83 FR 3615 - Difenoconazole; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 18 (January 26, 2018)

Page Range		3615-3622
FR Document		2018-01479

This regulation establishes tolerances for residues of difenoconazole in or on multiple commodities which are identified and discussed later in this document. In addition, this regulation removes several previously established tolerances that are superseded by this final rule. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 83 Issue 18 (Friday, January 26, 2018)

[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3615-3622]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-01479]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0254; FRL-9971-95]

Difenoconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
difenoconazole in or on multiple commodities which are identified and
discussed later in this document. In addition, this regulation removes
several previously established tolerances that are superseded by this
final rule. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective January 26, 2018. Objections and
requests for hearings must be received on or before March 27, 2018, 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-2016-0254, 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: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0254 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
March 27, 2018. 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

[[Page 3616]]

by docket ID number EPA-HQ-OPP-2016-0254, by one of the following
methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

In the Federal Register of July 26, 2017 (82 FR 34664) (FRL-9963-
50), 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
6E8484) by IR-4 Headquarters, Rutgers, The State University of New
Jersey, 500 College Road East, Suite 201W, 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-chlorophenoxy)phenyl]-4-methy-1,3-dioxolan-2-ylmethyl]-1H-
1,2,4-triazole, in or on Brassica, leafy greens, subgroup 4-16B at 35
parts per million (ppm); cranberry at 0.6 ppm; fruit, small, vine
climbing, except fuzzy kiwifruit, subgroup 13-07F at 4.0 ppm; guava at
3.0 ppm; kohlrabi at 2.0 ppm; papaya at 0.6 ppm; and vegetable,
Brassica, head and stem, group 5-16 at 2.0 ppm. Upon establishment of
proposed tolerances above, the petition requested that 40 CFR part
180.475 be amended by removing existing tolerances for residues of
difenoconazole in or on Brassica, head and stem, subgroup 5A at 1.9
ppm, Brassica, leafy greens, subgroup 5B at 35 ppm; grape at 4.0 ppm;
and turnip, greens at 35 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.
Tolerances being established vary from what was requested, for the
reasons explained 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 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
children.
Difenoconazole exhibits 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 toxicity studies with
difenoconazole in mice and rats showed decreased body weights and
effects on the liver (e.g. hepatocellular hypertrophy, liver necrosis,
fatty changes in the liver). No systemic toxicity was observed at the
limit dose in a rat dermal toxicity study.
The available toxicity studies indicated no increased
susceptibility of rats or rabbits from in utero or postnatal exposure
to difenoconazole. In prenatal developmental toxicity studies in rats
and rabbits and in the 2-generation reproduction study in rats, fetal
and offspring toxicity, when observed, occurred at equivalent or higher
doses than in the maternal and parental animals. In a rat developmental
toxicity study, developmental effects were observed at doses higher
than those which caused maternal toxicity. Developmental effects in the
rat included increased incidence of ossification of the thoracic
vertebrae and thyroid, decreased number of sternal centers of
ossification, increased number of ribs and thoracic vertebrae, and
decreased number of lumbar vertebrae. In the rabbit study,
developmental effects (increases in post-implantation loss and
resorptions and decreases in fetal body weight) were also seen at
maternally toxic (decreased body weight gain and food consumption)
doses. Since the developmental effects are more severe than the
maternal effects, qualitative susceptibility is indicated in the rabbit
developmental study; however, the selected POD is protective of this
effect. In the 2-generation reproduction study in rats, toxicity to the
fetuses and offspring, when observed, occurred at equivalent or higher
doses than in the maternal and parental animals.
In an acute neurotoxicity study in rats, reduced fore-limb grip
strength was observed on day one in males at the lowest-observed-
adverse-effect-level of 200 mg/kg (LOAEL), and clinical signs of
neurotoxicity were observed in females only at the highest dose tested
(2,000 mg/kg). In a subchronic neurotoxicity study in rats, decreased
hind limb strength was observed in males only at doses >=17.5 mg/kg/
day. The effects observed in acute and subchronic neurotoxicity studies
are transient with no histologic findings.
Although there is some evidence that difenoconazole affects
antibody levels at doses that cause systemic toxicity, there are no
indications in the available studies that organs associated with immune
function, such as the thymus and spleen, are affected by
difenoconazole. Difenoconazole is not mutagenic, and no evidence of
carcinogenicity was seen in rats. Evidence for carcinogenicity was seen
in mice as induction of liver tumors at doses which were considered to
be excessively high for carcinogenicity testing. Difenoconazole has
been classified as ``Suggestive Evidence of Carcinogenic Potential''
based on liver tumors observed in mice at 46.3 mg/kg/day and higher,
the absence of tumors at two lower doses of 1.5 and 4.6 mg/kg/day,
respectively, excessive toxicity

