[Federal Register Volume 77, Number 139 (Thursday, July 19, 2012)]
[Rules and Regulations]
[Pages 42433-42439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17628]



40 CFR Part 180

[EPA-HQ-OPP-2011-0300; FRL-9354-9]

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 identified and discussed 
in this document and amends the established tolerances in or on 
vegetable, tuberous and corm, subgroup 1C and potato, processed waste. 
In addition, this regulation removes established tolerances for certain 
commodities/groups superseded by this action. The Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 19, 2012. Objections and 
requests for hearings must be received on or before September 17, 2012, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2011-0300, is available at http://www.regulations.gov or at the OPP Docket in the Environmental 
Protection Agency Docket Center (EPA/DC), located in EPA

[[Page 42434]]

West, Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. 
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Public Reading Room is (202) 566-1744, and the telephone number for the 
OPP Docket is (703) 305-5805. Please review the visitor instructions 
and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; email address: jackson.sidney@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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2011-0300 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 
September 17, 2012. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0300, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting 
comments. Do not submit electronically any information you consider to 
be Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection 
Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania 
Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for 
hand delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm. Additional 
instructions on commenting or visiting the docket, 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 July 20, 2011 (76 FR 43231) (FRL-8880-
1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7852) 
by Interregional Research Project Number 4 (IR-4), IR-4 Headquarters, 
500 College Road East, Suite 201 W, Princeton, NJ 08540. 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-
triazole, including its metabolites and degradates in or on vegetable, 
fruiting, group 8-10 at 0.6 ppm; fruit, citrus, group 10-10 at 0.6 ppm; 
fruit, pome, group 11-10 at 1.0 ppm; and berry, low growing, subgroup 
13-07G, except cranberry at 2.5 ppm; and by amending the established 
tolerance in or on vegetable, tuberous and corm, subgroup 1C at 0.01 
ppm to raise to 4.0 ppm. In addition, the petition proposes to remove 
established tolerances in or on the raw agricultural commodities: 
Potato, processed waste at 0.04 ppm; vegetables, fruiting, group 8 at 
0.6 ppm; fruit, citrus, group 10 at 0.6 ppm; fruit, pome, group 11 at 
1.0 ppm; and strawberry at 2.5 ppm. That notice referenced a summary of 
the petition prepared by Syngenta Crop Protection, 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 this petition, EPA denied 
the Petitioner's request to remove the established tolerance on potato, 
processed waste at 0.04 ppm. Moreover, the Agency determined that the 
tolerance needs to be raised and the commodity terminology changed to 
potato, wet peel at 7.3 ppm. The Agency's rationale for these decisions 
is outlined in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

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

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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 their 
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. There are no indications in the available studies that organs 
associated with immune function, such as the thymus and spleen, are 
affected by difenoconazole.
    EPA is using the non-linear (Reference Dose) approach to assess 
cancer risk. Difenoconazole is not mutagenic, and no evidence of 
carcinogenicity was seen in rats. Evidence for carcinogenicity was seen 
in mice (liver tumors), but statistically significant carcinomas tumors 
were only induced at excessively-high doses. Adenomas (benign tumors) 
and liver necrosis only were seen at 300 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 in document ``Difenoconazole. Human Health Risk 
Assessment for Postharvest Use on Tuberous and Corm Vegetables Subgroup 
1C. and Low growing Berry Subgroup 13-07G, Except Cranberry,'' dated 
May 30, 2012 at p. 34 in docket ID number EPA-HQ-OPP-2011-0300.

B. Toxicological POD/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological POD and levels of concern (LOC) 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 discussed in Unit III. B. of the final 
rule published in the Federal Register of June 15, 2011 (76 FR 34877) 

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 an unrefined acute analysis for 
food and water that assumed tolerance-level residues, 100 percent crop 
treated (PCT), and the available empirical or dietary exposure 
evaluation model (DEEM\TM\ version 7.81) default processing factors.
    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, a refined chronic 
analysis for food and water assumed tolerance-level residues for some 
commodities, average field trial residues for the majority of 
commodities, the available empirical or DEEM\TM\ version 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. A separate quantitative cancer exposure 
assessment is unnecessary since the NOAEL (4.7 and 5.6 mg/kg/day in 
males and females, respectively) to assess cancer risk is higher than 
the NOAEL (0.96 and 1.27 mg/kg/day in males and females, respectively) 
to assess chronic risks and exposure for the purpose of assessing 
cancer risk would be no

