those situations in which the average PCT is 
less than one. In those cases, 1% is used as the average PCT and 2.5% 
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the highest observed maximum 
value reported within the recent 6 years of available public and 
private market survey data for the existing use and rounded up to the 
nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which difenoconazole may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for difenoconazole in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of difenoconazole. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    The drinking water assessment was performed using a total toxic 
residue (TTR) method which considers both parent difenoconazole and its 
major metabolite, CGA-205375, in surface and groundwater.
    Based on the surface water concentration calculator (SWCC) and 
screening concentration in ground water (SCI-GROW) and pesticide root 
zone model ground water (PRZM GW) models, the estimated drinking water 
concentrations (EDWCs) of difenoconazole for acute exposures are 
estimated to be 20.0 parts per billion (ppb) for surface water and 1.77 
ppb for ground water and for chronic exposure assessments are estimated 
to be 13.6 ppb for surface water and not detected for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 20.0 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 13.6 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to 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: Treatment of ornamental plants 
in commercial and residential landscapes and interior plantscapes. EPA 
assessed residential exposure using the following assumptions: For 
residential handlers, adult short-term dermal and inhalation exposure 
is expected from use on ornamentals (garden/trees). For residential 
post-application, short-term dermal exposure is expected for both 
adults and children from post-application activities in treated 
    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 (6-11 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/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Difenoconazole is a member of the triazole-containing class of 
pesticides. Although conazoles act similarly in plants (fungi) by 
inhibiting ergosterol biosynthesis, there is not necessarily a 
relationship between their pesticidal activity and their mechanism of 
toxicity in mammals. Structural similarities do not constitute a common 
mechanism of toxicity. Evidence is needed to establish that the 
chemicals operate by the same, or essentially the same, sequence of 
major biochemical events (EPA, 2002). In conazoles, however, a variable 
pattern of toxicological responses is found; some are hepatotoxic and 
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some 
induce developmental, reproductive, and neurological effects in 
rodents. Furthermore, the conazoles produce a diverse range of 
biochemical events including altered cholesterol levels, stress 
responses, and altered DNA methylation. It is not clearly understood 
whether these biochemical events are directly connected to their 
toxicological outcomes. Thus, there is currently no evidence to 
indicate that conazoles share common mechanisms of toxicity and EPA is 
not following a cumulative risk approach based on a common mechanism of 
toxicity for the conazoles. For information regarding EPA's procedures 
for cumulating effects from substances found to have a common mechanism 
of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
    Difenoconazole is a triazole-derived pesticide. This class of 
compounds can form the common metabolite 1,2,4-triazole and two 
triazole conjugates (triazolylalanine and triazolylacetic acid). To 
support existing tolerances and to establish new tolerances for 
triazole-derivative pesticides, including propiconazole, EPA conducted 
a human health risk assessment for exposure to 1,2,4-triazole, 
triazolylalanine, and triazolylacetic acid resulting from the use of 
all current and pending uses of any triazole-derived fungicide. The 

[[Page 17701]]

assessment is a highly conservative, screening-level evaluation in 
terms of hazards associated with common metabolites (e.g., use of a 
maximum combination of uncertainty factors) and potential dietary and 
non-dietary exposures (i.e., high end estimates of both dietary and 
non-dietary exposures). In addition, the Agency retained the additional 
10X FQPA safety factor for the protection of infants and children. The 
assessment includes evaluations of risks for various subgroups, 
including those comprised of infants and children. The Agency's 
complete risk assessment is found in the propiconazole reregistration 
docket at http://www.regulations.gov, docket identification (ID) number 
    The most recent update for the triazoles was conducted on October 
24, 2013. The requested new uses of difenoconazole did not 
significantly change the dietary exposure estimates for free triazole 
or conjugated triazoles. Therefore, an updated dietary exposure 
analysis was not conducted. The October 24, 2013 update for triazoles 
may be found in docket ID number EPA-HQ-OPP-2014-0149.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act (FQPA) Safety Factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The available Agency 
guideline studies indicated no increased qualitative or quantitative 
susceptibility of rats or rabbits to in utero and/or postnatal exposure 
to difenoconazole. In the prenatal developmental toxicity studies in 
rats and rabbits and the 2-generation reproduction study in rats, 
toxicity to the fetuses/offspring, when observed, occurred at 
equivalent or higher doses than in the maternal/parental animals.
    In a rat developmental toxicity study developmental effects were 
observed at doses higher than those which caused maternal toxicity. In 
the rabbit study, developmental effects (increases in 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 
    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. The dietary risk assessment is conservative, using tolerance 
level residues and 100 PCT for the acute assessment while the chronic 
assessment used USDA PDP monitoring data, average field trial residues 
for some commodities, tolerance level residues for remaining 
commodities, and average PCT for some commodities. These assumptions 
will not underestimate dietary exposure to difenoconazole. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to difenoconazole in drinking water. 
EPA used similarly conservative assumptions to assess post-application 
exposure of children. These assessments will not underestimate the 
exposure and risks posed by difenoconazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to difenoconazole will occupy 49% of the aPAD for all infants less than 
1 year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
difenoconazole from food and water will utilize 88% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
difenoconazole is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Difenoconazole is currently registered for uses that could result 
in short-term residential exposure, and the Agency has determined that 
it is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to difenoconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 170 for adults 
and 190 for children. Because EPA's level of concern for difenoconazole 
is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
    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