[[Page 3617]]

observed at the two highest doses of 423 and 819 mg/kg/day,
respectively, the absence of genotoxicity, and no evidence of
carcinogenicity in rats. EPA has concluded that the chronic point of
departure (POD) for assessing chronic risk (0.96 mg/kg/day) will be
protective of any cancer effects for the following reasons: (1) Tumors
were seen in only one species; (2) carcinoma tumors were observed only
at the two highest doses (2,500 and 4,500 ppm) in the mouse
carcinogenicity study; (3) benign tumors and necrosis were observed at
the mid- dose (300 ppm) ; (4) the absence of tumors at the study's
lower doses (30 ppm); (5) the absence of genotoxic or mutagenic
effects. The cRfD of 0.96 mg/kg/day is well below the no-observed-
adverse-effect-level (NOAEL) of the mouse carcinogenicity study of 30
ppm (4.7 and 5.6 mg/kg/day in males and females, respectively), at
which no effects on the biological endpoints relevant to tumor
development (i.e., hepatocellular hypertrophy, liver necrosis, fatty
changes in the liver and bile stasis) were seen. As a result, EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to difenoconazole and a separate quantitative cancer
exposure assessment is unnecessary.
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 ``SUBJECT: Difenoconazole. Human Health
Risk Assessment for Proposed New Foliar Uses on Cranberry, Guava, and
Papaya. Expansion of Registered Foliar Use on Grape to Crop Subgroup
13-07F (Fruit, Small, Vine Climbing, Except Fuzzy Kiwifruit).
Conversion of Registered Foliar Uses on Crop Subgroups 5A and 5B to
Crop Group 5-16 (Vegetable, Brassica, Head and Stem), Crop Subgroup 4-
16B (Brassica, Leafy Greens (includes Watercress)), and Kohlrabi,
October 11, 2017'' at pp. 42-50 in docket ID number EPA-HQ-OPP-2016-
0254.

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for difenoconazole used
for human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of April 2, 2015 (80 FR 17697) (FRL-
9923-82).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to difenoconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing difenoconazole
tolerances in 40 CFR 180.475. EPA assessed dietary exposures from
difenoconazole in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
Such effects were identified for difenoconazole. In estimating
acute dietary exposure, EPA used Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database DEEM-FCID which
incorporates consumption data from the United States Department of
Agriculture's (USDA) National Health and Nutrition Examination Survey,
What We Eat in America, (NHANES/WWEIA) conducted from 2003 to 2008. As
to residue levels in food, EPA assumed tolerance-level residues, 100
percent crop treated (PCT), and available empirical or DEEM (ver. 7.81)
default processing factors.
ii. Chronic exposure. In conducting a refined chronic dietary
exposure assessment EPA used the food consumption data from USDA's
NHANES/WWEIA survey program. As to residue levels in food, EPA assumed
tolerance-level residues for some commodities, average field trial
residues and USDA Pesticide Data Program monitoring samples for the
remaining commodities, available empirical or DEEM (ver.7.81) default
processing factors, and average PCT assumptions 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 used average
PCT

[[Page 3618]]

estimates for existing uses as follows: Almond 10%, apple 20%, apricot
10%, broccoli 2.5%, Brussels sprout 2.5%, cabbage 5%, cantaloupe 2.5%,
carrot 5%, cauliflower 2.5%, cherry 2.5%, cucumber 5%, garlic 5%, grape
10%, grapefruit 5%, hazelnut 1%, nectarine 2.5%, onion 5%, orange 2.5%,
pecan 2.5%, peach 2.5%, pear 10%, pepper 5%, pistachio 5%, plum 10%,
potato 20%, pumpkin 2.5%, soybean 2.5%, squash 5%, strawberry 2.5%,
sugar beet 15%, tangerine 2.5%, tomato 25%, walnut 1%, watermelon 5%,
and wheat 10%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT value for chronic dietary risk analysis.
The average PCT value for each existing use is derived by combining
available public and private market survey data for that use and
averaged across all observations and is rounded up to the nearest
multiple of 5%, for use in the analysis unless the average PCT value is
estimated at less than 2.5% or 1%, in which case the Agency uses 2.5%
or 1%, respectively, as the average PCT value in the analysis. EPA uses
a maximum PCT value for acute dietary risk analysis. The maximum PCT
value 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% for use in
the analysis, unless the maximum PCT value is estimated at less than
2.5%, in which case the Agency uses 2.5% as the maximum PCT value in
the analysis.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which difenoconazole may be applied in a particular area.
2. Dietary exposure from drinking water. The drinking water
assessment was performed using a total toxic residue method, which
considers both parent difenoconazole and its major metabolite, CGA
205375, or total toxic residues (TTR) from difenoconazole uses, in
surface and groundwater. The Agency used screening level water exposure
models in the dietary exposure analysis and risk assessment for
difenoconazole and CGA 205375 in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of difenoconazole, plus CGA 205375. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Tier II Pesticide in Water Calculator (PWC v1.52)
model and Tier 1 Rice Model, the estimated drinking water
concentrations (EDWCs) of TTR of difenoconazole for acute exposures are
estimated to be 33.4 parts per billion (ppb) for surface water and 2.0
ppb for ground water. For chronic exposures EDWCs of TTR of
difenoconazole for non-cancer assessments are estimated to be 27.8 ppb
for surface water and 0.60 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 33.4 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 27.8 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: Treatment of ornamental plants
in commercial and residential landscapes and interior plantscapes. EPA
assessed residential exposure using the following assumptions: For
residential handlers, adult short-term dermal and inhalation exposure
is expected from mixing, loading, and applying difenoconazole on
ornamentals (gardens and trees). For residential post-application
exposures, short-term dermal exposure is expected for both adults and
children from post-application activities in treated residential
landscapes.
The scenarios used in the aggregate assessment were those that
resulted in the highest exposures. The highest exposures consist of the
short-term dermal exposure to adults from post-application activities
in treated gardens and short-term dermal exposure to children 6 to 11
years old from post-application activities in treated gardens. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
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 conazole class of fungicides
containing the 1,2,4-triazole moiety. 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 difenoconazole shares a
common mechanism of toxicity with any other conazole pesticide, and

