
[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Rules and Regulations]
[Pages 79711-79718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32327]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0788; FRL-9939-83]


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 Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 23, 2015. Objections and 
requests for hearings must be received on or before February 22, 2016, 
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-2014-0788, 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

[[Page 79712]]

information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, 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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0788 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 
February 22, 2016. 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-2014-0788, 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 October 21, 2015 (80 FR 63731) (FRL-
9935-29), 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 
4E8321) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201 W, 
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-triazole 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: Dill, dried at 80 parts per million (ppm); dill, fresh at 
30 ppm; dill, seed at 15 ppm; fruit, stone, group 12-12, except plum at 
4 ppm and nut, tree, group 14-12 at 0.1 ppm; leafy Brassica greens, 
subgroup 5B at 20 ppm; quinoa, grain, at 3.0 ppm; radish, roots at 0.04 
ppm; radish, tops at 0.2 ppm; ti palm, leaves at 10 ppm; ti palm, roots 
at 0.3 ppm, and watercress at 6 ppm. IR-4 also requested that upon 
establishment of the above tolerances, that the existing tolerances for 
``fruit, stone, group 12, except plum'' and ``nut, tree, group 14'' be 
removed. That document referenced a summary of the petition prepared by 
Syngenta, the registrant, which is available in the docket, http://www.regulations.gov. The October 21, 2015 notice supersedes a notice of 
filing published in the Federal Register on February 11, 2015 (80 FR 
7559) (FRL-9921-94). The October 21, 2015 notice includes the commodity 
``quinoa, grain'' as well as the other commodities that were originally 
requested in the February 11, 2015 notice. Two comments were received 
in response to the October 21, 2015 notice of filing. EPA's response to 
these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified some of the commodity vocabulary and rounded the significant 
figures of some of the tolerances. The reason for these changes are 
explained in Unit IV.D.

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 its 
validity, completeness, and reliability as well as

[[Page 79713]]

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 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 milligram/kilogram/day (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 sternbrae) were 
reported at doses that were not maternally toxic. In the two 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 milligram/kilogram (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. The current acute dietary 
assessment for the general population is based on the NOAEL of 30 mg/kg 
from the acute neurotoxicity study. 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 male mice but was not 
carcinogenic to rats or to female mice. The Agency classified 
propiconazole as a possible human carcinogen and recommended that, for 
the purpose of risk characterization, the reference dose (RfD) approach 
be used for quantification of human risk. Propiconazole is not 
genotoxic and this fact, together with special mechanistic studies, 
indicates that propiconazole is a threshold carcinogen. Propiconazole 
produced liver tumors in male mice only at a high dose that was toxic 
to the liver. At doses below the RfD, liver toxicity is not expected; 
therefore, tumors are also not expected.
    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 Uses of Propiconazole on dill, leafy 
brassicas crop subgroup 5B, ti palm, watercress, and quinoa, along with 
expansion to fruit, stone, group 12-12; except plum, and nut, tree, 
group 14-12'' on pp. 37 in docket ID number EPA-HQ-OPP-2014-0788.

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 the NOAEL and the LOAEL are identified. 
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 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 (Females 13-50       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 79714]]

