[Federal Register Volume 77, Number 139 (Thursday, July 19, 2012)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17628]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
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commodities/groups superseded by this action.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
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: firstname.lastname@example.org.
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
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
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
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
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
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
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
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
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.
Therefore, tolerances are established for residues of
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
``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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: July 11, 2012.
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) * * *
* * * * *
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]
BILLING CODE 6560-50-P