[[Page 3619]]

EPA is not following a cumulative risk approach for this tolerance
action. For information regarding EPA's procedures for cumulating
effects from substances found to have a common mechanism of toxicity,
see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
Difenoconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
conjugated triazole metabolites (triazolylalanine and triazolylacetic
acid). To support existing tolerances and to establish new tolerances
for triazole-containing pesticides, including difenoconazole, EPA
previously conducted a human health risk assessment for exposure to
1,2,4-triazole, triazolylalanine, and triazolylacetic acid resulting
from existing and pending uses of any triazole-containing 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). The Agency retained a 3X
for the LOAEL to NOAEL safety factor when the reproduction study was
used. In addition, the Agency retained a 10X for the lack of studies
including a developmental neurotoxicity (DNT) study. 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 ID number EPA-HQ-OPP-2005-0497.
The Agency's latest updated aggregate risk assessment for the
triazole-containing metabolites was finalized on July 18, 2017 and
includes the new uses in this rule. It is titled, ``Common Triazole
Metabolites: Updated Aggregate Human Health Risk Assessment to Address
the New Section 3 Registrations for Use of Difenoconazole and
Tetraconazole.'' Aggregate risk estimates associated with 1,2,4-
triazole (T) and the conjugated triazole metabolites (i.e., combined
residues of triazolylalanine (TA) and triazolylacetic acid (TAA)), are
below the Agency's level of concern. There are no human health risk
issues for these metabolites that would preclude the new uses of
difenoconazole. The assessment may be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2016-0254.

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 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 prenatal and postnatal
toxicology database for difenoconazole includes rat and rabbit prenatal
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. The available Agency guideline studies indicated no
increased qualitative or quantitative susceptibility of rats 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). Since the developmental effects are more
severe than the maternal effects, qualitative susceptibility is
indicated in the rabbit developmental study; however, the selected POD
is protective of this effect. In the 2-generation reproduction study in
rats, toxicity to the fetuses/offspring, when observed, occurred at
equivalent or higher doses than in the maternal/parental animals.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for difenoconazole is complete.
ii. There are no clear signs of neurotoxicity following acute,
subchronic or chronic dosing in multiple species in the difenoconazole
database. The effects observed in acute and subchronic neurotoxicity
studies are transient and showed in one sex (males as reduced fore-limb
grip strength with no histologic findings), and the selected endpoints
of toxicity for risk assessment are protective of any potential
neurotoxicity. Based on the toxicity profile, and lack of concern for
neurotoxicity, there is no need for a developmental neurotoxicity study
or additional uncertainty factors (UFs) to account for neurotoxicity.
iii. There is no evidence that difenoconazole results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. The qualitative susceptibility seen in the rabbit developmental
study is adequately protected by the selected POD.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary risk assessment utilized tolerance-level
residues and 100 PCT for the acute assessment; a refined chronic
assessment incorporated 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 as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by difenoconazole.

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to difenoconazole will occupy 52% of the aPAD for all infants <1 year
old, the

[[Page 3620]]

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 51% of the cPAD for all
infants <1year 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 aggregate MOEs of
250 for children and 180 for adults. Because EPA's level of concern for
difenoconazole is a MOE of 100 or below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
difenoconazole is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
difenoconazole.
5. Aggregate cancer risk for U.S. population. Based on the data
summarized in Unit III.A., the chronic dietary risk assessment is
protective of any potential cancer effects. Based on the results of
that assessment, EPA concludes that difenoconazole is not expected to
pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to difenoconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodologies are available to enforce the
tolerance expression. An adequate enforcement method, gas
chromatography with nitrogen-phosphorus detection (GC/NPD) method AG-
575B, is available for the determination of residues of difenoconazole
per se in/on plant commodities. An adequate enforcement method, GC/MSD
method AG-676A, is also available for the determination of residues of
difenoconazole per se in/on canola and barley commodities. A
confirmatory method, GC/MSD method AG-676, is also available. The Limit
of Quantitation (LOQs) are 0.01-0.05 ppm.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.

B. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has established MRLs for difenoconazole in/on papaya at
0.2 ppm; grape at 3 ppm (a crop member of fruit, small, vine climbing,
except fuzzy kiwifruit crop subgroup 13-07F); dried grapes at 6 ppm;
and broccoli, Brussels sprouts, cabbage and cauliflower at 2 ppm (crop
members of vegetables, Brassica, head and stem crop group 5-16). The
U.S. tolerances are harmonized with these Codex MRLs with the exception
of the U.S. tolerance at 0.60 ppm in/on papaya due to differences in
U.S. good agricultural practices (GAP) and concerns that the Codex MRL
in/on papaya at 0.2 ppm is too low to cover residues in/on U.S. papaya
commodities treated in accordance with approved label directions for
difenoconazole.

