[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Rules and Regulations]
[Pages 80269-80275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32328]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0685; FRL-9940-01]


Propiconazole on Tea; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
propiconazole in or on tea. The Tea Association of the U.S.A., Inc. 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective December 24, 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-2015-0685, 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: 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: [email protected].

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-2015-0685 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

[[Page 80270]]

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-2015-0685, 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 
4E8300) by the Tea Association of the U.S.A., Inc., 362 5th Avenue, 
Suite 801, New York, New York, 10001. The petition requested that 40 
CFR 180.434 be amended by establishing a tolerance for residues of the 
fungicide propiconazole in or on tea at 4.0 parts per million (ppm). 
That document referenced a summary of the petition prepared by the Tea 
Association of the U.S.A., Inc., the registrant, which is available in 
the docket, http://www.regulations.gov. No comments concerning this 
tolerance action were received.

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 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 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 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 no-observed-
adverse-effect-level (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

[[Page 80271]]

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 NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in document, ``Propiconazole 
Human Health Risk Assessment for the New Use of Propiconazole on 
Imported Tea'' at pp. 41-46 in docket ID number EPA-HQ-OPP-2015-0685.

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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for propiconazole used for 
human risk assessment is shown in Table 1.

 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 MRID
 years of age).                    UFA = 10x...........   kg/day.              40425001
                                   UFH = 10x...........  aPAD = 0.3 mg/kg/    LOAEL = 90 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 increased incidence of
                                                                               rudimentary ribs, un-ossified
                                                                               sternebrae, as well as increased
                                                                               incidence of shortened and absent
                                                                               renal papillae and increased
                                                                               cleft palate.
Acute dietary (General population  NOAEL = 30 mg/kg/day  Acute RfD = 0.3 mg/  Acute neurotoxicity study Rat MRID
 including infants and children).  UFA = 10x...........   kg/day.              46604601
                                   UFH = 10x...........  aPAD = 0.3 mg/kg/    LOAEL = 100 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 clinical signs of toxicity
                                                                               (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.  Residential LOC for  Acute Neurotoxicity Study--Rats
 30 days).                         UFA = 10x...........   MOE = 100.           MRID 46604601
                                   UFH = 10x...........  Occupational LOC     LOAEL = 100 mg/kg/day based on
                                   FQPA SF= 1x.........   for MOE = 100.       clinical signs of toxicity
                                                                               (piloerection in one male,
                                                                               diarrhea in one female, tip toe
                                                                               gait in 3 females).
Incidental oral intermediate-term  NOAEL= 10 mg/kg/day.  Residential LOC for  24 Month carcinogenicity Study--
 (1 to 6 months).                  UFA= 10x............   MOE = 100.           Mice MRID 00129918
                                   UFH= 10x............  Occupational LOC     LOAEL = 50 mg/kg/day based on non-
                                   FQPA SF= 1x.........   for MOE = 100.       neoplastic liver effects
                                                                               (increased liver weight in males
                                                                               and increase in liver lesions:
                                                                               Masses/raised areas/swellings/
                                                                               nodular areas mainly).
Dermal Short Term (1-30 days)....  NOAEL= 30 mg/kg/day.  Residential LOC for  Acute Neurotoxicity Study--Rats
                                   UFA= 10x............   MOE = 100.           MRID 46604601
                                   UFH= 10x............  Occupational LOC     LOAEL = 100 mg/kg/day based on
                                                          for MOE = 100.       clinical signs of toxicity
                                                                               (piloerection in one male,
                                                                               diarrhea in one female, tip toe
                                                                               gait in 3 females).
Dermal Intermediate Term (1-6      NOAEL= 10 mg/kg/day.  Residential LOC for  24 Month carcinogenicity Study--
 months).                          UFA= 10x............   MOE = 100.           Mice MRID 00129918
                                   UFH= 10x............  Occupational LOC     LOAEL = 50 mg/kg/day based on non-
                                                          for MOE = 100.       neoplastic liver effects
                                                                               (increased liver weight in males
                                                                               and increase in liver lesions:
                                                                               Masses/raised areas/swellings/
                                                                               nodular areas mainly).
Inhalation Short-term (1 to 30     NOAEL= 30 mg/kg/day.  Occupational LOC     Acute Neurotoxicity Study--Rats
 days).                            UFA = 10x...........   for MOE = 100.       MRID 46604601
                                   UFH = 10x...........                       LOAEL = 100 mg/kg/day based on
                                                                               clinical signs of toxicity
                                                                               (piloerection in one male,
                                                                               diarrhea in one female, tip toe
                                                                               gait in 3 females).
Inhalation Intermediate-Term (1    NOAEL = 10 mg/kg/day  Occupational LOC     24 Month carcinogenicity Study--
 to 6 months).                     UFA = 10x...........   for MOE = 100.       Mice MRID 00129918
                                   UFH = 10x...........                       LOAEL = 50 mg/kg/day based on non-
                                                                               neoplastic liver effects
                                                                               (increased liver weight in males
                                                                               and increase in liver lesions:
                                                                               Masses/raised areas/swellings/
                                                                               nodular areas mainly).
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[[Page 80272]]

