[Federal Register Volume 84, Number 155 (Monday, August 12, 2019)]
[Rules and Regulations]
[Pages 39768-39774]
[FR Doc No: 2019-17143]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0127; FRL-9997-00]

Propiconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
propiconazole in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project No. 4
(IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 12, 2019. Objections and
requests for hearings must be received on or before October 11, 2019,
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-2018-0127, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>

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
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0127 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
October 11, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0127, 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 24, 2018 (83 FR 34968) (FRL-9980-
31), 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
8E8658) by Interregional Research Project No. 4 (IR-4), Rutgers, The
State University of New Jersey, 500 College Road East, Suite 201W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.434 be
amended by establishing tolerances for residues of the fungicide
propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]
methyl]-1H-1,2,4-triazol, and its metabolites determined as 2,4,-
dichlorobenzoic acid (2,4-DCBA), expressed as the stoichiometric
equivalent of propiconazole, in or on the following raw agricultural
commodities: Avocado at 0.2 parts per million (ppm); Brassica, leafy
greens, subgroup 4-16B, except watercress at 20 ppm; Celtuce at 5.0
ppm; Florence fennel at 5.0 ppm; Leaf petiole vegetable subgroup 22B at
5.0 ppm; Swiss chard at 5.0 ppm, Tomato subgroup 8-10A at 3.0 ppm and
Vegetable, root, except sugar beet, subgroup 1B at 0.30 ppm. The
petition also requested to remove the established tolerances for
residues of propiconazole, including its metabolites and degradates, in
or on the raw agricultural commodities: Beet, garden, roots at 0.30
ppm; Brassica leafy greens, subgroup 5B at 20 ppm; Carrot, roots at
0.25 ppm; Leaf petioles subgroup 4B at 5.0 ppm; Pistachio at 0.1 ppm;
Radish, roots at 0.04 ppm; and Tomato at 3.0 ppm. In addition, the
petition requested to amend 180.434(b) Section 18 emergency exemption
by removing the established time-limited tolerance for residues of
propiconazole and its metabolites in or on avocado at 10 ppm. That
document referenced a summary of the petition prepared by Interregional
Research Project No. 4 (IR-4), the registrant, which is available in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is
establishing, in accordance with section 408(d)(4)(a)(i), tolerances
that vary in some respects from what the petitioner requested. These
variations and the Agency's underlying rationale for those variations
are 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 propiconazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with propiconazole
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.
    The primary target organ for propiconazole toxicity in animals is
the

