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[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Rules and Regulations]
[Pages 38199-38204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15539]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0397; FRL-9350-9]

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. This regulation additionally removes 
an established tolerance on stone fruit crop group 12, as it will be 
superseded by the new tolerance for stone fruit crop group 12, except 
plum. Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective June 27, 2012. Objections and 
requests for hearings must be received on or before August 27, 2012, 
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-2011-0397, is available either 
electronically through http://www.regulations.gov or in hard copy at 
the OPP Docket in the Environmental Protection Agency Docket Center 
(EPA/DC), located in EPA West, 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: Andrew Ertman, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 308-9367; email address: ertman.andrew@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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0397 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 
August 27, 2012. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0397, 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 Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 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.htm.
    Additional instructions on commenting or visiting the docket,

[[Page 38200]]

along with more information about dockets generally, is available at 
http://www.epa.gov/dockets.

 II. Summary of Petitioned-For Tolerances

    In the Federal Register of July 20, 2011 (76 FR 43231) (FRL-8880-
1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7855) 
by IR-4,500 College Road East, Suite 201W, Princeton, NJ 08540. The 
petition requested that 40 CFR 180.434 be amended by establishing 
tolerances for residues of the fungicide propiconazole, 1-[[2-(2,4-
dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-triazole 
and its metabolites determined as 2,4,-dichlorobenzoic acid (DCBA) and 
expressed as parent compound, in or on bean, snap at 0.8 ppm; bean, 
succulent shelled at 0.15 ppm; bean, dry seed at 0.3 ppm; legume, 
foliage at 25 ppm; tomato at 2.5 ppm; fruit, citrus, group 10-10 at 8.0 
ppm; fruit, stone, group 12, except plum at 7.0 ppm; and plum at 1.0 
ppm. The petition also requested that the existing tolerance for stone 
fruit group 12 at 1.0 ppm be removed upon establishment of the 
requested tolerances. That notice referenced a summary of the petition 
prepared by Syngenta, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which tolerances are being set for various 
commodities as well as some commodity definitions. The reason for these 
changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue.* * 
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for propiconazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with propiconazole 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered 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.
    Propiconazole has low to moderate toxicity in experimental animals 
by the oral, dermal and inhalation routes. It is moderately irritating 
to the eyes, and minimally irritating to the skin. It is a dermal 
sensitizer. Propiconazole is readily absorbed by the rat skin with 40% 
absorption within 10 hours of dermal application.
    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 at doses greater than 50 
milligrams/kilograms/day (mg/kg/day). 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. Mice appear to be more susceptible to its toxicity 
than rats. Decreased body weight gain in experimental animals was seen 
in subchronic, chronic, developmental and reproductive studies. Dogs 
appeared to be more sensitive to the localized toxicity of 
propiconazole as manifested by stomach irritation at 6 mg/kg/day and 
above.
    In rabbits, developmental toxicity occurred at a higher dose than 
the maternally toxic dose, while in rats, developmental toxicity 
occurred at lower doses than the maternally 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 (incomplete 
ossification of the skull, caudal vertebrae and digits, extra 14th rib 
and missing sternebrae, malformations of the lung and kidneys) 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 parentally toxic dose, suggesting 
lower susceptibility of the offspring to the toxic doses of 
propiconazole in this study.
    Propiconazole was negative for mutagenicity in the in vitro BALB/C 
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. 
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. Propiconazole 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 docket ID number EPA-HQ-OPP-2011-0397 on pages 
43-49 of the document titled ``Propiconazole Human Health Risk 
Assessment for a Section 3 Registration on Snap beans, Succulent 
shelled beans, Dry Beans, and Post-harvest use on Tomato, Citrus Fruit, 
and Stone fruit.''

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies

[[Page 38201]]

toxicological points of departure (POD) and levels of concern to use in 
evaluating the risk posed by human exposure to the pesticide. For 
hazards that have a threshold below which there is no appreciable risk, 
the toxicological POD is used as the basis for derivation of reference 
values for risk assessment. PODs are developed based on a careful 
analysis of the doses in each toxicological study to determine the dose 
at which no adverse effects are observed (the NOAEL) and the lowest 
dose at which adverse effects of concern are identified (the LOAEL). 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for propiconazole used for 
human risk assessment is discussed in Unit B of the final rule 
published in the Federal Register of Wednesday, May 11, 2011 (76 FR 
27261) (FRL-8873-2).