 
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).
Chronic dietary (Adult Males and   NOAEL= 10 mg/kg/day.  Chronic RfD = 0.1    24-Month carcinogenicity study on
 Females 50+ yrs).                 UFA = 10x...........   mg/kg/day.           CD-1 mice. MRID 00129918
                                   UFH = 10x...........  cPAD = 0.1 mg/kg/    LOAEL = 50 mg/kg/day based on non-
                                   FQPA SF = 1x........   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= 30 mg/kg/day.  LOC for MOE = 100..  Acute Neurotoxicity Study--Rats
 30 days).                         UFA = 10x...........                       LOAEL = 100 mg/kg/day based on
                                   UFH = 10x...........                        clinical signs of toxicity
                                   FQPA SF = 1x........                        (piloerection in one male,
                                                                               diarrhea in one female, tip toe
                                                                               gait in 3 females).
Incidental oral intermediate-term  NOAEL= 10 mg/kg/day.  LOC for MOE = 100..  24-Month carcinogenicity Study--
 (1 to 6 months).                  UFA= 10x............                        Mice
                                   UFH= 10x............                       LOAEL = 50 mg/kg/day based on non-
                                   FQPA SF = 1x........                        neoplastic liver effects
                                                                               (increased liver weight in males
                                                                               and increase in liver lesions:
                                                                               Masses/raised areas/swellings/
                                                                               nodular areas mainly).
Dermal short-term (1 to 30 days).  Oral study NOAEL =    LOC for MOE = 100..  Acute Neurotoxicity Study--Rats
                                    30 mg/kg/day                              LOAEL = 100 mg/kg/day based on
                                    (dermal absorption                         clinical signs of toxicity
                                    rate = 40%).                               (piloerection in one male,
                                   UFA = 10x...........                        diarrhea in one female, tip toe
                                   UFH = 10x...........                        gait in 3 females).
                                   FQPA SF = 1x........
Dermal intermediate-term (1 to 6   Oral study NOAEL= 10  LOC for MOE = 100..  24-Month carcinogenicity Study--
 months).                           mg/kg/day (dermal                          Mice
                                    absorption rate =                         LOAEL = 50 mg/kg/day based on non-
                                    40%).                                      neoplastic liver effects
                                   UFA = 10x...........                        (increased liver weight in males
                                   UFH = 10x...........                        and increase in liver lesions:
                                   FQPA SF = 1x........                        Masses/raised areas/swellings/
                                                                               nodular areas mainly).
Inhalation short-term (1 to 30     Oral study NOAEL= 30  LOC for MOE = 100..  Acute Neurotoxicity Study--Rats
 days).                             mg/kg/day                                 LOAEL = 100 mg/kg/day based on
                                    (inhalation                                clinical signs of toxicity
                                    absorption rate =                          (piloerection in one male,
                                    100%).                                     diarrhea in one female, tip toe
                                   UFA = 10x...........                        gait in 3 females).
                                   UFH = 10x...........
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Group C, possible human carcinogen, RfD approach for risk
                                    characterization.
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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).

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) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). This 
dietary survey was conducted from 2003 to 2008. As to residue levels in 
food, EPA conducted an acute dietary analysis for propiconazole 
residues of concern using tolerance levels and 100 percent crop treated 
(PCT) for all existing and proposed uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. This dietary survey was conducted from 2003 to 2008. As to 
residue levels in food, EPA conducted a chronic dietary analysis for 
propiconazole residues of concern using tolerance levels for some 
commodities, average field trial residues for the remaining 
commodities, and 100 PCT for all existing and proposed uses.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has

[[Page 79715]]

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) models, 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 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).
    Propiconazole is currently registered for the following uses that 
could result in residential exposures: Turf, ornamentals, and in paint. 
The highest incidental oral and dermal exposure scenarios are expected 
from residential use on turf. EPA assessed short-term risk to toddlers 
from incidental oral and dermal exposure and short-term risk to adults 
from dermal and inhalation residential handler exposure as well as from 
post-application dermal exposure. The highest post-application exposure 
from residential use on turf was used to assess risk to short-term 
aggregate exposures.
    The only residential use scenario that will result in potential 
intermediate term exposure to propiconazole is wood treatment, which 
the Agency assumes may result in dermal and incidental oral post-
application exposures to children. No chronic exposures are expected. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Propiconazole is a member of the triazole-containing class of 
pesticides. Although conazoles act similarly in plants (fungi) by 
inhibiting ergosterol biosynthesis, there is not necessarily a 
relationship between their pesticidal activity and their mechanism of 
toxicity in mammals. Structural similarities do not constitute a common 
mechanism of toxicity. Evidence is needed to establish that the 
chemicals operate by the same, or essentially the same, sequence of 
major biochemical events (EPA, 2002). In conazoles, however, a variable 
pattern of toxicological responses is found; some are hepatotoxic and 
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some 
induce developmental, reproductive, and neurological effects in 
rodents. Furthermore, the conazoles produce a diverse range of 
biochemical events including altered cholesterol levels, stress 
responses, and altered DNA methylation. It is not clearly understood 
whether these biochemical events are directly connected to their 
toxicological outcomes. Thus, there is currently no evidence to 
indicate that conazoles share common mechanisms of toxicity and EPA is 
not following a cumulative risk approach based on a common mechanism of 
toxicity for the conazoles. For information regarding EPA's procedures 
for cumulating effects from substances found to have a common mechanism 
of toxicity, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
    Propiconazole is a triazole-derived pesticide. This class of 
compounds can form the common metabolite 1,2,4-triazole and two 
triazole conjugates (triazolylalanine and triazolylacetic acid). To 
support existing tolerances and to establish new tolerances for 
triazole-derivative pesticides, including propiconazole, EPA conducted 
a human health risk assessment for exposure to 1,2,4-triazole, 
triazolylalanine, and triazolylacetic acid resulting from the use of 
all current and pending uses of any triazole-derived fungicide. The 
risk assessment is a highly conservative, screening-level evaluation in 
terms of hazards associated with common metabolites (e.g., use of a 
maximum combination of uncertainty factors) and potential dietary and 
non-dietary exposures (i.e., high end estimates of both dietary and 
non-dietary exposures). The Agency retained a 3X for the LOAEL to NOAEL 
safety factor when the reproduction study was used. In addition, the 
Agency retained a 10X for the lack of studies including a DNT. The 
assessment includes evaluations of risks for various subgroups, 
including those comprised of infants and children. The Agency's 
complete risk assessment is found in the propiconazole reregistration 
docket at http://www.regulations.gov, Docket ID Number EPA-HQ-OPP-2005-
0497.
    An updated dietary exposure and risk analysis for the common 
triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA), 
triazolylacetic acid (TAA), and triazolylpyruvic acid (TP) was 
completed on April 9, 2015, in association with registration requests 
for several triazole fungicides, propiconazole, difenoconazole, and 
flutriafol. That analysis concluded that risk estimates were below the 
Agency's level of concern for all population groups. This assessment 
may be found on http://www.regulations.gov by searching for the 
following title and docket number: ``Common Triazole Metabolites: 
Updated Aggregate Human Health Risk Assessment to Address The New 
Section 3 Registrations For Use of Propiconazole on Tea, Dill, Mustard