 
Cancer (all routes--oral, dermal,    Classification: Group C, possible human carcinogen, RfD approach for risk
 inhalation).                                                     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). UFDB = to account for the absence of data or other
  data deficiency. 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 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 average field trial residues, 
tolerance levels and 100 PCT for all existing and proposed uses.
    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 and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    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://www.epa.gov/oppefed1/models/water/index.htm.
    The Agency does not expect any additional residues of propiconazole 
in drinking water as a result of the imported tea use. Therefore, the 
Agency is relying on the previous drinking water assessment for 
assessing propiconazole tolerances. The previously assessed turf EDWCs 
are approximately one order of magnitude higher and more protective 
than the EDWCs for the new use.
    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).
    Although there are no proposed residential uses associated with the 
imported tea use, propiconazole is currently registered for the 
following uses that could result in residential exposures: Turf, 
landscapes, 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 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. Further information regarding EPA 
standard assumptions and generic inputs for residential exposures may 
be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''

[[Page 80273]]

    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 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 rand 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 efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at  http://www.epa.gov/pesticides/cumulative.
    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 aggregate human health risk assessment 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 the 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 ID 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 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 
under docket ID number EPA-HQ-OPP-2015-0685.

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 post-
natally 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 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

[[Page 80274]]

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 85% 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 24% 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. 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 is based on a combination of 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. Additionally, the assessment 
could be further refined by using PCT estimates and anticipated 
residues for all crops. Although dietary (food and water) is not the 
aggregate exposure driver, incorporating PCT would likely increase the 
aggregate MOE further above 100. For example, the Agency's latest PCT 
figures indicate that the highest average PCT reported for 
propiconazole residues on crops is 55%, which is much less than the 100 
PCT the Agency used for all commodities in its assessment. Accordingly, 
even though this MOE for children 1-2 years old is slightly below the 
target MOE of 100, the difference is small and is more than offset by 
the conservative exposure assumptions and therefore 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 uses 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 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: 
[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 an MRL for propiconazole on tea.

V. Conclusion

    Therefore, tolerances are established for residues of 
propiconazole, including its metabolites and degradates, in or on tea 
at 4.0 ppm. As there are currently no U.S. registrations for 
propiconazole for use on tea, EPA is adding a footnote to the 
regulation to clarify that fact.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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,

[[Page 80275]]

entitled ``Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or 
Executive Order 13045, entitled ``Protection of Children from 
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 
1997). This 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 16, 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. Redesignate paragraph (a) as paragraph (a)(1).
0
b. Add a new paragraph (a)(2).
    The amendments read as follows:


Sec.  180.434  Propiconazole; tolerances for residues.

    (a) General. (1) * * *
    (2) Tolerances are established for propiconazole, including its 
metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only propiconazole, 1-[[2-(2,4-dichlorophenyl)-
4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole, in or on the 
commodity.

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
Tea \1\................................................             4.0
------------------------------------------------------------------------
\1\ There are no United States registrations for use of propiconazole on
  tea as of December 24, 2015.

* * * * *
[FR Doc. 2015-32328 Filed 12-23-15; 8:45 am]
 BILLING CODE 6560-50-P