[Federal Register Volume 84, Number 155 (Monday, August 12, 2019)]
[Rules and Regulations]
[Pages 39768-39774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 (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; main telephone 
number: (703) 305-7090; email address: [email protected].

[[Page 39769]]


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

[[Page 39770]]

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
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety  factors      risk assessment
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

[[Page 39771]]

 
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).
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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

[[Page 39772]]

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

[[Page 39773]]

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: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has 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

[[Page 39774]]

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