C. Revisions to Petitioned-for Tolerances

EPA is establishing the tolerance for Fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 3.0 ppm rather than the
requested 4.0 ppm for harmonization with the currently established
Codex MRL for residues of difenoconazole in/on grape which reflects
U.S. GAP. In addition, EPA corrected the tolerance level to include an
additional significant figure for cranberry and papaya from the
requested 0.6 ppm to 0.60 ppm. This is to avoid the situation where
rounding of an observed residue to the level of precision of the
tolerance expression would be considered non-violative (such as 0.64
ppm being rounded to 0.6 ppm).

V. Conclusion

Therefore, tolerances are established for residues of the fungicide
difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methy-1,3-
dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on Brassica, leafy
greens, subgroup 4-16B at 35 ppm; Cranberry at 0.60 ppm; Fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 3.0 ppm;
Guava at 3.0 ppm; Kohlrabi at 2.0 ppm; Papaya at 0.60 ppm; and
Vegetable, Brassica, head and stem, group 5-16 at 2.0 ppm. In addition,
established tolerances for ``Brassica, head and stem, subgroup 5A'';
``Brassica, leafy greens, subgroup 5B''; ``Grape''; ``Papaya''; and
``Turnip, greens'' are removed because they are superseded by the
tolerances being established in this action.

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

[[Page 3621]]

Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

Dated: December 27, 2017.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec. 180.475, paragraph (a)(1):
0
a. Remove the entries for ``Brassica, head and stem, subgroup 5A'' and
``Brassica, leafy green, subgroup 5B'';
0
b. Add alphabetically the entry for ``Brassica, leafy greens, subgroup
4-16B'';
0
c. Add alphabetically the entries for ``Cranberry'' and ``Fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F'';
0
d. Remove the entry for ``Grape'';
0
e. Add alphabetically the entries for ``Guava'' and ``Kohlrabi'';
0
f. Revise the entry for ``Papaya'';
0
g. Remove the entry for ``Turnip, greens''; and
0
h. Add alphabetically the entry for ``Vegetable, Brassica, head and
stem, group 5-16''.
The additions and revision read as follows:

Sec. 180.475 Difenoconazole; tolerances for residues.

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

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------

* * * * * * *
Brassica, leafy greens, subgroup 4-16B.................. 35

* * * * * * *
Cranberry............................................... 0.60

* * * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit, 3.0
subgroup 13-07F........................................

* * * * * * *
Guava................................................... 3.0
Kohlrabi................................................ 2.0

* * * * * * *
Papaya.................................................. 0.60

* * * * * * *
Vegetable, Brassica, head and stem, group 5-16.......... 2.0

* * * * * * *
------------------------------------------------------------------------

[[Page 3622]]