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) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA used 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 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA used tolerance levels 
and 100 PCT for all existing and proposed uses.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. 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. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for propiconazole. Tolerance level residues and/or 
100 PCT were assumed for all food commodities.
    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.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models the estimated drinking water concentrations (EDWCs) of 
propiconazole for acute exposures are estimated to be 55.78 parts per 
billion (ppb) for surface water and 0.64 ppb for ground water, for 
chronic exposures for non-cancer assessments are estimated to be 21.61 
ppb for surface water and 0.64 ppb for ground water and for chronic 
exposures for cancer assessments are estimated to be 13.24 ppb for 
surface water and 0.64 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 55.8 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 21.6 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. EPA assessed 
residential exposure using the following assumptions: Short-term risk 
to toddlers was assessed for incidental oral and dermal exposure. The 
highest incidental oral and dermal exposure scenarios are expected from 
residential use on turf. Short-term risk to adults was assessed for 
dermal and inhalation residential handler exposure as well as from 
post-application dermal exposure. Adult handlers have some inhalation 
exposure; however, based on the low vapor pressure of propiconazole, 
negligible post application inhalation exposure is anticipated to 
occur. 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 dermal and incidental 
oral post application exposure to children from wood treatment 
(antimicrobial use).
    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.''
    Propiconazole is a member of the conazole 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

[[Page 38202]]

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://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). In addition, the Agency retained the additional 
10X Food Quality Protection Act (FQPA) safety factor (SF) for the 
protection of infants and children. 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 Identification (ID) Number EPA-HQ-OPP-2005-0497, and an update 
to assess the addition of the commodities included in this action may 
be found in docket ID number EPA-HQ-OPP-2011-0397, in the document 
titled ``Common Triazole Metabolites: Updated Dietary (Food + Water) 
Exposure and Risk Assessment to Address The Amended Propiconazole 
Section 3 Registration to Add Uses on Snap beans, succulent shelled 
beans, dry beans, tomato (post-harvest, citrus (post-harvest), and 
stone fruit (post-harvest), Difenoconazole, and Flutriafol.''

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. In the developmental 
toxicity study in rats, fetal effects observed in this study at a dose 
lower than that evoking maternal toxicity are considered to be 
quantitative evidence of increased susceptibility of fetuses to in 
utero exposure to propiconazole. In the developmental toxicity study in 
rabbits, neither quantitative nor qualitative evidence of increased 
susceptibility of fetuses to in utero exposure to propiconazole was 
observed in this study. In the 2-generation reproduction study in rats, 
neither quantitative nor qualitative evidence of increased 
susceptibility of neonates (as compared to adults) to prenatal and/or 
postnatal exposure to propiconazole was observed. 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 mild neurobehavioral effects at 300 mg/kg/day, 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 except for 
the lack of immunotoxicity and subchronic neutotoxicity studies. In the 
absence of specific immunotoxicity studies, EPA has evaluated the 
available propiconazole toxicity data to determine whether an 
additional database uncertainty factor is needed to account for 
potential immunotoxicity. There was no evidence of adverse effects on 
the organs of the immune system in any propiconazole study. In 
addition, propiconazole does not belong to a class of chemicals (e.g., 
the organotins, heavy metals, or halogenated aromatic hydrocarbons) 
that would be expected to be immunotoxic. Based on the considerations 
in this Unit, EPA does not believe that conducting a special Harmonized 
Guideline 870.7800 immunotoxicity study will result in a POD less than 
the NOAEL of 10.0 mg/kg/day used in calculating the cPAD for 
propiconazole, and therefore, an additional database uncertainty factor 
is not needed to account for potential immunotoxicity.
    In the absence of the subchronic neurotoxicity study, EPA has 
evaluated the available propiconazole toxicity data to determine 
whether an additional database uncertainty factor is needed to account 
for potential neurotoxicity after repeated exposures. With the 
exception of the developmental studies in the rat, there were no 
indications in any of the repeated dose studies that propiconazole is 
neurotoxic. In the developmental studies in the rat, there were some 
clinical signs of neurotoxicity at 300 mg/kg/day but not at lower 
doses. Further, 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 mild neurobehavioral effects 
at 300 mg/kg, but no evidence of neuropathology from propiconazole 
administration. Based on the considerations in this Unit, EPA does not 
believe that conducting a Harmonized Guideline 870.6200b subchronic 
neurotoxicity study will result in a POD less than the NOAEL of 10 mg/
kg/day used in calculating the