[[Page 17702]]

at least as protective as the POD used to assess intermediate-term 
risk), no further assessment of intermediate-term risk is necessary, 
and EPA relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for difenoconazole.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A, the chronic dietary risk assessment is protective of any 
potential cancer effects. Based on the results of that assessment, EPA 
concludes that difenoconazole is not expected to pose a cancer risk to 
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to difenoconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement method, GC/NPD method AG-575B, is available 
for the determination of residues of difenoconazole per se in/on plant 
commodities. An adequate enforcement method, liquid chromatography/mass 
spectrometry/mass spectrometry (LC/MS/MS) method REM 147.07b, is 
available for the determination of residues of difenoconazole and CGA-
205375 in livestock commodities. Adequate confirmatory methods are also 
    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: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has an established MRL for the sum of difenoconazole and 
its metabolite, 1-[2-chloro-4-(4-chlorophenoxy)-phenyl]-2-(1,2,4-
triazol)-1-yl-ethano), expressed as difenoconazole in or on milk at 
0.02 ppm, which is the same as the recommended U.S. tolerance.
    The Codex has not established an MRL for difenoconazole in or on 
pea and bean, dried shelled, except soybean, subgroup 6C; bushberry 
subgroup 13-07B; pea, field, hay; pea, field, vines; or apple, wet 
    The Codex has an established MRL for difenoconazole in or on pome 
fruit at 0.5 ppm for residues incurred from foliar uses of 
difenoconazole. This MRL differs from the recommended U.S. tolerance 
for difenoconazole in or on fruit, pome, group 11-10 at 5.0 ppm. The 
Codex MRL is not adequate to cover residues incurred from the proposed 
post-harvest uses in the United States; therefore, harmonization with 
Codex is not possible at this time.

C. Response to Comments

    Several comments were received in response to the notice of filing, 
however, all were concerned with effects to bees and related to other 
petitions and chemicals contained in the same notice of filing, not 

D. Revisions to Petitioned-for Tolerances

    The tolerance being established for the bushberry subgroup 13-07B 
is 4.0 ppm, not 3.0 ppm as proposed. This is due to the independent 
field trial determination which resulted in the exclusion of one of the 
trials from the Organization for Economic Cooperation and Development 
(OECD) tolerance calculation procedures. The tolerance being 
established for the pea and bean, dried shelled, except soybean, 
subgroup 6C tolerance is being set at 0.20 ppm, not 0.2 ppm, and is 
based on the current practice of setting tolerances to 2 significant 
figures. The established tolerance in milk is being increased from 0.01 
ppm to 0.02 ppm because of the new pea hay and vine feedstuffs which 
significantly increased the maximum reasonably balanced dietary 
estimate for dairy cattle. Furthermore, the Agency is establishing 
tolerances for the fruit, pome, group 11-10 and apple, wet pomace (5.0 
ppm and 25 ppm, respectively) at higher levels than requested (3.0 ppm 
and 7.5 ppm, respectively). The established tolerances for fruit, pome, 
group 11-10 take into account maximum tolerance estimates that may 
result from post-harvest application techniques for pome fruit. The 
established tolerances for apple, wet pomace was calculated based on 
the highest average field trial residues in or on apples and the 
average processing factor for wet pomace. Lastly, some commodity terms 
were modified to be consistent with Agency's preferred food and feed 
commodity vocabulary.

 V. Conclusion

    Therefore, tolerances are established for residues of 
difenoconazole, in or on bushberry subgroup 13-07B at 4.0 ppm; pea and 
bean, dried shelled, except soybean, subgroup 6C at 0.20 ppm; pea, 
field, hay at 40 ppm; and pea, field, vines at 10 ppm. Additionally, 
existing tolerances are modified as follows: Apple, wet pomace from 7.5 
ppm to 25 ppm; fruit, pome, group 11-10 from 3.0 to 5.0 ppm; and milk 
from 0.01 to 0.02 ppm. Lastly, the existing chickpea tolerance is 
removed as unnecessary since it is now covered by the pea and bean, 
dried shelled, except soybean, subgroup 6C tolerance.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory

[[Page 17703]]

Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 25, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.475:
i. Remove ``Chickpea'' from the table in paragraph (a)(1).
    ii. Add alphabetically the entries for ``Bushberry subgroup 13-
07B'', ``Pea and bean, dried shelled, except soybean, subgroup 6C'', 
``Pea, field, hay'', and ``Pea, field, vines'' to the table in 
paragraph (a)(1).
iii. Revise the entries for ``Apple, wet pomace'' and ``Fruit, pome, 
group 11-10'' in the table in paragraph (a)(1).
iv. Revise the entry for ``Milk'' in the table in paragraph (a)(2).
    The amendments read as follows:

Sec.  180.475  Difenoconazole; tolerances for residues.

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

                                                               Parts per
                          Commodity                             million
                                * * * * *
Apple, wet pomace...........................................       25
                                * * * * *
Bushberry subgroup 13-07B...................................        4.0
                                * * * * *
Fruit, pome, group 11-10....................................        5.0
                                * * * * *
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.20
Pea, field, hay.............................................       40
Pea, field, vines...........................................       10
                                * * * * *

    (2) * * *

                                                               Parts per
                          Commodity                             million
                                * * * * *
Milk........................................................        0.02
                                * * * * *

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