[[Page 79716]]

Greens, Radish, and Watercress; Use of Difenoconazole on Globe 
Artichoke, Ginseng and Greenhouse Grown Cucumbers and Conversion of the 
Established Foliar Uses/Tolerances for Stone Fruit and Tree Nut Crop 
Groups to Fruit, Stone, Group 12-12 and the Nut, Tree, Group 14-12.; 
and Use of Flutriafol on Hops'' (located in docket ID number EPA-HQ-
OPP-2014-0788).

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 Food Quality 
Protection Act Safety Factor (FQPA 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 that evoking maternal toxicity are considered to be 
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 
postnatally 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. 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 an apparent increased quantitative susceptibility was 
observed in fetuses and offspring, for the reasons noted in this Unit 
residual uncertainties or concerns for prenatal and/or postnatal 
toxicity are minimal.
    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 post-application exposure of 
children as well as incidental oral exposure of toddlers. A turf 
transferable residue study is unavailable but being requested from the 
registrant for registration review of propiconazole. In all probability 
this study will reduce exposure estimates for both the incidental oral 
and post-application exposure to children. 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 84% of the aPAD for children 1-2 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 1-2 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 from post-
application activities (the highest exposure scenario) of 200 for 
adults and 96 for children 1-2 years old. Although the MOE for children 
1-2 years old is slightly below the target MOE of 100, the Agency does 
not believe that propiconazole poses short-term risks of concern 
because the difference is small and more than offset by the use of 
conservative endpoints and conservative exposure assumptions. This 
assessment is considered conservative since the short-term endpoints 
are based on a conservative LOAEL that is 3x higher than the NOAEL. 
Therefore, the true NOAEL is likely higher and would result in MOEs 
greater than 100. Further, the assessment combines conservative 
assumptions by using tolerance-level residues and reliable data on 
average field-trial residues and 100 PCT, conservative assumptions in 
the ground and surface water modeling, and conservative assumptions to 
assess post-application exposure of children as well as incidental oral 
exposure of toddlers. Refining any one of these conservatisms would 
result in MOEs for this age group that are not of concern. Although 
dietary (food and water) is not the aggregate exposure driver, 
incorporating PCT would likely increase the aggregate MOE further above 
100. For example, using the Agency's highest average PCT