[[Page 38203]]

cPAD for propiconazole, and therefore, an additional database 
uncertainty factor is not needed to account for potential neurotoxicity 
from repeated exposures.
    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 dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to propiconazole in drinking water. EPA used 
similarly conservative assumptions to assess postapplication exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
propiconazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to propiconazole will occupy 77% of the aPAD for children 1 to 2 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
propiconazole from food and water will utilize 63% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
propiconazole is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Propiconazole is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to propiconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 130 for toddlers 
(children 1 to 2 years old), between 110 and 1700 for adults from 
handler activities and 290 for adults from post-application activities. 
Because EPA's level of concern for propiconazole is a MOE of 100 or 
below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    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 an 
aggregate MOE of 74 for toddlers (children 1 to 2 years old). The 
aggregate MOE is 74, which is less than the target MOE of 100. However, 
this aggregate MOE is based on 100 PCT and tolerance-level residues 
concerning food exposure, conservative (protective) assumptions in the 
ground and surface water modeling, and similarly conservative 
assumptions to assess postapplication exposure of children as well as 
incidental oral exposure of toddlers. Additional refinements 
incorporating average field trial and/or percent crop treated 
information would result in MOEs well above the target MOE of 100. 
Therefore, this scenario is not of concern.
    5. Aggregate cancer risk for U.S. population. The Agency considers 
the chronic aggregate risk assessment, making use of the cPAD, to be 
protective of any aggregate cancer risk.
    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.
    The Codex has not established an MRL for propiconazole for any of 
the subject commodities in this document.

C. Revisions to Petitioned-For Tolerances

    Based on the Agency's evaluation of the residue data submitted with 
the petition, for all proposed commodities, with the exception of the 
level for the citrus fruit group 10-10 (8.0 ppm), the Agency has 
modified the levels for which tolerances are being established. The 
proposed tolerances for snap bean, succulent shelled beans, stone fruit 
group 12 except plum, and plum are being reduced to 0.70 ppm, 0.10 ppm, 
4.0 ppm, and 0.60 ppm, respectively. The proposed tolerances for 
foliage of legume foliage, dry bean seed, and tomato are being 
increased to 30 ppm, 0.40 ppm, and 3.0 ppm, respectively, and the 
commodity definition for legume foliage is being changed to 
``vegetable, foliage of legume, group 7.'' Lastly, a tolerance for 
citrus oil is being established at 1000 ppm. The Agency revised these 
tolerance levels based on analysis of the residue field trial data

[[Page 38204]]

using the Agency's Tolerance Spreadsheet in accordance with the 
Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial 
Data.

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 and expressed as parent compound, in or on bean, 
snap at 0.70 ppm; bean, succulent shelled at 0.10 ppm; vegetable, 
foliage of legume, group 7 at 30 ppm; bean, dry seed at 0.40 ppm; 
tomato at 3.0 ppm; fruit, citrus, group 10-10 at 8.0 ppm; fruit, stone, 
group 12, except plum at 4.0 ppm; plum at 0.60 ppm; and citrus, oil at 
1000 ppm. Additionally, the established tolerance is removed for fruit, 
stone, group 12 at 1.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: June 8, 2012.
Lois Rossi,
Director, Registration Division.

    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, the table in paragraph (a) is amended as follows:
0
i. Remove the entry ``fruit, stone, group 12'' and
0
ii. Add, alphabetically, the following commodities to read as follows:

Sec.  180.434  Propiconazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Bean, dry seed..............................................        0.40
Bean, snap..................................................        0.70
Bean, succulent shelled.....................................        0.10
 
                                * * * * *
Citrus, oil.................................................        1000
 
                                * * * * *
Fruit, citrus, group 10-10..................................         8.0
Fruit, stone, group 12, except plum.........................         4.0
 
                                * * * * *
Plum........................................................        0.60
 
                                * * * * *
Tomato......................................................         3.0
 
                                * * * * *
Vegetable, foliage of legume, group 7.......................          30
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2012-15539 Filed 6-26-12; 8:45 am]
BILLING CODE 6560-50-P
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