[[Page 42436]]

higher than chronic exposure. Therefore, the chronic dietary risk 
estimate will be protective of potential cancer risk.
    iv. Anticipated residue and PCT information. EPA did not use PCT 
information in the dietary assessment for difenoconazole and assumed 
100 PCT. EPA used anticipated residues in the form of average field 
trial residues for the majority of commodities in the chronic dietary 
exposure assessment.
    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 the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) for registered and proposed new uses and Screening 
Concentration in Ground Water (SCI-GROW) models, the estimated drinking 
water concentrations (EDWCs) of difenoconazole for acute exposures are 
estimated to be 17.4 parts per billion (ppb) for surface water and 
0.0128 ppb for ground water.
    For chronic exposures for non-cancer assessments are estimated to 
be 11.8 ppb for surface water and 0.0128 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 
17.4 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 11.8 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/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 homeowners 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 
difenoconozole 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 procedures 
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/Day_16/.
    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 (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 risk assessment is found in the 
propiconazole reregistration docket at http://www.regulations.gov, 
Docket Identification (ID) Number EPA-HQ-OPP-2005-0497. The requested 
amended uses of difenoconazole resulted in an increase in dietary 
exposure estimates for free triazole or conjugated triazoles. 
Therefore, updated dietary exposure analyses were conducted. The most 
recent update for triazoles may be found in docket ID number EPA-HQ-

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

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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 SF 
when reliable data available to EPA support the choice of a different 
    2. Prenatal and postnatal sensitivity. EPA determined that the 
available data indicated no increased 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 prenatal developmental 
toxicity study in rats, maternal toxicity was manifested as decreased 
body weight gain and food consumption at the LOAEL of 85 mg/kg/day; the 
NOAEL was 16 mg/kg/day. Developmental toxicity in this study was 
manifested as alterations in fetal ossifications at 171 mg/kg/day; the 
developmental NOAEL was 85 mg/kg/day. In a developmental toxicity study 
in rabbits, maternal and developmental toxicity were seen at the same 
dose level (75 mg/kg/day). Maternal toxicity in rabbits was manifested 
as decreased body weight gain and decreased food consumption, while 
developmental toxicity was manifested as decreased fetal weight. In a 
2-generation reproduction study in rats, there were decreases in 
maternal body weight gain and decreases in body weights of 
F1 males at the LOAEL of 12.5 mg/kg/day; the parental 
systemic and off spring toxicity NOAEL was 1.25 mg/kg/day.
    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 is complete except for results of a 
recently submitted immunotoxicity study required as a part of new data 
requirements in the 40 CFR part 158 for conventional pesticide 
registration. However, the existing toxicology database for 
difenoconazole does not show any evidence of treatment-related effects 
on the immune system. The overall weight of evidence suggests that this 
chemical does not directly target the immune system. Accordingly, the 
Agency does not believe that findings from the ongoing review of the 
immunotoxicity study will result in a lower POD than that currently in 
use for overall risk assessment, and therefore, a database uncertainty 
factor is not needed to account for lack of this study.
    ii. The acute and subchronic neurotoxicity studies in rats are 
available. These data show that difenoconazole exhibits some evidence 
of neurotoxicity, but the effects are transient or occur at the limit 
dose. EPA concluded that difenoconazole is not a neurotoxic compound. 
Based on the toxicity profile, and lack of neurotoxicity, a 
developmental neurotoxicity study in rats is not required.
    iii. There is no evidence that difenoconazole results in increased 
susceptibility of rats or rabbit fetuses to in utero and/or postnatal 
exposure in the developmental and reproductive toxicity data.
    iv. There are no residual uncertainties identified in the exposure 
databases. A conservative dietary food exposure assessment was 
conducted. Acute dietary food exposure assessments were performed based 
on tolerance-level residues, 100 PCT, and the available empirical or 
(DEEMTM version 7.81) default processing factors.
    Chronic dietary exposure assessments were based on tolerance-level 
residues for some commodities, average field trial residues for the 
majority of commodities, the available empirical or (DEEMTM 
version 7.81) default processing factors, and 100 PCT. These are 
conservative approaches and are unlikely to understate the residues in 
food commodities.
    EPA also made conservative (protective) assumptions in the ground 
water and surface water modeling used to assess exposure to 
difenoconazole in drinking water. Post-application residential exposure 
of children is not expected. 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 27% of the aPAD for children 1 to 2 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
difenoconazole from food and water will utilize 75% 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 200 or greater. 
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 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 

[[Page 42438]]

    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.
    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 to enforce 
the tolerance expression for residues of difenoconazole in/on plant 
commodities. An adequate enforcement method, liquid chromatography 
coupled 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 
    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: 