liver. Increased liver weights were seen in mice after subchronic or
chronic oral exposures to propiconazole. Liver lesions, including
effects such as vacuolation of hepatocytes, ballooned liver cells, foci
of enlarged hepatocytes, hypertrophy and necrosis, are characteristic
of propiconazole toxicity in rats and mice. Decreased body weight gain
was also seen in subchronic, chronic, developmental and reproductive
studies in animal studies. Dogs appeared to be more sensitive to the
localized toxicity of propiconazole as manifested by stomach
irritations at 6 mg/kg/day and above.
    In rabbits, developmental toxicity occurred at a higher dose than
the maternally toxic dose, while in rats, developmental toxicity
occurred at lower doses than maternal toxic doses. Increased incidences
of rudimentary ribs occurred in rat and rabbit fetuses. Increased cleft
palate malformations were noted in two studies in rats. In one
published study in rats, developmental effects (malformations of the
lung and kidneys, incomplete ossification of the skull, caudal
vertebrae and digits, extra rib (14th rib) and missing sternebrae) were
reported at doses that were not maternally toxic. In the 2-generation
reproduction study in rats, offspring toxicity occurred at a higher
dose than the parental toxic dose suggesting lower susceptibility of
the offspring to the toxic doses of propiconazole.
    The acute neurotoxicity study produced severe clinical signs of
toxicity (decreased activity, cold, pale, decreased motor activity,
etc.) in rats at the high dose of 300 mg/kg. Limited clinical signs
(piloerection, diarrhea, tip toe gait) were observed in the mid-dose
animals (100 mg/kg), while no treatment related signs were observed at
30 mg/kg. A subchronic neurotoxicity study in rats did not produce
neurotoxic signs at the highest dose tested that was associated with
decreased body weight.
    Propiconazole was negative for mutagenicity in the in vitro BALB/
3T3 cell transformation assay, bacterial reverse mutation assay,
Chinese hamster bone marrow chromosomal aberration assay, unscheduled
DNA synthesis studies in human fibroblasts and primary rat hepatocytes,
mitotic gene conversion assay and the dominant lethal assay in mice. It
caused proliferative changes in the rat liver with or without
pretreatment with an initiator, like phenobarbital, a known liver tumor
promoter. Liver enzyme induction studies with propiconazole in mice
demonstrated that propiconazole is a strong phenobarbital type inducer
of xenobiotic metabolizing enzymes. Hepatocellular proliferation
studies in mice suggest that propiconazole induces cell proliferation
followed by treatment-related hypertrophy in a manner similar to the
known hypertrophic agent phenobarbital.
    Propiconazole was carcinogenic to CD-1 male mice, producing
hepatocarcinomas in male mice at doses in excess of levels that induced
liver toxicity, including the chronic RfD. At doses at or below the
RfD, liver toxicity and carcinogenicity are not expected to occur;
therefore, the Agency used the Reference Dose (RfD) approach for
assessing cancer risk. Propiconazole was not carcinogenic to rats or to
female mice.
    Propiconazole showed no significant toxicity in a battery of acute
toxicity tests (Toxicity Category III or IV in all tests except eye
irritation (II)). It is slightly irritating to the skin and is a dermal
sensitizer.
    Specific information on the studies received and the nature of the
adverse effects caused by propiconazole 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 the document titled ``Propiconazole Human Health
Risk Assessment for the New Use of Propiconazole on Avocado, along with
Conversion to Brassica, leafy greens, subgroup 4-16B, except
watercress, Leaf petiole vegetable subgroup 22B, Celtuce, Florence
fennel, Swiss chard, and the expansion to Vegetable, root, except sugar
beet, subgroup 1B'' at pages 15-20 in docket ID number EPA-HQ-OPP-2018-
0127.

