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[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Rules and Regulations]
[Pages 75039-75045]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30447]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0772; FRL-9369-5]

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 sugarcane, cane. Syngenta Crop Protection, LLC 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective December 19, 2012. Objections and 
requests for hearings must be received on or before February 19, 2013, 
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-2011-0772, 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), EPA West 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: Erin Malone, Registration Division 
(7505P),

[[Page 75040]]

Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 347-0253; email address: malone.erin@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://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-2011-0772 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 19, 2013. 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 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-2011-0772, 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), (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, 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 November 9, 2011 (Volume 76, FR 69690) 
(FRL-9325-1), 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 
1F7892) by Syngenta Crop Protection, LLC, P.O. Box 18300 Greensboro, NC 
27419-8300. The petition requested that 40 CFR 180.434 be amended by 
establishing tolerances for residues of the fungicide propiconazole, 
1H-1,2,4-Triazole, 1-{[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl{time} -, and its metabolites determined as 2,4-
dichlorobenzoic acid and expressed as parent compound in or on 
sugarcane, cane at 1.0 parts per million (ppm). That notice referenced 
a summary of the petition prepared by Syngenta Crop Protection, LLC, 
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 
proposed a different tolerance level for the reasons 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 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 toxicology database for propiconazole is adequate for 
evaluating and characterizing toxicity and selecting endpoints for 
purposes of this risk assessment. 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 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

[[Page 75041]]

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.
    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. Propiconazole was not carcinogenic to rats or to female 
mice. The Agency has classified propiconazole as possible human 
carcinogen used the reference dose (RfD) approach 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.
    Propiconazole has low to moderate toxicity in experimental animals 
by the oral (Category III), dermal (Category III) and inhalation routes 
(Category IV), is moderately irritating to the eyes (Category III), 
minimally irritating to the skin (Category IV) and is a dermal 
sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by propiconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Propiconazole Human Health 
Risk Assessment for an Amended Section 3 Registration on Sugarcane'' on 
pages 12-18 in docket ID number EPA-HQ-OPP-2011-0772.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://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) 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% crop treated 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 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 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% crop treated 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 is 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. 
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

[[Page 75042]]

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.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) model, 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 EDWCs are 21.61 ppb for 
surface water and 0.64 ppb for ground water. For chronic exposures for 
cancer assessment EDWCs are 13.24 ppb for surface water and 0.64 ppb 
for groundwater.
    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).
    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://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, U.S. 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 FQPA safety factor 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-2011-0072, 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 Foliar Use on Sugarcane.''

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

[[Page 75043]]

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 neurotoxicity 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 immunotoxicity. 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.
    ii. 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 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 79% 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 21% 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 and 
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 
exposure result in aggregate MOEs of 200 for children and adults.
    4. Intermediate-term risk. The only residential use scenario that 
will result in potential intermediate term exposure to propiconazole is 
post application exposure to children from wood treatment 
(antimicrobial use). The aggregate MOE is 120, which is greater than 
the target MOE of 100. Therefore, this scenario is not of concern.
    5. Aggregate cancer risk for U.S. population. Propiconazole is 
classified as a possible human carcinogen with risk quantitated using a 
reference dose (RfD) approach, this determination is further explained 
in section III.C.1.iii. As noted in Unit III.E.2., chronic exposure is 
below the cPAD.
    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

[[Page 75044]]

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 established MRLs for propiconazole per se in or on 
sugarcane, cane at 0.02 ppm. These MRLs are different than the 
tolerances established for propiconazole in the United States. Codex 
MRLs apply only to applications by seed piece treatment for sugarcane. 
The Agency considers seed piece treatment to be a non-food use and did 
not set a tolerance for that use. In the U.S., application to sugarcane 
is by foliar spray. This results in higher residues in sugarcane, and 
thus EPA has established a higher tolerance level for propiconazole on 
sugarcane than the Codex MRL.

C. Response to Comments

    No comments received.

D. Revisions to Petitioned-for Tolerances

    The petitioned for tolerance level of 1.0 ppm has been revised to 
0.40 ppm. The Organization for Economic Cooperation and Development 
tolerance calculation procedures were utilized in determining the 
appropriate tolerance level for the requested amended use. Changes in 
recommended tolerance are based on the use of these calculation 
procedures. Additionally, the registrant made a calculation error in 
choosing the tolerance value.

V. Conclusion

    Therefore, tolerances are established for residues of 
propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole), in or on sugarcane, cane at 0.40 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) (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 of 1995 (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 10, 2012.
Lois Rossi,
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. Section 180.434 is amended by revising paragraph (a), introductory 
text, and by adding to the table, alphabetically, an entry for 
``sugarcane, cane'' to read as follows:

Sec.  180.434  Propiconazole; tolerances for residues.

    (a) General. Tolerances are established for residues of 
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 those 
propiconazole residues convertible to 2,4-dichlorobenzoic acid (2,4-
DCBA), expressed as the stoichiometric equivalent of propiconazole, in 
or on the commodity in the table below:

[[Page 75045]]

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Sugarcane, cane........................................             0.4
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-30447 Filed 12-18-12; 8:45 am]
BILLING CODE 6560-50-P
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