* * * * *
[FR Doc. 2018-01479 Filed 1-25-18; 8:45 am]
BILLING CODE 6560-50-P

Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations 3615

to this action. In addition, this action Parts per Expiration 20460–0001; telephone number: (703)
Commodity
does not impose any enforceable duty or million date 305–7090; email address:
contain any unfunded mandate as RDFRNotices@epa.gov.
described under Title II of the Unfunded Prickly pear, fruit 1.5 12/31/2020
SUPPLEMENTARY INFORMATION:
Mandates Reform Act (UMRA) (2 U.S.C. Prickly pear,
pads .............. 1.5 12/31/2020 I. General Information
1501 et seq.).
This action does not involve any A. Does this action apply to me?
technical standards that would require * * * * *
[FR Doc. 2018–01480 Filed 1–25–18; 8:45 am] You may be potentially affected by
Agency consideration of voluntary
consensus standards pursuant to section BILLING CODE 6560–50–P this action if you are an agricultural
12(d) of the National Technology producer, food manufacturer, or
Transfer and Advancement Act pesticide manufacturer. The following
ENVIRONMENTAL PROTECTION list of North American Industrial
(NTTAA) (15 U.S.C. 272 note). AGENCY Classification System (NAICS) codes is
VIII. Congressional Review Act not intended to be exhaustive, but rather
40 CFR Part 180 provides a guide to help readers
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will [EPA–HQ–OPP–2016–0254; FRL–9971–95] determine whether this document
submit a report containing this rule and applies to them. Potentially affected
other required information to the U.S. Difenoconazole; Pesticide Tolerances entities may include:
Senate, the U.S. House of AGENCY: Environmental Protection • Crop production (NAICS code 111).
Representatives, and the Comptroller Agency (EPA). • Animal production (NAICS code
General of the United States prior to 112).
ACTION: Final rule.
publication of the rule in the Federal • Food manufacturing (NAICS code
Register. This action is not a ‘‘major SUMMARY: This regulation establishes 311).
rule’’ as defined by 5 U.S.C. 804(2). tolerances for residues of • Pesticide manufacturing (NAICS
difenoconazole in or on multiple code 32532).
List of Subjects in 40 CFR Part 180
commodities which are identified and B. How can I get electronic access to
Environmental protection, discussed later in this document. In other related information?
Administrative practice and procedure, addition, this regulation removes
Agricultural commodities, Pesticides several previously established You may access a frequently updated
and pests, Reporting and recordkeeping tolerances that are superseded by this electronic version of EPA’s tolerance
requirements. final rule. Interregional Research Project regulations at 40 CFR part 180 through
Number 4 (IR–4) requested these the Government Printing Office’s e-CFR
Dated: December 28, 2017.
tolerances under the Federal Food, site at http://www.ecfr.gov/cgi-bin/text-
Michael L. Goodis, idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Director, Registration Division, Office of Drug, and Cosmetic Act (FFDCA).
40tab_02.tpl.
Pesticide Programs. DATES: This regulation is effective
January 26, 2018. Objections and C. How can I file an objection or hearing
Therefore, 40 CFR chapter I is requests for hearings must be received request?
amended as follows: on or before March 27, 2018, and must Under FFDCA section 408(g), 21
PART 180—[AMENDED] be filed in accordance with the U.S.C. 346a, any person may file an
instructions provided in 40 CFR part objection to any aspect of this regulation
■ 1. The authority citation for part 180 178 (see also Unit I.C. of the and may also request a hearing on those
continues to read as follows: SUPPLEMENTARY INFORMATION). objections. You must file your objection
Authority: 21 U.S.C. 321(q), 346a and 371. ADDRESSES: The docket for this action, or request a hearing on this regulation
identified by docket identification (ID) in accordance with the instructions
■ 2. In § 180.613, revise paragraph (b) to number EPA–HQ–OPP–2016–0254, is
read as follows: provided in 40 CFR part 178. To ensure
available at http://www.regulations.gov proper receipt by EPA, you must
§ 180.613 Flonicamid; tolerances for or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
residues. Regulatory Public Docket (OPP Docket) OPP–2016–0254 in the subject line on
* * * * * in the Environmental Protection Agency the first page of your submission. All
(b) Section 18 emergency exemptions. Docket Center (EPA/DC), West William objections and requests for a hearing
Time-limited tolerances specified in the Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
following table are established for Constitution Ave. NW, Washington, DC received by the Hearing Clerk on or
residues of the flonicamid, N- 20460–0001. The Public Reading Room before March 27, 2018. Addresses for
(cyanomethyl)-4-(trifluoromethyl)-3- is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections
pyridinecarboxamide) and its Monday through Friday, excluding legal and hearing requests are provided in 40
metabolites, TFNA (4- holidays. The telephone number for the CFR 178.25(b).
trifluoromethylnicotinic acid), TFNA- Public Reading Room is (202) 566–1744, In addition to filing an objection or
AM (4-trifluoromethylnicotinamide), and the telephone number for the OPP hearing request with the Hearing Clerk
and TFNG (N-(4- Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
trifluoromethylnicotinoyl)glycine), the visitor instructions and additional submit a copy of the filing (excluding
calculated as the stoichiometric information about the docket available any Confidential Business Information
daltland on DSKBBV9HB2PROD with RULES

equivalent of flonicamid, in or on the at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
specified agricultural commodities, FOR FURTHER INFORMATION CONTACT: Information not marked confidential
resulting from use of the pesticide Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be
pursuant to FFIFRA section 18 (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
emergency exemptions. The tolerances Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
expire on the date specified in the table. Pennsylvania Ave. NW, Washington, DC objection or hearing request, identified

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3620 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations