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 propiconazole used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Propiconazole for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety  factors      risk assessment
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Acute dietary (General population  NOAEL = 30 mg/kg/day  Acute RfD = 0.3 mg/  Acute Neurotoxicity Study--Rat.
 including infants and children).  UFA = 10x...........   kg/day.             LOAEL = 100 mg/kg/day based on
                                   UFH = 10x...........  aPAD = 0.3 mg/kg/     clinical signs of toxicity
                                   FQPA SF = 1x........   day.                 (piloerection in one male,
                                                                               diarrhea in one female, tip toe
                                                                               gait in 3 females).
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Acute dietary (Females 13 to 49    NOAEL = 30 mg/kg/day  Acute RfD = 0.3 mg/  Developmental Study--Rat.
 years of age).                    UFA = 10x...........   kg/day.             LOAEL = 90 mg/kg/day based on
                                   UFH = 10x...........  aPAD = 0.3 mg/kg/     increased incidence of
                                   FQPA SF = 1x........   day.                 rudimentary ribs, un-ossified
                                                                               sternebrae, as well as increased
                                                                               incidence of shortened and absent
                                                                               renal papillae and increased
                                                                               cleft palate.
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Chronic dietary (All populations)  NOAEL = 10 mg/kg/day  Chronic RfD = 0.1    24-month carcinogenicity study on
                                   UFA = 10x...........   mg/kg/day.           CD-1 mice.
                                   UFH = 10x...........  cPAD = 0.1 mg/kg/    LOAEL = 50 mg/kg/day based on non-
                                   FQPA SF = 1xa.......   day.                 neoplastic liver effects
                                                                               (increased liver weight in males
                                                                               and increase in liver lesions:
                                                                               Masses/raised areas/swellings/
                                                                               nodular areas mainly).
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Incidental oral short-term (1 to   NOAEL= 42 mg/kg/day.  Residential LOC for  2-Generation Reproduction Study--
 30 days) and intermediate-term    UFA = 10x...........   MOE = 100.           Rats.
 (1 to 6 months) Children.         UFH = 10x...........                       Offspring LOAEL =192 mg/kg/day
                                   FQPA SF = 1x........                        based on decreased offspring
                                                                               survival and body weights and an
                                                                               increased incidence of hepatic
                                                                               lesions (cellular swelling).
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Incidental oral short-term (1 to   NOAEL= 30 mg/kg/day.  Residential LOC for  Developmental Study--Rat.
 30 days) Adults including         UFA = 10x...........   MOE = 100.          Developmental LOAEL = 90 mg/kg/day
 females 13+.                      UFH = 10x...........                        based on increased incidence of
                                   FQPA SF = 1x........                        rudimentary ribs, un-ossified
                                                                               sternebrae, as well as increased
                                                                               incidence of shortened and absent
                                                                               renal papillae and increased
                                                                               cleft palate presumed to occur
                                                                               after single or multiple doses.
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Dermal short-term (1 to 30 days)   NOAEL= 42 mg/kg/day.  Residential LOC for  2-Generation Reproduction Study--
 and intermediate-term (1 to 6     UFA = 10x...........   MOE = 100.           Rats.
 months) DAF = 40% Children.       UFH = 10x...........                       Offspring LOAEL =192 mg/kg/day
                                   FQPA SF = 1x........                        based on decreased offspring
                                                                               survival and body weights and an
                                                                               increased incidence of hepatic
                                                                               lesions (cellular swelling).
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)   NOAEL= 30 mg/kg/day.  Residential LOC for  Developmental Study--Rat.
 and intermediate-term (1 to 6     UFA = 10x...........   MOE = 100.          Developmental LOAEL = 90 mg/kg/day
 months) DAF = 40% Adults.         UFH = 10x...........                        based on increased incidence of
                                   FQPA SF = 1x........                        rudimentary ribs, un-ossified
                                                                               sternebrae, as well as increased
                                                                               incidence of shortened and absent
                                                                               renal papillae and increased
                                                                               cleft palate presumed to occur
                                                                               after single or multiple doses.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     NOAEL= 30 mg/kg/day.  Residential LOC for  Developmental Study--Rat.
 days) and intermediate-term (1    UFA = 10x...........   MOE = 100.          Developmental LOAEL = 90 mg/kg/day
 to 6 months) Adults including     UFH = 10x...........                        based on increased incidence of
 females 13+.                      FQPA SF = 1x........                        rudimentary ribs, un-ossified
                                                                               sternebrae, as well as increased
                                                                               incidence of shortened and absent
                                                                               renal papillae and increased
                                                                               cleft palate presumed to occur
                                                                               after single or multiple doses.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)    Classification: Group C, possible human carcinogen, RfD approach for risk
                                                                  characterization.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). DAF = Dermal Absorption Factor.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to propiconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing propiconazole
tolerances in 40 CFR 180.434. EPA assessed dietary exposures from
propiconazole 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 propiconazole. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) Nationwide Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA) conducted from 2003-2008. As to
residue levels in food, the acute dietary analysis assumed 100 percent
crops treated (PCT) and tolerance-level residues for all existing and
proposed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA conducted from 2003-2008. As to residue levels in food, the
chronic dietary analysis assumed 100 PCT, average field trial residues
or tolerance-level residues for all existing and proposed 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 propiconazole. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue 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.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for propiconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of propiconazole. 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 Surface Water Concentration Calculator (SWCC) and
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of propiconazole for acute
exposures are