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.
    Codex maximum residue levels (MRLs) for residues of difenoconazole 
per se have been established at 0.5 ppm for tomato; 0.5 ppm for pome 
fruits; and 0.02 ppm for potato. Based on the available magnitude of 
the residue data, harmonization with these established Codex MRLs is 
not possible because, the Codex MRLs are too low to adequately cover 
residues resulting from the proposed use rates in the United States. 
Canadian MRLs for residues of difenoconazole have been established at 
0.6 ppm for a number of fruiting vegetables and 1.0 ppm for a number of 
pome fruit, and are in agreement with proposed U.S. tolerances. The 
data for vegetable, tuberous and corm, subgroup 1C at 4.0 ppm was a 
joint review between EPA and the Health Canada Pest Management 
Regulatory Agency (PMRA). The two agencies are in agreement regarding 
tolerance level for subgroup 1C.

C. Revisions to Petitioned-For Tolerances

    The Petitioner proposed removal of the established tolerance in or 
on potato, processed waste at 0.04 ppm. However, the Agency has 
determined that this tolerance needs to be retained and raised to 7.3 
ppm. Further, the commodity definition should be changed to potato, wet 
peel. The potato processing data indicate that residues of 
difenoconazole do not concentrate in flakes and chips but do 
concentrate in wet peel. Based on the highest-average-field-trial value 
for residues in/on potatoes (2.34 ppm) and the average processing 
factor (3.1x), expected residues could be as high as 7.3 ppm in potato, 
wet peel. Because this value is higher than the recommended 4.0 ppm 
tolerance for vegetable, tuberous and corm, subgroup 1C, a separate 
tolerance is needed in potato, wet peel at 7.3 ppm.
    The Petitioner's proposed commodity terminology for berry, low 
growing, subgroup 13-07G, except cranberry was corrected to comply with 
current crop terminology policy.

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, including its metabolites and 
degradates, in or on Berry, low growing, subgroup 13-07G, except 
cranberry at 2.5 ppm, Fruit, citrus, group 10-10 at 0.60 ppm, Fruit, 
pome, group 11-10 at 1.0 ppm, and Vegetable, fruiting, group 8-10 at 
0.60 ppm; and by revising the established tolerance in or on Vegetable, 
tuberous and corm, subgroup 1C at 0.01 ppm by increasing the residue 
level to 4.0 ppm. The difenoconazole tolerances are further amended by 
correcting the commodity terminology for Potato, processed waste to 
read Potato, wet peel and increasing the tolerance level from 0.04 ppm 
to 7.3 ppm. In addition, this regulation removes established tolerances 
in or on Vegetables, fruiting, group 8, Fruit, citrus, group 10, Fruit, 
pome, group 11 and Strawberry, as these commodities are included in new 
crop groups or subgroups for which tolerances are established by this 

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled

[[Page 42439]]

``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 
13175, entitled ``Consultation and Coordination with Indian Tribal 
Governments'' (65 FR 67249, November 9, 2000) do not apply to this 
final rule. In addition, this final rule does not impose any 
enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: July 11, 2012.
Lois Rossi,
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. Section 180.475, the table to paragraph (a)(1) is amended as 
i. Remove the entries for ``Fruit, citrus, group 10,'' ``Fruit, pome, 
group 11,'' ``Potato, processed waste,'' ``Strawberry,'' and 
``Vegetables, fruiting, group 8.''
ii. Add alphabetically new entries for Berry, low growing, subgroup 13-
07G, except cranberry; Fruit, citrus, group 10-10; Fruit, pome, group 
11-10; Potato, wet peel; and Vegetable, fruiting, group 8-10, as shown 
iii. Revise the entry in the table to paragraph (a)(1) for ``Vegetable, 
tuberous and corm, subgroup 1C''.
    The added and revised text read as follows:

Sec.  180.475  Difenconazole, tolerances for residues.

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

                                                              Parts per
                         Commodity                             million
                                * * * * *
Berry, low growing, subgroup 13-07G, except cranberry......         2.5
                                * * * * *
Fruit, citrus, group 10-10.................................         0.60
Fruit, pome, group 11-10...................................         1.0
                                * * * * *
Potato, wet peel...........................................         7.3
                                * * * * *
Vegetable, fruiting, group 8-10............................         0.60
Vegetable, tuberous and corm, subgroup 1C..................         4.0

* * * * *
[FR Doc. 2012-17628 Filed 7-18-12; 8:45 am]