population group receiving the greatest expected to pose a cancer risk to Brassica, head and stem crop group 5–
exposure. humans. 16). The U.S. tolerances are harmonized
2. Chronic risk. Using the exposure 6. Determination of safety. Based on with these Codex MRLs with the
assumptions described in this unit for these risk assessments, EPA concludes exception of the U.S. tolerance at 0.60
chronic exposure, EPA has concluded that there is a reasonable certainty that ppm in/on papaya due to differences in
that chronic exposure to difenoconazole no harm will result to the general U.S. good agricultural practices (GAP)
from food and water will utilize 51% of population, or to infants and children and concerns that the Codex MRL in/on
the cPAD for all infants <1year old, the from aggregate exposure to papaya at 0.2 ppm is too low to cover
population group receiving the greatest difenoconazole residues. residues in/on U.S. papaya commodities
exposure. Based on the explanation in treated in accordance with approved
Unit III.C.3., regarding residential use IV. Other Considerations label directions for difenoconazole.
patterns, chronic residential exposure to A. Analytical Enforcement Methodology
residues of difenoconazole is not C. Revisions to Petitioned-for Tolerances
expected. Adequate enforcement methodologies EPA is establishing the tolerance for
3. Short-term risk. Short-term are available to enforce the tolerance Fruit, small, vine climbing, except fuzzy
aggregate exposure takes into account expression. An adequate enforcement kiwifruit, subgroup 13–07F at 3.0 ppm
short-term residential exposure plus method, gas chromatography with rather than the requested 4.0 ppm for
chronic exposure to food and water nitrogen-phosphorus detection (GC/ harmonization with the currently
(considered to be a background NPD) method AG–575B, is available for established Codex MRL for residues of
exposure level). Difenoconazole is the determination of residues of difenoconazole in/on grape which
currently registered for uses that could difenoconazole per se in/on plant reflects U.S. GAP. In addition, EPA
result in short-term residential commodities. An adequate enforcement corrected the tolerance level to include
exposure, and the Agency has method, GC/MSD method AG–676A, is an additional significant figure for
determined that it is appropriate to also available for the determination of cranberry and papaya from the
aggregate chronic exposure through food residues of difenoconazole per se in/on requested 0.6 ppm to 0.60 ppm. This is
and water with short-term residential canola and barley commodities. A to avoid the situation where rounding of
exposures to difenoconazole. confirmatory method, GC/MSD method an observed residue to the level of
Using the exposure assumptions AG–676, is also available. The Limit of precision of the tolerance expression
described in this unit for short-term Quantitation (LOQs) are 0.01–0.05 ppm. would be considered non-violative
exposures, EPA has concluded the The methods may be requested from: (such as 0.64 ppm being rounded to 0.6
combined short-term food, water, and Chief, Analytical Chemistry Branch, ppm).
residential exposures result in aggregate Environmental Science Center, 701
MOEs of aggregate MOEs of 250 for Mapes Rd., Ft. Meade, MD 20755–5350; V. Conclusion
children and 180 for adults. Because telephone number: (410) 305–2905; Therefore, tolerances are established
EPA’s level of concern for email address: residuemethods@ for residues of the fungicide
difenoconazole is a MOE of 100 or epa.gov. difenoconazole, 1-[2-[2-chloro-4-(4-
below, these MOEs are not of concern. B. International Residue Limits chlorophenoxy)phenyl]-4-methy-1,3-
4. Intermediate-term risk. dioxolan-2-ylmethyl]-1H-1,2,4-triazole,
Intermediate-term aggregate exposure In making its tolerance decisions, EPA in or on Brassica, leafy greens, subgroup
takes into account intermediate-term seeks to harmonize U.S. tolerances with 4–16B at 35 ppm; Cranberry at 0.60
residential exposure plus chronic international standards whenever ppm; Fruit, small, vine climbing, except
exposure to food and water (considered possible, consistent with U.S. food fuzzy kiwifruit, subgroup 13–07F at 3.0
to be a background exposure level). An safety standards and agricultural ppm; Guava at 3.0 ppm; Kohlrabi at 2.0
intermediate-term adverse effect was practices. EPA considers the ppm; Papaya at 0.60 ppm; and
identified; however, difenoconazole is international maximum residue limits Vegetable, Brassica, head and stem,
not registered for any use patterns that (MRLs) established by the Codex group 5–16 at 2.0 ppm. In addition,
would result in intermediate-term Alimentarius Commission (Codex), as established tolerances for ‘‘Brassica,
residential exposure. Intermediate-term required by FFDCA section 408(b)(4). head and stem, subgroup 5A’’;
risk is assessed based on intermediate- The Codex Alimentarius is a joint ‘‘Brassica, leafy greens, subgroup 5B’’;
term residential exposure plus chronic United Nations Food and Agriculture ‘‘Grape’’; ‘‘Papaya’’; and ‘‘Turnip,
dietary exposure. Because there is no Organization/World Health greens’’ are removed because they are
intermediate-term residential exposure Organization food standards program, superseded by the tolerances being
and chronic dietary exposure has and it is recognized as an international established in this action.
already been assessed under the food safety standards-setting
appropriately protective cPAD (which is organization in trade agreements to VI. Statutory and Executive Order
at least as protective as the POD used to which the United States is a party. EPA Reviews
assess intermediate-term risk), no may establish a tolerance that is This action establishes tolerances
further assessment of intermediate-term different from a Codex MRL; however, under FFDCA section 408(d) in
risk is necessary, and EPA relies on the FFDCA section 408(b)(4) requires that response to a petition submitted to the
chronic dietary risk assessment for EPA explain the reasons for departing Agency. The Office of Management and
evaluating intermediate-term risk for from the Codex level. Budget (OMB) has exempted these types
difenoconazole. The Codex has established MRLs for of actions from review under Executive
5. Aggregate cancer risk for U.S. difenoconazole in/on papaya at 0.2 Order 12866, entitled ‘‘Regulatory
daltland on DSKBBV9HB2PROD with RULES

population. Based on the data ppm; grape at 3 ppm (a crop member of Planning and Review’’ (58 FR 51735,
summarized in Unit III.A., the chronic fruit, small, vine climbing, except fuzzy October 4, 1993). Because this action
dietary risk assessment is protective of kiwifruit crop subgroup 13–07F); dried has been exempted from review under
any potential cancer effects. Based on grapes at 6 ppm; and broccoli, Brussels Executive Order 12866, this action is
the results of that assessment, EPA sprouts, cabbage and cauliflower at 2 not subject to Executive Order 13211,
concludes that difenoconazole is not ppm (crop members of vegetables, entitled ‘‘Actions Concerning

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Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations 3621