estimated to be 35.2 parts per billion (ppb) for surface water and 37.9
ppb for ground water and for chronic exposures for cancer assessments
are estimated to be 18.6 ppb for surface water and 35.1 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 37.9 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 35.1 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). Although there are no
residential use patterns associated with the proposed uses,
propiconazole is currently registered for the following uses that could
result in residential handler and post-application exposures: Turf,
landscapes, ornamentals, and paint. EPA assessed several residential
exposure scenarios and incorporated the following scenarios into the
short-term aggregate assessment because they reflected the highest
exposure patterns for those age groups:
     Post-application dermal exposure for adults from high-
contact activities on treated turf;
     Post-application dermal exposure for children 11 to <16
years old from contact with treated turf during golfing;
     Post-application dermal exposure for children 6 to <11
years old from contact with treated gardens.
     Post-application combined dermal plus incidental oral
(hand-to-mouth) exposure for children 1 to <2 years old from high-
contact activities on treated turf.
    The following residential scenario was included in the
intermediate-term aggregate assessment:
     Post-application combined dermal plus incidental oral
(hand-to-mouth) exposure for children 1 to <2 years old from the
registered wood treatment (antimicrobial use).
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to propiconazole and any
other substances; the Agency's previous statements regarding the
potential for a common mechanism among the conazoles noted that the
underlying data available at the time were inconclusive. Although the
conazole fungicides (triazoles) produce 1,2,4 triazole and its acid-
conjugated metabolites (triazolylalanine and triazolylacetic acid),
1,2,4 triazole and its acid-conjugated metabolites do not contribute to
the toxicity of the parent conazole fungicides (triazoles). The Agency
has assessed the aggregate risks from the 1,2,4 triazole and its acid-
conjugated metabolites (triazolylalanine and triazolylacetic acid)
separately. The supporting risk assessment concludes that aggregate
risks are below the Agency's level of concern and can be found at
http://www.regulations.gov in the document titled ``Common Triazole
Metabolites: Updated Aggregate Human Health Risk Assessment to Address
New Section 3 Registrations For Use of Difenoconazole and
Mefentrifluconazole.'' in docket ID number EPA-HQ-OPP-2018-0002.
Propiconazole does not appear to produce any other toxic metabolite
produced by other substances. For the purposes of this action,
therefore, EPA has not assumed that propiconazole has a common
mechanism of toxicity with other substances.
    For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. In the developmental
toxicity study in rats, fetal effects observed in this study at a dose
lower than the maternal toxicity are quantitative evidence of increased
susceptibility of fetuses to in utero exposure to propiconazole.
Neither quantitative nor qualitative evidence of increased
susceptibility was observed in utero or post-natal in either the rabbit
developmental or 2-generation reproduction rat study. There is no
evidence of neuropathology or abnormalities in the development of the
fetal nervous system from the available toxicity studies conducted with
propiconazole. In the rat acute neurotoxicity study, there was evidence
of clinical toxicity at the high dose of 300 mg/kg, but no evidence of
neuropathology from propiconazole administration.
    Although there was quantitative evidence of increased
susceptibility of the young following exposure to propiconazole in the
developmental rat study, the Agency determined there is a low degree of
concern for this finding and no residual uncertainties because the
increased susceptibility was based on minimal toxicity at high doses of
administration, clear NOAELs and LOAELs have been identified for all
effects of concern, and a clear dose-response has been well defined.
    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 propiconazole is complete.
    ii. There is no indication that propiconazole is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity. Other than the mild
effects seen at 300 mg/kg in the acute neurotoxicity study,
neurotoxicity and neurobehavioral effects were not seen in the
propiconazole toxicity database. The liver, not the nervous system, is
the primary target organ of propiconazole toxicity.
    iii. Although quantitative susceptibility was observed in the rat
developmental study, a clear NOAEL is established for the developmental
effects. There are no remaining

uncertainties for prenatal and/or postnatal toxicity.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary food exposure assessments were performed
based on 100 PCT and tolerance-level residues, while the chronic used a
combination of tolerance-level residues and reliable data on average
field trial residues and 100 PCT. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to propiconazole in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by propiconazole.