[[Page 79717]]

reported for propiconazole residues on crops (i.e., 55%), which is 
approximately half the currently assumed dietary exposure, the MOE for 
this age group would exceed the target MOE of 100 and not be of 
concern. Therefore, the Agency has determined that there is no short-
term risk of concern from exposure to propiconazole.
    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 use as a wood treatment 
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 an 
aggregate MOE of 110 for children 1-2 years old. Because EPA's level of 
concern for propiconazole is a MOE of 100 or below, this MOE is 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, a high performance liquid 
chromatography with ultraviolet detection method (HPLC/UV 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: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are no Codex MRLs for dillweed (fresh or dried), dill seed, 
the brassica leafy greens subgroup 5B, ti palm, watercress, quinoa or 
radish.
    Codex does have MRLs in place for peach and plums (part of the U.S. 
stone fruit group), and pecans (part of the U.S. tree nut group) that 
are different than the U.S. tolerances. The U.S. tolerance expression 
is not harmonized with the Codex expression, which is expressed in 
terms of propiconazole per se, and therefore, the U.S. tolerance level 
for stone fruit and tree nuts cannot be harmonized with the Codex MRLs 
that are currently established.

C. Response to Comments

    Two comments were received in response to the October 21, 2015 
notice of filing. The first comment asserted that no residues should be 
allowed and that the pesticide should not be approved for sale or use. 
The Agency understands the commenter's concerns and recognizes that 
some individuals believe that pesticides should be banned on 
agricultural crops. However, the existing legal framework provided by 
section 408 of the FFDCA states that tolerances may be set when persons 
seeking such tolerances or exemptions have demonstrated that the 
pesticide meets the safety standard imposed by that statute. The 
comment appears to be directed at the underlying statute and not EPA's 
implementation of it; the citizen has made no contention that EPA has 
acted in violation of the statutory framework.
    The second comment was from the Center for Biological Diversity and 
concerned endangered species; specifically stating that EPA cannot 
approve this new use prior to completion of consultations with the U.S. 
Fish and Wildlife Service and the National Marine Fisheries Service 
(``the Services''). This comment is not relevant to the Agency's 
evaluation of safety of the propiconazole tolerances; section 408 of 
the FFDCA focuses on potential harms to human health and does not 
permit consideration of effects on the environment.

D. Revisions to Petitioned-for Tolerances

    The Agency is revising the petitioned-for tolerance requests for 
``dill, fresh'' and ``dill, dried'' to ``dillweed, fresh leaves'' and 
``dillweed, dried leaves'', respectively, for consistency with the 
Agency's commodity vocabulary for those commodities. For the same 
reason, the Agency is revising the petitioned-for tolerance request for 
``leafy Brassica greens, subgroup 5B'' to ``Brassica leafy greens, 
subgroup 5B''. In addition, EPA is revising the tolerance values for 
radish, tops; ti palm, roots; and watercress to be consistent with 
EPA's policy on significant figures for tolerances.

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 and its metabolites determined as 2,4,-
dichlorobenzoic acid (2,4-DCBA), expressed as the stoichiometric 
equivalent of propiconazole, in or on brassica leafy greens, subgroup 
5B at 20 ppm; dill seed at 15 ppm; dillweed, dried leaves at 80 ppm; 
dillweed, fresh leaves at 30 ppm; quinoa, grain at 3.0 ppm; radish, 
roots at 0.04 ppm; radish, tops at 0.20 ppm; ti palm, leaves at 10 ppm; 
ti palm, roots at 0.30 ppm; and watercress at 6.0 ppm. In addition, the 
existing fruit, stone, group 12, except plum and nut, tree, group 14 
tolerances are modified to read ``fruit, stone, group 12-12, except 
plum'' and ``nut, tree, group 14-12,'' respectively.

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

[[Page 79718]]

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: December 14, 2015.
Susan Lewis,
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. Revise the entries for ``Fruit, stone, group 12, except plum'' and 
``Nut, tree, group 14.''
0
b. Add alphabetically the following commodities to the table in 
paragraph (a).
    The revisions and additions read as follows:


Sec.  180.434  Propiconazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Brassica leafy greens, subgroup 5B......................           20
 
                                * * * * *
Dill, seed..............................................           15
Dillweed, dried leaves..................................           80
Dillweed, fresh leaves..................................           30
 
                                * * * * *
Fruit, stone, group 12-12, except plum..................            4.0
 
                                * * * * *
Nut, tree, group 14-12..................................            0.10
 
                                * * * * *
Quinoa, grain...........................................            3.0
Radish, roots...........................................            0.04
Radish, tops............................................            0.20
 
                                * * * * *
Ti palm, leaves.........................................           10
Ti palm, roots..........................................            0.30
 
                                * * * * *
Watercress..............................................            6.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-32327 Filed 12-22-15; 8:45 am]
 BILLING CODE 6560-50-P