Regulations That Significantly Affect government and the States or tribal and pests, Reporting and recordkeeping
Energy Supply, Distribution, or Use’’ (66 governments, or on the distribution of requirements.
FR 28355, May 22, 2001); Executive power and responsibilities among the Dated: December 27, 2017.
Order 13045, entitled ‘‘Protection of various levels of government or between Daniel Rosenblatt,
Children from Environmental Health the Federal Government and Indian
Acting Director, Registration Division, Office
Risks and Safety Risks’’ (62 FR 19885, tribes. Thus, the Agency has determined
of Pesticide Programs.
April 23, 1997); or Executive Order that Executive Order 13132, entitled
13771, entitled ‘‘Reducing Regulations ‘‘Federalism’’ (64 FR 43255, August 10, Therefore, 40 CFR chapter I is
and Controlling Regulatory Costs’’ (82 1999) and Executive Order 13175, amended as follows:
FR 9339, February 3, 2017). This action entitled ‘‘Consultation and Coordination
does not contain any information with Indian Tribal Governments’’ (65 FR PART 180—[AMENDED]
collections subject to OMB approval 67249, November 9, 2000) do not apply
■ 1. The authority citation for part 180
under the Paperwork Reduction Act to this action. In addition, this action
continues to read as follows:
(PRA) (44 U.S.C. 3501 et seq.), nor does does not impose any enforceable duty or
it require any special considerations contain any unfunded mandate as Authority: 21 U.S.C. 321(q), 346a and 371.
under Executive Order 12898, entitled described under Title II of the Unfunded ■ 2. In § 180.475, paragraph (a)(1):
‘‘Federal Actions to Address Mandates Reform Act (UMRA) (2 U.S.C. ■ a. Remove the entries for ‘‘Brassica,
Environmental Justice in Minority 1501 et seq.). head and stem, subgroup 5A’’ and
Populations and Low-Income This action does not involve any ‘‘Brassica, leafy green, subgroup 5B’’;
Populations’’ (59 FR 7629, February 16, technical standards that would require
■ b. Add alphabetically the entry for
1994). Agency consideration of voluntary
‘‘Brassica, leafy greens, subgroup 4–
Since tolerances and exemptions that consensus standards pursuant to section
16B’’;
are established on the basis of a petition 12(d) of the National Technology
■ c. Add alphabetically the entries for
under FFDCA section 408(d), such as Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note). ‘‘Cranberry’’ and ‘‘Fruit, small, vine
the tolerance in this final rule, do not climbing, except fuzzy kiwifruit,
require the issuance of a proposed rule, VII. Congressional Review Act subgroup 13–07F’’;
the requirements of the Regulatory Pursuant to the Congressional Review ■ d. Remove the entry for ‘‘Grape’’;
Flexibility Act (RFA) (5 U.S.C. 601 et Act (5 U.S.C. 801 et seq.), EPA will ■ e. Add alphabetically the entries for
seq.), do not apply. submit a report containing this rule and ‘‘Guava’’ and ‘‘Kohlrabi’’;
This action directly regulates growers, other required information to the U.S. ■ f. Revise the entry for ‘‘Papaya’’;
food processors, food handlers, and food Senate, the U.S. House of ■ g. Remove the entry for ‘‘Turnip,
retailers, not States or tribes, nor does Representatives, and the Comptroller greens’’; and
this action alter the relationships or General of the United States prior to ■ h. Add alphabetically the entry for
distribution of power and publication of the rule in the Federal ‘‘Vegetable, Brassica, head and stem,
responsibilities established by Congress Register. This action is not a ‘‘major group 5–16’’.
in the preemption provisions of FFDCA rule’’ as defined by 5 U.S.C. 804(2). The additions and revision read as
section 408(n)(4). As such, the Agency follows:
has determined that this action will not List of Subjects in 40 CFR Part 180
have a substantial direct effect on States Environmental protection, § 180.475 Difenoconazole; tolerances for
or tribal governments, on the Administrative practice and procedure, residues.
relationship between the national Agricultural commodities, Pesticides (a) * * * (1) * * *

Parts per
Commodity million

* * * * * * *
Brassica, leafy greens, subgroup 4–16B ............................................................................................................................................ 35

* * * * * * *
Cranberry ............................................................................................................................................................................................. 0.60

* * * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13–07F .................................................................................................. 3.0

* * * * * * *
Guava .................................................................................................................................................................................................. 3.0
Kohlrabi ................................................................................................................................................................................................ 2.0

* * * * * * *
Papaya ................................................................................................................................................................................................. 0.60
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* * * * * * *
Vegetable, Brassica, head and stem, group 5–16 .............................................................................................................................. 2.0

* * * * * * *

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3622 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations