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 propiconazole will occupy 85% 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
propiconazole from food and water will utilize 25% 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
propiconazole 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).
    Propiconazole 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 propiconazole.
    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 120 for children
1 to 2 years and an MOE of 130 for adults from post-application
activity on treated turf. Because EPA's level of concern for
propiconazole is an 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).
    Propiconazole is currently registered for wood treatment use that
could result in intermediate-term residential exposure, and the Agency
has determined that it is appropriate to aggregate chronic exposure
through food and water with intermediate-term residential exposures to
propiconazole.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 470 for children 1 to 2 years old from post-
application exposure from wood treatment (antimicrobial use). Because
EPA's level of concern for propiconazole is an MOE of 100 or below,
these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the
discussion in Unit III.A., EPA considers the chronic aggregate risk
assessment to be protective of any aggregate cancer risk. As there is
no chronic risk of concern, EPA does not expect any cancer risk to the
U.S. population from aggregate exposure to propiconazole.
    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 propiconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, high-performance liquid
chromatography/ultraviolet (HPLC/UV) detector, Method AG-671A, is
available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<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.
    The Codex has not established MRLs for propiconazole for any of the
commodities in this action.

C. Revisions to Petitioned-For Tolerances

    Based on current policy to use consistent commodity terminology
across tolerances, the tolerance ``Florence fennel'' is being
established as ``Fennel, Florence, fresh leaves and stalk''. Moreover,
tolerances are being established without the requested trailing zeros
in accordance with the Agency's current rounding class practice.
Finally, EPA is not removing the tolerance for tomato or establishing a
new tomato subgroup 8-10A tolerance because the request for that
expansion was withdrawn by the petitioner and therefore, was not
assessed.

V. Conclusion

    Therefore, tolerances are established for residues of
propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole, in or on Avocado at 0.2 ppm; Brassica,
leafy greens, subgroup 4-16B, except watercress at 20 ppm; Celtuce at 5
ppm; Fennel, Florence, fresh leaves and stalk at 5 ppm; Leaf petiole
vegetable subgroup 22B at 5 ppm; Swiss chard at 5 ppm, and Vegetable,
root, except sugar beet, subgroup 1B at 0.3 ppm.
    Additionally, the existing tolerances on the following commodities
are removed as unnecessary due to the establishment of the above
tolerances: Avocado (time-limited tolerance); Beet, garden, roots;
Brassica leafy greens, subgroup 5B; Carrot, roots; Leaf petioles

subgroup 4B; and Radish, roots. In addition, EPA is removing the
tolerance for pistachio; that individual tolerance is unnecessary since
pistachio is included in group 14-12, and the tolerance levels are the
same.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under 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 tolerances 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: August 2, 2019.
Michael Goodis,
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.  180.434,
0
 a. Add alphabetically the entries ``Avocado''; ``Brassica, leafy
greens, subgroup 4-16B, except watercress''; ``Celtuce''; ``Fennel,
Florence, fresh leaves and stalk''; ``Leaf petiole vegetable subgroup
22B''; ``Swiss chard''; and ``Vegetable, root, except sugar beet,
subgroup 1B'' to the table in paragraph (a)(1).
0
 b. Remove the entries ``Beet, garden, roots''; ``Brassica leafy
greens, subgroup 5B''; ``Carrot, roots''; ``Leaf petioles subgroup
4B''; ``Pistachio''; and ``Radish, roots'' from the table in paragraph
(a)(1).
0
 c. Remove the entry ``Avocado'' from the table in paragraph (b).
    The additions read as follows:

Sec.  180.434  Propiconazole; tolerances for residues.

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

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

                                * * * * *
Avocado.................................................             0.2

                                * * * * *
Brassica, leafy greens, subgroup 4-16B, except                        20
 watercress.............................................

                                * * * * *
Celtuce.................................................               5

                                * * * * *
Fennel, Florence, fresh leaves and stalk................               5

                                * * * * *
Leaf petiole vegetable subgroup 22B.....................               5

                                * * * * *
Swiss chard.............................................               5

                                * * * * *
Vegetable, root, except sugar beet, subgroup 1B.........             0.3

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

* * * * *
[FR Doc. 2019-17143 Filed 8-9-19; 8:45 am]
 BILLING CODE 6560-50-P