* * * * * agree to adopt and administer local floodplain management measures are
[FR Doc. 2018–01479 Filed 1–25–18; 8:45 am] floodplain management measures aimed met prior to the effective suspension
BILLING CODE 6560–50–P at protecting lives and new construction date. Since these notifications were
from future flooding. Section 1315 of made, this final rule may take effect
the National Flood Insurance Act of within less than 30 days.
DEPARTMENT OF HOMELAND 1968, as amended, 42 U.S.C. 4022, National Environmental Policy Act.
SECURITY prohibits the sale of NFIP flood FEMA has determined that the
insurance unless an appropriate public community suspension(s) included in
Federal Emergency Management body adopts adequate floodplain this rule is a non-discretionary action
Agency management measures with effective and therefore the National
enforcement measures. The Environmental Policy Act of 1969 (42
44 CFR Part 64 communities listed in this document no U.S.C. 4321 et seq.) does not apply.
[Docket ID FEMA–2018–0002; Internal longer meet that statutory requirement Regulatory Flexibility Act. The
Agency Docket No. FEMA–8517] for compliance with program Administrator has determined that this
regulations, 44 CFR part 59. rule is exempt from the requirements of
Suspension of Community Eligibility Accordingly, the communities will be the Regulatory Flexibility Act because
suspended on the effective date in the the National Flood Insurance Act of
AGENCY: Federal Emergency third column. As of that date, flood 1968, as amended, Section 1315, 42
Management Agency, DHS. insurance will no longer be available in U.S.C. 4022, prohibits flood insurance
ACTION: Final rule. the community. We recognize that some coverage unless an appropriate public
SUMMARY: This rule identifies of these communities may adopt and body adopts adequate floodplain
communities where the sale of flood submit the required documentation of management measures with effective
insurance has been authorized under legally enforceable floodplain enforcement measures. The
the National Flood Insurance Program management measures after this rule is communities listed no longer comply
(NFIP) that are scheduled for published but prior to the actual with the statutory requirements, and
suspension on the effective dates listed suspension date. These communities after the effective date, flood insurance
within this rule because of will not be suspended and will continue will no longer be available in the
noncompliance with the floodplain to be eligible for the sale of NFIP flood communities unless remedial action
management requirements of the insurance. A notice withdrawing the takes place.
program. If the Federal Emergency suspension of such communities will be Regulatory Classification. This final
Management Agency (FEMA) receives published in the Federal Register. rule is not a significant regulatory action
documentation that the community has In addition, FEMA publishes a Flood under the criteria of section 3(f) of
adopted the required floodplain Insurance Rate Map (FIRM) that Executive Order 12866 of September 30,
management measures prior to the identifies the Special Flood Hazard 1993, Regulatory Planning and Review,
effective suspension date given in this Areas (SFHAs) in these communities. 58 FR 51735.
rule, the suspension will not occur and The date of the FIRM, if one has been Executive Order 13132, Federalism.
a notice of this will be provided by published, is indicated in the fourth This rule involves no policies that have
publication in the Federal Register on a column of the table. No direct Federal federalism implications under Executive
subsequent date. Also, information financial assistance (except assistance Order 13132.
identifying the current participation pursuant to the Robert T. Stafford Executive Order 12988, Civil Justice
status of a community can be obtained Disaster Relief and Emergency Reform. This rule meets the applicable
from FEMA’s Community Status Book Assistance Act not in connection with a standards of Executive Order 12988.
(CSB). The CSB is available at https:// flood) may be provided for construction Paperwork Reduction Act. This rule
www.fema.gov/national-flood- or acquisition of buildings in identified does not involve any collection of
insurance-program-community-status- SFHAs for communities not information for purposes of the
book. participating in the NFIP and identified Paperwork Reduction Act, 44 U.S.C.
for more than a year on FEMA’s initial 3501 et seq.
DATES: The effective date of each FIRM for the community as having
community’s scheduled suspension is flood-prone areas (section 202(a) of the List of Subjects in 44 CFR Part 64
the third date (‘‘Susp.’’) listed in the Flood Disaster Protection Act of 1973, Flood insurance, Floodplains.
third column of the following tables. 42 U.S.C. 4106(a), as amended). This Accordingly, 44 CFR part 64 is
FOR FURTHER INFORMATION CONTACT: If prohibition against certain types of amended as follows:
you want to determine whether a Federal assistance becomes effective for
particular community was suspended the communities listed on the date PART 64—[AMENDED]
on the suspension date or for further shown in the last column. The
information, contact Adrienne L. Administrator finds that notice and ■ 1. The authority citation for Part 64
Sheldon, PE, CFM, Federal Insurance public comment procedures under 5 continues to read as follows:
and Mitigation Administration, Federal U.S.C. 553(b), are impracticable and Authority: 42 U.S.C. 4001 et seq.;
Emergency Management Agency, 400 C unnecessary because communities listed Reorganization Plan No. 3 of 1978, 3 CFR,
Street SW, Washington, DC 20472, (202) in this final rule have been adequately 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367,
212–3966. notified. 3 CFR, 1979 Comp.; p. 376.
SUPPLEMENTARY INFORMATION: The NFIP Each community receives 6-month,
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§ 64.6 [Amended]
enables property owners to purchase 90-day, and 30-day notification letters
Federal flood insurance that is not addressed to the Chief Executive Officer ■ 2. The tables published under the
otherwise generally available from stating that the community will be authority of § 64.6 are amended as
private insurers. In return, communities suspended unless the required follows:

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Document Created: 2018-10-26 10:03:44
Document Modified: 2018-10-26 10:03:44

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective January 26, 2018. Objections and requests for hearings must be received on or before March 27, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
FR Citation		83 FR 3615
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements